The invention described here provides compositions for the efficient and effective treatment of vitamin C deficiency-related diseases and other conditions comprising the administration of pharmaceutical compositions comprising ascorbic acid compound(s), such as sodium ascorbate, and an antioxidant component. Compositions can further comprise one or more additional excipient(s), such as, e.g., a buffer component, a chelating component, or both. Compositions are provided in ready-to-use (RTU) form, not requiring dilution or further manipulation prior to their use, and are provided in single unit dose packaging. Compositions are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Further provided are methods of efficiently and effectively treating diseases(s) and condition(s) related to vitamin C deficiency using disclosed compositions.
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
A61K 31/407 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with heterocyclic ring systems, e.g. ketorolac, physostigmine
A61K 9/00 - Medicinal preparations characterised by special physical form
The present invention is directed to pharmaceutical composition(s) comprising a tiotropium compound, a formoterol compound, and a propellant component. The present invention is further directed to the process of preparing such composition(s) and method(s) of their use for the treatment of asthma, COPD, and related respiratory disorders.
A61K 31/4436 - Non-condensed pyridinesHydrogenated derivatives thereof containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom
A61K 31/166 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon atom of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
The invention described here provides ready-to-use (RTU) pharmaceutical compositions in single unit dose packaging, such compositions including ascorbic acid compound(s), such as sodium ascorbate, and one or more pharmaceutically acceptable excipients (e.g., a carrier and optionally other agents, such as a tonicity agent, a chelator, or both). The compositions provided by the invention are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Compositions provided by the invention comprise an osmolality of between about 270 mOsm/kg to about 340 mOsm/kg and do not require dilution or further manipulation prior to use. In certain aspects, the invention comprises methods of using such compositions in the treatment of diseases, conditions, or symptoms related to vitamin C deficiency, such as, in specific embodiments, scurvy.
The invention described here provides ready-to-use (RTU) pharmaceutical compositions in single unit dose packaging, such compositions including ascorbic acid compound(s), such as sodium ascorbate, and one or more pharmaceutically acceptable excipients (e.g., a carrier and optionally other agents, such as a tonicity agent, a chelator, or both). The compositions provided by the invention are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Compositions provided by the invention comprise an osmolality of between about 270 mOsm/kg to about 340 mOsm/kg and do not require dilution or further manipulation prior to use. In certain aspects, the invention comprises methods of using such compositions in the treatment of diseases, conditions, or symptoms related to vitamin C deficiency, such as, in specific embodiments, scurvy.
The present invention provides pharmaceutically acceptable and ophthalmologically suitable gel compositions comprising a therapeutically effective amount of a bimatoprost compound, a therapeutically effective amount of a timolol compound, and benzalkonium chloride. In certain embodiments, compositions provided by the invention further comprise a penetration enhancer component other than benzalkonium chloride. Further, the invention provides a process of preparing such compositions and methods of their use in treating ocular conditions, such as methods of reducing elevated intraocular pressure and/or treating glaucoma, such as open-angle glaucoma.
The present invention provides methods of treating one or more ocular conditions, such as, e.g., elevated intraocular pressure, glaucoma (e.g., open-angle glaucoma), or both comprising administration of effective amounts of pharmaceutically acceptable and ophthalmologically suitable compositions. The invention further provides compositions for use in such methods comprising a therapeutically effective amount of a bimatoprost compound, a therapeutically effective amount of a timolol compound, benzalkonium chloride, a viscosity enhancer component, and a penetration enhancer component other than benzalkonium chloride. Further, in aspects the invention also provides processes for the preparation of compositions for use in such methods.
The present invention provides pharmaceutically acceptable and ophthalmologically suitable compositions comprising a therapeutically effective amount of a bimatoprost compound, a therapeutically effective amount of a timolol compound, benzalkonium chloride, and a penetration enhancer component other than benzalkonium chloride. In specific embodiments, compositions are provided as aqueous solutions. Further, in aspects, the invention also provides a process of preparing such compositions and methods of their use in treating ocular conditions, such as methods of reducing elevated intraocular pressure and/or treating glaucoma, such as open-angle glaucoma.
