Kashiv Specialty Pharmaceuticals, LLC

Kashiv Biosciences, LLC

Hoffmann-la Roche Inc.

Asana Biosciences, LLC

Amneal Complex Products Research LLC

F. Hoffmann-la Roche Ag

Ashish Chatterji

Navnit Hargovindas Shah

Dipen Desai

Wantanee Phuapradit

Harpreet Kaur Sandhu

Siva Ram Kiran Vaka

Kanji Meghpara

Jaydeep Vaghashiya

Namdev B Shelke

Atsawin Thongsukmak

Jingjun Huang

Helen Usansky

Louis Denis

Sarper Toker

Jaydeep Vagashiya

Kai Lindenstruth

Niranjan Rao

Harpreet Sandhu

Stephanie Koennings

Murali Mohan Bommana

Gaurang Patel

Siddhartha Banerjee

Anita Kumar

Petra Inbar

Priti L Jagani

Furong Liu

Srinivas Kone

The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.

Gastroretentive dosage forms for sustained drug delivery

Disclosed are abuse resistant oral pharmaceutical compositions that reduce the likelihood of improper administration of drugs that are susceptible to abuse. The oral pharmaceutical formulations contain abuse deterrent agents that cause discomfort to the user when administered in an improper manner and make the extraction of an active ingredient more difficult. Methods of making and using the compositions are also disclosed.

Abuse-resistant drug formulations

Embodiments of the disclosure relate generally to formulations, methods, kits, and dosage forms for improved stability of an active pharmaceutical ingredient, wherein the active ingredient comprises a compound of the formula: wherein X is N, Y is H or optionally substituted C-Calkyl; Ris morpholine optionally substituted with by C-Calkyl; Ris C-Calkyl optionally substituted by one or more F; Ris halogen; and Ris wherein Ris H, C-Calkyl, halogen, CN or CF; Ris H or halogen; Ris H, halogen or C-Calkyl; and Ris H, C-Calkyl, (C-Calkyl)-NH; and, pharmaceutically acceptable salts and free bases thereof, wherein the active ingredient remains in substantially amorphous form after storage of the pharmaceutical formulation for a predetermined time and conditions. In one embodiment the formulations, methods, kits and dosage forms comprising the active pharmaceutical ingredient with improved stability can be used in the treatment of a condition characterized by the dysregulation of one of both of the RAS/RAF/MEK/ERK and PI3K/AKT/PTEN/mTOR pathways.

Formulations, methods, kit, and dosage forms for improved stability of an active pharmaceutical ingredient

Disclosed are solid oral pharmaceutical compositions that that are intended to provide protection against overdose and tampering, as well as abuse deterrence. The compositions contain a plurality of granules or multi-particulates. A first population of multi particulates contains an API or drug susceptible to abuse, a polymer matrix, and an outer coating that contains a cationic pH dependent polymer. These multi particulates also contain a plasticizer and a surfactant. A second population of multi particulates contains a viscosity building polymer and an alkaline buffering agent. Compositions may further include a disintegrant, and/or additional viscosity building polymers and/or alkaline buffering agents and/or ion exchange polymers. Also disclosed are the methods of making and using the compositions.

Abuse-resistant drug formulations with built-in overdose protection

The present invention provides novel formulations of isobutyric acid (2R,3R,4R,5R)-5-(4-amino-2-oxo-2H-pyrimidin-1-yl)-4-fluoro-2-isobutyryloxymethyl-4-methyl-tetrahydro-furan-3-yl ester) and hydroxypropylcellulose that provide high bulk density, low particle size better suited for improved compression and flow, good compression, and fast dissolution profiles.

Pharmaceutical compositions with superior product performance and patient compliance

Growing community of inventors

East Brunswick, NJ, United States of America

Ashish Chatterji