Abstract
Buccal route of administration has many advantages such as improving patient compliance, bypassing the GIT and hepatic first pass effect. The objectives are to formulate mucoadhesive buccal tablet using Mefenamic acid and compatible excipients, and to evaluate the product using quality control tests and in vitro tests. The ingredients were subjected to Differential Scanning Calorimetry and Fourier Transform Infrared Spectroscopy studies for compatibility test and the results showed no interaction. Two batches of mefenamic buccal tablet were prepared. The tablet thickness and diameter are 3.75 mm and 12 mm respectively. All tablets are within the specification of +/- 5%. The in-house tablet hardness is 6.8-15kg and percent friabilation is not more than 0.8%. The disintegration test showed that all tablets disintegrated within 4 hours. The content uniformity showed that tablets are within the range of 85%-115%. The tablet weight is within the 5% range. The percent swelling is 53.83% to 58.86% and moisture absorption is 14.79% to 15.56%. The surface pH of the tablet is close to the salivary pH, which means that it would not irritate the buccal mucosa. The buccal tablet has a mucoadhesiveness of 0.196 to 0.200. There was no change in pH and size after subjecting it to stability studies in human saliva. Drug release studies showed 80.7% to 83.4% after 3 hours. Even after 3 months of subjecting the tablets to 40 oC and 75% RH, results are within acceptable range. The results show the potential of the formulation as a mucoadhesive buccal tablet.
Highlights
The oral route of drug administration is the most suitable route and widely accepted by patients and healthcare professionals for the delivery of therapeutically active drugs (Velmurugan, Srinivas, 2013)
Compatibility tests of mefenamic acid with excipients
DSC studies were conducted on the pure drug and the excipients of the formulation to check for the compatibility
Summary
The oral route of drug administration is the most suitable route and widely accepted by patients and healthcare professionals for the delivery of therapeutically active drugs (Velmurugan, Srinivas, 2013). The samples were analyzed using the quality control tests such as hardness, friability, thickness, content uniformity, weight variation, and moisture absorption studies and in-vitro tests such as swelling studies, mucoadhesive strength, stability in human saliva, and drug release.
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