DOSAGE FORM HAVING IDENTIFICATION INFORMATION, METHOD FOR MANUFACTURING SAME, PESTLE FOR USE IN MANUFACTURING DOSAGE FORM, AND METHOD FOR MANUFACTURING SAME
In one embodiment, the present invention provides a dosage form having identification information, a method for manufacturing the dosage form having identification information, or a pestle for use in manufacturing the dosage form having identification information. One embodiment of the present invention provides a dosage form that is provided with a first part in which a plurality of uneven shape structures are arranged on a surface of the dosage form, and a second part in which a plurality of uneven shape structures are not arranged on the surface of the dosage form, wherein the first part is arranged adjacent to the second part, and the first part or the second part constitutes at least one pattern having identification information.
B30B 11/02 - Presses spécialement adaptées à la fabrication d'objets à partir d'un matériau en grains ou à l'état plastique, p. ex. presses à briquettes ou presses à tablettes utilisant un pilon exerçant une pression sur le matériau dans une cavité de moulage
A61K 31/4985 - Pyrazines ou pipérazines condensées en ortho ou en péri avec des systèmes hétérocycliques
The present invention provides a film coating composition for a solid preparation that is easy to take. The present invention also provides a solid preparation that is easy to take. A film coating composition according to an embodiment of the present invention contains a polyvinyl alcohol-polyethylene glycol graft copolymer and a thickening agent. The thickening agent may be composed of one or more substances that are selected from the group consisting of xanthan gum, locust bean gum, pectin, carrageenan, guar gum, gellan gum, and carboxy vinyl polymer.
One embodiment of the present invention provides a pharmaceutical composition in which enzalutamide is amorphized as a result of solid dispersion, and consequently a supersaturated state is maintained. Alternatively, one embodiment of the present invention provides a formulation comprising a pharmaceutical composition in which enzalutamide is amorphized as a result of solid dispersion, and consequently a supersaturated state is maintained. According to one embodiment of the present invention, the pharmaceutical composition includes an enzalutamide solid dispersion comprising enzalutamide in an amorphous form and a base. The pharmaceutical composition includes a pharmaceutically acceptable cationic polymer. The pharmaceutically acceptable cationic polymer may be a pharmaceutically acceptable cationic acrylic polymer or a pharmaceutically acceptable cationic vinyl polymer.
A61K 47/58 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p. ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique macromoléculaire, p. ex. une molécule oligomérique, polymérique ou dendrimérique obtenu par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. poly[méth]acrylate, polyacrylamide, polystyrène, polyvinylpyrrolidone, alcool polyvinylique ou résine d’acide sulfonique de polystyrène
A61P 13/08 - Médicaments pour le traitement des troubles du système urinaire de la prostate
One embodiment according to this invention provides a method for selecting an additive agent for suppressing a nitrosation reaction. Alternatively, one embodiment of the present invention provides a formulation that suppresses the generation of nitroso compounds, including an additive agent selected by a method for selecting an additive agent for suppressing a nitrosation reaction. In one embodiment, a method for selecting an additive agent for suppressing a nitrosation reaction includes adding an amine source and an NOx source to an additive agent to generate nitroso compounds, quantifying an amount of the generated nitroso compounds, and evaluating a suppressing effect of the nitrosation reaction of the additive agent based on the amount of the generated nitroso compounds.
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/16 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant de l'azote
5.
SOLID DISPERSION, PREPARATION CONTAINING SOLID DISPERSION, AND METHOD FOR PRODUCING SOLID DISPERSION
One embodiment of the present invention provides a solid dispersion which suppresses the production of related substances. Alternatively, one embodiment of the present invention provides a preparation containing a solid dispersion which suppresses the production of related substances. Alternatively, one embodiment of the present invention provides a method for producing a solid dispersion which suppresses the production of related substances. According to one embodiment of the present invention, provided is a solid dispersion comprising: a drug in an amorphous form; an amorphousness-maintaining polymer; and a pharmaceutically acceptable acidic pH adjuster. The pharmaceutically acceptable acidic pH adjuster may be an organic acid.
An embodiment of the present invention provides a method for quantifying reactive NOx which is a source of NOx that may be involved in the generation of nitroso compounds. Alternatively, an embodiment of the present invention provides a formulation that suppresses the generation of a nitroso compound, designed based on a method for quantifying reactive NOx that may be involved in the generation of the nitroso compounds. In one embodiment, a method for quantifying reactive NOx includes adding an amine source to a sample to generate a nitroso compound. In one embodiment, nitroso compounds may be generated by heating under a sealed condition.
G01N 31/00 - Recherche ou analyse des matériaux non biologiques par l'emploi des procédés chimiques spécifiés dans les sous-groupesAppareils spécialement adaptés à de tels procédés
7.
DOSE SENSATION EVALUATION METHOD, DOSE SENSATION EVALUATION DEVICE, AND NON-TRANSITORY COMPUTER READABLE STORAGE MEDIUM
A dose sensation evaluation method of a pharmaceutical preparation includes attaching a part of an electromyograph to a human body and acquiring measurement data measured when dosing a pharmaceutical preparation using the attached electromyograph and generating dose sensation evaluation information when dosing a pharmaceutical preparation based on the measurement data. In the dose sensation evaluation method, when measuring the measurement data, the electromyograph may be attached to either the suprahyoid or subhyoid muscle group of the human body.
A61M 5/172 - Moyens pour commander l'écoulement des agents vers le corps ou pour doser les agents à introduire dans le corps, p. ex. compteurs de goutte-à-goutte électriques ou électroniques
8.
SITAGLIPTIN PREPARATION AND METHOD OF STORAGE THEREOF
An embodiment of the present invention provides a sitagliptin preparation in which the production of nitrosamines is suppressed. Alternatively, an embodiment of the present invention provides a method of storage of a sitagliptin preparation to suppress the production of nitrosamines. According to an embodiment of the present invention, a sitagliptin preparation is provided comprising a sitagliptin containing tablet, and a case or a packing sealing the sitagliptin containing tablet, wherein an equilibrium relative humidity of the sitagliptin containing tablet as converted at 24° C. is 0.3% or less when the sitagliptin preparation is stored for one month under a condition of 25° C. and a relative humidity of 60%.
