Teva Women's Health, Inc.

Abon Pharmaceuticals LLC

Ferring B.v.

Barr Laboratories, Inc.

Watson Laboratories Inc.

Teva Woman's Health, Inc.

Tian, Shiying

Neelam, Karunakar

Muntazim, Saad

Ahmed, Salah U.

Zu, Yanming

Chowdhury, Tahseen, A.

Salah Uddin Ahmed

Tahseen A Chowdhury

Yanming Zu

Saad Muntazim

Diane Deborah Harrison

Anu Mahashabde

Jiaxiang Tsao

Sudhir Gorukanti

Sundeep Sethia

Karunakar Neelam

Shiying Tian

Sanjeev K Gupta

Yi Luo

Madhu Sudhan Shaik

Mohammed Irfan Syed

Carole Ben-Maimon

Kathleen Z Reape

Charles E DiLiberti

Howard Hait

Gandha V Naringrekar

Hetalben N Prajapati

Chandra Vattikonda

Raj R Mahajan

Lianli Li

Jason LePree

Gandha Naringrekar

Sudhir R Gorukanti

Diane D Harrison

The present disclosure relates to an oral eliglustat transmucosal delivery system. More specifically, the present disclosure is related to an oral transmucosal dosage form comprising a non-disintegrating solid mass comprising (a) a hydrophilic viscosity modifying agent selected from a natural or a synthetic gum with a molecular weight of 10,000 Daltons or greater, (b) a low molecular weight water soluble component with a molecular weight of less than 10,000 Daltons and (c) not more than 70 mg eliglustat, wherein the dosage form is 500 mg or less and provides an oral cavity residence time of at least about 5 minutes, and wherein the dosage form generates a microenvironment inside the oral cavity exhibiting a thixotropic behavior with viscosities of at least 50 poises at 1/sec shear rate and at least 10 poises at 10/sec share rate. The dosage forms of as described herein have at least 30% dose reduction as compared to commercially available eliglustat capsules. In addition, unlike the dosing prerequisite for commercially available eliglustat capsules, the oral eliglustat transmucosal dosage form described herein can be administered to patients with Gaucher disease type 1 without pre-determination of patients' CYP2D6 genotype.

Oral eliglustat transmucosal delivery system

The invention relates to extended-release formulations comprising: (i) a poorly water-soluble active pharmaceutical ingredient; and (ii) a non-aqueous liquid vehicle comprising (a) a hydrophobic lipid comprising a glyceryl ester of a C-Cfatty acid, or (b) a hydrophilic organic compound selected from the group consisting of polyethylene glycol, propylene glycol, glycerin, and dimethylsulfoxide, or (c) a combination of (a) and (b), and (iii) an amphiphilic agent wherein the active pharmaceutical ingredient is dispersed as discrete particles having a Dparticle size of about 0.5 &#x3bc;m to about 25 &#x3bc;m in the formulation, and wherein the formulation is non-gelling and thixotropic with a viscosity of less than 10 poise at a shear rate of 10/s at 25&#xb0; C.

Long acting injectable formulations

The present invention relates to monolithic intravaginal rings comprising progesterone, methods of making, and uses thereof. The intravaginal rings comprise progesterone, a polysiloxane elastomer, and a pharmaceutically acceptable hydrocarbon or glycerol esters of a fatty acid.

Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof

This invention relates to dosage forms for the delivery of drugs across the oral mucosa having improved transmucosal permeability. More specifically, the invention relates to an oral transmucosal dosage form comprising a primary vehicle comprising a crystallization inhibition agent (CIA) system and a drug, and a secondary vehicle. It also relates to methods of designing and making this dosage form, methods of administering this dosage form and methods of packaging the dosage forms.

Oral transmucosal drug delivery system

Oral dosage forms for poorly soluble amine drugs are provided. Such dosage forms include an ionizable compound such as an organic acid, an amphiphilic polymer and a release rate-controlling membrane. Such dosage forms allow for the consistent release of the active agent in both gastric pH conditions and in the intestine. Methods of making such dosage forms are also provided.

Extended-release oral dosage forms for poorly soluble amine drugs

The present invention relates to an oral pharmaceutical dosage form comprising micronized progesterone, an edible oil, a disintegrant, and a hydrophilic excipient. Particularly, the invention relates to a pharmaceutical dosage form wherein the dosage form is in a powder form and is contained in a pharmaceutically acceptable capsule. The present invention is also directed toward methods of making the dosage form, methods of using the dosage form, and kits comprising the dosage form.

Oral dosage forms comprising progesterone and methods of making and using the same

The present invention is directed to flexible, compressed intravaginal rings comprising a substantially homogeneous compressed mixture comprising a polymethacrylate, a plasticizer, and an active agent, and methods of making and using the same, and apparatus for making the same.

Flexible, compressed intravaginal rings, methods of making and using the same, and apparatus for making the same

The present invention is directed to methods of treating vasomotor symptoms in castrated prostatic cancer patients in need of treatment, comprising administering about 15 mg or less of cyproterone acetate per day to the patients. The present invention is further directed to dosage forms comprising about 1 mg to about 15 mg of cyproterone acetate and a package comprising a plurality of dosage forms comprising about 1 mg to about 15 mg of cyproterone acetate.

Methods for treating vasomotor symptoms in castrated prostatic cancer patients with low dose cyproterone acetate

The present invention is directed to monophasic pharmaceutical compositions comprising a conjugated estrogen and a hydrophilic or lipophilic excipient. The present invention is also directed to kits and applicators comprising the pharmaceutical compositions. The invention is also directed to methods for treating menopausal conditions in a female comprising administration of the pharmaceutical compositions.

Conjugated estrogen compositions, applicators, kits, and methods of making and use thereof

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New City, NY, United States of America

Salah Uddin Ahmed