Paroxetine hydrochloride controlled release POLYOX® matrix tablets: Screening of formulation variables using Plackett-Burman screening design

摘要

The aim of the present study was to screen the effects of the formulation variables — POLYOX® molecular weight (X₁), the ratio of POLYOX®/Avicel® PH102 (X₂) and the amount of POLYOX® and Avicel® PH102 (X₃), hardness (X₄), HPMCP amount (X₅), Eudragit® L100 amount (X₆), and citric acid amount (X₇) — on the paroxetine hydrochloride release from POLYOX® matrix tablet using the Plackett-Burman screening design. Paroxetine hydrochloride matrix tablets were prepared according to a 7-factor-12-run statistical model and subjected to a 8-h dissolution study in Tris buffer at pH 7.5. The regression results showed that POLYOX® molecular weight (X₁) and POLYOX®/Avicel® PH102 ratio (X₂) had significantly influence on the drug release mechanism and drug release rate as main effects. Hardness (X₄) had an insignificant effect on the drug release mechanism but a significant effect on the drug release rate. On the other hand, HPMCP, Eudragit® L100 and citric acid had an insignificant effect on the both responses. The information obtained by screening design study can be expected to be useful for further formulation studies.