At Milton Pharmaceutical Company, we are highly experienced in preformulation and analysis of Active Pharmaceutical Ingredients (APIs), including those that present particular challenges. We regularly help early stage companies to evaluate the physicochemical properties of their new drug, carrying out the essential groundwork for optimising the formulation and delivery method. We can then create a product that is appropriate for your needs, whether you require a fit-for-purpose formulation for initial preclinical safety and efficacy testing or a formulation strategy designed to help your drug progress into clinical use.
Our Preformulation Capabilities Include:
- API stability profiling (including an evaluation of the effects of heat, light, and pH).
- Solubility profiling in buffers and non-aqueous solvents, and determining the partition coefficient of an API.
- Compatibility testing of APIs and excipients.
- In vitro diffusion studies using Franz cells with synthetic and/or biological membranes.
- Rheology and viscoelastic pre-formulation studies of liquids, creams and gels.
- Specific gravity testing.
- Informal stability/formulation stress testing (both physical and chemical).
- Formulation and packaging compatibility studies.
- Tablet compaction analysis.
- Powder formulation investigations using an Xcelolab™ powder dispenser for method development, powder dispense head selection and powder characterisation studies.
- Parenteral formulations for early phase toxicity evaluation.
- Management of characterisation services such as, but not limited to, particle size, DSC, TGA, powder X-ray diffraction, FTIR and particle morphology.
- Writing CMCs and other regulatory documents for product registration with the MHRA, FDA and EMEA regulatory bodies.
- Supply of liquids, mini-capsules and mini-tablets for use in animal studies.