B65D 75/36 - Objets ou matériaux enveloppés entre deux feuilles ou flans opposés à bords réunis, p. ex. par adhésifs à pression, pliage, thermosoudage ou soudage une ou les deux feuilles ou flans étant renfoncés pour épouser la forme du contenu une feuille ou un flan étant renfoncés et l'autre fait d'une feuille plate relativement rigide, p. ex. empaquetage pour ampoules
B65D 77/04 - Objets ou matériaux enfermés dans plusieurs réceptacles disposés les uns dans les autres
B65D 81/26 - Adaptations pour empêcher la détérioration ou l'altération du contenuApplications au réceptacle ou au matériau d'emballage d'agents de conservation des aliments, de fongicides, d'insecticides ou de produits repoussant les animaux avec dispositifs pour évacuer ou absorber les fluides, p. ex. s'écoulant du contenuEmploi de produits empêchant la corrosion ou de dessiccateurs
9.
GRANULES, GRANULE-CONTAINING PHARMACEUTICAL PREPARATION, AND GRANULE-CONTAINING FOOD
One of the purposes of the present invention is to provide granules which can be applied to a granular or tablet preparation containing a fat-soluble or oily drug or food or a water- or oxygen-labile drug or food. In one embodiment, one of the purposes of the present invention is to provide granules containing a solidified liquid oil and applicable to a granular or tablet preparation containing a fat-soluble or oily drug or food or a water- or oxygen-labile drug or food. According to one embodiment of the present invention, granules are provided, each granule comprising: a gel particle containing a liquid oil and stearic acid, calcium stearate or magnesium stearate; and a powder additive layer disposed on the surface of the gel particle. In the gel particle, the mass ratio of the amount of stearic acid, calcium stearate or magnesium stearate to the amount of the liquid oil may be 1:1 or greater.
A23L 33/115 - Acides gras ou leurs dérivésGraisses ou huiles
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
A61K 47/44 - Huiles, graisses ou cires couvertes par plus d’un des groupes Huiles, graisses ou cires naturelles ou naturelles modifiées, p. ex. huile de ricin, huile de ricin polyéthoxylée, cire de lignite, lignite, gomme-laque, colophane, cire d’abeille ou lanoline
One embodiment of the present invention provides a prasugrel hydrochloride-containing formulation in which the production of similar substances is suppressed. According to one embodiment of the present invention, provided is a prasugrel hydrochloride-containing formulation comprising prasugrel hydrochloride and at least one disintegrant selected from the group consisting of carmellose calcium, croscarmellose sodium, and sodium carboxymethyl starch. An uncoated tablet containing prasugrel hydrochloride and the disintegrant may contain 1-20 mass% of the disintegrant.
A61K 31/4365 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec un azote comme seul hétéro-atome d'un cycle condensés en ortho ou en péri avec des systèmes hétérocycliques le système hétérocyclique ayant le soufre comme hétéro-atome du cycle, p. ex. ticlopidine
One embodiment of the present invention provides an enzalutamide solid dispersion that maintains the amorphous state of enzalutamide and has improved dissolution properties. Alternatively, one embodiment of the present invention provides an enzalutamide-containing preparation that maintains the amorphous state of enzalutamide and has improved dissolution properties. Alternatively, one embodiment of the present invention provides a method for producing an enzalutamide solid dispersion that maintains the amorphous state of enzalutamide and has improved dissolution properties. Alternatively, one embodiment of the present invention provides a method for producing an enzalutamide-containing preparation that maintains the amorphous state of enzalutamide and has improved dissolution properties. According to one embodiment of the present invention, an enzalutamide solid dispersion which includes enzalutamide in an amorphous state and hydroxypropyl cellulose that serves as an amorphousness-maintaining polymer is provided.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
One problem addressed by one embodiment of the present invention is to provide a teneligliptin-containing preparation in which an amorphous form of teneligliptin is maintained and an increase in related substances is suppressed after storage under open conditions susceptible to humidity. According to one embodiment of the present invention, provided is a teneligliptin-containing preparation comprising porous silica, amorphous teneligliptin supported on the porous silica, an organic acid, and propyl gallate. The teneligliptin-containing preparation may comprise particles comprising porous silica, amorphous teneligliptin supported on the porous silica, and an organic acid.
JAPAN AS REPRESENTED BY DIRECTOR-GENERAL OF NATIONAL INSTITUTE OF INFECTIOUS DISEASES (Japon)
SAWAI PHARMACEUTICAL Co., Ltd. (Japon)
Inventeur(s)
Watashi, Koichi
Saso, Wakana
Terashima, Toru
Abrégé
In an embodiment, a Stephania cepharantha-derived alkaloid-containing preparation for treatment of a novel coronavirus infection is provided. According to an embodiment of the present invention, a preparation for treatment of a novel coronavirus infection comprises Cepharanthine, Isotetrandrine, Cycleanine, and Berbamine. A preparation for treatment of a novel coronavirus infection is for treatment of an infection caused by the novel coronavirus mutant strain. According to an embodiment of the present invention, a Stephania cepharantha-derived alkaloid-containing preparation for treatment of a novel coronavirus infection is provided.
A61K 36/71 - Ranunculaceae (famille du bouton d'or), p. ex. pied d'alouette, hépatique, hydrastis, ancolie
A61K 31/4375 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec un azote comme seul hétéro-atome d'un cycle condensés en ortho ou en péri avec des systèmes hétérocycliques le système hétérocyclique contenant un cycle à six chaînons ayant l'azote comme hétéro-atome du cycle, p. ex. quinolizines, naphtyridines, berbérine, vincamine
A61P 31/14 - Antiviraux pour le traitement des virus ARN
14.
TENELIGLIPTIN-CONTAINING PARTICLES AND FORMULATION CONTAINING SAME
One problem to be addressed by an embodiment of the present invention is to provide teneligliptin-containing particles that maintain the amorphous form of teneligliptin after storage in an opened condition susceptible to the effects of humidity. Moreover, another problem to be addressed by an embodiment of the present invention is to provide teneligliptin-containing particles where generation of analog substances during production is suppressed. An additional problem to be addressed by an embodiment of the present invention is to provide a formulation comprising such teneligliptin-containing particles. According to an embodiment of the present invention, teneligliptin-containing particles comprising porous silica and amorphous teneligliptin supported on the porous silica are provided.