The described invention provides, among other things, stable, ophthalmologically pilocarpine compounds characterized by markedly reduced buffer content and reduced buffering capacity as compared to previously developed or described pilocarpine compositions. In aspects, compositions provided by the invention comprise an effective amount of a uniform buffer component, wherein the pilocarpine compound and the uniform buffer component are present in amounts such that the concentration of pilocarpine in the compositions is remarkably higher than that the concentration of the uniform buffer component, particularly as compared against previously developed or described pilocarpine compositions. Such compositions surprisingly demonstrate pharmaceutically acceptable stability and, in aspects, stability equal to or statistically significantly greater than that of one or more previously developed or described reference product(s), while remaining suitable for use in treatment of ocular diseases. Further, the invention provides methods of manufacturing such or similar compositions and methods of use thereof.
The present disclosure provides, among other things, pilocarpine compound formulations that are surprisingly suitable for ophthalmological use and have pharmaceutically acceptable stability characteristics despite having markedly different formulation characteristics from previously developed or described pilocarpine products. The compositions described herein can be suitable for, among other things, treating an ocular condition. Such compositions typically comprise pilocarpine as the single active agent, a buffer component, benzalkonium chloride, and pharmaceutically acceptable water (e.g., sterilized water). In aspects, the buffer component comprises a single buffer constituent/compound having a relatively high pKa (e.g., at least 7 or at least 8) and the compositions comprise pilocarpine compound and benzalkonium chloride concentrations in specified amounts that are consistent with specified ingredient ratios. Additional aspects of this disclosure provide new methods of manufacturing such and similar compositions, and methods of their use in treating ocular conditions such as presbyopia.
Disclosed herein, are, among other things, stable, pharmaceutically acceptable and ophthalmologically suitable reduced buffer content and reduced buffering capacity pilocarpine compound compositions. In aspects, such compositions comprise therapeutically effective amounts of a pilocarpine compound, an effective amount of a uniform buffer component, wherein the concentrations of pilocarpine compound and uniform buffer component are limited to specific relative amounts and wherein the uniform buffer component is defined by one or more markedly distinguishing characteristics from buffers used in developed pilocarpine products (e.g., a unique pKa and/or concentration). Aspects of the invention include compositions defined by unique concentrations of such and other ingredients. Such compositions surprisingly exhibit pharmaceutically acceptable stability and, in aspects, stability equal to or statistically significantly greater than that of one or more on-market/developed reference product(s). Further, the invention provides methods of manufacturing such and similar compositions, and methods of their use in treating ocular conditions such as presbyopia.
The present invention provides stable, pharmaceutically acceptable and ophthalmologically suitable compositions comprising therapeutically effective amounts of both a pilocarpine compound and a brimonidine compound for treating an ocular condition, the compositions comprising a low amount of sodium chloride present in a limited ratio with the active pharmaceutical ingredient(s). In certain embodiments, provided compositions are free of both a borate buffer and a citrate buffer. Compositions provided by the invention surprisingly demonstrate pharmaceutically acceptable stability characteristics when stored under controlled room temperature conditions for an extended period of time. Further, the invention provides methods of manufacturing such compositions in both liquid (solution) and gel form, and methods of their use in treating ocular conditions, such as presbyopia.
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
13.
Gel ophthalmic formulations of pilocarpine and brimonidine compounds and related methods
The present invention provides, stable, pharmaceutically acceptable and ophthalmologically suitable gel compositions comprising therapeutically effective amounts of both a pilocarpine compound and a brimonidine compound and effective amount(s) of at least one polyethoxylated castor oil, which in aspects is/are present in a defined ratio with one or more active pharmaceutical ingredients. In aspects, such compositions are formulated as gel compositions. In certain embodiments, provided compositions are free of both a borate buffer and a citrate buffer. Compositions provided by the invention demonstrate stability, e.g., pH and active pharmaceutical ingredient stability, when stored under controlled room temperature conditions for an extended period of time. Further, the invention provides methods of manufacturing such compositions and methods of their use in treating ocular conditions, such as presbyopia.
