The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.
An aqueous pharmaceutical composition for intravenous administration that includes dalbavancin or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable buffer having a pH of from about 4.0 to about 8.0. The aqueous composition further includes either or both of a pharmaceutically acceptable divalent salt wherein the divalent salt is distinct from the buffer and/or a pharmaceutically acceptable cyclodextrin. The formulation demonstrates improved long-term stability for storage at room or elevated temperatures. Methods of using the aqueous pharmaceutical composition of dalbavancin to treat skin infections.
Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as an N-acetyl amino acid are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl amino acids.
The present disclosure is related to micafungin formulations, particularly stable aqueous pharmaceutical compositions comprising micafungin. The disclosure also describes the process for making such compositions and use of such compositions for treatment of a patient in need thereof.
This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 7/16 - Fermeture de réceptacles ou récipients semi-rigides ou rigides, non déformés par le contenu ou n'en prenant pas la forme, p. ex. boîtes ou cartons
B65B 55/06 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par la chaleur
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of anaphylaxis; Pharmaceutical preparations for the treatment of allergic reactions, namely, emergency treatment of type 1 allergic reactions; Pharmaceutical preparations for the treatment of low blood pressure, intraocular pressure and broncho-constriction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of anaphylaxis; Pharmaceutical preparations for the treatment of allergic reactions, namely, emergency treatment of type I allergic reactions; Pharmaceutical preparations for the treatment of low blood pressure, intraocular pressure and broncho-constriction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of anaphylaxis; Pharmaceutical preparations for the treatment of allergic reactions, namely, emergency treatment of type I allergic reactions; Pharmaceutical preparations for the treatment of low blood pressure, intraocular pressure and broncho-constriction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of anaphylaxis; Pharmaceutical preparations for the treatment of allergic reactions, namely, emergency treatment of type I allergic reactions; Pharmaceutical preparations for the treatment of low blood pressure, intraocular pressure and broncho-constriction
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of anaphylaxis; Pharmaceutical preparations for the treatment of allergic reactions, namely, emergency treatment of Type I allergic reactions; Pharmaceutical preparations for the treatment of low blood pressure, intraocular pressure and broncho-constriction
The present invention relates to compositions comprising daptomycin and at least one amino acid, methods of providing such compositions and the uses thereof.
The present disclosure relates to compositions including benzimidazole derivatives. Specifically, the disclosure is generally directed to storage stable formulations of benzimidazole derivatives.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.
A stable liquid composition suitable for intravenous administration that includes micafungin or a pharmaceutically acceptable salt thereof. The formulation includes a net zero charge tonicity modifier, a basic amino acid, and an optional antioxidant in an aqueous solution that has a pH of 4 to 6.5. The liquid composition is a stable formulation that is supplied as a ready to administer, or ready-to-use or ready-to-dilute product in a container.
The present disclosure relates to a stable aqueous composition of dalbavancin, the process for making such compositions and use of such compositions for treatment of a patient in need thereof.
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
The present disclosure relates to a ready-to-administer (RTA), intravenous (IV) bag presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride in sodium chloride packaged in an RTA IV bag. The present disclosure also relates to methods of treating patients by administration of such formulations and RTA IV bags containing such formulations.
The present disclosure relates to a multi-dose vial presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride packaged in a multi-dose glass vial. The present disclosure also relates to methods of treating patients by administration of such formulations and glass vials containing such formulations.
The present disclosure relates to a multi-dose vial presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride packaged in a multi-dose glass vial. The present disclosure also relates to methods of treating patients by administration of such formulations and glass vials containing such formulations.
Liquid pharmaceutical compositions of tofacitinib or its pharmaceutically acceptable salts thereof are described, which are suitable for oral administration, and which are stable under varying storage conditions for extended periods of time. Methods of treating auto-immune disorders are also described, using the stable liquid pharmaceutical compositions of tofacitinib. A stable liquid pharmaceutical composition of tofacitinib according to the invention comprises of (a) tofacitinib at a concentration of about 1 mg/mL or more; (b) a pharmaceutically acceptable liquid vehicle; (c) at least one anti-oxidant; and (d) optionally one or more other pharmaceutically acceptable excipients.
