Effects of Drug Loading and Relative Molecular Weight of Film Forming Material HPMC on Critical Quality Attributes of Flunarizine Hydrochloride Nanocrystalline Orodispersible Films
The low solubility of flunarizine hydrochloride(1)can lead to the low oral bioavailability.In order to increase the solubility of 1,1 nanocrystal suspension was prepared by the antisolvent crystallization method in this study.The orodispersible films containing 1 nanocrystals were then prepared by the solvent casting method.The effects of drug loading and relative molecular weight(Mr:5×104-4×105)of HPMC on the critical quality attributes of the orodispersible films were investigated.The results revealed that the redispersibility of the nanocrystalline orodispersible films was not significantly affected when the drug loading was lower than 40％.However,within the test ranges,the larger the Mr of HPMC,the worse the redispersibility of the 1 nanocrystalline orodispersible films.When the drug loading was in the range of 20％-30％,1 nanocrystal was evenly distributed in the films containing HPMC E15,HPMC E50,or HPMC E4M as the film forming material.However,when the drug loading was higher than 40％,1 nanocrystal tended to aggregate in the films.Furthermore,the results showed a good correlation between the erosion and dissolution performance of the films,where the higher the drug loading and Mr of HPMC resulted in the slower the erosion and dissolution rates of the film.
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