Preparation and in vitro dissolution evaluation of sitagliptin phosphate/metformin hydrochloride tablets
LIU Zhuo
LI Yi-tong
ZHANG Jian-mei
WANG Dong-kai
Abstract：Objective:To optimize the formulation of sitagliptin phosphate/metformin hydrochloride tablets to obtain similar dissolution profiles with RLD (reference listed drug,JANUMAT(R)).Methods:The formulation of sitagliptin phosphate/metformin hydrochloride tablets was optimized in terms of dissolution,appearance,hardness and tablet weight difference by single factor test,and the dissolution profiles were compared with RLD in four kind of dissolution media.Results:MCC,PVP K30,SDS and sodium stearyl fumarate were selected as diluent,adhesive,solubilizer and lubricant,respectively.MCC was added after granulation and the amounts of PVP K30,SDS and sodium stearyl fumarate in one tablet were 35 mg,7 mg and 3.5 mg,respectively.The dissolution was above 85％ for both self-prepared preparations and RLD in 15 min,and the dissolution profiles were similar.Conclusion:The method of preparing sitagliptin phosphate/metformin hydrochloride tablets is simple and can meet the requirements of large-scale production.
Keywords：metformin hydrochloridesitagliptintabletsingle-factor testdissolution
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2076-2081 )