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 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
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 stable liquid formulation for parenteral administration that includes lidocaine or a pharmaceutically acceptable salt thereof. The formulation includes a low concentration of a sodium bicarbonate buffer, sodium chloride, and an optional pH adjuster in an aqueous solution that has a pH of about 6.5 to about 7.2. The liquid formulation is a stable formulation that is supplied as a ready-to-use or product in a container or vial with a carbon dioxide rich headspace.
A61K 31/167 - Amides, p. ex. acides hydroxamiques ayant des cycles aromatiques, p. ex. colchicine, aténolol, progabide ayant l'atome d'azote d'un groupe carboxamide lié directement au cycle aromatique, p. ex. lidocaïne, paracétamol
25.
Buffered Lidocaine Injectable Formulations and Methods for Making Same
A stable liquid formulation for parenteral administration that includes lidocaine or a pharmaceutically acceptable salt thereof. The formulation includes a low concentration of a sodium bicarbonate buffer, sodium chloride, and an optional pH adjuster in an aqueous solution that has a pH of about 6.5 to about 7.2. The liquid formulation is a stable formulation that is supplied as a ready-to-use or product in a container or vial with a carbon dioxide rich headspace.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 31/167 - Amides, p. ex. acides hydroxamiques ayant des cycles aromatiques, p. ex. colchicine, aténolol, progabide ayant l'atome d'azote d'un groupe carboxamide lié directement au cycle aromatique, p. ex. lidocaïne, paracétamol
The present disclosure relates to a ready-to-administer formulation of oxytocin, its pharmaceutically acceptable salts, or derivatives thereof, as well as products including the formulation. Specifically, the disclosure is directed to storage stable ready-to-administer formulations of oxytocin, method of producing such formulations and uses thereof.
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
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
The present disclosure relates to a stable aqueous composition of dalbavancin, the process for making such compositions and use of such compositions for treatment of a patient in need thereof.
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
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone
disease, oncological and metabolic diseases and disorders,
and complications associated therewith.
The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone
disease, oncological and metabolic diseases and disorders,
and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone
disease, oncological and metabolic diseases and disorders,
and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone
disease, oncological and metabolic diseases and disorders,
and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone
disease, oncological and metabolic diseases and disorders,
and complications associated therewith.
The present invention relates to compositions comprising daptomycin and at least one amino acid, methods of providing such compositions and the uses thereof.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
(1) Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of hypotension; pharmaceutical preparation in the nature of vasopressors for treatment of shock to raise blood pressure; pharmaceutical injectable preparations for increasing systolic blood pressure, diastolic blood pressure, mean arterial pressure and total peripheral vascular resistance; decongestant and vasoconstrictor preparation; phenylephrine pharmaceutical injectable preparation for use as a decongestant and vasoconstrictor
41.
Pharmaceutical compositions of tofacitinib for oral administration
Liquid pharmaceutical compositions of tofacitinib or its pharmaceutically acceptable salts thereof are described, which are suitable for oral administration, and which are stable under varying storage conditions for extended periods of time. Methods of treating auto-immune disorders are also described, using the stable liquid pharmaceutical compositions of tofacitinib. A stable liquid pharmaceutical composition of tofacitinib according to the invention comprises of (a) tofacitinib at a concentration of about 1 mg/mL or more; (b) a pharmaceutically acceptable liquid vehicle; (c) at least one anti-oxidant; and (d) optionally one or more other pharmaceutically acceptable excipients.
A61K 31/519 - PyrimidinesPyrimidines hydrogénées, p. ex. triméthoprime condensées en ortho ou en péri avec des hétérocycles
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 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
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
The present invention is directed to epinephrine spray formulations. The present invention is further directed to methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatments.
An aqueous pharmaceutical composition for intravenous administration that includes dalbavancin or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable buffer having a pH of from about 4.0 to about 8.0. The aqueous composition further includes either or both of a pharmaceutically acceptable divalent salt wherein the divalent salt is distinct from the buffer and/or a pharmaceutically acceptable cyclodextrin. The formulation demonstrates improved long-term stability for storage at room or elevated temperatures. Methods of using the aqueous pharmaceutical composition of dalbavancin to treat skin infections.
