Abstract: A topical pharmaceutical formulation comprising 0.5 ppm to 1000 ppm of a tertiary amine oxide of general formula I wherein R1 is a C8-C18alkyl, and R2 and R3 are independently selected from a C1-C4alkyl or C1-C4hydroxyalkyl. The tertiary amine oxide functions as a preservative or enhances the preservative efficacy in such formulations developed for topical administration. In particular, the topical formulation is an ophthalmic composition.

Abstract: There is provided a pharmaceutical composition suitable for topical administration to an eye, the composition comprising (a) a pharmacologically effective concentration of an active agent and (b) a combination of at least two ophthalmically compatible polymers comprising a novel gum system. In preferred embodiments of the present invention, the compositions increase the retention time of the active agent in the eye, when compared to compositions with other gums or gum systems.

Abstract: The present invention relates to a container comprising, one or more polyolefins exhibiting less than 20% sorption of one or more active ingredients as determined by a suitably acceptable method; and a composition comprising one or more active ingredients. The invention also provides a method of determining whether a package material will provide a desired stability of an active ingredient of a pharmaceutical composition; a method of maintaining the concentration of an active ingredient of a pharmaceutical composition upon storage in a container; and a method of manufacturing a storage container utilizing a pharmaceutically acceptable material comprising one or more active ingredients in a therapeutically effective concentration.

Abstract: A packaged medicinal product comprising (a) a pharmaceutical composition, and b) a plastic container. The composition comprises a prostaglandin, or an analogue or a derivative thereof. The plastic container has a surfactant barrier layer on an inner surface of the container wall and is filled with the pharmaceutical composition. There is also provided method of packaging such a pharmaceutical composition. The method comprises the steps of (a) providing such a plastic container, and (b) filling the container with the pharmaceutical composition.

Abstract: A packaged medicinal product comprising a medicinal preparation packaged in a plastic container having a fluorinated barrier layer on a surface of its body wall is disclosed. The fluorinated barrier layer on the surface of container body wall reduces the loss of an ingredient in the medicinal preparation through the container body wall, and reduces the transfer of impurities into the medicinal preparation from the container materials, from label-related materials, or from the environment where the packaged medicinal preparation is stored.

Abstract: There is provided a pharmaceutical preservative free composition suitable for topical administration to an eye, the composition comprising (a) an oxazolidinone antimicrobial drug, for example linezolid, in a therapeutically or prophylactically effective drug concentration that is above the practical limit of solubility of the drug in a substantially isotonic aqueous solution at a physiologically compatible pH, and (b) a pharmaceutically acceptable cyclodextrin compound in a concentration sufficient to maintain the drug in solution at such a drug concentration. The composition is particularly useful for the treatment and/or prevention of eye infections due to gram positive bacteria.

Abstract: There is provided a pharmaceutical composition suitable for topical administration to an eye, the composition comprising (a) an antibiotic antibiotic drug, for example linezolid, in a therapeutically or prophylactically effective drug concentration, (b) as a solubilizing agent, a pharmaceutically acceptable cyclodextrin compound in a concentration sufficient to maintain the drug in solution at such a drug concentration, and (c) as a preservative, cetyl pyridinium chloride. The composition is particularly useful for the treatment and/or prevention of eye infections due to gram positive bacteria.

Abstract: There is provided a pharmaceutical composition suitable for topical administration to an eye, the composition comprising (a) a pharmacologically effective concentration of an active agent and (b) a combination of at least two ophthalmically compatible polymers comprising a novel gum system. In preferred embodiments of the present invention, the compositions increase the retention time of the active agent in the eye, when compared to compositions with other gums or gum systems.

Abstract: There is provided a pharmaceutical composition suitable for topical administration to an eye, the composition comprising as active agent at least one oxazolidinone antibacterial drug, for example linezolid, in a concentration effective for treatment and/or prophylaxis of a gram-positive bacterial infection of an eye, and at least one ophthalmically acceptable excipient ingredient that reduces a rate of removal of the composition from the eye by lacrimation such that the composition has an effective residence time in the eye of about 2 to about 24 hours. The composition is, for example, an in situ gellable solution, suspension or solution/suspension.

Abstract: The present invention concerns compositions and methods for the introduction of specific genetic changes in endogenous genes of the cells of an animal. The genetic changes are effected by oligonucleotides or oligonucleotide derivatives and analogs, which are generally less than about 100 nucleotides in length. The invention provides for macromolecular carriers, optionally incorporating ligands for clathrin coated pit receptors. In one embodiment the ligand is a lactose or galactose and the genetic changes are made in hepatocytes. By means of the invention up to 40% of the copies of a target gene have been changed in vitro. Repair of mutant genes having a Crigler-Najjar like phenotype and Hemophilia B phenotype were observed.

Abstract: There is provided a pharmaceutical preservative free composition suitable for topical administration to an eye, the composition comprising (a) an oxazolidinone antimicrobial drug, for example linezolid, in a therapeutically or prophylactically effective drug concentration that is above the practical limit of solubility of the drug in a substantially isotonic aqueous solution at a physiologically compatible pH, and (b) a pharmaceutically acceptable cyclodextrin compound in a concentration sufficient to maintain the drug-in solution at such a drug concentration. The composition is particularly useful for the treatment and/or prevention of eye infections due to gram positive bacteria.

Abstract: There is provided a pharmaceutical composition suitable for topical administration to an eye, the composition comprising as active agent at least one oxazolidinone antibacterial drug, for example linezolid, in a concentration effective for treatment and/or prophylaxis of a gram-positive bacterial infection of an eye, and at least one ophthalmically acceptable excipient ingredient that reduces a rate of removal of the composition from the eye by lacrimation such that the composition has an effective residence time in the eye of about 2 to about 24 hours. The composition is, for example, an in situ gellable solution, suspension or solution/suspension.