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Preformulation and Formulation Development

Drug development projects begin with pre-formulation and formulation development.

Pre-formulation and formulation development are critical steps that lead to the manufacture of Clinical Supplies (CTM) and eventually contract manufacturing of products. Products are formulated based on the physical and chemical characteristics of the API (Active Pharmaceutical Ingredient) and the intended use of the compound.

Pre-Formulation Capabilities

	Excipients Compatibility Studies
	Micronization
	Particle Size Analysis
	Bulk and Tap Density
	pH-stability Profile
	pH-solubility Profile
	Intrinsic Dissolution
	pKa Determination
	Partition Coefficient Measurement
	Hygroscopicity Studies
	Thermal Analysis
	API Compatibility
	Water and Cosolvent Solubility
	Stability Indicating Method Development
	Degradation Path Elucidation
	Crystal Morphology by Light Microscopy
	FTIR
	Forced Degradation Studies

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Formulation Development Capabilities

	Specialty ANDA Development
	Control Release Formulations
	Line Extensions of existing products
	Reformulation of existing products
	Typical Formulation Development Program
	Prototype Formulation Development
	Scale-up of selected prototype formulation
	Accelerated stability of prototypes and selection of lead prototype
	Accelerated stability of prototypes and selection of lead prototype
	Manufacture of dress rehearsal batch in preparation for clinical supplies

	Conventional tablets/capsules
	Controlled/delayed release tablets and capsules
	Hard gelatin/HPMC liquid filled capsules
	Soft gelatin capsules
	Coating: film, sugar and functional

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