A61K 31/4178 - 1,3-Diazoles not condensed and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
A61K 31/498 - Pyrazines or piperazines ortho- or peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 31/14 - Quaternary ammonium compounds, e.g. edrophonium, choline
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
14.
Low pH pilocarpine and brimonidine compound formulations and related methods
The present invention provides relatively low pH, stable, pharmaceutically acceptable and ophthalmologically suitable compositions comprising effective amounts of pilocarpine and brimonidine compounds for treating an ocular condition, wherein compositions demonstrate a significant difference in the amount or rate of one or more pharmaceutical ingredient(s) absorbed or retained by ocular tissue or compared to reference composition(s) with similar compositional characteristics but having a significantly higher pH. In aspects compositions are characterizable by other elements, e.g., the inclusion of benzalkonium chloride, a limited amount of sodium chloride, or both. In embodiments, compositions are free of both a borate and a citrate buffer. Compositions provided by the invention surprisingly demonstrate pharmaceutically acceptable stability when stored under controlled room temperature conditions for an extended period of time. Further, the invention provides methods of manufacturing such compositions in liquid (solution) and gel forms, and methods of their use in treating conditions such as presbyopia.
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
The invention described here provides ready-to-use (RTU) pharmaceutical compositions in single unit dose packaging, such compositions including ascorbic acid compound(s), such as sodium ascorbate, and one or more pharmaceutically acceptable excipients (e.g., a carrier and optionally other agents, such as a tonicity agent, a chelator, or both). The compositions provided by the invention are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Compositions provided by the invention comprise an osmolality of between about 270 mOsm/kg to about 340 mOsm/kg and do not require dilution or further manipulation prior to use. In certain aspects, the invention comprises methods of using such compositions in the treatment of diseases, conditions, or symptoms related to vitamin C deficiency, such as, in specific embodiments, scurvy.
The invention described here provides methods of efficiently treating vitamin C deficiency-related diseases and other conditions comprising the administration of pharmaceutical compositions comprising ascorbic acid compound(s), such as sodium ascorbate, and one or more pharmaceutically acceptable excipients (e.g., a carrier and optionally other agents, such as a tonicity agent, a chelator, or both). The methods comprise administration of such compositions in ready-to-use (RTU) form, provided in single unit dose packaging, wherein the compositions are stable when stored at 20° C. to 25° C.±2° C. for at least about 3 months. Compositions provided by the invention comprise an osmolality of between about 270 mOsm/kg to about 340 mOsm/kg and do not require dilution or further manipulation prior to use.
Provided are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a quinolone antibiotic, e.g., a fourth-generation fluoroquinolone, and an effective amount of an anti-inflammatory agent. In aspects, the anti-inflammatory agent is an anti-inflammatory steroid, NSAID, or a combination thereof. In aspects, compositions are stable suspensions, which maintain physical and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical conditions). In aspects, compositions are suspensions including a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, compositions also or alternatively comprise a non-ionic surfactant, non-ionic suspension agent, or both, or an agent providing both functions. In aspects, compositions further comprise a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in treating or preventing of bacterial eye infections.
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
18.
Buffer-free, stable ophthalmological compositions of ketorolac and phenylephrine and applications thereof
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
A61K 31/407 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with heterocyclic ring systems, e.g. ketorolac, physostigmine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/137 - Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
A61K 31/407 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with heterocyclic ring systems, e.g. ketorolac, physostigmine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/137 - Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
A61K 31/407 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with heterocyclic ring systems, e.g. ketorolac, physostigmine
A61K 9/00 - Medicinal preparations characterised by special physical form
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
A61K 31/407 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with heterocyclic ring systems, e.g. ketorolac, physostigmine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/137 - Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine
Disclosed herein are new compositions comprising (1) an antibacterial component comprising (a) a complex comprising (i) an active pharmaceutical ingredient (API) wherein the active pharmaceutical ingredient is tobramycin, a similar compound, or a derivative of either thereof and (ii) a complexing agent, or (b) a derivative of tobramycin or a similar compound comprising one or more conjugates/derivatizing groups, wherein the complexing agent or conjugate(s) cause a detectable increase in API permeation of corneal cells, retention in corneal cells, or both, as compared to the non-complexed or non-derivatized API, and (2) an effective amount of an anti-inflammatory agent, such as dexamethasone or another dexamethasone compound. This disclosure also describes new methods of using such compositions, producing such compositions, and the like.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
23.
