Topical Product Manufacturing

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 the 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, the 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)