Formulation Development

The team at Cormica can meet your formulation needs, developing “phase – appropriate”  formulations tailored to the characteristics of the API, for NCEs and generics alike.

Formulation Development process flow

offer a fast, cost effective and flexible approach to formulation development of drug product:

  • The team have considerable expertise of developing and testing formulations from simple to complex (e.g. powders, solids, liquids, creams, gels, slow release, fast release) across a range of delivery routes (oral, nasal, inhalable, injectable, topical).
  • The team works alongside material science, DMPK investigators and toxicologists to design an effective formulation screening programmes to de-risk your programme and solve challenges with formulation development.

Formulation Development image


Drug Product Development

Drug Product Development

More Analytical Chemistry:
Analytical Chemistry Resources

Drug Product Development

Analytical techniques typically deployed for Q1/Q2/Q3 equivalence studies include:

  • XRPD
  • FTIR
  • DSC, mDSC, TGA
  • Isothermal Microcalorimetry (Amorphicity and relaxation studies)
  • BET Specific Surface Area
  • Helium Pycnometry
  • Spraytec
  • Morphologi 4-ID / Morphologically Directed Raman Spectroscopy
  • Particle size / charge
  • NGI (Next Generation Impactor)
  • Inverse Gas Chromatography
  • Size Exclusion Chromatography
  • HPLC / uHPLC
    • UV, PDA, DAD, Fluorescence
    • ELS, RI, CAD, MS, MS/MS
  • Inductively Plasma – Optical Emission Spectroscopy / Mass Spectrometry

IVBE (in vitro Bioequivalence) studies to FDA recommendations for a range of dosage forms including:

  • Nasal sprays and nebulizers
  • Dry powder & metered dose inhalers
  • Topical creams & ointments
  • Ophthalmics
  • Liposomes
  • Oral solid dose

Identification / structural elucidation of impurities / synthesis of unknown impurities in the API and generic prototypes finished products:

  • Preparative Mass-Directed Impurity Isolation
  • LC-MS/MS
  • NMR

Method development and GxP capabilities:

  • Analytical method development, verification, validation and transfer
  • GMP release testing of Generic API and critical excipients
  • We are GMP and GLP accredited; FDA inspected

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