Pharmaceutical compositions and methods utilizing neostigmine and an NK-1 antagonist for treating myasthenia gravis
The present invention describes the administration of an NK1 antagonist, in combination with neostigmine methylsulfate, intravenously, via subcutaneous infusion, or both intravenously and via subcutaneous infusion to facilitate the treatment of a patient suffering from myasthenia gravis by providing a therapeutically effective neostigmine methylsulfate daily dose without the dose-limiting gastrointestinal adverse effects associated with neostigmine methylsulfate.
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A61K 31/5377 - 1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
A61P 21/04 - Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
24.
Moxifloxacin and triamcinolone compositions and associated methods
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a triamcinolone compound. In aspects, the compositions are stable suspensions, which maintain physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a triamcinolone compound in suspension, wherein the particles of the suspension are limited in size. In aspects, the compositions are stable suspensions, maintaining physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent providing both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a triamcinolone compound and a suspension component comprising a polysorbate, hyaluronic acid, or both. In aspects, the compositions are stable suspensions maintaining physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions comprise a non-ionic surfactant or, e.g., a non-ionic suspension agent providing both surfactant and suspension functionality. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
The invention relates to formulations and compositions comprising one or more glycopeptide antibodies or a pharmaceutically acceptable salt thereof for parenteral administration. In particular, stable liquid formulations and compositions comprising vancomycin or a pharmaceutically acceptable salt thereof, N-acetyl-methionine and one or more pharmaceutically acceptable excipients. The invention also relates to a process of preparing such compositions and methods and uses thereof.
The invention relates to formulations and compositions comprising one or more glycopeptide antibodies or a pharmaceutically acceptable salt thereof for parenteral administration. In particular, stable liquid formulations and compositions comprising vancomycin or a pharmaceutically acceptable salt thereof, N-acetyl-methionine and one or more pharmaceutically acceptable excipients. The invention also relates to a process of preparing such compositions and methods and uses thereof.
Disclosed herein are pharmacologically acceptable and ophthalmologically suitable compositions and methods of their use in treating ophthalmic diseases or related conditions. In aspects, the invention provides compositions comprising effective amounts of carbonic anhydrase inhibitor(s) and alpha-2-adrenergic agonist(s). In facets, compositions comprise a penetration enhancer component comprising one or more penetration enhancer compound(s)/molecule(s). In aspects, the invention provides compositions comprising effective amounts of brimonidine compound(s) and brinzolamide compound(s) capable of being administered once or twice daily for the treatment of elevated intraocular pressure, but which provide similar efficacy to a similar or substantially identical reference product requiring administration three times per day. In facets, the invention provides compositions capable of being administered at a frequency resulting in providing a lower total dose of both brinzolamide and brimonidine compound(s) to a recipient, but nonetheless are as or more effective in IOP control as such similar or substantially identical reference products.
A61K 31/542 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and at least one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
A61K 31/498 - Pyrazines or piperazines ortho- or peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/32 - Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
30.
Bromfenac, prednisolone, and moxifloxacin compositions and methods
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of moxifloxacin, prednisolone, and bromfenac. In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/196 - Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
A61K 31/4709 - Non-condensed quinolines containing further heterocyclic rings
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a triamcinolone compound. In aspects, the compositions are stable suspensions, which maintain physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of gatifloxacin, prednisolone, and bromfenac. In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/196 - Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
A61K 31/4709 - Non-condensed quinolines containing further heterocyclic rings
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a loteprednol compound. In aspects, the compositions are stable suspensions, which maintain physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
A61K 31/4709 - Non-condensed quinolines containing further heterocyclic rings
A61K 31/567 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/36 - PolysaccharidesDerivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
34.
