Development of medicines and placebo for clinical trials and for patients
The development of a new product/formulation for clinical trial starts with a physical-chemical characterisation of API (active substances), such as by determining particle size and particle size distribution, solubility and compatibility studies, and density measurement. Based on the results of these studies, we produce one or several composition proposals for preliminary stability studies.
Proposed formulations and manufacturing processes for medicine preparations and medicine-promixate products are developed. The proposals are based on the result of the pre-formulation studies and the desired product
The preparation forms we develop include:
We develop and validate the physical-chemical and microbiological analysis methods used to characterise products and in stability studies. We base these on the
product’s characteristics and propose a suitable method before carrying out development and validation. All work is carried out according to the ICH guidelines.
We work using techniques such as UPLC, HPLC, GC-fid, GC-headspace, HPLC-MS, GC-MS, IR, UV/vis, DSC, TGA and release analyses. We also have very long experience of wet chemical analysis according to pharmacopeia.
To enable us to state product durability periods, we carry out stability studies to see how well they do over time and under differing conditions. We set up stability studies in climate rooms according to the ICH guidelines.
The scope of the stability studies is determined on the basis of the product durability required.
Pre-formulations, products in clinical trials and commercial products can all be put through stability studies.