Preparation of Clonidine Orodispersible Films Based on Inclusion Technology
Based on the phase solubility determination results of clonidine in different cyclodextrin derivatives,methyl-β-cyclodextrin was screened out because of the high inclusion efficiency.Then the inclusion complexes with the inclusion ratio of methyl-β-cyclodextrin to clonidine of 1∶1 were prepared by rotary evaporation method.The drug loading and encapsulation rates of the inclusion complexes were(13.45±0.22)％and(88.78±0.56)％,respectively.After that,the orodispersible films based on the obtained inclusion complexes were prepared by cast coating method.The for-mulation compositions were optimized by single factor tests,and the results were as follows:PVA 5-88(80％),inclusion complex(4％),1,2-propylene glycol(10％),and low-substituted hydroxypropyl cellulose(10％).The quality attributes of the optimized films were determined.The results showed that the thickness,water content,surface pH value,tensile strength and elongation at break of the self-made films were(91.72±1.74)μm,4.71％,6.75±0.09,(62.44±3.19)N/mm2,and(107.15±7.02)％,respectively.Finally,the taste masking effect was evaluated by the electronic tongue techniques.The results showed that the taste masking effect of the inclusion complex was better than that of aspartame.In conclusion,cyclodextrin inclusion technology can significantly mask the bitterness of a drug.
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