A61K 47/50 - 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
Prefilled syringes containing a rocuronium bromide solution, where the prefilled syringes comprise a syringe barrel and a syringe tip comprising cyclic olefin monopolymer ("COP") or cyclic olefin copolymer ("COC"), and having a plunger rod stopper comprising bromobutyl rubber. The syringes can also comprise a luer adapter integral with the syringe tip, where the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. The rocuronium bromide solutions include rocuronium bromide, a tonicity agent, one or more buffering agents, and one or more pH adjusters in an aqueous solution having a pH from about 3.8-4.2. The prefilled syringes containing the rocuronium bromide solutions are storage-stable for extended periods of time at a temperature of 2 - 8°C, have acceptable physical parameters such as glide force and break force, and make safe and robust connections with needles and needleless luer adapter devices ("NLADs").
A61K 31/58 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes contenant des hétérocycles, p. ex. danazol, stanozolol, pancuronium ou digitogénine
Prefilled syringes containing a rocuronium bromide solution, where the prefilled syringes comprise a syringe barrel and a syringe tip comprising cyclic olefin monopolymer (“COP”) or cyclic olefin copolymer (“COC”), and having a plunger rod stopper comprising bromobutyl rubber. The syringes can also comprise a luer adapter integral with the syringe tip, where the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. The rocuronium bromide solutions include rocuronium bromide, a tonicity agent, one or more buffering agents, and one or more pH adjusters in an aqueous solution having a pH from about 3.8-4.2. The prefilled syringes containing the rocuronium bromide solutions are storage-stable for extended periods of time at a temperature of 2-8° C., have acceptable physical parameters such as glide force and break force, and make safe and robust connections with needles and needleless luer adapter devices (“NLADs”).
A61K 31/58 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes contenant des hétérocycles, p. ex. danazol, stanozolol, pancuronium ou digitogénine
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61P 21/02 - Relaxants musculaires, p. ex. pour la tétanie ou les crampes
The present disclosure relates to a ready -to-administer (RTA), intravenous (IV) bag presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride in sodium chloride packaged in an RTA IV bag. The present disclosure also relates to methods of treating patients by administration of such formulations and RTA IV bags containing such formulations.
A61K 31/485 - Dérivés du morphinane, p. ex. morphine, codéine
A61L 2/07 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques de la chaleur des gaz chauds de la vapeur
A61P 25/04 - Analgésiques centraux, p. ex. opioïdes
A61M 5/148 - Perfusion sous pression, p. ex. utilisant des pompes utilisant des réservoirs sous pression, p. ex. au moyen de pistons flexibles
The present disclosure relates to a ready-to-administer (RTA), intravenous (IV) bag presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride in sodium chloride packaged in an RTA IV bag. The present disclosure also relates to methods of treating patients by administration of such formulations and RTA IV bags containing such formulations.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of autoimmune disorders; pharmaceutical preparations for the treatment of psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of autoimmune disorders; pharmaceutical preparations for the treatment of psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of autoimmune disorders, excluding chronic hand eczema; pharmaceutical
preparations for the treatment of psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of autoimmune disorders, excluding chronic hand eczema; pharmaceutical
preparations for the treatment of psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis.
The present disclosure relates to compositions including benzimidazole derivatives. Specifically, the disclosure is generally directed to storage stable formulations of benzimidazole derivatives.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
Sustained release pharmaceutical dosage forms include a core containing at least one swellable, water soluble, pH independent polymer and a first water insoluble, pH independent polymer, and a permeable membrane coat containing a swellable, water soluble, pH independent polymer and a second water insoluble, pH independent polymer. The sustained release pharmaceutical dosage forms are free of osmagens and/or diluents and demonstrate similar release characteristics as compared to known sustained release formulations that contain osmagens and/or diluents. Additionally, the release profile for the sustained release pharmaceutical dosage forms is resistant to dose dumping in the presence of alcohol.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Anti-infective, injectable pharmaceutical products in liquid finished dosage form for use in hospitals and clinics or by home health care professionals
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Pharmaceutical preparations for the treatment of bone disease, oncological and metabolic diseases and disorders, and complications associated therewith
A liquid pharmaceutical composition for intravenous administration that includes vasopressin or a pharmaceutically acceptable salt thereof. The formulation further includes a lactate buffer or lactic acid, optionally in combination with a pH adjuster. The pharmaceutical composition can have a pH of from about 3.0 to about 4.1 and demonstrates improved stability for long term storage, particularly at room temperature.
The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as an N-acetyl amino acid are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl amino acids.
