4‐in‐1 Multipurpose Excipient from Musa acuminata Fruit by Alkaline‐Steeping/Retrogradation (ASR) in Acetaminophen Tablet Formulation

Abstract

The conventional approach in the tablet formulation of acetaminophen (ACM) suggests the use of five or more different excipients in a wet granulation tableting process. The use of many excipients in tablet formulation may negatively create excipient-excipient interactions, excipient-drug interactions, exaggerated product side effects, and high drug load. Cutting-edge technology would be the use of one excipient with a quadrupled functional purpose (4-in-1) by direct compression tableting. In this study, a novel two-phase process called "alkaline-steeping/retrogradation" (ASR) is employed to obtain the desired starch polymer excipient of quadrupled functional purpose. In phase I, the biopolymer is extracted from the unripe fruits of Musa acuminata by a modified alkaline solution steeping method, while in phase II, 50% w/w of the extracted polymer is retrograded. The retrograded product is re-mixed with the non-retrograded 50% w/w that is left from phase I. This gives a novel 50-50% w/w blend named Musa acuminata advanced starch polymer (MAP). To authenticate the efficiency of the ASR, the physicomechanical, analytical, and drug release properties of different concentrations of MAP/ACM solid systems are characterized to ascertain the compatibility. The ASR method produces a unique semi-hygroscopic biopolymer excipient of quadruple-function in ACM high-dose tablet formulation by direct compression.