Novel Abuse Resistant Controlled Drug Delivery Systems

This novel polymer matrix system comprises biocompatible, biodegradable, GRAS status, pharmaceutically acceptable, readily available and inexpensive materials that can be used to prepare novel drug delivery systems using readily scalable and efficient hot melt extrusion or micro moulding processing techniques. When the matrix is prepared with drug substance, the resultant drug product will have the desired quality attributes required by the FDA for Abuse Resistant Systems (Tier 1) and have been shown to comply with the FDA’s required product characteristics in terms of ability to crush and ease of extraction (see preliminary data below). The prototype formulations also release the full drug loading over a 12hr period and the rate of release can be modified by changing the blend of matrix components. In addition, the novel polymer matrix can be formed into microneedles for controlled transdermal drug delivery using micro injection moulding processing techniques.