Batch-to-batch consistency in the quality attributes of a phyto-pharmaceutical MA001 used to treat typhoid in Ghana

Authors

  • O. Adi-Dako Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Accra, Ghana
  • M. A. Archer Department of Pharmaceutics, University of Cape Coast, Cape Coast, Ghana
  • D. Kumadoh Department of Pharmaceutics, Centre for Plant Medicine Research, Mampong-Akuapem, Ghana
  • N. Y. A Ofori-Atta Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Accra, Ghana
  • C. Osei-Asare Department of Pharmaceutics, Kwame Nkrumah University of Science Technology, Kumasi, Ghana
  • F. W .A Owusu Department of Pharmaceutics, Kwame Nkrumah University of Science Technology, Kumasi, Ghana
  • B. B. N’guessan Department of Pharmacology and Toxicology, School of Pharmacy, University of Ghana, Legon, Accra, Ghana
  • E. Adase 4Department of Production, Centre for Plant Medicine Research, Mampong-Akuapem, Ghana
  • I. Y. Attah Department of Pharmaceutical Chemistry, University of Cape Coast, Cape Coast, Ghana
  • J. A. Sarkodie Department of Pharmacognosy and Herbal Medicine, School of Pharmacy, University of Ghana, Legon, Accra, Ghana

DOI:

https://doi.org/10.54106/251.jmbs7z

Keywords:

MA001, , batch-to-batch, consistency, elemental content, microbial load, spectroscopic markers, physicochemical test

Abstract

In pharmaceutical manufacturing, products are made using standard operating procedures which are specific for each product. As a result, it is expected that, any number of batches of the same product selected at random for evaluation should either have the same results for all tested criteria or the difference between them should be within the acceptable limits. Batch-to-batch consistency study of herbal products is an important quality control parameter for assessing their reproducibility, efficacy and safety profile. This study sought to assess the batch-to-batch consistency of MA001, a herbal product using parameters such as colour, odour, taste, pH and total solid residue. Other assays conducted on the products included UV spectrometry and HPLC fingerprinting. Elemental analysis of the three batches of MA001 were selected for the study. The results from this study showed that, the products from the different batches had the same physico-chemical parameters as specified by the manufacturer. Ultimately, the sampled batches passed the batch-to-batch consistency test, hence, the reproducibility, efficacy and safety of MA001 decoction is assured.

Downloads

Published

2023-07-09

Issue

Vol. 9 No. 1 (2023)

Section

Articles

License

 The Journal of Medical and Biomedical Science publishes original, novel, peer-reviewed reports that pertain to medical and allied health sciences; confirmatory reports of previously described phenomena that either contain a novel finding or are of such magnitude to enhance the field; as well as laboratory or basic science investigational studies that are meritorious.