One embodiment of the present invention provides a method for quantifying reactive NOx, which is an NOx source that could contribute to the generation of nitroso compounds. Another embodiment of the present invention provides a formulation for suppressing the generation of nitroso compounds, the formulation being designed on the basis of the method for quantifying reactive NOx, which could contribute to the generation of nitroso compounds. A method for quantifying reactive NOx according to one embodiment includes adding an amine source to a sample and generating nitroso compounds. According to this embodiment, it is permissible to carry out heating under hermetic conditions to generate the nitroso compounds.
G01N 31/00 - Recherche ou analyse des matériaux non biologiques par l'emploi des procédés chimiques spécifiés dans les sous-groupesAppareils spécialement adaptés à de tels procédés
A61K 47/16 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant de l'azote
One embodiment of the present invention provides a method for selecting an additive capable of inhibiting a nitrosation reaction. Another embodiment of the present invention provides a preparation prevented from the generation of a nitroso compound, the preparation containing an additive selected by a method for selecting an additive capable of inhibiting a nitrosation reaction. The method for selecting an additive capable of inhibiting a nitrosation reaction according to one embodiment comprises: adding an amine source and an NOx source to an additive to generate a nitroso compound, quantifying the amount of the generated nitroso compound, and evaluating about the nitrosation reaction inhibition effect of the additive on the basis of the amount of the generated nitroso compound.
G01N 31/00 - Recherche ou analyse des matériaux non biologiques par l'emploi des procédés chimiques spécifiés dans les sous-groupesAppareils spécialement adaptés à de tels procédés
A61K 47/00 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
C07C 53/126 - Acides contenant au moins cinq atomes de carbone
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for medical or veterinary purposes for the prevention and treatment of disorders or diseases of the central nervous system, the peripheral nervous system, the musculo-skeletal system, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, the endocrine system, the metabolic system, the immune system, the psychological system; Pharmaceutical preparations for medical or veterinary purposes for use in dermatology, oncology, ophthalmology, the treatment of allergies, the treatment of infections, the treatment of circulatory system diseases, the treatment of diabetes, the treatment of hyperlipidemia, the treatment of osteoporosis; Pharmaceutical preparations in the nature of vitamins and vitamin preparations for medical or veterinary purposes; Diagnostic pharmaceutical preparations for medical or veterinary purposes for the treatment of disorders or diseases of the central nervous system, the peripheral nervous system, the musculo-skeletal system, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, the endocrine system, the metabolic system, the immune system, the psychological system; Pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for medical or veterinary purposes for the prevention and treatment of disorders or diseases of the central nervous system, the peripheral nervous system, the musculo-skeletal system, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, the endocrine system, the metabolic system, the immune system, the psychological system; Pharmaceutical preparations for medical or veterinary purposes for use in dermatology, oncology, ophthalmology, the treatment of allergies, the treatment of infections, the treatment of circulatory system diseases, the treatment of diabetes, the treatment of hyperlipidemia, the treatment of osteoporosis; Pharmaceutical preparations in the nature of vitamins and vitamin preparations for medical or veterinary purposes; Diagnostic pharmaceutical preparations for medical or veterinary purposes for the treatment of disorders or diseases of the central nervous system, the peripheral nervous system, the musculo-skeletal system, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, the endocrine system, the metabolic system, the immune system, the psychological system; Pharmaceutical preparations for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders
20.
Preparation containing saxagliptin and method for producing the same
A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.
A61K 31/403 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil condensés avec des carbocycles, p. ex. carbazole
21.
METHOD FOR PRODUCING FESOTERODINE FUMARATE-CONTAINING FORMULATION
One embodiment of the present invention provides a method for producing a stable fesoterodine fumarate-containing formulation. In said method the generation of related substances is suppressed by using an easy-to-handle general-purpose additive and a simple method. One embodiment of the present invention provides a method for producing a fesoterodine fumarate-containing formulation, the method comprising dry-granulating fesoterodine fumarate, lactose, crystalline cellulose, and a lubricant to obtain an agglomerated material. Further, one embodiment of the present invention provides a method for producing a fesoterodine fumarate-containing formulation, the method comprising mixing and tableting fesoterodine fumarate, lactose, crystalline cellulose, hypromellose, and a lubricant. In the method, the fesoterodine fumarate, the lactose, the crystalline cellulose, the hypromellose, and the lubricant are each rendered as a dry powder and mixed.
A61K 31/222 - Esters, p. ex. nitroglycérine, sélénocyanates d'acides carboxyliques d'acides acycliques, p. ex. pravastatine avec des composés ayant des groupes aromatiques, p. ex. dipivéfrine, ibopamine
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A medicinal preparation containing an apremilast hydrate is provided in which the apremilast hydrate is inhibited from undergoing crystal transition or dissolution delay. The medicinal preparation containing an apremilast hydrate according to an embodiment of the present invention is characterized by including an apremilast hydrate and a lubricant having a melting point of 220°C or higher. In the medicinal preparation containing an apremilast hydrate, the lubricant may be sodium stearyl fumarate or talc. The lubricant may be sodium stearyl fumarate.
A61P 29/00 - Agents analgésiques, antipyrétiques ou anti-inflammatoires non centraux, p. ex. agents antirhumatismauxMédicaments anti-inflammatoires non stéroïdiens [AINS]
JAPAN AS REPRESENTED BY DIRECTOR-GENERAL OF NATIONAL INSTITUTE OF INFECTIOUS DISEASES (Japon)
SAWAI PHARMACEUTICAL CO., LTD. (Japon)
Inventeur(s)
Watashi Koichi
Saso Wakana
Terashima Toru
Abrégé
In one embodiment, provided is a Stephania cephalantha-derived alkaloid-containing preparation for treating SARS-CoV-2 infection. According to one embodiment of the present invention, the preparation for treating SARS-CoV-2 infection contains cepharanthine, isotetrandrine, cycleanine and berbamine. This preparation for treating SARS-CoV-2 infection is for treating infection caused by a SARS-CoV-2 variant. According to one embodiment of the present invention, provided is a Stephania cephalantha-derived alkaloid-containing preparation for treating SARS-CoV-2 infection.
A61K 31/4353 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec un azote comme seul hétéro-atome d'un cycle condensés en ortho ou en péri avec des systèmes hétérocycliques
A61K 36/59 - Menispermaceae (famille du cocculus), p. ex. hyperbaena
A61P 31/14 - Antiviraux pour le traitement des virus ARN
24.
