Abstract:
OBJECTIVE To consummate drug specifications and improve the overall level of generic drugs in our country, the consistency evaluation method of Vitamin B2 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 Vitamin B2 tablets had been suggested.
RESULTS The pharmaceutical research of Vitamin B2 tablets should be focused on related substances, dissolution(including establishment, validation of dissolution profiles method and investigation of dissolution profiles of products under different pH values), polymorphism and stability. The necessity of its in vivo evaluation was open to discuss.
CONCLUSION When no reference listed drug(RLD) is available, e.g. Vitamin B2 tablets, the consistency evaluation shall be carried out by pharmaceutical factories case by case.