Monday 13 April 2009

Sample of Formulation Development Outline

NextPharma PDS provides pre-formulation evaluation and formulation development services for oral solid, semi-solid, liquid and parenteral dosage forms of both small molecules and biologics.

Pre-formulation evaluation services include:

  • pKa determination
  • Partition coefficient
  • Chemical stability profile
  • Solubility determination
  • Crystal properties and polymorphism (DSC, XRPD)
  • Particle size, shape and surface area

Formulation Development Capabilities include:

DOSAGE FORM AVAILABLE FORMS CHARACTERISTIC OTHER FEATURES
Solid Dosage Tablets Uncoated tablets


Film coated tablets


Effervescent tablets

Capsules Hard capsules Granulation available

Pellet Immediate release


Extended release


Gastric-resistant release

Powder Lyophilized sterile or
non-sterile




Non-sterile
Semi-solid Dosage Ointments Non-sterile filled in tubes and single dose-units

Creams Non-sterile filled in tubes and single dose-units

Gels Non-sterile filled in tubes and single dose-units
Liquid Dosage Solutions Sterile or Non-sterile
(oral and topical)
Aqueous or solvent based

Emulsions Sterile or Non-sterile
(oral and topical)
Aqueous or solvent based

Suspensions Sterile or Non-sterile
(oral and topical)
Aqueous or solvent based


Process Validation

  • Manufacturing of development trial batches
  • Stability testing of trial batches
  • Selection of optimal formulation
  • Scale-up and from laboratory-scale to pilot scale and then to production scale batches
  • Manufacturing process validation
  • Technology transfer

Monday 6 April 2009