The Impact of Some Processing and Formulation Variables on Stability of 75mg Aspirin in Different Tablet Dosage Forms

Abstract

In order to examine the impact of excipients, packaging systems and storage conditions on acetylsalicylic acid stability in different 75mg aspirin tablets, 2 3 and 3 2 full factorial designs were adopted for the development of acetylsalicylic acid chewable and effervescent tablets, respectively. The study revealed that most of excipients have a profound influence in physicochemical behaviors of aspirin tablets. Due to their hygroscopicity, PVP, starch, sodium bicarbonate and sorbitol were shown to affect the hardness, weight variation, friability, free salicylic acid and content percent of aspirin in both chewable tablets and effervescent tablets. Using combination of mannitol and sorbitol in different ratios, as filler in chewable tablets has resulted in lowering the cost of the formulations with enhanced product stability. Both blister and strip packaging systems showed no significant difference (cp ≥0.05) with regard to dosage form protection in case ofchewable tablets where no added moisture protection was observed with PVC blister pack. It has been shown that effervescent tablets manufacturing process involves some critical steps which need to be addressed carefully during formulations and factory design. The conventional aspirin tablets formulated with starch, saccharin sodium and talc where found tohave undesirable physical characteristics. Among the three tablet dosage forms ofaspirin 75mg, the chewable tablets were found to be the best. From this, one formula was selected, modified by using a combination of mannitol and sorbitol as filler and finally upgraded by the study of the particle size range, powder flow, mixing process and selection of a suitable manufacturing process. Two batches of upgraded formula were subjected to six monthsaccelerated stability study and were found to be stable.