Prednisolone and moxifloxacin compositions and methods
Provided here are new ophthalmologically suitable pharmaceutical compositions comprising an effective amount of a moxifloxacin compound and an effective amount of a prednisolone compound. In aspects, the compositions are stable suspensions, which maintain physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, the compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension agent. In aspects, the composition also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent/component. Further described are related compositions and methods of making and using such compositions, e.g., in the treatment of eye infections.
A61K 31/567 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/36 - PolysaccharidesDerivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Provided here are new ophthalmological methods for the treatment or prophylaxis of ocular bacterial infections and related conditions comprising delivering an effective amount of an ophthalmologically suitable composition comprising an effective amount of a moxifloxacin compound and an effective amount of a triamcinolone compound. In aspects, methods comprise delivery of the composition by injection. In aspects, the delivered compositions are stable suspensions, which maintain physical stability and chemical stability for extended periods of time (e.g., exhibiting no sustained flocculation, coagulation, or clumping after several months of storage under typical storage conditions). In aspects, compositions are suspensions that include a suspension component comprising one or more suspension agents. In aspects, the suspension component includes an ionic suspension and may also or alternatively comprises a non-ionic surfactant, non-ionic suspension agent, or both, or, an agent that provides both functions. In aspects, such compositions further comprise an effective amount of a chelating agent.
Disclosed herein are compositions comprising tobramycin or a tobramycin derivative that exhibit improvements in permeation of corneal cells, retention in corneal cells, or both. Such compositions can comprise tobramycin or tobramycin derivative(s) complexed to an agent which facilitates improved permeation of corneal cells, retention in corneal cells, or both. The invention also relates to a process of preparing such compositions.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
Disclosed herein are compositions comprising tobramycin or a tobramycin derivative that exhibit improvements in permeation of corneal cells, retention in corneal cells, or both. Such compositions can comprise tobramycin or tobramycin derivative(s) complexed to an agent which facilitates improved permeation of corneal cells, retention in corneal cells, or both. The invention also relates to a process of preparing such compositions.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 9/00 - Medicinal preparations characterised by special physical form
38.
Tobramycin compound-copolymer conjugates and derivative compositions
Disclosed herein are compositions comprising tobramycin or a tobramycin derivative that exhibit improvements in permeation of corneal cells, retention in corneal cells, or both. Such compositions can comprise tobramycin or tobramycin derivative(s) complexed to an agent which facilitates improved permeation of corneal cells, retention in corneal cells, or both. The invention also relates to a process of preparing such compositions.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
The present invention relates to liquid formulations of levothyroxine or a pharmaceutically acceptable salt thereof intended for parenteral administration, wherein the formulations are devoid of tromethamine. In particular, the invention provides a stable ready-to-use liquid formulation of levothyroxine or a pharmaceutically acceptable salt thereof intended for parenteral administration, wherein the formulation is devoid of tromethamine. The formulations prepared by using the current invention exhibit good physical and chemical stability.
Disclosed herein are methods of treating conditions of the eye comprising delivering an effective amount of a composition comprising tobramycin or a tobramycin derivative exhibiting similar properties complexed to an agent which facilitates improved permeation of corneal cells, retention in corneal cells, or both. In aspects, such compositions further comprise, or such methods further comprise associated administration of (e.g., as a combined product or via co-administration), one or more additional active agents capable of supporting the treatment of the indication for which the compounds of the invention are directed, such as additional antibacterial compounds, anti-inflammatory agents (e.g., steroids), and the like.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
41.
