Topical pharmaceutical product formulations can be used to treat local and systematic indications. They offer ease of delivery, facilitate patient compliance, and avoid the problem of first-pass metabolism. These formulations may be liquids, creams, gels, or other semisolid forms. Successfully developing a topical formulation requires an understanding of the physiochemical properties, such as release characteristics, composition of the drug-delivery system, and the nature of the drug delivery vehicle.

In addition organoleptic properties (appearance, feel, scent) may be important. For process development and manufacturing of a semisolid dosage form a CMC strategy must be implemented that ensures not only efficacy, chemical and physical stability, but a minimization of process impurities.

Processing and Production Capabilities:

  • Liquid, Cream & Gel Manufacturing
  • Novel formulation development or existing formulation optimization
  • Controlled substances (Schedule I – V)
  • Identification and optimization of critical process parameters, using DOE when appropriate
  • Development and implement process controls using Quality by Design to streamline pre-market approval
  • High and low shear homogenization
  • Semi-automated vial, bottle, tube filling
  • Laboratory & pilot batches to scale-ups & technology transfer
  • Temperature controls
  • Variable speed mixing
  • Double-sided agitation
  • Blending & granulation
  • Trial runs on new products
  • cGMP batch sizes (1 to 20 L)