Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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).

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to ophthalmic compositions comprising from 0.005% to 0.02% bimatoprost by weight, less than 100 ppm benzalkonium chloride, and a secondary penetration enhancer that detectably enhances 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.

Abstract: 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.

Abstract: 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.