For industrially manufactured pharmaceutical dosage forms, specific types of tests are required to ascertain the quality of the final product, prior to its arrival to the market. Current compendial requirements determine disintegration and/or dissolution tests as a crucial component of the quality control analysis. For the most of the drugs these requrements are well known and precisely defined. However, the challenge arises, when for some of the oral dosage forms - with specific formulation, the implementation of the effective instructions and monographs is difficult and does not reflect the actual quality of the dosage form.
The Master’s thesis is focused on the development of a method for evaluation of paracetamol dissolution from granules packed in straws. During the development of the method monographs from European and American pharmacopeia were considered. The practical part of the thesis consists of three main phases. The first phase summarizes only a part of the validation parameters of the analytical method in terms of specificity, linearity and range, repeatability, and stability of solutions (defined in accordance with the international conference on harmonization). In order to obtain a better basic understanding of the physicochemical properties of paracetamol, preliminary studies were performed, which also represent the second phase of the thesis. In this section parameters such as: active pharmaceutical ingredient solubility, filter compatibility, media type, volume media and the adequacy of USP apparatus 1 and USP apparatus 2 were evaluated. Obtained results were important and therefore considered while performing the third phase of the thesis-method development. This section refers to the actual procedure and its final parameters used for the sample analysis. Parameters such as deaeration, agitation, and hydrodynamics and its influence on the coning effect were determined. Despite following the official instructions, an additional test as a part of method development was performed in order to define the taste masking ability of granules, as a quality control parameter of the final dosage form.
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