Abstract: Stick formulations for topical delivery of water soluble and/or water insoluble agents are disclosed. The stick formulations may contain steroids, antibiotics, antifungals, antihistamines anti inflammatories or local anesthetics. The vehicles comprise a combination of waxes and oils and a surfactant in embodiments involving water soluble agents. Methods for preparing the various stick formulations are also disclosed.

Abstract: Multi-phase polymeric microspheres containing a molecular compound dispersed in a polymeric matrix are described. Methods for preparing the multi-phase microspheres are also described, which includes a multiple emulsion solvent evaporation technique. Drug loading efficiencies between 80 to 100% were achieved using the described methods. Particular ratios of the W/O emulsion to polymer, and concentration of surfactant and dispersion media (mineral oil) provide highly efficient multi-phase microspheres. In particular embodiments, the multi-phase microspheres feature a high loading efficiency of water-soluble drugs, and also eliminates partitioning of the water soluble agent into the polymer acetonitrile (solvent) phase, thus preventing low encapsulation efficiency.

Abstract: The present invention relates to a composition of matter for the time-dependent liberation of therapeutic agents. This composition of matter comprises a polymeric slab and a homogeneously dispersed enzyme which degrades the polymeric slab in the presence of moisture. The therapeutic agent is physically entrapped in the polymeric slab by inclusion during polymerization to form the polymeric slab or by mixture of the therapeutic agent with a liquid form of the polymeric slab and conversion of the liquid to a solid form. The therapeutic agent is not chemically bound to the polymer, and thus release of the agent is immediately effected upon the specific moisture-activated enzymatic degradation of the polymer slab. Moisture for enzymatic activation is provided by the biological surface on which the slab is emplaced, such as the dermal surface. The composition comprises a polymer such as poly (DL-lactide) and an enzyme such as proteinase K together with chlorpheniramine maleate as the therapeutic agent.

Abstract: A vaginal progesterone suppository is provided in the form of a tablet which delivers biologically effective amounts of progesterone for at least about 48 hours, and blood amounts above basal levels for 72 hours. The tablet is formulated to preferably have a hardness on its edge of 8-13 kg, and disintegrates from its surface to form a milky suspension in 6-8 hours after it is inserted in the vaginal vault. The tablet contains, by weight, about 13-20% progesterone, 65-85% lactose, 2-10% corn starch paste binder, 3-10% corn starch disintegrant, and 0.1-0.9% magnesium stearate as a lubricant. The ratio by weight of progesterone to lactose is preferably 1:6, and the ratio of starch paste binder to starch disintegrant is preferably 1:1. This dosage form is an effective treatment for many progesterone deficiency conditions, and provides enhanced bioavailability.

Abstract: A vaginal progesterone suppository is provided in the form of a tablet which delivers biologically effective amounts of progesterone for at least about 48 hours, and blood amounts above basal levels for 72 hours. The tablet is formulated to preferably have a hardness on its edge of 8-13 kg, and disintegrates from its surface to form a milky suspension in 6-8 hours after it is inserted in the vaginal vault. The tablet contains, by weight, about 13-20% progesterone, 65-85% lactose, 2-10% corn starch paste binder, 3-10% corn starch disintegrant, and 0.1-0.9% magnesium stearate as a lubricant. The ratio by weight of progesterone to lactose is preferably 1:6, and the ratio of starch paste binder to starch disintegrant is preferably 1:1. This dosage form is an effective treatment for many progesterone deficiency conditions, and provides enhanced bioavailability.

Abstract: The invention is a sustained release dosage or delivery form, such as a tablet, pill, granule or the like capable of providing sustained release of a functionally active ingredient and the method for its manufacture. The invention comprises a matrix of a polymer containing functionally active ingredient and an excipient shaped at or above the glass transition temperature of said polymer into a form such as a granule, tablet or the like. Preferably the excipient is a microcrystalline cellulose.

Abstract: A polyvinylpyrrolidone(PVP)/Silver Sulfadiazine (SSD) hydrogel dressing in which the gel is formed by the use of electron beam (E-Beam) radiation to cross-link the polyvinylpyrrolidone (PVP); in which the color of the hydrogel dressing has been stabilized by the addition thereto of magnesium trisilicate and, optionally but preferably, also hydrogen peroxide and/or polyacrylic acid is disclosed; and also the process of stabilizing the color by adding magnesium trisilicate, to a water dispersion of PVP and SSD before it is exposed to E-Beam radiation is disclosed.

Abstract: An oral lubricant effective in reducing the discomfort associated with the wearing of a mouth protector during periods of activity consisting essentially of a thickening agent, a preservative, a flavoring agent, a sweetener, an emulsifier, if needed, and a liquid diluent.

Abstract: Nylon coated microcapsules containing hydrophilic solvent-soluble anionic, cationic or quaternary drug salts were prepared by interfacial polycondensation techniques. In a first stage, the drug substance to be encapsulated is dissolved in an aqueous phase. Examples of drugs encapsulated are morphine sulfate, diphenhydramine hydrochloride, and methantheline bromide. Next the aqueous drug solution is dispersed in an organic phase. In a second stage complementary polycondensation reactants each in an organic phase are added separately, either sequentially or simultaneously, to the dispersion prepared in the first stage. Microcapsules of nylon form around the hydrophilic solvent soluble core drug substance.