Preparation and Quality Evaluation of Tandospirone Citrate Orodispersible Films
The orodispersible films(ODFs)of tandospirone citrate were prepared by solvent casting method.The film-forming materials,taste masking agent and plasticizer were screened and optimized by single factor tests.The optimal formulation was as follows:10.8％of tandospirone citrate,37.5％of HPMC E5,7.5％of hydroxypropyl cellulose,27.0％of hydroxypropyl-β-cyclodextrin,15％of glycerin,and 2.2％of sucralose.The obtained ODFs had good film properties with a disintegration time of about 40 s.The requirements for content uniformity and related substances were met.The dissolution rate in water at 15 min exceeded 85％,which was similar to that of the commercially available tablets.The bitterness of the drug was well masked on the basis of the inclusion effect of hydroxypropyl-β-cyclodextrin.The stability tests were conducted under photolysis,high temperature,and high humidity conditions.The results showed that the ODFs had good stability except for high temperature at 60 ℃.The appearance,drug content and related substances of the ODFs stored under other conditions had not significantly changed.After being stored for one month under accelerated test condition(40 ℃ and 75％of relative humidity),the API crystal form remained stable.
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