Abstract: A bioadhesive controlled, extended release progressive hydration composition wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process, as necessary or desired, and more importantly may be protected from moisture and the immediate septic environment until well after the patient has applied the composition, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the composition is available for absorption (bioavailable).

Abstract: The present invention relates to a delivery system for pharmaceutical compositions relying in part on an ionic interaction to control and facilitate release of the treating agent. More specifically, the invention relates to an extended controlled-release system having an ionic treating agent and an ionic polymer, wherein the polymer is sufficiently ionized to release the treating agent in a controlled manner over an extended period of time and the composition does not require an emulsion system for administering the treating agent.

Abstract: The invention relates to a pharmaceutical vaginal composition for treating or preventing vaginal infections. The composition includes a synergistic mix of a bioadhesive, extended release formulation that decreases the pH and that contains a peroxide in an amount sufficient to increase oxygen concentration without sterilizing the vagina or substantially killing the normally-desired local vaginal flora. The invention also relates to a method of treating or preventing vaginal infections in a patient comprising inserting vaginally an amount of the pharmaceutical vaginal composition in an amount sufficient to decrease the pH and increase oxygen concentration without sterilizing the vagina or substantially killing the normally-desired local vaginal flora.

Abstract: A bioadhesive controlled, extended release progressive hydration composition wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process, as necessary or desired, and more importantly may be protected from moisture and the immediate septic environment until well after the patient has applied the composition, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the composition is available for absorption (bioavailable).

Abstract: The present invention concerns compositions and methods for using a &bgr;-adrenergic agonist for treating endometriosis, for treating infertility, and for improving fertility. The present invention further concerns formulating such a composition or method in such a way as to provide therapeutically sufficient levels of the &bgr;-adrenergic agonist locally while avoiding adverse systematic concentrations in the host, thereby minimizing or avoiding adverse side effects.

Abstract: The present invention teaches a composition comprising a &bgr;-adrenergic agonist in a bioadhesive carrier. Preferably, the composition comprises terbutaline in polycarbophil. The present invention additionally teaches the local administration of a &bgr;-adrenergic agonist for the purpose of treating or preventing dysmenorrhea or premature labor. Using this composition and the method of treatment provides sufficient local levels of the drug to provide therapeutic efficacy, but avoids many untoward adverse events.

Abstract: A bioadhesive composition wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process and more importantly may be protected from moisture and the immediate septic environment until after the patient has applied the composition, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the composition is available for absorption (bioavailable).

Abstract: The present invention teaches that daily, cyclical vaginal delivery of progestin may be used to provide regular, predictable withdrawal bleeding during hormone replacement therapy. The present invention also teaches that constant administration of progestin in a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer may be used to maintain amenorrhea. Either regimen is accompanied by a significant decrease in adverse side effects.

Abstract: The present invention concerns compositions and methods for preventing miscarriage and premature labor, and for treating and preventing Bacterial Vaginosis using a pH-buffering polymer. The present invention further concerns formulating such a composition or method in such a way as to provide therapeutically sufficient levels of the composition to a patient in need thereof.

Abstract: The present invention teaches that daily, cyclical vaginal delivery of progestin may be used to provide regular, predictable withdrawal bleeding during hormone replacement therapy. The present invention also teaches that constant administration of progestin in a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer may be used to maintain amenorrhea. Either regimen is accompanied by a significant decrease in adverse side effects.

Abstract: The present invention concerns compositions and methods for preventing miscarriage and premature labor, and for treating and preventing Bacterial Vaginosis using a pH-buffering polymer. The present invention further concerns formulating such a composition or method in such a way as to provide therapeutically sufficient levels of the composition to a patient in need thereof.

Abstract: A bioadhesive tablet wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process and more importantly may be protected from moisture and the immediate septic environment until after the patient has applied the tablet, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the tablet is available for absorption (bioavailable).

Abstract: The present invention teaches a composition comprising a .beta.-adrenergic agonist in a bioadhesive carrier. Preferably, the composition comprises terbutaline in polycarbophil. The present invention additionally teaches the local administration of a .beta.-adrenergic agonist for the purpose of treating or preventing dysmenorrhea or premature labor. Using this composition and the method of treatment provides sufficient local levels of the drug to provide therapeutic efficacy, but avoids many untoward adverse events.

Abstract: The present invention provides a method of treating or reducing ischemia or incidence of cardiovascular events by administering progesterone. Progesterone, unlike synthetic progestins, has been demonstrated to supplement, rather than to decrease, the beneficial effects of estrogen therapy on myocardial ischemia in females.

Abstract: The present invention relates to the use of a bioadhesive aqueous composition to control the pH of the vagina to alleviate microorganism growth and feminine odor such as presented by bacterial vaginosis. The composition contemplated herein comprises water and an acidic polymer, specifically one wherein 80% of the monomers contain at least one carboxyl group [--COOH] and wherein the polymer is cross-linked so as to be water-swellable, but water-insoluble. The composition of the present invention is additionally a bioadhesive providing for a long-lasting benefit and control of vaginal pH.

Abstract: The present invention provides a method of treating or reducing ischemia or incidence of cardiovascular events by administering progesterone. Progesterone, unlike synthetic progestins, has been demonstrated to supplement, rather than to decrease, the beneficial effects of estrogen therapy on myocardial ischemia in females.

Abstract: A composition and method of moisturizing mammalian membranous tissue is disclosed. The composition utilized in this method includes water, a bioadhesive polymer as the moisturizing agent, and preferably, a consistency-enhancing agent. The bioadhesive is a water-swellable, but water-insoluble, particulate, fibrous, cross-linked carboxy-functional polymer containing (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 percent cross-linking agent substantially free from polyalkenyl polyether. The consistency-enhancing agent, when present, is a water-soluble or -dispersible anionic or non-ionic polymer. The composition is contacted with the tissue to be moisturized, and that contact is maintained for a time period sufficient to moisturize the contacted area.

Abstract: The present invention provides a composition and use of a composition comprising a bioadhesive cross-linked polycarboxylic acid polymer formulation that enables the use of relatively low mounts of anti-STD infectants, such as N-9, to be used to prevent infection by STDs without causing the irritation to genital tissue that often accompanies higher doses of anti-STDs. The bioadhesive polymer maintains greater contact between the anti-STD agent and the infectant for a much greater period of time, enabling a lower concentration to act longer on the infectant, when compared to currently-available commercial applications containing N-9. Such delivery will enable a safe and non-irritating decrease in the risk of infection with STDs, including HIV.

Abstract: The present invention teaches that relatively low levels of serum progesterone, 1 to 6 ng/ml, may be used to prevent endometrial cancer. The vaginal delivery of progesterone using a cross-linked polycarboxylic polymer produces this low serum progesterone level while also providing the full secretory transformation of the endometrium, indicating the efficacy of the progesterone. Such low levels of serum progesterone will decrease the risk of breast cancer experienced by women undergoing hormone replacement therapy ("HRT") and minimize the potential of other undesirable progesterone associated side effects.