Optimization of Prescription and in Vitro Dissolution of Ketorolac Tromethamine Orally Disintegrating Tablets
Objective To optimize the prescription of Ketorolac Tromethamine Orally Disintegrating Tablets,and to establish a method for the determination of the in vitro dissolution.Methods Taking subjective indexes(taste,appearance)and objective indexes(hardness,disintegration time)as the factors,the dosage of filling agent microcrystalline cellulose(MCC),mannitol,disintegrating agent cross-linked carboxymethyl cellulose sodium(CCMC-Na)and magnesium stearate was optimized by using fuzzy comprehensive evaluation method combined with L9(34)orthogonal test,and the prescription process was verified.The dissolution rate of Ketorolac Tromethamine Orally Disintegrating Tablets was determined by the high-performance liquid chromatography(HPLC)method.Results The optimal prescription of Ketorolac Tromethamine Orally Disintegrating Tablets was 150 mg of MCC,90 mg of mannitol,10 mg of CCMC-Na,and 1.5 mg of magnesium stearate.The prepared Ketorolac Tromethamine Orally Disintegrated Tablets had good taste,smooth surface,strong compressibility,moderate hardness,complete disintegration,and good inter-batch reproducibility.The linear range of ketorolac tromethamine was 1-100 µg/mL(r = 0.999 9,n = 5).The average recovery rate of ketorolac tromethamine was 98.76%with an RSD of 0.75%(n = 9).The RSDs of precision,stability,and repeatability test results were all lower than 1.0%(n = 6).The sample could be completely dissolved in the solvent after 10 min,with dissolution rates>90%.Conclusion The optimal prescription process is simple and reproducible,which can provide a reference for the industrial production of Ketorolac Tromethamine Orally Disintegrating Tablets.
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