Intellipharmaceutics is currently using new and customized equipment to manufacture clinical batches of drugs aiming to deter abuse. The company says it has completed qualification of the primary manufacturing equipment used to produce the new formulation for controlled-release oxycodone hydrochloride.
Successful manufacture puts the drugmaker on the path to Phase I studies and the setup of a clinical program with the FDA.
Equipment qualification is a major milestone in Rexista development. The company made equipment modifications to accommodate the proprietary paste-in-a-capsule dosage form. The capsule targets known abuses via inhalation, crushing, powdering, and injection when mixed with solvents, according to an announcement. Rexista products also aim to prevent release of an entire dose when the user takes the drug with alcohol.
If all goes well, Rexista will join Embeda, approved by the FDA last August, as a pain drug not easily abused. Embeda is made by King Pharma, which provides the drug with a core of naltrexone hydrochloride, a chemical that counteracts the morphine. The core triggers when released by chewing, crushing or dissolving in alcohol.
- see the announcement for more