Abstract: The present invention relates generally to antifugal compositions. In an embodiment, the antifungal compositions are effective for application to nails and surrounding skin, and comprise at least one volatile solvent, at least one film forming substance, and at least one pyrimidone derivative of formula I, such as albaconazole. These compositions are capable of treating an infection caused by fungi, such as onychomychosis.

Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

Abstract: Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

Abstract: Pharmaceutical gel compositions containing estrogen for vaginal administration, as well as a method of making the same, are disclosed.

Abstract: The present invention relates to a process for the preparation of an intravaginal matrix drug delivery device. The process comprises the steps of combining at least one therapeutic agent in a therapeutically effective amount with at least one biocompatible elastomeric polymer to form a mix; curing said mix in a mold having a shape of said intravaginal drug delivery device, to form a polymer matrix; and maturing said polymer matrix to form the intravaginal drug delivery device. The maturing step alters the release rate characteristics of a device prepared in accordance with the process of the invention.

Abstract: The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

Abstract: Ampoules made of plastics material and containing 0.5 to 5 ml of a pharmaceutical formulation are sealed, together with an oxygen scavenger, within a pouch.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: A mesalamine pharmaceutical composition with reduced delivery variability for delivery of mesalamine to the colon that includes multiple dosage elements, and each dosage element includes mesalamine and an enteric coating. The enteric coating of each different dosage element differs so the release point of the mesalamine in the GI tract is varied. In one embodiment, a first dosage element releases about 30% to about 60% by weight of the total mesalamine in the composition after 60 minutes at a pH of about 6.6 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm and a second dosage element releases about 40% to about 70% by weight of the total mesalamine after 60 minutes at a pH of about 7.2 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm.

Abstract: A method of making an intraocular lens including providing a fixation member having a proximal end portion with the proximal end portion including an elongated filament, converting a region of said filament at said proximal end portion from a first configuration into a second configuration which is adapted to provide a mechanical interlock and molding an optic about the proximal end portion of the fixation member to form a mechanical interlock between the second configuration and the optic and to attach the fixation member to the optic.

Abstract: Compositions and methods useful for enhancing the transdermal and transmembrane drug delivery of topical and systemic agents. The compositions and methods comprise the active agent together with an effective amount of certain amides of heterocyclic amines as defined herein as penetration enhancers and topically administering to human or animal skin or other membranes the resulting compositions.

Abstract: A one step method for cleaning and disinfecting contact lenses is accomplished by immersing the lenses in a solution containing peroxide and a peroxide-active enzyme.

Abstract: A topical lodoxamide composition having enhanced efficacy for treatment of ocular allergic diseases. The composition comprises the addition of polyvinyl alcohol to an aqueous solution containing lodoxamide tromethamine.

Abstract: A method of preparing solutions containing thimerosal and polyvinylpyrrolidone which results in improved stability of thimerosal is disclosed. The method involves applying a certain amount of heat to the polyvinylpyrrolidone while it is in aqueous solution and prior to its combination with thimerosal. The required thermal input to the polyvinylpyrrolidone solution is a function of four variables: solution temperature, heating time, external pressure and polyvinylpyrrolidone concentration. Advantageously this method may be employed in the manufacture of contact lens solutions.

Abstract: A method and composition for the treatment of contact lenses, and especially soft contact lenses such as silicone and hydrophilic plastic contact lenses to remove inorganic deposits. The method consists of treating a contact lens with an aqueous solution containing an effective amount of a sequestering agent, such as a polymetaphosphate, gluconic acid or salts thereof. A preferred polymetaphosphate is sodium hexametaphosphate.

Abstract: Low serum zinc concentrations in humans have been associated with multiple sclerosis in some patients, particularly those patients under 50 years of age. Increasing the concentration of serum zinc in such patients has been found to lower the number of, or decrease the severity of recurrent attacks and/or improve neurologic function in some patients.

Abstract: A method for topically treating inflammation in humans or animals by administering to the inflamed area a therapeutically effective amount of an alkyl- or aralkyl-substituted acetylsalicylic acid such as methyl-, ethyl-, allyl- or benzyl acetylsalicylate. The method may also be used to treat acne by applying a therapeutically effective amount of the acetylsalicylate ester to the affected skin in a human having skin affected by acne.

Abstract: A method of treating vascularization of the eye as a result of traumatic injury, surgery, such as, corneal transplant, or onset of diabetic retinopathy by topically treating the eye with Flurbiprofen or a pharmaceutically acceptable salt thereof.