PSS network have decades of experience testing hundreds of pharmaceutical drug products and provide clients with excellent analytical chemistry expertise. 

 

This includes the development of analytical methods by U/HPLC/ LC-MS and other techniques as well as the development and validation of potency and related substances with stability-indicating methods. Our scientists are also highly experienced with a large number of USP and Pharm. Eur. tests.

Our team has extensive experience in Bio-relevant Dissolution tests and has in his network an access to sophisticated and by EMA and FDA well accepted bio-relevant dissolution method, simulating the Gastro-Intestinal Tract (TIM model*). 

The TIM system has demonstrated an ability to support the development of poorly soluble drug products using the ‘lipid membrane’ set up and captures dissolution under dynamic physiologically relevant conditions. Uniquely it also mimics the concurrent ‘absorption’ step thus providing greater insight into formulation performance than static systems, in which dissolved drug is not removed thus curtailing further dissolution that would occur in vivo. The design of the system means that it can quickly provide insight into the impact of GI physiological variability such as variable gastric pH.

This model was used successfully in the different product development stages (Candidate selection early and late development) to select the most promising candidate or formulation prototype and increase the probability of success in clinical studies.

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*An Investigation into the Utility of a Multi-compartmental, Dynamic, System of the Upper Gastrointestinal Tract to Support Formulation Development and Establish Bioequivalence of Poorly Soluble Drugs 

Paul Alfred Dickinson, et al. February 2012 The AAPS Journal 14(2):196-205