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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

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Area of Expertise Oral Solids

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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Content Copyright Emcure Pharmaceuticals USA, inc. 2006