口腔崩解片直压预混辅料Starlac的粉体学性能评价

Micromeritic evaluation of the direct compression excipient Starlac for orally disintegrating tablets

目的:考察Starlac的粉体学性质,为其应用粉末直接压片技术制备口腔崩解片提供理论参考。方法:观察Starlac的外观形态;测定Starlac的粒径分布、休止角、卡氏指数、流出速度、抗张强度、弹性复原率、屈服压力、润滑敏感性、稀释潜能等粉体学指标。将Starlac应用于5种模型药物口腔崩解片的粉末直接压片工艺中,并与其相应物理混合物辅料制备的口腔崩解片进行比较。结果:Starlac与其物理混合物的休止角、流速和卡氏指数分别为30.38°、4.205 6 g·s-1、15.94%和36.55°、2.608 7 g·s-1、27.27%;Starlac的流动性略优于其相应的物理混合物;在可压性、压实性和润滑敏感性方面Starlac均具有优越性;Starlac对亲水性、疏水性模型药物的稀释潜能均较好;采用Starlac制备的口腔崩解片在口感、压片难易和崩解时限等关键指标上均优于其物理混合物。结论:Starlac是一种性能优良的口腔崩解片直压预混辅料,适用于粉末直接压片技术制备口腔崩解片。

OBJECTIVE To investigate the micromeritic properties of Starlac, which is expected to provide preliminary theoretical basis for the direct compression technology of orally disintegrating tablets （ODTs）. METHODS The appearance of Starlac was observed and the particle size distribution,angle of repose, flow velocity, the Carr＇ index, tensile strength, elastic recovery, yield stress, lubricating sensitivity, dilution potential of Starlac were also determined respectively to evaluate its mi cromeritic properties. Five model drugs of ODTs were selected for direct compression tableting by Starlac, and the physical mixtures were compared respectively. RESULTS The angle of reposes, flow rates and Carr＇s indexes of Starlac and physical mixtures were 30. 38%,4. 2（75 6 g. s^- 1 , 15.94% and 36. 55%, 2. 608 7 g. s^- 1 , 27.27 %, respectively. The flow ability of Starlac was preferable to its physical mixtures, the aspects of compressibility, compact ability and lubricating sensitivity of Starlac were much better. The dilution potential of Starlac was high for most of hydrophilic and hydrophobic drugs. The ODTs pre- pared by Starlac were superior to its physical mixtures in taste, disintegration time and difficulty in tablet compression. CON- CLUSION Starlac is an excellent co processed excipient and it is very suitable for ODTs prepared by direct compression tableting.