Disintegration and Dissolution Studies of Plain and Soluble Brands of Aspirin Tablets Embedded in Food Bolus

Abstract

Background: The practice of embedding solid drugs such as tablets and capsules in food bolus is very common in some parts of Africa especially Nigeria. The reasons for this practice range from an attempt to alleviate the side effect of gastric irritation to masking the unpleasant taste and odour of the drugs.The effects of concomitant administration of food on the disintegration, dissolution and bioavailability of orally administered drugs are well documented. However, information on orally administered solid drugs embedded in food bolus is very scarce.
Objective: This study investigated disintegration and dissolution profiles of plain and soluble brands of aspirin tablets embedded in food bolus.
Methodology: Disintegration and dissolution tests were carried out on two different brands of commercial, uncoated, immediate release (IR) aspirin tablets (300 mg) using Erweka disintegration test apparatus (GMB, Germany) and USP dissolution apparatus 2 respectively. The two different brands were coded as P (plain aspirin tablet) and S (soluble aspirin tablet). Twenty tablets from P and S brands were randomly selected and embedded in 3 g of freshly prepared food bolus made from gelatinized cassava flour (commonly called “eba”) and labelled PB (plain aspirin tablet embedded in food bolus) and SB (soluble aspirin tablet embedded in food bolus). Disintegration test and dissolution test were equally conducted on PB and SB and compared with P and S.
Results: The results indicated that both P and S passed the disintegration test for uncoated tablets, while PB and SB failed the test. Moreover, P, S and SB passed the in vitro dissolution test by releasing more than 80 % of the drug in 30 minutes, while PB failed the test. Embedding the tablets in food bolus significantly prolonged the disintegration time of SB and PB and also significantly affected the dissolution profile and kinetic of drug release from PB but had insignificant effect on SB. ANOVA for the dissolution parameters generated for all the samples showed that the dissolution profile of S was significantly higher (P < 0.05) than the rest. There was no significant difference (P > 0.05) between the dissolution data of SB and P while the dissolution profile of PB was significantly lower (P < 0.05) than that of SB and P.
Conclusion: Disintegration and dissolution of plain brand of aspirin may be significantly affected if embedded in food bolus. This may not be so for soluble brand of aspirin.

Keywords: Disintegration, Dissolution, Plain and Soluble, Aspirin tablets, Food Bolus