FILM-COATED GRANULE, PHARMACEUTICAL PREPARATION CONTAINING THE SAME, AND MANUFACTURING METHODS THEREOF
One of the problems of one embodiment of the present invention is to provide film-coated granules which have a new film constitution. Alternatively, one of the problems of one embodiment of the present invention is to provide a pharmaceutical preparation containing the film-coated granules which have a new film constitution. Alternatively, one of the problems of one embodiment of the present invention is to provide a new dry manufacturing method of the film-coated granules. Alternatively, one of the problems of one embodiment of the present invention is to provide a new dry manufacturing method of the pharmaceutical preparation containing the film-coated granules. According to one embodiment of the present invention, a film-coated granule is provided that comprises a core particle having a melt component, and a film arranged on a surface of the core particle, wherein the film includes a porous substance, a plasticizer and a polymer.
Provided is a melt granulated product with a high particle size homogeneity. Alternatively, provided is a pharmaceutical composition using said melt granulated product. Alternatively, provided is a melt granulated product with a high drug content. Alternatively, provided is a pharmaceutical composition using the melt granulated product. According to one embodiment of the present invention, a granule is provided that comprises an active ingredient, a melt component, and a polymer, wherein the active ingredient, the melt component and the polymer are bound. In addition, the melt component may be solid at room temperature, and have a melting point of 100° C. or less. The polymer may be solid at room temperature, and have a glass transition point of 100° C. or less.
According to one embodiment of the present invention, granules having a high content of an active ingredient and a high uniformity of particle size are provided. Alternatively, according to one embodiment of the present invention, a preparation containing granules having a high content of an active ingredient and a high uniformity of particle size is provided. According to one embodiment of the present invention, a granule is provided that comprises a nuclear material, a melt component layer arranged on a surface of the nuclear material, and an active ingredient-containing layer arranged on a surface of the melt component layer, wherein the melt component layer contains a first melt component and the active ingredient-containing layer contains an active ingredient and a second melt component or a polymer having compatibility with the first melt component.
A solid preparation containing tafamidis includes tafamidis, and a carrier containing one or more selected from a group consisting of magnesium aluminometasilicate, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and calcium silicate, and a method for producing the same are provided.
The present invention provides: a linagliptin-containing orally disintegrating tablet which is capable of sufficiently masking bitterness; and a method for producing the same. According to an embodiment of the present invention, provided is a linagliptin-containing orally disintegrating tablet containing: linagliptin; and an additive including at least one selected from the group consisting of carmellose calcium, crosscarmellose sodium, carmellose, and sodium starch glycolic acid. The additive may also include at least one selected from the group consisting of carmellose calcium, crosscalmellose sodium, and carmellose.
A61P 3/10 - Médicaments pour le traitement des troubles du métabolisme de l'homéostase du glucose de l'hyperglycémie, p. ex. antidiabétiques
C07D 473/06 - Composés hétérocycliques contenant des systèmes cycliques purine avec des atomes d'oxygène, de soufre ou d'azote liés directement en positions 2 et 6 deux atomes d'oxygène avec des radicaux contenant uniquement des atomes d'hydrogène et de carbone, liés en position 1 ou 3
29.
METHOD FOR MANUFACTURING ORALLY DISINTEGRATING TABLET, AND ORALLY DISINTEGRATING TABLET
A method for manufacturing an orally disintegrating tablet, in which adequate hardness for preventing breakage of the tablet during transport or handling by a medical practitioner or a patient is provided while rapid disintegration is maintained. The method for manufacturing an orally disintegrating tablet according to an embodiment of the present invention comprises spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20° C. of 150 mPa·s or more and 400 mPa·s on additives, and performing fluid bed granulation. The liquid including hydroxypropyl cellulose may be sprayed or dropped on the additives so that the content of the hydroxypropyl cellulose with respect to 100 wt % of the orally disintegrating tablet is 0.2 wt % to 5 wt %.
One of the objects of the present invention is to provide a granule capable of sufficiently masking bitterness. Alternatively, one of the objects of the present invention is to provide a preparation containing a granule capable of sufficiently masking bitterness. According to an embodiment of the present invention, a granule is provided including a core substance on which a melt component and an active ingredient are disposed, a gelling substance-containing layer disposed on a surface where the melt component and the active ingredient are disposed, and a hydrophobic polymer-containing layer disposed on a surface of the gelling substance-containing layer.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
The present invention provides a film coating composition for a solid preparation that is easy to take. The present invention also provides a solid preparation that is easy to take. A film coating composition according to an embodiment of the present invention contains a polyvinyl alcohol-polyethylene glycol graft copolymer and a thickening agent. The thickening agent may be composed of one or more substances that are selected from the group consisting of xanthan gum, locust bean gum, pectin, carrageenan, guar gum, gellan gum, and carboxy vinyl polymer.
A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.
A61K 31/403 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil condensés avec des carbocycles, p. ex. carbazole
Provided is a melt granulated substance with a high grain size homogeneity. Furthermore, provided is a pharmaceutical composition using said melt granulated substance. Furthermore, provided is a melt granulated substance that has high content of active pharmaceutical ingredient. Furthermore, provided is a pharmaceutical composition using said melt granulated substance. An embodiment of the present invention provides granules that contain: an active pharmaceutical ingredient, a melt component, and a polymer, wherein the active pharmaceutical ingredient, the melt component and the polymer are bound together. Furthermore, the melt component is solid at ordinary temperature, and may have a melting point of 100℃ or less. The polymer is solid at ordinary temperature, and may have a glass transition point of 100℃ or less.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
An embodiment of the present invention provides granules with a high content of active pharmaceutical ingredient and with a high degree of grain size homogeneity. Another embodiment of the present invention provides a preparation containing granules with high content of active pharmaceutical ingredient and with a high degree of grain size homogeneity. Another embodiment of the present invention provides granules containing: a core substance, a melt component layer disposed on the surface of the core substance, and an active pharmaceutical ingredient-containing layer disposed on the surface of the melt component layer, wherein the melt component layer contains a first melt component, and the active pharmaceutical ingredient-containing layer contains an active pharmaceutical ingredient and a second melt component or a polymer exhibiting compatibility with the first melt component.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
METHOD FOR PRODUCING GRANULES CONTAINING A CORE PARTICLE, GRANULES CONTAINING A CORE PARTICLE, PHARMACEUTICAL COMPOSITION CONTAINING THE GRANULES CONTAINING THE CORE PARTICLE, AND PREPARATION CONTAINING THE PHARMACEUTICAL COMPOSITION
A method for producing granules containing a core particle by using a general granulation method is provided. Granules containing a core particle produced by the method are provided. In addition, a pharmaceutical composition and preparation containing the granules containing the core particle are provided. The granulation method according to an embodiment of the present invention granulates by splaying granulation liquid having a mist diameter (D50) not more than the particle size (D50) of the core particle on a mixture containing a drug substance and a core particle. The granulation liquid may be water. The particle size of the core particle (D50) may be larger than the particle size (D50) of the drug substance.
