8The primary drug quality requirements, safety, efficacy and reliability, for oral pharmaceutical 9 products in tablet form, translate into bioavailability, and tablet weight and strength. The 10 bioavailability of an oral drug, i.e., the amount of the drug that can reach the systemic 11 circulation, depends on drug permeation rate through the epithelial membrane or on dissolution 12 rate, in case of bioequivalence. Thus, the critical quality attributes affecting bioavailability can 13 be the dissolution profile, tablet weight and tablet hardness, which are affected by process 14 conditions and drug product composition, i.e., active pharmaceutical ingredients (APIs) and 15 excipients and their mass fractions. A Mixture Design (DOE) experiment has been carried out 16 for a generic oral drug, with input factors the mass fractions of three excipients and response 17 variables the dissolution profile, tablet weight and hardness. While the last two response 18 variables are single-point-value attributes, a dissolution profile is a multi-point-value attribute 19 and is assessed using integral measures, e.g., similarity factor, from pair-wise, model-20 independent methods. The data from the Mixture Design experiment are used to develop a multi-21 regression and multi-response optimization model, which, in turn are used to determine the 22 Design Space (DS) for the pharmaceutical product of interest. 23
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