Contract Services
Pharmaceutical Characterisation & Analytical Development.- Skin Disease Drug Targets.
- Topical Drug Delivery.
- Transdermal Drug Delivery.
- Nasal Drug Delivery.
- Pulmonary Drug Delivery.
- Oral & Parenteral Drug Delivery.
- Pediatric Formulations.
- In-vitro Performance Testing.
- Preclinical & Clinical Product Development Services.
- GLP Facilities.
- GMP Manufacturing.
- The Process.
Pharmaceutical Analytical Development
The first step in any development process is the implementation of a suitable analytical method for the drug. This can be achieved by adaptation of an existing method or by developing a completely new assay.
Further along the formulation development work, a range of physical and chemical characterisation methods specific to the selected formulation will then complement the drug assay.
The team of pharmaceutical experts of MedPharm is experienced in a large field of chemical and physical characterisation methods and can provide a high-quality analytical service, tailored to the specific requirements of the respective project.
For perspective, MedPharm can undertake:
- Solubility studies, logP and pKa determination.
- Investigation of crystalline states and polymorphism.
- Method development and validation to ICH requirements.
- Isolation and identification of impurities, degradation products and metabolites.
- Stress modelling for drug substances and drug products.
- Dissolution testing to BP and USP requirements.
- Drug release testing.
- Particle sizing.
- Stability testing to ICH guidelines.
- Microscopical and rheological characterisation
MedPharm utilises a broad range of modern analytical techniques including:
- High Performance Liquid Chromatographs (HPLC) with UV, PDA, MS/MS, LS, fluorescence and RI detectors.
Size exclusion and ion pair chromatography .
Gas Chromatography – Mass Spectrometry (GC – MS).
Gel electrophoresis.
Immunoassay.
Modulated Differential Scanning Calorimetry (MtDSC).
Thermogravimetric Analysis (TGA).
Spectroscopic techniques