Relationship between granule flowability under different humidity and quality of guaifenesin sustained release tablet / 中国药学杂志

ABSTRACT

OBJECTIVE: To study influence of humidity on granule flowability, explore relationship between flowability and quality of guaifenesin sustained tablet, give a basis for industrialization. METHODS: By hygroscopicity study, CRH was measured. After 10 days in RH 33%, 60%, 75%, 84%, 92.5%, flowability of granule and quality index of tablet, such as appearance, extremum of weighty friability was measured and compared with result of 0 d. Functional relationship between micromeritics parameter and quality index of tablet was fitted. RESULTS: CRH of granule is between RH 67%-68%. When relative humidity is above RH 60%, flow-ability and quality of tablet is changed obviously. Used compressbiliity as X1, repose angle as X2, extremum of tablet weight as Y1, friability as Y2, linear relationship of them is Y1 = 0.192X1+ 0.092X2- 7.398 (r = 0.9921), Y2= 0.069X1 + 0.087X2 - 3.505 (r = 0.9881), when P < 0.001, the equations had statistical significance in the range of observation. CONCLUSION: Relative humidity of production and storage of granule should less than RH 60%. Functional relationship between micromeritics parameter of granule (compressbiliity and repose angle) and quality index of tablet (extremum of weighty friability) had statistical significance in the range of observation. Copyright 2012 by the Chinese Pharmaceutical Association.