According to the pharmaceutical technology process, every medicine should be approved by manufacturing process design. And the first step for this design is investigation of critical process parameters (CPP). CPP is a process parameter that its variability has an impact on critical material attribute and therefore it needs to be monitored and controlled to have an ensured process in a desired quality. Generally it is accepted to type the CPP based on the knowledge of the team and experience. Seven methods for wet granulation were seen for critically.
The setting of wide operational ranges is represented as high and low levels of each factor which mean their maximal and minimal levels. Active substance coded A06, lactose monohydrate, microcrystalline cellulose), povidone, pregelatinized starch, sodium starch glycolate, colloidal silica, magnesium stearate, purified was used as a granulating fluid.The processes were run in according to experiments with the given materials. Which were conducted some levels of factors. During runs, C1 and C3 factors were central levels. Tablets made in each run were tested for main and additional outcomes.
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None of the investigated process factors has critical impact on tablet mass uniformity and friability. According to the trials, the critical parameters of wet granulations are: the amount of binding solution, impeller speed during massing and massing time. Tablets of unacceptable dissolution can cause from high levels of factors operational settings. Because of the complexity and highly dynamic process high shear wet granulation is still not fully explained.Conclusion:In Conclusion, we need to know the variability and sustainability of the products that we have and in order to do the Critical Parameter process by wet granulation we need to understand the factors of CPPs. Understanding the manufacturing process of CPPs requires the CPPs to be perfectly typed, and set as high and low , maximal and minimal settings of their operational factors.
