The increase in both the abuse of prescription pain medication and the misuse of consumer pseudoephedrine products are increasing public health concerns that has resulted in both public and regulatory pressure to develop new technologies that will effectively deter the inhalation, intravenous injection, and conversion by decreasing the API available for abuse.
Catalent continues to expand the versatility of the softgel technology and addresses the aforementioned market needs with the launch of the abuse deterrence OptiGel Lock™ technology for both Pharmaceutical and Consumer Products.
The OptiGel Lock™ technology limits abuse of the dose form by incorporating multistage levels of deterrence technology, preventing the manipulation of the product into an inhalable or injectable form, and rendering the recovered product unusable for further manipulation. In addition, the Softgel dose form cannot be ground, blended, or crushed to create powder or microparticle form. OptiGel Lock™ technology therefore offers effective deterrence, preventing many common methods of abuse.
For the Consumer Health market, the conversion of OTC pseudoephedrine to methamphetamine is also a growing public health concern, resulting in the relocation of the pseudoephedrine containing products to behind the pharmacy counters in the US in 2006. Pseudoephedrine is concentrated from the tablets through both sophisticated and crude solvent extraction methods and then converted to methamphetamine. OptiGel Lock™ technology limits the extractable pseudoephedrine available from the softgel capsule, preventing the conversion to methamphetamine, and providing the product in a convenient, easy to swallow and consumer preferred Softgel dose form.
OptiGel Lock™ technology offers a rapid path to commercialization enabling effective abuse deterrence to meet the stringent demands of the current public and regulatory environment.
Our deep formulation expertise supported by a global infrastructure of FDA, EMA and locally accredited cGMP softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.