Combination products of tobramycin compounds and dexameihasone compounds
Disclosed herein are new compositions comprising (1) an antibacterial component comprising (a) a complex comprising (i) an active pharmaceutical ingredient (API) wherein the active pharmaceutical ingredient is tobramycin, a similar compound, or a derivative of either thereof and (ii) a complexing agent, or (b) a derivative of tobramycin or a similar compound comprising one or more conjugates/derivatizing groups, wherein the complexing agent or conjugate(s) cause a detectable increase in API permeation of corneal cells, retention in corneal cells, or both, as compared to the non-complexed or non-derivatized API, and (2) an effective amount of an anti-inflammatory agent, such as dexamethasone or another dexamethasone compound. This disclosure also describes new methods of using such compositions, producing such compositions, and the like.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
42.
Tobramycin compound conjugates and derivative compositions
Disclosed herein are compositions comprising tobramycin or a tobramycin derivative that exhibit improvements in permeation of corneal cells, retention in corneal cells, or both. Such compositions can comprise tobramycin or tobramycin derivative(s) complexed to an agent which facilitates improved permeation of corneal cells, retention in corneal cells, or both. The invention also relates to a process of preparing such compositions.
A61K 31/7036 - Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations, namely, general anesthetics, anti-infectives, antipsychotics, anti-inflammatories, cardiovasculars and ophthalmics; pharmaceuticals for the treatment of vitamin deficiency
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations, namely, general anesthetics, anti-infectives, antipsychotics, anti-inflammatories, cardiovasculars and ophthalmics; pharmaceuticals for the treatment of vitamin deficiency
45.
Injectable suspension comprising an insoluble corticosteroid and a soluble corticosteroid
The present invention relates to a process for preparation of an insoluble corticosteroid and a soluble corticosteroid composition by moist heat sterilization and homogenization. In particular, the invention relates to a process for the preparation of a sterilized suspension of betamethasone acetate and betamethasone sodium phosphate, wherein the process comprises sterilizing a slurry of the betamethasone acetate by moist heat sterilization or autoclaving in about 30% to about 70% of water to a temperature of about 115° C. to about 128° C. for about 15 minutes to about 60 minutes under nitrogen atmosphere. The suspensions prepared by using the current invention exhibited good physical and chemical stability. Compositions related thereto are also disclosed.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 9/00 - Medicinal preparations characterised by special physical form
46.
Preparation of microparticulate methylprednisolone acetate suspension
The present invention relates to a process for preparation of a water-insoluble steroid composition by moist heat sterilization. The invention particularly relates to a process for preparation of a water-insoluble steroid composition comprising moist heat sterilization or autoclaving of an aqueous slurry of methylprednisolone acetate in the presence of a specified quantity of polysorbate. The suspensions prepared by using the current invention exhibited good physical and chemical stability. Compositions related thereto are also disclosed.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
47.
Low benzalkonium chloride bimatoprost ophthalmic compositions with effective penetration and preservation properties
The present invention relates to ophthalmic compositions comprising from 0.005% to 0.02% bimatoprost by weight, less than 100 ppm benzalkonium chloride, and one or more secondary penetration enhancers that detectably enhance(s) penetration of bimatoprost into a mammalian eye such that elevated intraocular pressure is effectively reduced to an extent statistically comparable to compositions comprising higher amounts of bimatoprost and benzalkonium chloride. Further, the invention also provides a process of preparing such compositions and methods of their use for lowering intraocular pressure and treating glaucoma.
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
The present invention relates to an ophthalmic composition comprising from 0.005% to 0.02% bimatoprost by weight and one or more pharmaceutically acceptable excipient, wherein said composition is free of benzalkonium chloride. The invention also relates to bimatoprost ophthalmic compositions comprising one or more penetration enhancers other than benzalkonium chloride. Further, the invention also provides a process of preparing such compositions and their use for lowering intraocular pressure and treating glaucoma.
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 31/165 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
An aqueous ophthalmic solution containing a relatively high concentration of olopatadine in solubilized form is provided. The solution comprises a combination of at least two non-ionic surfactants and is essentially devoid of cyclodextrins. The solution is useful for providing enhanced relief from symptoms of ocular allergic disorders (e.g. conjunctivitis).
