The composition is a hydrogel which may be used to deliver therapeutics vaginally. The hydrogel may include a glycosaminoglycan. The glycosaminoglycan may include multiple thiol groups. The composition may also include a molecule that includes at least two thiol reactive sites. The composition may include a mucoadhesive agent as well as a therapeutic agent. The composition may deliver the therapeutic at a pH that is optimal for the vaginal environment, namely between about 3.5 and 5.0.

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Described herein are compositions and methods for treating cancer of a body cavity, specifically urinary tract cancer, by way of a combination of at least two immunomodulatory agents, wherein one or more of the therapeutic agents are embedded in, and slowly released from, a biocompatible hydrogel composition.

The present disclosure provides pharmaceutical compositions for treating fungal and bacterial infections. The pharmaceutical compositions of the disclosure comprise a cationic surfactant, a chelating agent, and at least one solvent. The pharmaceutical compositions of the disclosure can be used to treat drug-sensitive or multi drug-resistant bacterial or fungal infections.

The disclosure provides compositions, methods, and devices for use in delivering Mitomycin-C(MMC), an antineoplastic chemotherapy drug often used for bladder instillations to treat bladder cancer, which degrades in both acidic and alkaline environments. The disclosure provides a solution of buffered MMC (or a different drug) in 50% propylene glycol that maintains a pH from 7.0 to 8.0 when introduced into acidic solutions (pH of 5.0) and is stable when stored at 2-8° C. for greater than 134 days. This formulation can be produced in an FDA registered 503B Outsourcing facility in a pre-filled, ready-to-administer syringe kit with pre-attached closed system transfer device and accessories required for bladder instillation.

The present invention relates to a pharmaceutical formulation for vaginal administration, wherein the formulation comprises a pharmaceutical acceptable excipient and glucono δ-lactone, wherein the glucono δ-lactone is present in an amount of 5 to 99 wt % of the formulation. The invention also relates to a pharmaceutical formulation according to the invention for use in the prevention or treatment of a urogenital fungal infection. Furthermore, the invention relates to glucono δ-lactone (formula (III)), for use in the in the prevention or treatment of a fungal infection.

The present invention includes pourable, non-toxic lubricating compositions containing carrageenan and more precisely λ carrageenan as an anti-viral agent, for protection from Human Papillomavirus (HPV), and methods of using the lubricating compositions as a non-oily, pseudoplastic lubrication product and administering the carrageenan for reducing the propagation of HPV during sexual activity.

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

The present invention relates to the intravaginal use of sex steroid precursor (e.g. DHEA) for the reduction of the incidence or recurrence of breast cancer in postmenopausal women. The dosage of sex steroid precursor is limited to 25 mg per day or less. Further administration of selective estrogen receptor modulator is disclosed for the above-reduction.

Particles offering multiple doses of an active agent to a subject via a single administration of the active agent to the subject are provided. The particles comprise multiple layers, including two dosing layers each having the active agent and an intervening layer that separates the two dosing layers, and provide a first dose of the active agent from the dosing layer covering the intervening layer upon exposure to an aqueous environment after the particles are administered to the subject, and later a second dose of the active agent from the dosing layer covered by the intervening layer after the intervening layer degrades in the body of the subject. Methods for preparing the particles are also provided. Methods for treating or preventing a disease or disorder in a subject in need thereof with two or more doses of an active agent via a single administration to the subject are further provided.