Dissolution profile comparison and IVIVC(In vitro in Vivo control) study of substances is required to apply in the regulatory agency for any post-approval change. The dissolution curve is plotted between the Rate of Dissolution and Time. The rate of Dissolution is Studied using various models.
Various Factors in Dissolution studies:
- F1 Factor or Dissimilarity factor value is Directly proportional to the Difference between 2 Dissolution profiles Acceptable F1 value by regulatory agencies is 0-15 value above 15 indicates the significant dissimilarity between 2 Processes
- F2 Factor Or Similarity factor is inversely proportional to the square of Difference 2 Dissolution profiles values between 50-100 is considered significantly similar. F2 factor 100 indicates that 2 processes are the same.
- Q Factor in Dissolution indicates Active Ingredient.
Importance Of Factors In Dissolution studies:
- Biowaiver: Biowaiver is granted byUSFA for Drugs categorized in Class 1 and Class 3 of the Biopharmaceutical classification system to apply for Biowaiver drug must have high solubility. It is granted by the regulatory agencies to avoid unnecessary exposure of healthy subjects to drugs. Once biowaiver is approved by the concerned authority the need for in vivo studies is not required and changes in the process can be made on the basis of in vitro studies.
- Post-approval changes: If we want to make changes in the existing process FDA requires us to conduct a Dissolution profile comparison.
- In a nutshell, the Dissolution profile comparison helps us to compare the Degree of Similarity(F2) and Degree of Dissimilarity(F1) between 2 Different Dissolution processes F1 and F2 are the factors of Dissolution studies.
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