Abstract: The present invention provides compositions and methods for providing sustained release of an active agent through the skin of a subject, wherein a pharmaceutical percutaneous composition comprises at least one fatty acid ester and a therapeutically effective amount of active agent.

Abstract: Provided herein are dry pharmaceutical compositions for transmucosal delivery, comprising spray-dried particles that include pharmaceutically active agent nanoparticles, a binder, and a pharmaceutically acceptable carrier, where the active agent nanoparticles have an average particle size diameter prior to spray-drying of less than about 1 ?m, and wherein up to 10% of the spray-dried particles have a particle size of less than 10 ?m; at least 50% of the spray-dried particles have a particle size of at least about 15 ?m; and at least 90% of the spray-dried particles have a particle size of up to about 55 ?m. Also provided are methods for making such pharmaceutical compositions and therapeutic methods comprising transmucosally aministering the compositions, such as intranasally or intravaginally.

Abstract: Provided herein are dry pharmaceutical compositions for transmucosal delivery, comprising spray-dried particles that include pharmaceutically active agent nanoparticles, a binder, and a pharmaceutically acceptable carrier, where the active agent nanoparticles have an average particle size diameter prior to spray-drying of less than about 1 ?m, and wherein up to 10% of the spray-dried particles have a particle size of less than 10 ?m; at least 50% of the spray-dried particles have a particle size of at least about 15 ?m; and at least 90% of the spray-dried particles have a particle size of up to about 55 ?m. Also provided are methods for making such pharmaceutical compositions and therapeutic methods comprising transmucosally administering the compositions, such as intranasally or intravaginally.

Abstract: Provided herein are dry pharmaceutical compositions for transmucosal delivery, comprising spray-dried particles that include pharmaceutically active agent nanoparticles, a binder, and a pharmaceutically acceptable carrier, where the active agent nanoparticles have an average particle size diameter prior to spray-drying of less than about 1 ?m, and wherein up to 10% of the spray-dried particles have a particle size of less than 10 ?m; at least 50% of the spray-dried particles have a particle size of at least about 15 ?m; and at least 90% of the spray-dried particles have a particle size of up to about 55 ?m. Also provided are methods for making such pharmaceutical compositions and therapeutic methods comprising transmucosally administering the compositions, such as intranasally or intravaginally.

Abstract: The present invention relates to transdermal pharmaceutical compositions such as gels containing a SERM selected from the group consisting of endoxifen, droloxifene, clomifene, raloxifene, tamoxifen, 4-OH tamoxifen, toremifene, danazol and the pharmaceutically acceptable salts thereof, and to methods of making and using the same.

Abstract: The present invention provides compositions and methods for providing sustained release of an active agent through the skin of a subject, wherein a pharmaceutical percutaneous composition comprises at least one fatty acid ester and a therapeutically effective amount of active agent.

Abstract: The present invention provides compositions and methods for providing sustained release of an active agent through the skin of a subject, wherein a pharmaceutical percutaneous composition comprises at least one fatty acid ester and a therapeutically effective amount of active agent.

Abstract: The present invention relates to a pharmaceutical composition in the form of a hydro-alcoholic gel or a solution for transdermal application, comprising: from about 0.2% to about 1.5% of dihydrotestosterone; and from about 0.2 to about 3% of isopropyl myristate.

Abstract: Described are a sterile, ready-to-use, pharmaceutical oil-in water emulsion compositions for parenteral administration comprising: 0.015 to 1.2% wt/vol of progestogen; 0.5-30% wt/vol oil, wherein the oil comprises at least 85% wt/wt triglyceride; 0.0425-12.5% wt/vol phospholipid; 61.4-99.4% wt/vol aqueous medium; wherein the phospholipid is present in an amount of 6.8%-43% of the oil (wt/wt), and wherein the progestogen is present in an amount greater than or equal to 2.1 wt % of the oil. Also described are methods of making such compositions and method of using such compositions in therapeutic or prophylactic treatment, such as treatments comprising intravenous administration of the pharmaceutical composition.

Abstract: Described herein are therapeutic methods using progesterone and progesterone analogs to improve sleep quality. The methods may be particularly useful to treat subject with perturbed sleep patterns, such as subjects who suffer from mid-sleep period awakenings.

Abstract: Described herein are therapeutic methods using progesterone and progesterone analogs to improve sleep quality. The methods may be particularly useful to treat subject with perturbed sleep patterns, such as subjects who suffer from mid-sleep period awakenings.

Abstract: Described herein are therapeutic methods using progesterone and progesterone analogs to improve sleep quality. The methods may be particularly useful to treat subject with perturbed sleep patterns, such as subjects who suffer from mid-sleep period awakenings.

Abstract: Described are sterile, ready-to-use, pharmaceutical oil-in-water emulsion compositions for parenteral administration comprising: 0.015 to 0.5% wt/vol progesterone; 0.5 to 10% wt/vol oil, wherein the oil comprises at least 85% wt./wt. triglyceride; 0.0425 to 4.1% wt/vol phospholipid; 80-99.4% wt/vol aqueous medium; wherein the composition has an osmolality in the range of 200-1000 mOsm/kg. Also described are methods of making such compositions and method of using such compositions in therapeutic or prophylactic treatment, such as treatments comprising intravenous administration of the pharmaceutical composition.

Abstract: The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

Abstract: Provided herein are dry pharmaceutical compositions for transmucosal delivery, comprising spray-dried particles that include pharmaceutically active agent nanoparticles, a binder, and a pharmaceutically acceptable carrier, where the active agent nanoparticles have an average particle size diameter prior to spray-drying of less than about 1 ?m, and wherein up to 10% of the spray-dried particles have a particle size of less than 10 ?m; at least 50% of the spray-dried particles have a particle size of at least about 15 ?m; and at least 90% of the spray-dried particles have a particle size of up to about 55 ?m. Also provided are methods for making such pharmaceutical compositions and therapeutic methods comprising transmucosally administering the compositions, such as intranasally or intravaginally.

Abstract: Described are sterile, ready-to-use, pharmaceutical oil-in-water emulsion compositions for parenteral administration comprising: 0.015 to 0.5% wt/vol progesterone; 0.5 to 10% wt/vol oil, wherein the oil comprises at least 85% wt./wt. triglyceride; 0.0425 to 4.1% wt/vol phospholipid; 80-99.4% wt/vol aqueous medium; wherein the composition has an osmolality in the range of 200-1000 mOsm/kg. Also described are methods of making such compositions and method of using such compositions in therapeutic or prophylactic treatment, such as treatments comprising intravenous administration of the pharmaceutical composition.

Abstract: The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

Abstract: The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

Abstract: The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

Abstract: Described are a sterile, ready-to-use, pharmaceutical oil-in water emulsion compositions for parenteral administration comprising: 0.015 to 1.2% wt/vol of progestogen; 0.5-30% wt/vol oil, wherein the oil comprises at least 85% wt/wt triglyceride; 0.0425-12.5% wt/vol phospholipid; 61.4-99.4% wt/vol aqueous medium; wherein the phospholipid is present in an amount of 6.8%-43% of the oil (wt/wt), and wherein the progestogen is present in an amount greater than or equal to 2.1 wt % of the oil. Also described are methods of making such compositions and method of using such compositions in therapeutic or prophylactic treatment, such as treatments comprising intravenous administration of the pharmaceutical composition.