Prefilled syringes containing a succinylcholine chloride composition, where the prefilled syringes comprise a syringe barrel and a syringe tip comprising cyclic olefin monopolymer (“COP”) or cyclic olefin copolymer (“COC”). The syringes can also comprise a luer adapter integral with the syringe tip, where the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. The succinylcholine chloride compositions include succinylcholine chloride, a tonicity agent and one or more pH adjusters in an aqueous solution having a pH from about 3.0-4.5. The prefilled syringes containing the succinylcholine compositions are storage-stable for extended periods of time at a temperature of 2-8° C., have acceptable physical parameters such as glide force and break force, and make safe and robust connections with needles and needleless luer adapter devices (“NLADs”).
A61K 31/221 - Esters, p. ex. nitroglycérine, sélénocyanates d'acides carboxyliques d'acides acycliques, p. ex. pravastatine avec des composés ayant un groupe amino, p. ex. acétylcholine, acétylcarnitine
A61J 1/20 - Dispositions pour le transfert des liquides, p. ex. du flacon à la seringue
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61M 5/315 - PistonsTiges de pistonGuidage, blocage, ou limitation des mouvements de la tigeAccessoires disposés sur la tige pour faciliter le dosage
A61M 5/50 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaireAccessoires à cet effet, p. ex. dispositifs de remplissage ou de nettoyage, appuis-bras avec des moyens pour empêcher la réutilisation ou pour indiquer si le dispositif est défectueux, usagé, non stérile ou si l'on a tenté de l'utiliser
A61M 5/00 - Dispositifs pour faire pénétrer des agents dans le corps par introduction sous-cutanée, intravasculaire ou intramusculaireAccessoires à cet effet, p. ex. dispositifs de remplissage ou de nettoyage, appuis-bras
The present disclosure relates to a solid formulation of daptomycin comprising at least one branched aliphatic amino acid. Solid daptomycin formulation of the present disclosure shows improved reconstituted time. The disclosure further relates to a method of preparation of the solid daptomycin formulation according to this disclosure.
This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 7/16 - Fermeture de réceptacles ou récipients semi-rigides ou rigides, non déformés par le contenu ou n'en prenant pas la forme, p. ex. boîtes ou cartons
B65B 55/06 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par la chaleur
The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Stable and bioavailable oral dosage forms of ibrutinib, the dosage forms comprising ibrutinib and an acidifying agent. The dosage forms can further comprise a binder, such as sodium alginate, a surfactant, a lubricant, a filler and/or a disintegrant. Methods of treating cancers, particularly blood cancers, and graft versus host disease comprising administering to a patient in need thereof a dosage form comprising ibrutinib and an acidifying agent.
A61K 9/48 - Préparations en capsules, p. ex. de gélatine, de chocolat
A61K 31/539 - 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 oxygène comme hétéro-atomes d'un cycle, p. ex. 1,2-oxazines ayant plusieurs atomes d'oxygène dans le même cycle, p. ex. dioxazines
A61P 35/02 - Agents anticancéreux spécifiques pour le traitement de la leucémie
Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.
Stable and bioavailable oral dosage forms of ibrutinib, the dosage forms comprising ibrutinib and an acidifying agent. The dosage forms can further comprise a binder, such as sodium alginate, a surfactant, a lubricant, a filler and/or a disintegrant. Methods of treating cancers, particularly blood cancers, and graft versus host disease comprising administering to a patient in need thereof a dosage form comprising ibrutinib and an acidifying agent.
The present disclosure is related to providing a stable daptomycin aqueous pharmaceutical formulations as a contrast to the inconvenient and potentially problematic methods of lyophilized drug preparation and administration, wherein the aqueous formulations of daptomycin offer the advantage of ease of handling with a high degree of patient acceptability and compliance.
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
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
The stable liquid formulations for parenteral administration include fentanyl or a pharmaceutically acceptable salt thereof. The formulations include a diluent and buffer, either containing sodium, in an aqueous solution that has a pH of about 3 to about 4.5. The parenteral liquid formulations are stable formulations that are supplied as a ready-to-administer product in an infusion container or bag. The stable formulations are terminally sterilized in the infusion container. The stable formulations are suitable for administration to a patient in need of therapy with fentanyl or a pharmaceutically acceptable salt thereof.
