Research and development
|
The laboratory specializes in development of research methods and drug quality assessment. We are able to perform dissolution tests of both solid dosage forms (tablets, capsules) and suspensions in compliance with the Ph. Eur. requirements and current EMEA’s guidelines. The laboratory performs the validation of methods in accordance with the ICH Q2 (R1) guidelines. We measure the effectiveness of penetration and permeation of active ingredients (API) for epidermic formulations (ointments, gels, creams, emulsions, suspensions, solutions). For this purpose in vitro diffusion studies with the Franz-type cell are used. The advantage of this system is the low volume of fluid release and a very practical diffusion chamber allowing very precise deposition of the formulation to the pre-prepared skin. We develop statistical measurements made in the laboratory of pharmaceutical availability (comparing the release profiles of the coefficients F1; F2) in accordance with the cpmp/ewp/qwp/1401/98 guidelines „Gudeline on the investigation of bioequivalence” and Guidance for Industry „Dissolution testing of immediate release solid oral dosage forms”. |
![]() |
