Abstract: A pharmaceutical formulation to treat vaginal conditions in a human patient comprises: at least one active agent; a modified release dosage form which provides extended release of the anti-infective agent upon vaginal administration to the patient; and wherein the formulation, when containing a total dose of the anti-infective agent of about 25 ?g to about 500 mg based on the active agent will produce a plasma concentration versus time curve (ng/mL versus hours) having an area under the curve (AUC) of less than about 600 ng/mL·hr.

Abstract: An enteric coating composition including about 0.01% to about 10% resin and about 0.01% to about 10% polymer. The enteric coating composition may be applied to a substrate, such as a pharmaceutical, nutraceutical, fruit, vegetable, agricultural product, or industrial product, to form an enteric coating on the substrate. Also provided is a multiple-component system having a first component including a resin and a second component including a polymer, wherein mixing the first component and the second component forms an enteric coating composition having about 0.01% to about 10% resin and about 0.01% to about 10% polymer. Methods for coating a substrate with the enteric coating compositions are also provided.

Abstract: A pharmaceutical formulation to treat vaginal conditions in a human patient comprises: at least one active agent; a modified release dosage form which provides extended release of the anti-infective agent upon vaginal administration to the patient; and wherein the formulation, when containing a total dose of the anti-infective agent of about 25 ?g to about 500 mg based on the active agent will produce a plasma concentration versus time curve (ng/mL versus hours) having an area under the curve (AUC) of less than about 600 ng/mL·hr.

Abstract: A pharmaceutical delivery system that releases an active agent in a controlled manner for an extended period in the vaginal cavity to treat or cure ailments associated with the vaginal cavity or proximal areas. The delivery system includes an applicator which is composed of a high internal phase emulsion, allowing the delivery system to adhere to the mueosal surfaces of the body, primarily the lining of vaginal cavity. The delivery system can maintain the high internal phase emulsion at a temperature of 86° F. for at least one month, without decomposition or instability of the emulsion.

Abstract: A pharmaceutical delivery system that releases an active agent in a controlled manner for an extended period in the vaginal cavity to treat or cure ailments associated with the vaginal cavity or proximal areas. The delivery system includes an applicator which is composed of a high internal phase emulsion, allowing the delivery system to adhere to the mueosal surfaces of the body, primarily the lining of vaginal cavity. The delivery system can maintain the high internal phase emulsion at a temperature of 86° F. for at least one month, without decomposition or instability of the emulsion.

Abstract: A pharmaceutical composition comprises at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to a vaginal mucosal surface, and comprises danazol in an amount of about 3% to about 30% by weight of the composition, wherein upon application of the composition to the vaginal mucosal surface the danazol is released over a period of about 1 to about 10 days. The composition is useful for intravaginal administration to treat a condition such as endometriosis for which danazol is indicated.

Abstract: A pharmaceutical delivery system that releases an active agent in a controlled manner for an extended period in the vaginal cavity to treat or cure ailments associated with the vaginal cavity or proximal areas. The delivery system includes an applicator which is composed of a high internal phase emulsion, allowing the delivery system to adhere to the mueosal surfaces of the body, primarily the lining of vaginal cavity. The delivery system can maintain the high internal phase emulsion at a temperature of 86° F. for at least one month, without decomposition or instability of the emulsion.

Abstract: The present invention relates to a novel essentially pH neutral vaginal drug delivery system suitable for modified delivery of a therapeutically active material in the vaginal cavity. The vaginal drug delivery system comprises an essentially pH neutral emulsion having globules having two phases, an internal water soluble phase and an external water-insoluble phase or film, wherein the water-soluble interior phase contains a therapeutically active drug or drugs. One novel aspect of the vaginal drug delivery system is that the internal water soluble phase comprises an acidic buffered phase.

Abstract: This invention relates to a novel transcellular drug delivery system suitable for controlled delivery of a therapeutically active material across various membranes. The transcellular drug delivery system has a bioadhesive unilamellar vesicle defining an amphiphilic exterior and an aqueous interior, wherein a therapeutically active ingredient is contained inside the aqueous interior.

