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Formulation Development

Solid dose forms: tablets, capsules
Spray-dried powders, nebuliser and dry powder inhalers
Lipid-based formulations and self-emulsifying systems
Enhancing drug solubility
Liposome and nanosuspension systems
Analytical Testing

Assays, method development & validation (HPLC & GC/LCMS)
Stability assessments under accelerated and ICH conditions
Product characterisation: DSC, XRD, NMR, FTIR, DLS, DVS, BET, TGA
Pharmacopeial methods, e.g. dissolution studies
Chemistry and Biological Therapeutics

Isolation & identification of impurities, metabolites, & degradants
Purification of active ingredients & products
Synthesis & isolation of related compounds
Scale-Up and Consultancy

Technology transfer and scale-up manufacturing support
Technical consultancy in project design and development, including data interpretation

Focus Areas

Facts and figures

Biological therapeutics and large molecules

Expertise in stabilisation, formulation, and complex assay development
Small molecules

Expertise in drugs with solubility and stability challenges
Controlled drug substances, selected cytotoxic compounds and botanical extracts
Contaminant, precipitant and foreign material analysis

Encountered during development and manufacturing

Facts and figures

Inhaled

Lung and nasal delivery, including liquid and dry powder-based systems and device assessments
Parenteral

Intravenous, subcutaneous and intramuscular, including dose volume and physiological considerations
Oral

Tablets, capsules, liquids, sublingual/buccal with consideration of GI physiology, biochemical processes and first-pass metabolism
Topical

Gels, emulsion-based systems, including ophthalmic