The pharmaceutical industry is increasingly focusing on the Quality by Design approach in the development of new products, which is based on in-depth processes and material understanding. A common first step in tablet manufacturing is often granulation, which can be performed using a roller compactor. This technique enables good process control, allows higher drug load in the dosage form, and ensures granules with suitable properties for further processing. One of the critical quality attributes for solid oral dosage forms is the drug dissolution, which directly affects its bioavailability. The parameters used during granulation and the product formulation itself can influence drug substance dissolution. Therefore, the impact of these parameters must be assessed using an appropriate dissolution method. The aim of this master's thesis was to develop and qualify a selective in vitro dissolution method for immediate-release tablets containing a poorly water-soluble DS (drug substance). The goal was to establish a robust and discriminatory method capable of detecting changes in Critical Material Attributes and Critical Process Parameters that may influence drug release and, consequently, product efficacy. We evaluated filtration, the stability of the sample and standard solutions, and selected appropriate conditions for conducting the dissolution tests (USP apparatus 2, 900 mL of 0.1 M citrate buffer pH 4.6, and a paddle speed of 60 rpm). Subsequently, due to the product's specificity, a test to assess drug substance carry-over was performed, and an appropriate cleaning procedure was selected. When evaluating the impact of formulation parameters, we determined that DS particle size and the amount of intragranular disintegrant have a significant influence on DS dissolution. Regarding roller compaction process parameters, we determined that a higher compaction force slows down the initial dissolution, while the roller gap and sieve size within the investigated ranges did not have a statistically significant impact on the overall dissolution profile. Based on the results of the tested samples, the discriminatory power of the developed dissolution method was evaluated. The method detects major changes leading to non-comparable dissolution profiles, while also demonstrating the impact of minor changes that remain within the established limits. The developed method is suitable for quality control testing and as a supporting tool in product development.
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