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.
Cormica 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.
- Alongside analytical characterisation, early microbiological studies can help optimise preservative systems, assess antimicrobial performance and identify stronger formulation candidates before formal GMP or GLP testing begins.
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
Microbiological Support for Formulation Development
Preservative selection and antimicrobial performance can be assessed early in development, helping teams identify promising formulations before progressing into formal GMP or GLP testing.
Fit-for-purpose R&D studies can be used to screen multiple formulations, preservative systems or concentrations quickly and cost-effectively. This gives development teams practical evidence to refine their formulation, reduce unnecessary later-stage testing and make more informed decisions.
Support can include:
- R&D preservative efficacy testing and formulation screening
- Preservative selection and concentration comparisons
- Antimicrobial effectiveness studies
- Screening of multiple formulation candidates
- Bespoke in vitro infection and antimicrobial models
- Laboratory evidence to support antimicrobial performance claims
- Progression into formal GMP or GLP testing when required
With decades of experience and expert microbiologists across our global laboratory network, projects can be supported from early exploratory studies through to clinical, regulatory and commercial testing.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
