Abon Pharmaceuticals LLC

Teva Women's Health, Inc.

Barr Laboratories, Inc.

Watson Laboratories Inc.

Teva Woman's Health, Inc.

Tahseen A Chowdhury

Salah Uddin Ahmed

Yanming Zu

Saad Muntazim

Karunakar Neelam

Shiying Tian

Sudhir Gorukanti

Yi Luo

Sundeep Sethia

Edward J Gabrielski

Mohammed Irfan Syed

Christopher H Baker

Gandha V Naringrekar

Hetalben N Prajapati

Lianli Li

Jason LePree

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

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

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 non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising progestin and methods of making and using the dosage forms to treat conditions in females in need thereof.

Orally disintegrating solid dosage forms comprising progestin and methods of making and using thereof

The present invention relates to a method of attaching a handle to a solid oral dosage form by use of high frequency mechanical vibrations. The present invention also relates to a method of attaching a handle to a solid oral dosage form, the method comprising: (a) placing a handle in contact with a solid oral dosage form, wherein an area of contact between the handle and the solid oral dosage form forms a joint interface; (b) applying high frequency mechanical vibrations to the joint interface until the solid oral dosage form at the joint interface reaches a molten state; and (c) cooling the joint interface in a molten state to allow solidification, thereby attaching the handle to the solid oral dosage form.

Attachment of a handle to a solid oral dosage form

A method for attaching a handle to a tablet to form a lollipop utilizes a specific work holder. The work holder has a tooling pallet with a plurality of openings going from a top surface to a bottom surface. A bullet and a spring are located in each opening and held in place by a plate that slides through a groove in the bottom surface of the tooling pallet to block the openings in the bottom surface. Each spring is positioned between a bullet and the plate. A tablet is placed in a cavity of each bullet and a handle is placed in contact with each tablet. High frequency mechanical vibrations, such as ultrasonic vibrations, are applied to a joint interface between each tablet and bullet until the joint interface reaches a molten state. The joint interfaces are then allowed to cool, thereby attaching a handle to each tablet and forming a lollipop.

Method for making a lollipop

Orally disintegrating solid dosage forms comprising progestin and methods of making and use thereof

A non-effervescent, solid dosage form containing mirtazapine, which is used to form mirtazapine pharmaceutical tablets. The dosage form contains mirtazapine, a hydrophilic component, and at least one lubricant. In some embodiments, the dosage forms contain a salivating agent. Processes for producing mirtazapine orally disintegrating tablets are also provided.

Mirtazapine solid dosage forms

The present invention is directed to non-effervescent, orally disintegrating dosage forms comprising free base clozapine that are substantially free of acids, water-soluble polymers, taste-masking polymers, and coatings, and methods of making and using the same.

Non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising clozapine and methods of making and using the same

An ondansetron solid orally disintegrating dosage form for oral administration having at least one first water-dispersible component or water-insoluble cellulose derivative, a component having a &#x2014;CHOH functional group, a disintegrating agent and at least one lubricant is provided. The dosage form can comprise ondansetron, a hydrophilic polymer such as microcrystalline cellulose, a component having a &#x2014;CHOH functional group such as mannitol or xylitol and a disintegrating agent such as crospovidone. The lubricant may be a mixture of magnesium stearate, sodium stearyl fumarate and colloidal silicon dioxide. The present invention provides a non-effervescent tablet comprising the ondansetron dosage form. Another aspect of the invention is the treatment of emesis such as nausea and vomiting caused by cancer chemotherapy and radiation by the administration of the ondansetron formulation of the present composition. Finally, a process of forming an ondansetron disintegrating tablet using the ondansetron dosage form is disclosed.

Growing community of inventors

Washington Township, NJ, United States of America

Tahseen A Chowdhury