A61K 31/343 - Composés hétérocycliques ayant l'oxygène comme seul hétéro-atome d'un cycle, p. ex. fungichromine ayant des cycles à cinq chaînons avec un oxygène comme seul hétéro-atome d'un cycle, p. ex. isosorbide condensés avec un carbocycle, p. ex. coumarane, bufaralol, béfunolol, clobenfurol, amiodarone
A61K 31/137 - Arylalkylamines, p. ex. amphétamine, épinéphrine, salbutamol, éphédrine
Provided are a vildagliptin-containing dry granulated powder, a vildagliptin-containing tablet, and methods for producing these, with which the generation of vildagliptin analogs during storage is inhibited. An embodiment of the present invention provides a vildagliptin-containing dry granulated powder that contains at least 50% by weight of vildagliptin. An embodiment of the present invention also provides a vildagliptin-containing tablet that is produced by tableting a mixture that contains the vildagliptin-containing dry granulated powder. The present invention provides a vildagliptin-containing dry granulated powder, a vildagliptin-containing tablet, and methods for producing these, with which the generation of vildagliptin analogs during storage is inhibited.
A61K 31/40 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil
37.
METHOD FOR MANUFACTURING ORALLY DISINTEGRATING TABLET, AND ORALLY DISINTEGRATING TABLET
Provided is a method for manufacturing an orally disintegrating tablet, in which adequate hardness for preventing breakage of the tablet during transport or handling by a medical practitioner or a patient is provided while rapid disintegration is maintained. A method for manufacturing an orally disintegrating tablet according to an embodiment of the present invention comprises spraying or dropping a liquid including hydroxypropyl cellulose having a viscosity in a 2% aqueous solution at 20°C of 150 mPa∙s to 400 mPa∙s into an additive, and performing fluid bed granulation. The liquid including hydroxypropyl cellulose may be sprayed or dropped into the additive so that the content of the hydroxypropyl cellulose with respect to 100 wt% of the orally disintegrating tablet is 0.2 wt% to 5 wt%.
An anhydrous dasatinib-containing preparation comprising an anhydrous dasatinib and a titanium oxide or colorant or antioxidant is provided. In one embodiment, the anhydrous dasatinib-containing preparation improves photostability upon storage. The weight ratio of the titanium oxide per the anhydrous dasatinib may be more than 0 and 2 or less, or the weight ratio of the colorant per the anhydrous dasatinib may be more than 0 and 1 or less, or the weight ratio of the antioxidant per the anhydrous dasatinib may be more than 0 and 0.5 or less.
The present invention provides a film coating composition for a solid preparation that is easy to take. The present invention also provides a solid preparation which is easy to take. A film coating composition according to one embodiment of the present invention contains a polyvinyl alcohol-polyethylene glycol graft copolymer and a thickening agent. The thickening agent may be composed of one or more substances that are selected from the group consisting of xanthane gum, locust bean gum, pectin, carrageenan, guar gum, gellan gum and carboxy vinyl polymers.
C09D 129/04 - Alcool polyvinyliqueHomopolymères ou copolymères partiellement hydrolysés d'esters d'alcools non saturés avec des acides carboxyliques saturés
A61K 9/32 - Revêtements organiques contenant des polymères synthétiques solides
A61K 45/00 - Préparations médicinales contenant des ingrédients actifs non prévus dans les groupes
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61K 47/36 - PolysaccharidesLeurs dérivés, p. ex. gommes, amidon, alginate, dextrine, acide hyaluronique, chitosane, inuline, agar-agar ou pectine
C09D 171/00 - Compositions de revêtement à base de polyéthers obtenus par des réactions créant une liaison éther dans la chaîne principaleCompositions de revêtement à base de dérivés de tels polymères
40.
Sustained-release preparation containing pseudoephedrine or a pharmaceutically acceptable salt thereof
A sustained-release preparation containing pseudoephedrine is provided comprising pseudoephedrine or a pharmaceutically acceptable salt thereof, and a hardened oil or stearic acid. The sustained-release preparation containing pseudoephedrine may contain a hardened oil or stearic acid in an amount of 100% by mass to 500% by mass with respect to the content of the pseudoephedrine or a pharmaceutically acceptable salt thereof. In addition, the sustained-release preparation containing pseudoephedrine may have a first part and a second part, the first part may contain the pseudoephedrine or a pharmaceutically acceptable salt thereof, and the first part or the second part may contain an optional active ingredient.
Provided is an orally disintegrating tablet film-coated with a composition for film coating containing hypromellose and hydroxypropyl cellulose but not containing a plasticizer.
Provided is a novel additive for an orally disintegrating tablet providing quick disintegrability and tablet hardness to the orally disintegrating tablet, and a producing method therefor. According to an embodiment of the present invention, there is provided an additive for an orally disintegrating tablet characterized by including D-mannitol, low-substituted hydroxypropyl cellulose (however, excluding the low-substituted hydroxypropyl cellulose having a mean particle size of 20 μm or less and a substitution degree of hydroxypropoxy groups of 11%, a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 14%, and a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 11% and a 90% cumulated particle size of 100 μm or less), crospovidone, and microcrystalline cellulose, wherein the low-substituted hydroxypropyl cellulose and the crospovidone are included in a ratio of 5:4.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
Provided is an anhydrous dasatinib-containing preparation which is characterized by containing anhydrous dasatinib, titanium oxide or a coloring agent or an antioxidant. In one embodiment, the anhydrous dasatinib-containing preparation has improved photostability during storage. When the content of the anhydrous dasatinib is taken as 1, the weight ratio of the titanium oxide may be more than 0 and not more than 2. When the content of the anhydrous dasatinib is taken as 1, the weight ratio of the coloring agent may be more than 0 and not more than 1. When the content of the anhydrous dasatinib is taken as 1, the weight ratio of the antioxidant may be more than 0 and not more than 0.5.
