Partial least square projections to latent structures analysis (PLS) in evaluating and predicting drug release from starch acetate matrix tablets.

The aim of this study was to evaluate whether or not starch acetate can act as a release-controlling excipient with physicochemically different drugs, using multivariate data analyses (PLS) for the modelling of drug release from starch acetate tablets. In addition, variables contributing to drug release at certain points of time were studied. Physicochemical properties of drugs were calculated by the VolSurf method. Nine different formulations were produced with six different model drugs. In vitro dissolution studies were carried out for the determination of the drug release profiles for each formulation. PLS analysis was used to evaluate the properties dominating the drug release. Drug release profiles varied widely, depending on the formulation, process, and physicochemical properties of drugs. PLS models were developed to describe the release phenomena. It was observed that at the beginning of the dissolution process, formulation and process variables played a major role in the drug release. Later in the dissolution process, the molecular properties of drugs became the dominant variables. Starch acetate was able to act as a release-controlling excipient with different drugs. Multivariate data analyses were found to be a powerful tool for the evaluation and prediction of drug-release characteristics from the tableted starch acetate matrix.