Discussion on Consistency Evaluation Method of Calcium Gluconate Tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To consummate drug specifications and improve the overall level of generic drugs in our country, the consistency evaluation method of calcium gluconate tablets is proposed. METHODS: With its critical quality attributes(CQA) as the evaluation starting point, as well as combination of production process and specifications described in pharmacopoeias, the evaluation method of calcium gluconate tablets has been suggested. RESULTS: The pharmaceutical research of calcium gluconate tablets should be focused on production process of tablets and its effect on the quality and stability of products, the method establishment and validation of determination for dissolution profiles, dissolution profiles investigation of products under different pH values, differences on the dissolution profiles of products. And some CQA such as dissolution, friability and content etc. should also be considered. The necessity of its in vivo evaluation is open to discuss. CONCLUSION: When no reference listed drug(RLD) is available, eg calcium gluconate tablets, the consistency evaluation should be carried out by pharmaceutical factories case by case.