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: 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: 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: 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.

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 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.

Abstract: 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.

Abstract: The present invention provides an emulsion composition comprising aprepitant for treatment of emesis. Particularly, the invention is a ready-to-use emulsion compositions comprising aprepitant and medium chain triglycerides for administration by intravenous infusion, wherein the emulsion composition is also free of ethanol. Further, the invention also provides processes of preparing such compositions and their use for the prevention and control of acute and delayed chemotherapy-induced nausea and vomiting, and/or for prevention of postoperative nausea and vomiting.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.