BINDER AND SUPERDISINTEGRANT
INFLUENCE ON THE PROPERTIES OF ORALLY
DISINTEGRATING HIGH DOSES
ACETAMINOPHEN TABLETS.
GRAŢIELA POPA1*, LĂCRĂMIOARA OCHIUZ1, IULIAN
STOLERIU2, IULIANA POPOVICI1
1University of Medicine and Pharmacy „Gr. T. Popa” Iaşi, Faculty of
Pharmacy, 16 Universităţii st., 700115.
2 University „Al. I. Cuza” Iaşi, Faculty of Mathematics
*corresponding author: gratielapopa@yahoo.com
Download Full Article
Abstract:
The purpose of our study was the formulation and preparation of orally disintegrating tablets (ODT) containing an analgesic combination: a high dose of acetaminophen (500mg) and codeine phosphate (35 mg). The tablets were prepared by wet granulation using a combination of binders (Gelucire 44/14-Kollidon VA64). Formulation variables were: the proportion of binder Kollidon VA64 (0-3%) and the proportion of superdisintegrant Ac-Di-Sol (2-9%). All formulations contained a proportion of 2% Gelucire 44/14. The response variables to be analysed were hardness, friability and disintegration time of the tablets. Factorial analysis of data showed a high influence of Kollidon proportion on hardness and disintegrating time of the tablets and a minimum value of 1% Kollidon was set for satisfactory friability values. The proportion of Ac-Di-Sol alone had small influence on the response variables. The multiple regression equations revealed a very good prediction model for hardness (R2 = 0.85) and disintegration time (R2 = 0.94), and a good prediction for friability (R2 = 0.75).
Top