TY - JOUR
T1 - 4-in-1 Multipurpose Excipient from Musa acuminata Fruit by Alkaline-Steeping/Retrogradation (ASR) in Acetaminophen Tablet Formulation
AU - Autamashih, Musa
AU - Ebrahim, Naushaad
AU - Egieyeh, Samuel
AU - Aucamp, Marique
AU - Rosa, Paulo Cesar Pires
AU - Poka, Madan S.
AU - Ngilirabanga, Jean Baptiste
AU - Samsodien, Halima
N1 - Funding Information:
The authors wish to express gratitude to the staff of the School of Pharmacy at the University of the Western Cape for their technical support. This work was supported by “The World Academy of Science” (TWAS) in partnership with the “National Research Foundation” (NRF) of South Africa. Award reference: PD‐TWAS150925143012).
Publisher Copyright:
© 2021 Wiley-VCH GmbH
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - 4-in-1 multipurpose excipient
KW - Musa acuminata
KW - acetaminophen tablet formulation
KW - alkaline-steeping
KW - retrogradation
UR - http://www.scopus.com/inward/record.url?scp=85111359625&partnerID=8YFLogxK
U2 - 10.1002/star.202100016
DO - 10.1002/star.202100016
M3 - Article
AN - SCOPUS:85111359625
SN - 0038-9056
VL - 73
JO - Starch/Staerke
JF - Starch/Staerke
IS - 9-10
M1 - 2100016
ER -