The present invention relates to an in-vivo bulking agent which can be used as a medicinal agent for prevention or treatment of at least one disease selected from the group consisting of urinary incontinence, fecal incontinence, and gastroesophageal reflux or as a filler for use in a plastic surgery procedure, and to a preparation method therefor. The in-vivo bulking agent can exhibit a bulking effect when injected into the body and particularly, is highly biocompatible because a first composition in which silicone particles are coated with a zwitterionic polymer having a surfactant property is introduced into a second composition, whereby the bulking agent can inhibit inflammatory reactions in vivo.

A tertiary amine pharmaceutical composition includes a drug having a tertiary amine structure, a biocompatible polymer material, and a quaternary ammonium salt impurity. The pharmaceutical composition is obtained by dissolving or dispersing the drug in a halogenated hydrocarbon or a mixed solvent mainly containing halogenated hydrocarbon or a solution containing halogenated hydrocarbon. The quaternary ammonium salt impurity is generated from reacting the drug having the tertiary amine structure with the halogenated hydrocarbon. The pharmaceutical composition comprises 40 wt % to 80 wt % of the biocompatible polymer material, and 20 wt % to 60 wt % of the drug with the tertiary amine structure. The content of the quaternary ammonium salt impurity is less than 0.05 wt %, the content of the halogenated hydrocarbon in the composition is less than 1.5 wt %, and the quaternary ammonium salt impurity does not increase or increases slowly during storage, which complies with requirements of pharmaceutical regulations.

Lyophilized formulations of tegavivint, methods of making such formulations, and methods of treatment of cancer by administering the formulations.

Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.

The present invention relates to a solid pharmaceutical preparation of 3-Fluoro-4-[7-methoxy-3-methyl-8-(1-methyl-1H-pyrazol-4-yl)-2-oxo-2,3-dihydro-imidazo[4,5-c]quinolin-1-yl]-benzonitrile, a method of making same, and medical uses thereof.

The invention is directed to a biodegradable, phase separated, thermoplastic multi-block copolymer, to a process for preparing a biodegradable, phase separated, thermoplastic multi-block copolymer, to the use of a biodegradable, semi-crystalline, phase separated, thermoplastic multi-block copolymer, and to a composition for the delivery of at least one biologically active compound to a host.

The biodegradable, phase separated, thermoplastic multi-block copolymer of the invention comprises at least one amorphous hydrolysable pre-polymer (A) segment and at least one semi-crystalline hydrolysable pre-polymer (B) segment, wherein said multi-block copolymer under physiological conditions has a T.sub.g of 37° C. or less and a T.sub.m of 50-110° C.; the segments are linked by a multifunctional chain extender; the segments are randomly distributed over the polymer chain; and the pre-polymer (B) segment comprises a X-Y-X tri-block, wherein Y is a polymerisation initiator, and X is a poly(p-dioxanone) segment with a block length expressed in p-dioxanone monomer units of 7 or more.

The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

A method of treating vaginal dryness by administering a vaginal care composition, which includes an effective amount of a vaginal care agent, to vaginal tissue of a user experiencing vaginal dryness. The vaginal care agent may be selected to specifically treat symptoms of vaginal dryness exhibited by the introitus and/or labia, based on the transcriptomic data of skin cells obtained therefrom. In some instances, the vaginal care composition may be applied to introitus and/or labia with a suitable implement configured for such use.

The present invention relates to a composition comprising a water-insoluble anti-cancer agent present as surface modified and unmodified drop particles in water, a method for producing such a composition, a lyophilizate of such a composition and such a composition for use in the treatment of cancer.

The disclosure relates to coronavirus ribonucleic acid (RNA) vaccines as well as methods of using the vaccines and compositions comprising the vaccines.