Altus Formulation Inc.

Laurent Pharmaceuticals

Marc Lemieux

Damon Smith

Sonia Gervais

Aimesther Betancourt

Roch Thibert

Bradut Mitrasca

There is provide an extended release dosage form comprising a release modifying excipient comprising high amylose starch, cross-linked hydroxypropylated amylopectin, and a pre-gelatinized common starch; wherein the release modifying excipient is substantially free of crosslinks between amylose and amylopectin and substantially free of crosslinks between amylose and amylose. It has been found that the extended release properties of conventional cross-linked high amylose starches (e.g., Contramid&#xae;) can be reproduced by intimately mixing i) cross-linked chemically modified amylopectin; ii) a high amylose, non-chemically modified starch and; iii) a pre-gelatinized common starch. Producing a release modifying excipient in this way means that no chemical cross linking between (a) amylose and amylopectin or (b) amylose and amylose has occurred&#x2014;properties heretofore considered vital for Contramid&#xae; function. The release modifying excipient blends overcome problems associated with use of Contramid, and provide a flexible platform for formulation of active pharmaceutical ingredients for controlled release applications.

Starch-based release modifying excipients and pharmaceutical compositions derived therefrom

Amorphous solid dispersions suitable for oral delivery comprising fenretinide or an analog thereof and at least one matrix polymer, and processes for making the dispersions, are disclosed. Also disclosed are solid oral formulations comprising the amorphous solid dispersions, as well as uses thereof for the prevention and/or treatment of diseases or conditions treatable by fenretinide, including but not limited to cancers, conditions associated with a lipid imbalance, cystic fibrosis, osteoporosis, conditions associated with inflammation or opportunistic infections, and other diseases such as diabetes, obesity, dry-form age-related macular degeneration.

Solid oral formulation of fenretinide

Growing community of inventors

Mascouche, Canada

Marc Lemieux