Formulation
Preformulation
Primera delivers high quality formulation development services including pre-clinical/phase I formulation, pre-formulation study, formulation screening, formulation testing, stability testing, bioavailability enhancement, novel drug delivery, and generic product development. Our formulation development team offers unsurpassed skill and experience in designing formulation strategy, developing and optimizing formulation methodologies and supporting analytical procedures.
· Physicochemical Properties
o Particle size analysis
o Solubility profile
o pH and pKa determination
o Solid and solution state stability
o Drug-excipient compatibility
· Drug-drug compatibility (for combination drugs)
Formulation screening
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Dosage form
o Solid dosage form (tablets, capsules, softgels, pellets, etc.)
o Liquid dosage form (liquids, suspensions, emulsions, etc.)
o Topical dosage form (creams, patches, gels, etc.)
- Formulation and process development
o Prototype formulation screening (powder flowability, tablet compressibility, dissolution rate, disintegration time)
o Analytical method development for dosage forms (dissolution, assay, impurity, stability indicating)
o Controlled-release tablets and capsules (matrix or membrane system)
- Generic drug development
o Use innovator as reference drug to develop bioequivalent ANDA product.
Stability testing and QC testing for finished product
- Informal stability testing in early drug development stage with elevated temperature and humidity, and shortened storage time point
- Formal stability testing in compliance with the ICH guidelines