盐酸二甲双胍格列齐特缓释片的研制与评价

K.Manga, M.Sudhakar, K.Meghana, K.Avanthi, G.Swathi
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引用次数: 0

摘要

本研究的目的是制备并评价盐酸二甲双胍缓释片和格列齐特速释片的质量。缓释用高分子聚合物为HMPC K100M,直接压缩法直接释放胶卡拉卡与交联棉糖钠成比例的超崩解剂。本研究采用湿造粒法制备含格列齐特(IRL)和二甲双胍(SRL)的双层片剂,目的是使制剂的IRL尽可能小,使格列齐特尽快释放以对抗餐后高血糖水平,随后二甲双胍长期释放以控制稳态血糖。不同配方的硬度范围为7.5-8.5 kg/cm。所有配方的脆性均小于1%。所有制剂中二甲双胍和格列齐特的含量分析均在IP限制范围内(±5%),表明药物在片剂中分布均匀。对第一层(二甲双胍)进行了长达12小时的邀请物溶出研究(每隔1小时后),对第二层(格列齐特)进行了长达40分钟的邀请物溶出研究(每隔5分钟后)。该双层片剂具有初始载药量大且溶出快的特点,其余药物以恒定速率缓释,直至溶出结束。红外光谱证实聚合物、赋形剂与二甲双胍、格列齐特无相互作用。
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Formulation and evaluation of bilayered tablets of sustained release metformin HCl and gliclazide
The aim of the present work is to formulate and evaluate a bilayered tablet (BT) ofMetformin HCl as Sustained release and Gliclazide as Immediate release (IR). The polymer usedin sustained release is HMPC K100M and the super disintegrate used in immediate release inproportion of Gum Karaka & Croscarmellose sodium by direct compression method. In thisstudy, a bilayered tablet containing Gliclazide in IRL and Metformin in SRL was made using thewet granulation method, with the goal of making the formulations IRL as small as possible, Willrelease Gliclazide as soon as possible to combat postprandial hyperglycemic level, followed bysteady-state plasma glucose management by Metformin with along-termrelease. The hardnessof the different formulations ranged from 7.5-8.5 kg/cm. All the formulations exhibited less than1% friability. The drug content analysis of Metformin and Gliclazide in all formulations wasfound within the IP limits (±5%) which indicate that the drug was uniformly distributed in thetablets. The inviter dissolution study was performed for layer I (Metformin) up to 12 hrs (afterevery 1hour intervals) and for layer II (Gliclazide) up to 40 min (after every 5 min interval). Thebilayered tablet contributing initial loading dose and dissolves rapidly, the remainder of the drugin the extended release was constant rate till the end of the dissolution process. The I.R spectraprovedthattherewasno interactionbetweenthepolymer,Excipients andMetformin,Gliclazide.
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