Formulation Development

Drug or pharmaceutical formulation development involves combining the drug’s active pharmaceutical ingredient (API) with other inactive components (excipients) to generate a final drug product. Formulation development and subsequent analytical testing are among the most critical aspects of a drug’s clinical development pipeline.

A well-developed formulation ensures the stability of the API, ascertains the route and ease of administration of the drug, affects solubility and influences the drug’s bioavailability and toxicity profiles. On the other hand, deficiencies in a formulation can lead to significant delays and can have negative implications late in the drug’s development process.

At Emery Pharma, we have significant experience with all aspects of formulation development: pre-formulation studies, formulation trials, functional assays, stability assessments, analytical testing, and bioavailability and ADME studies. We are happy to be the partnering lab for Clients considering formulation development.

Formulation Development Using Your API or Compound of Interest

  • Discovery: producing oral formulations and topicals such as solutions, gels, creams, lotions, ointments, etc.
  • Optimization: formulation robustness, excipient compatibility, skin permeation/retention measurements, dissolution.
  • Stability: Per ICH Q1A (R2) or customized to your needs.
  • Scalability: initial prototype design through to scale-up and technology transfer for commercial batches.

Functional Assays

  • Oral administration: Dissolution Testing
    • USP Apparatus 2 (Paddle apparatus) per USP <711>, suitable for testing products that release small particles e.g., tablets made by direct compression or powder-filled capsules. The rate of dissolution in various solid formulations can be determined by using USP Apparatus 2 followed by UV-Vis or LC-MS/MS detection techniques.
  • Topical/non-oral administration: In vitro release/permeation testing (IVRT/IVPT)
    • Offering the industry standard 6 Franz vertical diffusions cells from PermeGear
    • Availability of dermatomed cadaver skin
    • Aiding in a new drug or generic registration through batch release and bioequivalence testing

Stability

  • Climatic zones based on ICH Q1A (R2) to resemble the temperature and humidity changes across the United States.
  • Customized stability conditions include simulating “real-world” storage or in support of global registration.