Abuse Deterrent Technology

OVERVIEW

Catalent Benefits      Valuable Product Differentiation      Facilities

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 resistant technology 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 resistance to meet the stringent demands of the current public and regulatory environment.

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CATALENT BENEFITS

• Accessible technology enabling an effective and innovative abuse resistant product.
• Multi-level abuse prevention technology incorporated into each capsule.
• Product is a patient/consumer preferred Softgel dose form.
• Rapid commercialization with Catalent’s development and manufacturing expertise.

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VALUABLE PRODUCT DIFFERENTIATION

• Proprietary technology providing market protection.
• Innovative and effective abuse resistance to meet FDA scrutiny and public pressure hurdles.
• Immediate and Extended Release therapeutic profiles available.

We have a long track record of customizing successful programs involving our proprietary advanced technologies:

• Pre-formulation and feasibility studies.
• Solubility screening of New Chemical Entities.
• Softgel capsule fill formulation development.
• Small-scale lab encapsulation for early stability data and final formulation selection.
• Capsule shell development.
• Strong IP (intellectual property) positions including fill formulations for improved bioavailability.
• Extensive technical support in softgel capsule product development.
• Reliable supply from clinical phases to commercial manufacturing.
• Contingency planning and quality assurance via our large global network.

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FACILITIES

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.