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Latest Headlines
Xcelience and IriSys business alliance agreement strengthens regional access to CMC/Regulatory expertise
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| Xcelience Adds Piccola B10 Minipress for GMP Tablet Formulation Development in Experimental Area
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| Xcelience and Penn Pharma Form a Joint Venture to Provide API Into Capsule Services in Europe and Asia Pacific Markets
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Case Studies
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Case Study 7
Formulation of Low Density and Unstable Drug for Controlled Release Delivery
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The characteristics of the API included low density, low melting point, cohesive nature and unstable in presence of water in addition to lot-to-lot variation.
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An API densification process was used to make the API suitable for uniform filling into hard capsules for Phase 1 pharmacokinetics studies.
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The PK data and pre-formulation characterization of the API (determination of pKa, solubility in various solvents, moisture uptake and DSC and TGA) were used to design and develop a controlled-release tablet for continued clinical study.
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A suitable dosage form has been developed and the sponsor has filed a patent to protect their intellectual property.
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