Formulation and Optimization of Metronidazole and Lactobacillus spp. Layered Suppositories via a Three-Variable, Five-Level Central Composite Design for the Management of Bacterial Vaginosis

Autor: Margaret O. Ilomuanya, Busayo B. Salako, Modupe O. Ologunagba, Omonike O. Shonekan, Kruga Owodeha-Ashaka, Eseosa S. Osahon, Andrew N. Amenaghawon
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Pharmaceutics, Vol 14, Iss 11, p 2337 (2022)
Druh dokumentu: article
ISSN: 14112337
1999-4923
DOI: 10.3390/pharmaceutics14112337
Popis: Bacterial vaginosis, a polymicrobial clinical syndrome characterized by a shift in healthy vaginal microbiota due to bacterial colonization, is characterized by high recurrence rates after conventional treatment with an antimicrobial agent. This has necessitated the need to develop a formulation that has the potential to ensure Lactobacilli viability and bacterial clearance. This study seeks to develop and optimize a layered suppository using a five-level central composite design to ensure optimized metronidazole release and lactic acid viability. Layered suppositories were formulated using the fusion method using polyethylene glycol blend 1500/4000 and Ovucire® as suppository bases. Lactobacillus fermentum was incorporated in the molten mass before molding the solid body suppositories into the cavity of hollow-type suppositories and sealing the molten excipients. Artificial neural network model predictions for product optimization showed high predictive capacity, closely resembling experimental observations. The highest disintegration time recorded was 12.76 ± 0.37 min, with the optimized formulations showing lower times of 5.93 ± 0.98 min and an average weight of 1.17 ± 0.07 g. Histopathological observations determined high compatibility of suppositories with vaginal cells with no distortion or wearing of the vagina epithelium. This optimized formulation provides a safe and promising alternative to conventional suppositories in the treatment and prevention of the recurrence of bacterial vaginosis.
Databáze: Directory of Open Access Journals
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