A mouthfeel evaluation method for an orally disintegrating test object is provided, the method including, by a measurement apparatus, giving a predetermined distortion with a predetermine cycle as applying a predetermined pressure to the orally disintegrating test object, adding a predetermined amount of a test liquid to the test object, and measuring a loss tangent of the test object with time.
G01N 3/00 - Recherche des propriétés mécaniques des matériaux solides par application d'une contrainte mécanique
G01N 3/08 - Recherche des propriétés mécaniques des matériaux solides par application d'une contrainte mécanique par application d'efforts permanents de traction ou de compression
G01N 3/40 - Recherche de la dureté ou de la dureté au rebondissement
G01N 13/00 - Recherche des effets de surface ou de couche limite, p. ex. pouvoir mouillantRecherche des effets de diffusionAnalyse des matériaux en déterminant les effets superficiels, limites ou de diffusion
45.
Additive composition for orally disintegrating tablet
Provided is a novel additive for an orally disintegrating tablet which imparts a rapid disintegration property and a tablet hardness to the orally disintegrating tablet and a method for producing the same. An additive for an orally disintegrating tablet according to one embodiment of the present invention includes a D-mannitol, a low-substituted hydroxypropyl cellulose (excluding those having a mean particle size of 20 μm or less and a substitution degree of the hydroxypropoxy groups of 11%, having a mean particle size of 45 μm or less and a substitution degree of the hydroxypropoxy groups of 14% and having a mean particle size of 45 μm or less and a substitution degree of the hydroxypropoxy groups of 11% together with a 90% cumulated particle size of 100 μm or less), a crospovidone and a crystalline cellulose.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
water absorption rate of tablet=(mass of tablet after measurement of time for solution to penetrate−mass of tablet before measurement of time for solution to penetrate)/(time for solution to penetrate from one end to other end) (1).
G01N 5/02 - Analyse des matériaux par pesage, p. ex. pesage des fines particules séparées d'un gaz ou d'un liquide en absorbant ou adsorbant les constituants d'un matériau et en déterminant la variation de poids de l'adsorbant, p. ex. en déterminant la teneur en eau
G01N 15/08 - Recherche de la perméabilité, du volume des pores ou de l'aire superficielle des matériaux poreux
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
G01N 33/00 - Recherche ou analyse des matériaux par des méthodes spécifiques non couvertes par les groupes
47.
Mirabegron-containing tablet, method for producing mirabegron-containing pharmaceutical preparation, and method for producing mirabegron-containing granulated product
To provide a mirabegron-containing tablet that maintains the amorphous form of mirabegron even after long-term storage. Also, to provide a mirabegron-containing pharmaceutical preparation that can maintain the purity of mirabegron while preventing the generation of related substances at the time of storage, a method for producing a mirabegron-containing pharmaceutical preparation, and a method for producing a mirabegron-containing granulated product. According to an embodiment of the present invention, there is provided a mirabegron-containing pharmaceutical preparation containing mirabegron, hypromellose, and polyvinylpyrrolidone. The mirabegron-containing pharmaceutical preparation may contain a spray-dried granulated product containing the mirabegron, the hypromellose, and the polyvinylpyrrolidone.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
Provided are: a novel orally disintegrating tablet additive composition that provides orally disintegrating tablets with high disintegrability and tablet hardness; and a method for producing the same. An orally disintegrating tablet additive composition according to an embodiment of the present invention is characterized by including: D-mannitol; a low degree-of-substitution hydroxypropylcellulose (excluding: those having the average particle diameter of 20 μm or less, and having the degree of substitution of hydroxypropoxy group of 11%; those having the average particle diameter of 45 μm or less, and having the degree of substitution of hydroxypropoxy group of 14%; and those having the average particle diameter of 45 μm or less, and having the degree of substitution of hydroxypropoxy group of 11%, and having 90% cumulative particle diameter of 100 μm or less); crospovidone; and crystalline cellulose. The content ratio of the low degree-of-substitution hydroxypropylcellulose to the crospovidone is 5:4.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
01 - Produits chimiques destinés à l'industrie, aux sciences ainsi qu'à l'agriculture
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
Produits et services
Chemicals. Pharmaceuticals (not for agriculture purposes). Banners of paper; paper bunting; hygienic hand towels of
paper; towels of paper; table napkins of paper; hand towels
of paper; handkerchiefs of paper; paper and cardboard;
stationery; printed matter; photographs [printed];
photograph stands.
Provided is an evaluation method for evaluating the texture of food or a medicine disintegrable in the oral cavity, such as an orally disintegrable tablet or tablet candy, by imitating the environment in the oral cavity. Further provided is an evaluation apparatus for evaluating the texture of food or a medicine disintegrable in the oral cavity, such as an orally disintegrable tablet or tablet candy, by imitating the environment in the oral cavity. The texture evaluation method for an orally disintegrable test object according to one embodiment of the present invention is characterized in that a measurement device gives prescribed distortion at a prescribed cycle to the orally disintegrable test object while applying prescribed pressure to the test object, and measures the loss tangent of the test object over time by adding a prescribed amount of a test liquid to the test object.
Provided are: a novel additive which is for an orally disintegrating tablet and imparts rapid disintegratability and tablet hardness to the orally disintegrating tablet; and a method for producing the additive. An additive for an orally disintegrating tablet according to one embodiment of the present invention is characterized by comprising D-mannitol, low-substituted hydroxypropyl celluloses (excluding those in which the average particle size is 20 μm or less and the degree of substitution of hydroxypropoxy groups is 11%, those in which the average particle size is 45 μm or less and the degree of substitution of hydroxypropoxy groups is 14%, and those in which the average particle size is 45 μm or less, the degree of substitution of hydroxypropoxy groups is 11%, and the particle diameter at 90% of the cumulative particle size distribution is 100 μm or less), crospovidone, and crystalline cellulose.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
Provided is an intraorally disintegrable tablet containing olmesartan medoxomil, said tablet having improved mechanical strength of the tablet. Also provided is an intraorally disintegrable tablet containing olmesartan medoxomil, said tablet maintaining the chemical stability of the drug. The intraorally disintegrable tablet according to the present invention containing olmesartan medoxomil contains olmesartan medoxomil and a mixture in which magnesium metasilicate aluminates of multiple grades are combined together. The intraorally disintegrable tablet according to the present invention containing olmesartan medoxomil may contain the mixture, in which magnesium metasilicate aluminates of multiple grades are combined together, in an amount of 1-3 wt% inclusive relative to the total tablet weight.
