The Impact of Some Processing and Formulation Variables on Stability of 75mg Aspirin in Different Tablet Dosage Forms
The Impact of Some Processing and Formulation Variables on Stability of 75mg Aspirin in Different Tablet Dosage Forms
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Date
2015-04-06
Authors
Suliman, Eltayeb
Journal Title
Journal ISSN
Volume Title
Publisher
UOFK
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.
Description
92page
Keywords
formulation variables,via wet granulation ,Hydrolysis