Altus Formulation Inc. a Quebec – based drug formulation and development company, leveraging it’s patented drug delivery technology to develop safer formulations for its partners and their patients is pleased to announce the Notice of Allowance in the USA for its new Patent entitled sustained drug release compositions (U.S. Patent Application No.: 12/905,577)
This patent covers twelve or twenty four hour controlled release formulations which can be broken into 2 to 4 pieces without dose dumping or any change to controlled release properties. The technology is simple to employ requiring powder blending and compression of only commonly available low cost USP/EP/JP excipients on conventional equipment. The platform is ideal for (though not restricted to) high strength tablets. For example the technology has been used to produce a 1000mg tablet for an OTC application which can be broken in two or four pieces for easier swallowing (avoidance of dysphagia) and simple titration (extended release 250mg, 500mg, 750mg, 1000mg doses from a single tablet) avoiding the need to develop, manufacture or inventory, multiple formulation strengths. The technology also;
- Allows new step titrations which may not already be available in the market but desired by doctors. Good for ‘start low go slow medications’.
- Allows new labeling from a simple low risk PK study so providing cost effective differentiation for both ANDA and 505b2 / 10(3) approaches .
- A safer experience for the patient avoiding inadvertent dose dumping if tablets are broken to eke out a prescription or avoid dysphagia.
Single layer and bilayer products containing 1 or 2 actives with extended release or immediate release/extended release performance have been developed and approved on the platform.
For more information please contact.
CEO Altus Formulation
tel: (1) 514 883 3447