CN

Formulation Development Service

Tai Heng provides total solution for formulation development, enabling our customer benefit from our development resources, from fully validated equipment to experience development expertise. Starting from pre-formulation, Tai Heng helps our customer to select the most suitable dosage form for preclinical and clinical studies. With vast analytical technology assessable only to Tai Heng, we are able to provide complete characterization on key physical and chemical properties of API, and Reference Drug, if it is for generic development. We can assist our customer quickly identify and select best formulations from our in-house database, thanks for our years of development experience and vast network of internal and external resources. Our formulation expertise mainly focuses upon oral dosages, including both immediate release and modified release tablets and capsules, with various release mechanisms, from simple matrix based release to pulse release, and osmotic pump.

Pre-Formulation Service:

· API Solubility Evaluation

· Excipient compatibility Evaluation

· Intrinsic Dissolution Study

· Forced Degradation Study and Degradation Pathway Determination

· Solid State Studies(Polymorphism、Particle Size, Particle Distribution, and Particle Morphology, etc.)

Formulation Development Service:

· Deformulation Study (for generic drug development only)

· Preliminary Formulation Development for New Chemical Entity (NCE)

· Composition and Process Optimization based upon QbD principle

· Novel Dosage Form Development

· Scale up, Tech Transfer, and Gap Analysis on Manufacturing Process

· GMP Manufacturing for early and later phase clinical supply.

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