Provided is an evaluating method capable of appropriately evaluating a degree of disintegration of an orally disintegrating tablet irrespective of the prescription system. Also provided is an evaluating device capable of appropriately evaluating a degree of disintegration of an orally disintegrating tablet irrespective of the prescription system. The method of evaluating an orally disintegrating tablet according to one mode of embodiment of the present invention includes: measuring the mass of the orally disintegrating tablet; placing the orally disintegrating tablet on a preparation placement surface of a test solution supply unit; measuring a water absorption time for a test solution to penetrate from one end of the orally disintegrating tablet in contact with the preparation placement surface to the other end of the orally disintegrating tablet; measuring the mass of the orally disintegrating tablet for which the time for the test solution to penetrate has been measured; and calculating a water absorption rate of the orally disintegrating tablet from the following formula (1); wherein the water absorption rate of the orally disintegrating tablet is evaluated relative to a water absorption rate of 0.004 g/sec. [Formula 1] Water absorption rate of orally disintegrating tablet = (mass of orally disintegrating tablet after measurement of time for test solution to be absorbed - mass of orally disintegrating tablet before measurement of time for test solution to be absorbed) / time for test solution to penetrate from one end to other end of orally disintegrating tablet (1)
01 - Produits chimiques destinés à l'industrie, aux sciences ainsi qu'à l'agriculture
05 - Produits pharmaceutiques, vétérinaires et hygièniques
16 - Papier, carton et produits en ces matières
Produits et services
Chemicals and chemical preparations for use in the manufacture of pharmaceuticals Pharmaceutical preparations for medical or veterinary purposes for the prevention and treatment of disorders or diseases of the central nervous system, the peripheral nervous system, the musculo-skeletal system, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, the endocrine system, the metabolic system, the immune system, the psychological system; pharmaceutical preparations for medical or veterinary purposes for use in dermatology, oncology, ophthalmology, the treatment of allergies, the treatment of infections, the treatment of circulatory system diseases, the treatment of diabetes, the treatment of hyperlipidemia, the treatment of osteoporosis; pharmaceutical preparations in the nature of vitamins and vitamin preparations for medical or veterinary purposes; diagnostic pharmaceutical preparations for medical or veterinary purposes; pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders Banners of paper; paper bunting; hygienic hand towels of paper; towels of paper; table napkins of paper; hand towels of paper; handkerchiefs of paper; paper and cardboard; stationery; printed matter, namely, business cards and integrated reports featuring information regarding pharmaceutical clinical trials; printed photographs; photograph stands
The purpose of the present invention is to provide a gefinitib-containing tablet that has an improved supersaturation-maintaining capacity and an improved tablet stability. The gefinitib-containing tablet according to the present invention is characterized by comprising a plain tablet containing gefinitib and a coating part containing a graft copolymer of polyvinyl alcohol with polyethylene glycol. The tablet may contain 0.5-8.0 wt% inclusive of the graft copolymer of polyvinyl alcohol with polyethylene glycol per 100 wt% of gefinitib.
A61K 31/5377 - 1,4-Oxazines, p. ex. morpholine non condensées et contenant d'autres hétérocycles, p. ex. timolol
A61K 9/32 - Revêtements organiques contenant des polymères synthétiques solides
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61P 43/00 - Médicaments pour des utilisations spécifiques, non prévus dans les groupes
57.
MIRABEGRON-CONTAINING TABLET, METHOD FOR PRODUCING MIRABEGRON-CONTAINING PHARMACEUTICAL PREPARATION AND METHOD FOR PRODUCING MIRABEGRON-CONTAINING GRANULATED PRODUCT
[Problem] To provide a mirabegron-containing tablet which retains the amorphous state of mirabegron after long-term storage; a mirabegron-containing pharmaceutical preparation capable of retaining mirabegron purity by preventing analog formation during storage; a method for producing a mirabegron-containing pharmaceutical preparation; and a method for producing a mirabegron-containing granulated product. [Solution] According to one embodiment of the present invention, provided is a mirabegron-containing pharmaceutical preparation, characterized in comprising mirabegron, and hypromellose and polyvinyl pyrrolidone. The mirabegron-containing pharmaceutical preparation may comprise a spray-dried granulated product comprising the mirabegron and the hypromellose and the polyvinyl pyrrolidone.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
Provided is an orally disintegrating tablet coated with film that allows the time elapsed before a film thereof dissolves to be shorter, has a good feel when the tablet is taken, and is capable of being easily mass-produced. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature, and contains the plasticizer in 10% by weight or more with respect to a weight of the film coating base.
The present invention addresses the main problem of providing a novel method for producing a freeze-dried preparation (combination drug) for injection that comprises tazobactam sodium and piperacillin sodium. An example of the production method according to the present invention is as follows. A method for producing a freeze-dried preparation for injection, said method being characterized by comprising: (a) a step for blowing carbon dioxide gas into an aqueous sodium hydroxide solution; and (b) a step for dissolving tazobactam and piperacillin in the solution obtained in step (a). According to the present invention, a freeze-dried preparation showing good defoaming performance after redissolution can be obtained.
A61K 31/43 - Composés contenant des systèmes cycliques thia-4 aza-1 bicyclo [3.2.0] heptane, c.-à-d. composés contenant un système cyclique de formule , p. ex. pénicillines, pénèmes
A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p. ex. poudres lyophilisées
A candesartan cilexetil-containing preparation contains candesartan cilexetil and lauromacrogol. The lauromacrogol may be contained at a ratio of 2.4 parts by weight or less with respect to 100 parts by weight of the candesartan cilexetil-containing preparation. The candesartan cilexetil-containing preparation may further contain at least one kind of pharmacologically acceptable additives among a diluent, a disintegrant and a binder.
