Aslani Abolfazl, Sharifian Tahereh
Department of Pharmaceutics, School of Pharmacy and Novel Drug Delivery Systems Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Adv Biomed Res. 2014 Oct 20;3:209. doi: 10.4103/2277-9175.143252. eCollection 2014.
Amoxicillin is a semisynthetic antibiotic, which is used as an antimicrobial drug. This study was designed to formulate amoxicillin effervescent tablets, aimed at improved patient compliance and increased drug stability.
In this study, nine effervescent tablet formulations were prepared from amoxicillin trihydrate. The effervescent base was comprised of various amounts of citric acid and sodium bicarbonate. Powders and granules were evaluated for their particle size, bulk density, tapped density, compressibility index, Hausner's ratio and angle of repose. The effervescent tablets were then prepared from powders and granules of acceptable quality by direct compression and fusion methods. The tablets were evaluated for weight variation, friability, pH of solution, carbon dioxide (CO2) content, hardness, effervescence time, thickness, assay, content uniformity, water content and equilibrium moisture content.
The results indicated better flowability of granules prepared by fusion method as compared with the direct compression. The percent weight variations of tablets were within the acceptable limit of 0.5%. The friability was less than 1% in all formulations. The solution pH of tablets prepared by direct compression and fusion methods ranged from 4.55 to 5.74 and 4.74-5.84, respectively. The CO2 amounts generated by of fusion method tablets were smaller as compared to the direct compression method. The hardness of tablets was 40.66-56 for direct compression method and 60.6-74.6 for fusion method. The tablets produced by the fusion method had a larger thickness and lower water content than tablets produced by direct compression method.
Tablets prepared by the fusion method exhibited superior pre- and post-compression characteristics as compared to tablets prepared by direct compression method.
阿莫西林是一种半合成抗生素,用作抗菌药物。本研究旨在制备阿莫西林泡腾片,以提高患者依从性并增强药物稳定性。
在本研究中,用三水合阿莫西林制备了9种泡腾片制剂。泡腾碱由不同量的柠檬酸和碳酸氢钠组成。对粉末和颗粒进行粒度、堆密度、振实密度、压缩指数、豪斯纳比和休止角评估。然后通过直接压片法和熔融法,由质量合格的粉末和颗粒制备泡腾片。对片剂进行重量差异、脆碎度、溶液pH值、二氧化碳(CO₂)含量、硬度、泡腾时间、厚度、含量测定、含量均匀度、水分含量和平衡水分含量评估。
结果表明,与直接压片法相比,熔融法制备的颗粒流动性更好。片剂的重量差异百分比在可接受的0.5%限度内。所有制剂的脆碎度均小于1%。直接压片法和熔融法制备的片剂溶液pH值分别为4.55至5.74和4.74 - 5.84。与直接压片法相比,熔融法片剂产生的CO₂量较少。直接压片法制备的片剂硬度为40.66 - 56,熔融法制备的片剂硬度为60.6 - 74.6。熔融法制备的片剂比直接压片法制备的片剂厚度更大,水分含量更低。
与直接压片法制备的片剂相比,熔融法制备的片剂在压片前和压片后的特性更优。