Abstract: The present invention relates to a novel essentially pH neutral vaginal drug delivery system suitable for modified delivery of a therapeutically active material in the vaginal cavity. The vaginal drug delivery system comprises an essentially pH neutral emulsion having globules having two phases, an internal water soluble phase and an external water-insoluble phase or film, wherein the water-soluble interior phase contains a therapeutically active drug or drugs. One novel aspect of the vaginal drug delivery system is that the internal water soluble phase comprises an acidic buffered phase.

Abstract: The present invention relates to a means for creating a mass having structural integrity, including a rapidly disintegratable tablet for administration with or without the use of water. The present invention has a wide variety of different uses and applications. One embodiment is a tablet intended for oral administration. The tablet comprises at least one active ingredient and a mixture of excipients. The excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained. The tablet is intended primarily for oral administration and dissolves in the presence of water. Also disclosed is a process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water.

Abstract: The present invention relates to a means for creating a mass having structural integrity, including a rapidly disintegratable tablet for administration with or without the use of water. The present invention has a wide variety of different uses and applications. One embodiment is a tablet intended for oral administration. The tablet comprises at least one active ingredient and a mixture of excipients. The excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained. The tablet is intended primarily for oral administration and dissolves in the presence of water. Also disclosed is a process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water.

Abstract: The present invention relates to a means for creating a mass having structural integrity, including a rapidly disintegratable tablet for administration with or without the use of water. The present invention has a wide variety of different uses and applications. One embodiment is a tablet intended for oral administration. The tablet comprises at least one active ingredient and a mixture of excipients. The excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained. The tablet is intended primarily for oral administration and dissolves in the presence of water. Also disclosed is a process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water.

Abstract: A solid or semi-solid bioadherent, orally ingestible drug delivery system containing a water-in-oil system having at least two phases, one phase comprises from about 25% to about 75% by volume of an internal hydrophilic phase and the other phase comprises from about 25% to about 75% by volume of an external hydrophobic phase and wherein the external hydrophobic phase is comprised of three components, a) an emulsifier, b) a glyceride ester and c) a wax material.

Abstract: A substantially tasteless pharmaceutical delivery system, which comprises a) an active material; and b) a spatially oriented matrix comprising (i) a wax core material having a melting point within the range of about 50.degree. C. and about 200.degree. C.; and (ii) a regional hydrophobic polymer material and method for making the same.

Abstract: Systems and their methods of preparation and use that release an active agent in a controlled manner for an extended period in a vaginal cavity environment. When an antifungal agent such as an imidazole, is incorporated into the system it has been found that the conventional treatment time is reduced by at least 25%.

Abstract: Solid delivery systems which at body temperature exhibit controlled release and bioadherence characteristics. These systems are emulsions which are water in oil in nature and whose internal phase is greater than that of the external phase. That is, the internal phase comprises at least 60% of the system.

Abstract: Systems and their methods of preparation and use that release an active agent in a controlled manner for an extended period in a vaginal cavity environment. The systems are capable of delivering the active agent for periods greater than three hours at a predictable rate to a predetermined site, the vaginal cavity.

Abstract: In a welding procedure for joining of adjacent, possibly partially enclosed metal components, such as pipe sections, wherein the welding procedure can be of a gas tungsten arc type such as a heli-arc type, or similar process, and wherein oxidation of metal frequently occurs within the components at the joinder point due to presence of oxygen in the region of weld during the welding procedure; introducing under pressure and at least initially pressure blowing, at a relatively high pressure, an inert gas into the interior of the components in a substantial swirling and interior surface wiping motion. The inert gas is blown through the components, from the entry end, beyond the weld region to rapidly, and substantially completely remove from the interior and weld region, any oxygen or other possible deleterious gas or material. Subsequently a lower pressure introduction of gas will serve to maintain the interior free of oxygen and the like.