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Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
410-584-0001
Fax: 410-584-0007

Pre-formulation 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 Trial Materials (CTM) and eventually commercial products. Products are formulated based on the physical and chemical characteristics of the Active Pharmaceutical Ingredient (API) and the intended use of the compound.

Formulation Development

Pre-Formulation Capabilities:
Excipient 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

Formulation Development Capabilities:
New Chemical Entity (NCE) development
Specialty ANDA development
Orphan Drugs
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
Packaging in bottles or blister packs
Manufacture of dress rehearsal batch in preparation for CTM supplies
Areas of Expertise
Oral/Solids:
Conventional tablets/capsules
Controlled/delayed release tablets and capsules
Hard gelatin/HPMC liquid filled capsules
Hot melt
Over-encapsulation
Soft gelatin capsules
Coating: film, sugar and functional
Powders
Taste masking, fast-dissolving tablets
 Semi-solids and Liquids:
Ointments/Creams/Gels
Suspensions/Syrups/Solutions
Suppositories/Pessaries

 

 

 

Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development service which meets all of our customers’ needs in a timely fashion