纳米悬浮液负载黏附口溶膜的研制

V. Mastiholimath, Sujit Prabhu Khope, Pallavi Chiprikar, A. Ammanage, U. Patel
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引用次数: 0

摘要

盐酸美氯嗪本质上属于H1类拮抗剂、止吐剂和抗眩晕剂,是生物制药分类系统(BCS)ⅱ类药物,几乎不溶于水。采用自底向上的方法制备纳米悬浮液,分别以甲醇和微孔水为溶剂和反溶剂,制备的稳定剂为聚乙烯吡罗烷酮K30 (PVP K30)和羟丙基甲基纤维素E15 (HPMC E15),经傅里叶变换红外(FTIR)和差示扫描量热仪(DSC)研究发现它们与配方相容。用甘油润滑的培养皿,用溶剂铸造法配制口腔溶解膜,在45°C的热风烘箱中加热过夜。对纳米混悬液黏附口溶膜的各项性能进行了表征,其中MDF - 2的药物含量最高,为92.43±0.49%。体外释药研究表明,纳米混悬液黏附口腔溶出膜与普通口腔溶出膜及市售片剂相比,具有较快的释药速度。
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Nano-suspension loaded mucoadhesive mouth dissolving film of meclizine hydrochloride
Meclizine Hydrochloride belongs to class H1 antagonist, antiemetic and anti-vertigo in nature, it is a Biopharmaceutical classification system (BCS) class II drug and is practically insoluble in water. The bottom-up approach was used in the formulation of nanosuspension in which methanol and millipore water was used as solvent and anti-solvent respectively, the stabilizers used for preparation were Polyvinylpyrrolidone K30 (PVP K30) and Hydroxypropyl Methylcellulose E15 (HPMC E15) which were found to be compatible with the formulation after Fourier Transform Infrared (FTIR) and Differential scanning calorimeter (DSC) studies. Mouth dissolving films were formulated by solvent casting method using glycerine lubricated petri dish and were kept for heating in a hot air oven at 45°C overnight. Characterization of nanosuspension-loaded mucoadhesive mouth dissolving films was done by evaluating various characteristics, the highest drug content was found to be 92.43±0.49% in Mouth dissolving film (MDF) 2. In-vitro drug release studies indicate that nanosuspension-loaded mucoadhesive mouth-dissolving film has a rapid drug release rate as compared to plain drug-loaded mouth-dissolving films and marketed tablet formulation.
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