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: 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) 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: 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 (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: The present disclosure relates to novel compositions which provide improved nutritional support for premenopausal and menopausal women and/or relief from symptoms associated with menopause, as well as prophylactic effects, and methods for using same.

Abstract: The present disclosure relates to novel nutritional methods and compositions containing essential fatty acids which optimize embryonic, fetal and child neurological development and provides 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: The present invention provides a transdermal spray drug delivery system which comprises: a therapeutically effective amount of a hormone; at least one dermal penetration enhancer; and at least one volatile liquid. The invention also provides a method for administering at least one systemic acting hormone which comprises applying an effective amount of the hormone in the form of the drug delivery system of the present invention.

Abstract: The present disclosure relates to novel compositions which provide improved nutritional support for premenopausal and menopausal women and/or relief from systems associated with menopause, as well as prophylactic effects, and methods for using same.

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: 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 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: This invention relates generally to pharmaceutical compositions for treating seizures, and, more particularly, to pharmaceutical compositions that are bioadherent to oral and/or nasal mucosa, comprise one or more anti-acute seizure agents, and can be used to treat one or more conditions selected from the group consisting of acute seizure, repetitive seizures, and status epilepticus. This invention also relates generally to methods for preparing such compositions, methods of treatment using such compositions, uses of such compositions to prepare medicaments, and kits comprising such compositions.

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 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: 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.