磷酸二甲啡烷微球口腔速溶膜剂的制备及质量评价

Preparation and quality evaluation of dimemorfan phosphate microspheres oral fast disintegrating film

目的 研制一种兼顾速溶膜剂的剂型优势和掩味效果的儿童药物新剂型-磷酸二甲啡烷微球口腔速溶膜剂(DPM-OFDF)。方法 采用溶剂浇铸法制备DPM-OFDF,以美国市售Listerine■口腔速溶膜剂(口气清新速溶膜片)为参照,采用膜剂外观、溶化时限、机械性能指标评价联合制剂质量。结果 以磷酸二甲啡烷微球(DPM)0.430 g、HPMC 0.5 g、增塑剂0.25 g、木糖醇0.25 g、纯化水50 ml处方制备的DPM-OFDF,能在29秒内完全溶化,含量均匀度(A+2.2S<15)符合规定,30分钟药物溶出达80%以上,pH中性环境中磷酸二甲啡烷基本不溶出。结论 溶剂浇铸法制备的DPM-OFDF外观平整光滑、掩盖苦味、口感好、速溶、体外释放度好。

Objective To develop a new dosage form for children which has both the advantages of instant film agent and the effect of taste masking-dimemorfan phosphate microspheres oral fast disintegrating film(DPM-OFDF).Methods DPM-OFDF was prepared by solvent casting method, and the quality of the combined preparation was evaluated by assessing the appearance, dissolution time and mechanical properties takeListerinesold in America(breath fresh instant film)as the reference.Results DPM-OFDF was prepared with DPM 0.430 g, HPMC 0.5 g, plasticizer 0.25 g, xylitol 0.25 g and purified water 50 mL,and the product could be completely dissolved within 29 seconds.The content uniformity(A+ 2.2 s<15)was in line with the requirements, and the dissolution of the drug was more than 80% in 30 min.The dissolution of dimemorfan phosphate was almost doesn’t dissolving out in PH neutral environment.Conclusions DPM-OFDF prepared by this method present smooth appearance, bitter taste was cover up, good taste, instant, and good in vitro release.