This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 55/06 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par la chaleur
B65B 7/16 - Fermeture de réceptacles ou récipients semi-rigides ou rigides, non déformés par le contenu ou n'en prenant pas la forme, p. ex. boîtes ou cartons
This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 55/06 - Stérilisation des enveloppes d'emballage ou récipients avant ou pendant l'emballage par la chaleur
B65B 7/16 - Fermeture de réceptacles ou récipients semi-rigides ou rigides, non déformés par le contenu ou n'en prenant pas la forme, p. ex. boîtes ou cartons
05 - Produits pharmaceutiques, vétérinaires et hygièniques
40 - Traitement de matériaux; recyclage, purification de l'air et traitement de l'eau
Produits et services
Pharmaceutical, medicinal, and veterinary preparations and
substances, namely, systemic anti-infectives; pharmaceutical
and medicinal substances for the prevention, curing, and
treatment of viral, metabolic, alimentary, endocrine,
musculoskeletal, cardiovascular, cardiopulmonary,
genitourinary, sexual dysfunction, oncological,
hepatological, ophthalmic, respiratory, neurological,
gastrointestinal, hormonal, dermatological, parasitic,
psychiatric, and immune system related diseases and
disorders; pharmaceutical and medicinal substances for the
prevention, curing, and treatment of allergies,
inflammation, pain, infectious diseases, blood diseases and
disorders, nervous system diseases and disorders, malignant
neoplastic diseases and disorders, and immunomodulating
agent diseases and disorders; chemical preparations for
pharmaceutical or medical purposes, namely, for viral,
metabolic, alimentary, endocrine, musculoskeletal,
cardiovascular, cardiopulmonary, genitourinary, sexual
dysfunction, oncological, hepatological, ophthalmic,
respiratory, neurological, gastrointestinal, hormonal,
dermatological, parasitic, psychiatric, and immune system
related diseases and disorders, allergies, inflammation,
pain, infectious diseases, blood diseases and disorders,
nervous system diseases and disorders, malignant neoplastic
diseases and disorders, and immunomodulating agent diseases
and disorders. Custom manufacture of pharmaceutical preparations and
substances for others.
The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
The present invention relates to liquid pharmaceutical compositions of tofacitinib or its pharmaceutically acceptable salts thereof, suitable for oral administration, that are stable under varying storage conditions for extended periods of time. The present invention also relates to methods of treating auto-immune disorders using the stable liquid pharmaceutical compositions of tofacitinib. A stable liquid pharmaceutical composition of tofacitinib according to the invention comprises of (a) tofacitinib at a concentration of about 1 mg/mL or more; (b) a pharmaceutically acceptable liquid vehicle; (c) at least one anti-oxidant; and (d) optionally one or more other pharmaceutically acceptable excipients.
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
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
The present invention is directed to methods of stabilizing a pharmaceutical composition comprising epinephrine containing the steps filling a container, capping the container, assembling the container and placing the assembled capped container (assembled device) in a secondary packaging system.
Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.
The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
The present invention is directed to epinephrine spray formulations. The present invention is further directed to methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatments.
The stable liquid formulations for parenteral administration include fentanyl or a pharmaceutically acceptable salt thereof. The formulations include a diluent and buffer, either containing sodium, in an aqueous solution that has a pH of about 3 to about 4.5. The parenteral liquid formulations are stable formulations that are supplied as a ready-to-administer product in an infusion container or bag. The stable formulations are terminally sterilized in the infusion container. The stable formulations are suitable for administration to a patient in need of therapy with fentanyl or a pharmaceutically acceptable salt thereof.
The present invention relates to compositions comprising daptomycin and at least one amino acid, methods of providing such compositions and the uses thereof.
A stable liquid formulation for parenteral administration that includes levothyroxine or a pharmaceutically acceptable salt thereof. The formulation includes a low concentration of an antioxidant, an amino acid as a pH adjuster and a stabilization agent in an aqueous solution that has a pH of about 9 to about 11.5. The parenteral liquid formulation is a stable formulation that is supplied as a ready -to-use or ready-to-administer product in a container or vial.
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/20 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant du soufre, p. ex. sulfoxyde de diméthyle [DMSO], docusate, laurylsulfate de sodium ou acides aminosulfoniques
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 31/325 - Acides carbamiquesAcides thiocarbamiquesLeurs anhydrides ou sels
A61P 5/14 - Médicaments pour le traitement des troubles du système endocrinien des hormones thyroïdiennes, p. ex. T3, T4
The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
Produits et services
Anti-infective, injectable pharmaceutical products in liquid finished dosage form for use in hospitals and clinics or by home health care professionals
