Department of Pharmaceutics, Himalayan Pharmacy Institute, Majhitar, Rangpo, Sikkim, India.
Saudi Pharm J. 2009 Jul;17(3):233-41. doi: 10.1016/j.jsps.2009.08.004. Epub 2009 Aug 7.
Hydroxy propyl methyl cellulose (HPMC) 5cPs, an aqueous soluble polymer was employed for coating diclofenac sodium (DFS) tablets 25 mg for protecting the integrity of the drug yet rendering the drug to release at a faster rate on contact with the gastric environment. Proper optimization for the aqueous based film coating formulation was undertaken primarily employing plasticizers like polyethylene glycol (PEG) 400 and propylene glycol (PG). The defect free selected formulations were further subjected for studying the effects of surfactants like sodium lauryl sulphate (SLS) and Tween-80 along with the plasticizers. The quality of the aqueous film coats or the plasticizer efficiency in case of PEG-400 is in the order 1.5 > 0.5 > 1.0% and for PG 1 > 4 > 3% which can be stated on the basis of less incidence of major coat defects like chipping, cracking, orange peel, roughness, blistering, blooming, picking. The quality of aqueous film coat or the surfactant efficiency in case of SLS + PEG-400 is in the order 0.3 < 0.5 < 0.1% and SLS + PG is in the order 0.5 < 0.1 < 0.3%. In case of Tween-80 + PEG-400 the order is 0.3 < 0.5 < 0.1% and Tween-80 + PG is in the order 0.3 < 0.1 < 0.5%. Elegant film formation can be stated from fewer incidences of coat defects. The obtained coated tablets eventually satisfied all the normal physical parameters like thickness, weights, and weight gain, drug content, crushing strength, percent friability, disintegration time, dissolution profile and possible drug-polymer interactions. ANOVA was undertaken followed by Dunnet multiple comparison for the dissolution profile considering uncoated as the standard. The difference was considered significant at p ⩽ 0.01.
羟丙基甲基纤维素（HPMC）5cPs 是一种水溶性聚合物，用于包衣 25mg 双氯芬酸钠（DFS）片剂，以保护药物的完整性，同时使药物在接触胃环境时更快释放。主要使用增塑剂如聚乙二醇（PEG）400 和丙二醇（PG）对水基薄膜包衣配方进行适当优化。无缺陷的选定配方进一步进行研究表面活性剂如十二烷基硫酸钠（SLS）和吐温-80 以及增塑剂的影响。水膜包衣的质量或 PEG-400 增塑剂的效率按 1.5>0.5>1.0%的顺序排列，对于 PG 则按 1>4>3%的顺序排列，可以根据主要涂层缺陷如剥落、开裂、桔皮、粗糙度、起泡、开花、剥落的发生率较低来判断。在 SLS+PEG-400 的情况下，水膜包衣的质量或表面活性剂的效率按 0.3<0.5<0.1%的顺序排列，在 SLS+PG 的情况下，其顺序为 0.5<0.1<0.3%。在 Tween-80+PEG-400 的情况下，其顺序为 0.3<0.5<0.1%，在 Tween-80+PG 的情况下，其顺序为 0.3<0.1<0.5%。从涂层缺陷的发生率较低可以看出，包衣工艺非常出色。最终得到的包衣片剂满足所有正常物理参数，如厚度、重量和增重、药物含量、抗压强度、百分破碎度、崩解时间、溶出度曲线和可能的药物-聚合物相互作用。考虑到未包衣片作为标准，对溶出度曲线进行了方差分析，然后进行 Dunnet 多重比较。差异被认为在 p ⩽ 0.01 时有统计学意义。
