Fast path to market: Going from GMP1 to PPQ in just 12 months

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Lucy Zhou, Director of Skin Lab at CPL, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy dicusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.

Localized treatment approaches for diabetic neuropathic pain management, like pregabalin liposomal topical formulations, offer a novel strategy by directly targeting affected areas. Liposomes enhance skin permeability and sustain drug release, delivering pregabalin efficiently to peripheral nerves while reducing systemic exposure. In a proof-of-concept study using an IVPT and a diabetic neuropathic pain rat model, improved skin penetration and significant reductions in mechanical allodynia and thermal hyperalgesia were shown.

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing IVPT during formulation development of novel topical compounds to help select excipients and permeation enhancers that will properly deliver the drug into the desired layer of the skin or system.

Semi-solid dosage forms are complex drug delivery systems containing one or more active ingredients dissolved or dispersed uniformly in the product. Viscosity modifiers are polymers that hydrate upon interaction with solvents and impart an increase in viscosity. It is often difficult to choose the right grade of the polymer and identify the correct amount that produces a consistent viscosity. The video presentation and research poster discuss the importance of polymer selection during formulation development.