Archer Mary-Ann, Kumadoh Doris, Gaizer Samuel Nii-Bortier, Mensah Adelaide, Jato Jonathan, Kyene Micheal Odoi, Mintah Susana Oteng, Yeboah Genevieve Naana, Sodzi Paul Kwesi, Adi-Dako Ofosua
Department of Pharmaceutics, University of Cape Coast, Cape Coast, Ghana.
Department of Drug Production and Quality Assurance, West African Postgraduate College of Pharmacist, Accra, Ghana.
Adv Pharmacol Pharm Sci. 2022 Apr 27;2022:5340953. doi: 10.1155/2022/5340953. eCollection 2022.
is a monoherbal decoction produced by the Centre for Plant Medicine Research (CPMR), Mampong-Akuapem, Ghana. It is prepared from the stem bark of Engl. (Moraceae), prescribed, and dispensed to patients for the management of nervous disorders. This current formulation presents notable challenges in patients' adherence to treatment regimen due to its bulkiness and bitterness. These challenges have resulted in a decrease in therapeutic outcome. This study sought to transform into oral capsules to mask its bitter taste and reduce bulkiness of the product to improve patients' convenience. In this study, four (4) conventional release capsule formulations were successfully prepared from the decoction via wet granulation using corn starch, lactose, light magnesium carbonate (LMC), and microcrystalline cellulose (MCC) and labelled A01, A02, A03, and A04 respectively. The drug-excipient compatibility studies on A01, A02, A03, and A04 were investigated using Fourier transform infrared (FTIR) spectroscopy. The flow properties of the granules as well as the quality assessment of the formulations such as dissolution, disintegration, uniformity of weight, and assay tests were evaluated using pharmacopoeial and nonpharmacopoeial methods. Appropriate models were used to investigate the difference factor ( ) and similarity factor ( ) of the dissolution profiles of the formulations and . From the study, all formulated granules had excellent flow properties with Carr's index from 7.83 to 9.56%, Hausner's ratio from 1.09 to 1.10, and angle of repose from 25.13 to 27.87°. Drug-excipient compatibility studies demonstrated no interaction between extract and used excipients. All formulations passed the uniformity of weight, disintegration, assay, and dissolution tests. Formulation A02 had the highest dissolution efficiency of 100.12%, while A03 recorded the least value of 97.22% in the 1 h dissolution studies. A comparison of their various dissolution profiles, respectively, to that of its decoction demonstrated their similarity, since, in all comparisons, < 15 and > 50. This implies that, any of these four formulations could be a good substitute for .
是一种由加纳曼蓬 - 阿夸佩姆植物医学研究中心(CPMR)生产的单味草药煎剂。它由桑科植物英格氏(Engl.)的茎皮制备而成,按规定调配并分发给患者用于治疗神经紊乱。由于其体积大且味苦,目前这种制剂在患者坚持治疗方案方面存在显著挑战。这些挑战导致治疗效果下降。本研究旨在将其转化为口服胶囊,以掩盖其苦味并减小产品体积,提高患者的便利性。在本研究中,通过湿法制粒,使用玉米淀粉、乳糖、轻质碳酸镁(LMC)和微晶纤维素(MCC),从煎剂中成功制备了四种(4)普通释放胶囊制剂,分别标记为A01、A02、A03和A04。使用傅里叶变换红外(FTIR)光谱对A01、A02、A03和A04进行药物 - 辅料相容性研究。使用药典和非药典方法评估颗粒的流动性以及制剂的质量评估,如溶出度、崩解度、重量均匀度和含量测定试验。使用适当的模型研究制剂和的溶出曲线的差异因子()和相似因子()。从研究中可知,所有制备的颗粒具有优异的流动性,卡尔指数为7.83%至9.56%,豪斯纳比为1.09至1.10,休止角为25.13°至27.87°。药物 - 辅料相容性研究表明提取物与所用辅料之间无相互作用。所有制剂均通过了重量均匀度、崩解度测定、含量测定和溶出度试验。在1小时溶出度研究中,制剂A02的溶出效率最高,为100.12%,而A03记录的值最低,为97.22%。将它们各自的各种溶出曲线与其煎剂的溶出曲线进行比较,表明它们具有相似性,因为在所有比较中,<15且>50。这意味着这四种制剂中的任何一种都可以很好地替代。
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