Abstract: The present invention relates to a multiphase release oral pharmaceutical formulation having a dopamine agonist as an active ingredient. The multiphase composition comprises at least two different release components. The invention relates to controlled release pharmaceutical compositions of pramipexole or a pharmaceutically acceptable salt thereof for once-daily administration.

Abstract: A method for treating oral mucositis in a subject comprises topically administering to an oral mucosal surface of the subject phenyloin or a pharmaceutically acceptable salt thereof in an amount effective to inhibit mucosal degeneration or promote mucosal regeneration, and optionally an analgesic agent in an amount effective, in combination with the phenyloin or salt thereof, to reduce pain associated with the oral mucositis. The phenyloin or salt thereof and optionally the analgesic agent can be administered in a pharmaceutical composition comprising an excipient vehicle suitable for intraoral administration, said composition being bioadhesive to an oral mucosal surface, for example having at least one non-lipoidal internal phase and at least one lipoidal external phase that is bioadhesive to said surface.

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: The present invention relates to spatially arranging a plurality of particles in a device for the oral delivery of a pharmaceutical. In particular, the plurality of particles is utilized for the oral delivery of a pharmaceutical to a subject via the drinking device.

Abstract: The present invention provides pharmaceutical compositions and methods for improving the absorption of nutrients and/or drugs in the gastrointestinal tract of a subject. Typically, the pharmaceutical compositions comprise a first agent that increases the pH of the stomach, and one or more agents selected from a pH lowering agent, a vitamin, a mineral, and a drug.

Abstract: The invention provides methods and compositions for the oral delivery of pharmaceutically active agents. In particular, the compositions generally comprise a plurality of pharmaceutically active agents embedded in a matrix that is substantially erodable when contacted with an aqueous medium. The compositions may also include an inner core comprising an inert material. The compositions may be introduced into the oral cavity of a subject by liquid beverage or food product comprising a composition of the invention.

Abstract: The present invention relates to methods of treatment of vulvovaginitis caused by nonspecified Candida isolates using controlled release antimycotic delivery systems. The invention utilizes a minimal number of administrations to obtain cessation of the condition. The methods and systems are especially effective against any Candida species causing vaginal irritation, and thus reduce the need for identification of the isolate prior to treatment.

Abstract: A pharmaceutical composition comprises clonidine or a pharmaceutically acceptable salt or prodrug thereof. The composition, when administered to a patient in an amount delivering a clonidine dose of about 0.1 to about 2 mg/day, exhibits clonidine release properties providing a 24-hour profile of plasma clonidine concentration that (a) does not substantially or protractedly fall below about 0.2 ng/ml and exhibits a peak concentration that is therapeutically effective and does not cause unacceptable side effects in the patient; and/or (b) exhibits a peak that substantially coincides with or closely anticipates a time of maximum plasma concentration of a catecholamine occurring in a diurnal cycle of a patient having a catecholamine-mediated disease or disorder. A method for treating a disease or disorder for which clonidine is indicated in a patient comprises administering such a composition one to three times daily in a dose of about 0.1 to about 2 mg/day to the patient.

Abstract: A pharmaceutical composition comprising levodopa is provided that, when administered in a unit dosage amount of levodopa of about 100 to about 500 mg at a dosage interval of about 6 to about 24 hours, exhibits a sufficiently long release period and a sufficiently long residence time in the upper gastrointestinal tract to provide a trough concentration of levodopa in plasma of the subject that is not lower than a minimum threshold concentration below which adverse motor effects are observed in the subject. A method for treating Parkinson's disease in a subject is also provided, comprising orally administering such a composition to the subject in a unit dosage amount of levodopa of about 50 to about 1000 mg at a dosage interval of about 3 to about 24 hours.

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 method for preventing or treating a catamenial migrainous disorder in a female subject comprises administering to a vulvovaginal surface of the subject a pharmaceutical composition that is bioadhesive thereto and comprises at least one estrogenic compound in an amount of about 50 ?g to about 1000 ?g estradiol equivalent per unit dose of the composition. A related method comprises administering to a vulvovaginal surface of the subject a pharmaceutical composition comprising at least one estrogenic compound, wherein upon administration of the composition to the vulvovaginal surface, a decline in serum estradiol concentration during a luteal phase of a menstrual cycle is moderated.