Provided is an orally disintegrating tablet coated with a film, in which the time required for dissolving the film is short, and which has good feeling upon ingestion and can be produced readily in a large quantity. The orally disintegrating tablet according to the present invention is coated with a composition for film coating purposes, wherein the composition comprises a water-soluble and ethanol-insoluble coating film base material and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol that has a liquid or semisolid form at room temperature. Alternatively, the orally disintegrating tablet according to the present invention is coated with a composition for film coating purposes, wherein the composition comprises a water-soluble and ethanol-insoluble coating film base material and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol that has a liquid or semisolid form at room temperature, and wherein the amount of the plasticizer contained is larger by 10% by weight or more than the amount of the coating film base material.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
The present invention provides a pharmaceutical composition containing candesartan cilexetil, which is produced by wet granulation using a dispersion liquid of candesartan cilexetil together with a powder of an additive. The dispersion liquid may contain a water-soluble polymer, a sugar alcohol or a stabilizer. The water-soluble polymer may be hydroxypropyl cellulose. The sugar alcohol may be mannitol. The stabilizer may be lauromacrogol.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
Provided is a stable multilayer tablet containing telmisartan and hydrochlorothiazide, which is suppressed in decomposition of hydrochlorothiazide during storage, or the like. Provided is a multilayer tablet which comprises: a first layer that contains telmisartan, meglumine and a moisture-absorbing substance; and a second layer that contains hydrochlorothiazide. The moisture-absorbing substance may be a porous moisture-absorbing substance. The porous moisture-absorbing substance may be selected from among light anhydrous silicic acid, synthetic aluminum silicate, natural aluminum silicate, calcium silicate, magnesium silicate, magnesium aluminosilicate, magnesium aluminometasilicate, hydrated silicon dioxide and silicon dioxide.
A61K 31/549 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à six chaînons avec au moins un azote et au moins un soufre comme hétéro-atomes d'un cycle, p. ex. sulthiame ayant plusieurs atomes d'azote dans le même cycle, p. ex. hydrochlorothiazide
A candesartan cilexetil-containing preparation contains candesartan cilexetil and lauromacrogol. The lauromacrogol may be contained at a ratio of 2.4 parts by weight or less with respect to 100 parts by weight of the candesartan cilexetil-containing preparation. The candesartan cilexetil-containing preparation may further contain at least one kind of pharmacologically acceptable additives among a diluent, a disintegrant and a binder.
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
The present invention provides: a pitavastatin-containing preparation containing pitavastatin or a pharmacologically acceptable salt thereof and at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation having a pH of more than 8 and 10 or less; and a method for producing a pitavastatin-containing preparation, including blending at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds with pitavastatin or a pharmacologically acceptable salt thereof, to make an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation have a pH of more than 8 and 10 or less.
A01N 43/42 - Biocides, produits repoussant ou attirant les animaux nuisibles, ou régulateurs de croissance des végétaux, contenant des composés hétérocycliques comportant des cycles avec un atome d'azote comme unique hétéro-atome du cycle des cycles à six chaînons condensés avec des carbocycles
The present invention provides: a pitavastatin-containing preparation, which is characterized by containing pitavastatin or a pharmacologically acceptable salt thereof and at least one basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and which is also characterized in that an aqueous solution or aqueous dispersion thereof has a pH of more than 8 but 10 or less; and a method for producing a pitavastatin-containing preparation, which is characterized in that the above-described specific basic additive is blended with pitavastatin or a pharmacologically acceptable salt thereof so that an aqueous solution or aqueous dispersion thereof has a pH of more than 8 but 10 or less.
An atrovastatin-containing coated preparation characterized by comprising a solid material comprising atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt and a coating agent comprising a poly(vinyl alcohol) copolymer, wherein the solid material is coated with the coating agent; and a method for preventing the production of an analogue of atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt and a method for stabilizing atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt, each of which is characterized by coating the solid material with a coating agent comprising a poly(vinyl alcohol) copolymer.
A61K 31/40 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil
A61K 9/32 - Revêtements organiques contenant des polymères synthétiques solides
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
The invention provides an orally disintegrating tablet containing (a) one or more saccharides or sugar alcohols selected from the group consisting of mannitol, lactose, xylitol, sucrose, erythritol and glucose and (b) low substituted hydroxypropylcellulose and substantially free of a starch disintegrant, which tablet is produced by steps of granulating a composition containing the above-mentioned components (a) and (b) by an agitation granulation method, and compression-molding the obtained granulation product. The invention also provides a method of producing an orally disintegrating tablet substantially free of a starch disintegrant, including steps of granulating a composition containing the above-mentioned components by an agitation granulation method, and compression-molding the obtained granulation product.
Disclosed are: a process for producing spherical microparticles comprising tamsulosin hydrochloride; spherical microparticles produced by the process; coated microparticles produced by coating the spherical microparticles; and an orally disintegrating tablet comprising the coated microparticles. The process comprises the following steps (1) to (3): (1) mixing/stirring tamsulosin hydrochloride (a), microcrystalline cellulose (b) and water together until water is penetrated into the mixture of the components (a) and (b) homogeneously; (2) granulating the mixture produced in step (1) into granules by using a rotating granulator in which the peripheral speed is set to 5.5 to 9.0 m/s; and (3) drying the granules produced in step (2).
The purpose of this object is to provide an oral cavity disintegrating tablet which quickly disintegrates in the oral cavity, can be easily produced, has a desired appropriate hardness and is excellent in storage stability, and a method of producing the same. An oral cavity disintegrating tablet which contains (a) one or more sugars or sugar alcohols selected from the group consisting of mannitol, lactose, xylitol, sucrose, erythritol and glucose and (b) a hydroxypropyl cellulose having a low substitution degree and is produced by a process comprising the steps of granulating a composition containing the components (a) and (b) as described above by the agitation granulation method and then compression-molding the granular product thus obtained, wherein the oral cavity disintegrating tablet is substantially free from a starch-based disintegrating agent. A method of producing an oral cavity disintegrating tablet which is substantially free from a starch-based disintegrating agent, comprising the steps of granulating a composition containing the components as described above by agitating and then compression-molding the granular product thus obtained.
A61K 31/4422 - 1,4-Dihydropyridines, p. ex. nifédipine, nicardipine
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
