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 the use of transgenic plants for the expression of vitamin B12 (cobalamin) binding proteins. Plant cells are transformed with nucleotide sequences adapted for expression and secretion of vitamin B12 binding proteins. The present invention also relates to the use of recombinant vitamin B12 binding proteins from plants in analytical tests and treatment of vitamin B12 deficiency. Also disclosed is a method for purification of recombinant vitamin B12 binding proteins.

Abstract: The present invention relates to a method for determining absorption of cobalamin or analogues thereof in an individual comprising (ii providing two blood samples from said individual, wherein the first sample comprises said individual's blood prior to ingestion by said individual of non-radioactive cobalamin or an analogue thereof and the second sample comprises said individual's blood after said ingestion, (ii) determining the concentration of cobalamin or analogue thereof in the first sample, (iii) determining the concentration of cobalamin or analogue thereof in the second sample by treating complexes of cobalamin or analogue thereof and one or more carrier proteins with one or more enzymes to release cobalamin or analogue thereof from said one or more carrier proteins, and (iv) determining, on the basis of comparison of said concentrations in said two samples, whether said cobalamin or analogue thereof has been absorbed in the blood stream.

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 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 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 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.

Abstract: The efficacy of vitamins and other nutritional agents in treating and preventing various disease states is improved by administering therapeutically effective levels of these agents on a substantially continuous, 24-hour basis. The concentration of lipid peroxides formed by the autoxidation of lipids, and the concentration of oxygen free radicals, are reduced by continuously administering antioxidant agents. The regeneration of nerve tissue is improved by continuously administering at least one pharmaceutically-acceptable B complex vitamin.

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: The present disclosure relates to novel nutritional compositions containing linoleic acid and/or linolenic acid which optimize child neurological development and provide improved nutritional support for women prior to and during lactation. The nutritional compositions are 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 disclosure relates to novel nutritional compositions and methods for augmenting the possibility of conception while increasing nutritional stores to aid development of healthy embryos and child growth. The nutritional compositions are intended for use by both males and females planning to conceive a child.

Abstract: The present inventive subject matter is directed to novel chewable prenatal nutritional supplements which contain vitamin C, as well as novel methods for providing optimal vitamin C supplementation to pregnant women. The present invention is also directed to novel compositions and methods for providing nutritional supplementation to individuals planning to conceive a child.

Abstract: The invention relates to a pharmaceutical composition comprising a therapeutically effective amount of levodopa and of carbidopa, dispersed in a hydrophilic matrix, said composition further comprising an organic acid. A subject of the invention is also a process for preparing the composition, comprising granulation, in particular in a fluidized bed, of the various components and compression of the granules obtained.