Abstract: A method for treating non-infectious inflammatory vulvovaginitis comprises administering to a vulvovaginal surface a pharmaceutical composition that comprises clindamycin in an amount of about 125 mg to about 400 mg per unit dose of the composition; wherein the composition is bioadhesive to the vulvovaginal surface, and upon application of the composition to the vulvovaginal surface the clindamycin is released over a period of about 3 hours to about 14 days. A related method comprises administering to a vulvovaginal surface a pharmaceutical composition comprising clindamycin or a pharmaceutically acceptable salt or ester thereof, wherein the composition has at least one non-lipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface. A pharmaceutical composition comprises (a) clindamycin or a pharmaceutically acceptable salt or ester thereof in a clindamycin equivalent amount of about 2.

Abstract: Compositions comprising calcium carbonate and processes for making such compositions are provided. The invention provides a granulation comprising about 95% to about 99% by weight calcium carbonate, about 0.5% to about 5% by weight of a binder and about 0.03% to about 3% by weight of a porosity increasing agent. A pharmaceutical or nutritional composition prepared from such a granulation comprises about 90% to about 99% by weight calcium carbonate, about 0.03% to about 3% by weight of a porosity increasing agent, and about 1% to about 10% by weight of other excipients. The composition provides a smaller tablet than conventional calcium carbonate compositions, for improved ease of swallowing.

Abstract: A pharmaceutical composition comprises (a) metronidazole in an antibacterially effective amount; and (b) an antifungal agent in an antifungally effective amount, illustratively comprising butoconazole or a pharmaceutically acceptable salt or ester thereof. The composition is adapted for application in a unit dose amount to a vulvovaginal surface and has at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface. The composition is useful for administration to a vulvovaginal surface to treat a mixed bacterial vaginosis and vulvovaginal candidiasis infection.

Abstract: A pharmaceutical composition comprises a first active (e.g., antibacterial) agent and a second (e.g., antifungal) active agent, and comprises a component that is adapted for bioadhesion to a vulvovaginal surface. The composition provides differential release of the active agents at such a surface, wherein the second active agent exhibits a release profile that is substantially delayed, extended and/or inverted relative to the release profile of the first active agent.

Abstract: A pharmaceutical composition comprises at least one estrogenic compound, the composition being adapted for application in a unit dose amount to a vulvovaginal surface and having at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface, wherein the at least one estrogenic compound is present in an amount of about 5 to about 1000 ?g estradiol equivalent per unit dose of the composition, and upon application of the composition to the vulvovaginal surface the at least one estrogenic compound is released over a period of about 3 hours to about 30 days. The composition is useful for vulvovaginal administration to treat atrophic vaginitis or a disorder associated therewith, for example in a menopausal or postmenopausal woman.

Abstract: The present disclosure relates to novel nutritional methods and compositions containing essential fatty acids which optimize embryonic, fetal and child neurological development and provide improved nutritional support for women prior to and during lactation. Further the methods and compositions improve gestational length and birth weight. The nutritional methods and compositions are also intended for use by women to optimize infant neurological development and provide improved nutritional support for women prior to, during and after lactation.

Abstract: A pharmaceutical composition comprises (a) an antibacterial agent in an antibacterially effective amount, illustratively comprising clindamycin or a pharmaceutically acceptable salt or ester thereof, and (b) an antifungal agent in an antifungally effective amount, illustratively comprising butoconazole or a pharmaceutically acceptable salt or ester thereof. The composition is adapted for application in a unit dose amount to a vulvovaginal surface and has at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface. The composition is useful for administration to a vulvovaginal surface to treat a mixed bacterial vaginosis and vulvovaginal candidiasis infection.

Abstract: This invention relates to novel nutritional supplements comprising essential fatty acids and iron, as well as methods related thereto.

Abstract: This invention relates to novel dosage formulations for nutritional compositions comprising fatty acids derived from both plant and animal sources and methods for minimizing unpleasant taste, regurgitation, gastroesophageal reflux, dyspepsia, nausea, or difficulty in swallowing or ingesting nutritional agents. The nutritional compositions are intended for use by pregnant or lactating women.