Abstract:
Orally Disintegrating Tablets (ODTs) provide a solution, rapidly
dissolving in the mouth to improve bioavailability and compliance. Metformin is an
oral hypoglycemic agent and is widely prescribed among patients with Type II
Diabetes mellitus. Natural superdisintegrants: jackfruit seed starch (Artocarpus
heterophyllus) and banana powder (Musa paradisiaca) are cost-effective, sustainable
alternatives to synthetic superdisintegrants.
Objectives: The objective of the study was to develop and evaluate orally
disintegrating metformin tablets using natural superdisintegrants.
Methodology: Metformin ODTs were prepared using the wet granulation method.
Three formulations were developed, each containing 5% of a superdisintegrant:
alkali-extracted Artocarpus heterophyllus seed starch, dehydrated Musa paradisiaca
powder, and sodium starch glycolate (SSG). Tablet properties were evaluated using
pre- and post-compression tests such as hardness, friability, wetting time, water
absorption, disintegration, and dissolution. Drug-excipient compatibility was
confirmed using Fourier Transform Infrared Spectroscopy (FTIR). Based on the post
compression tests, the best formulation will be selected and subjected to a stability
study at 30∘C/65% RH. A t-test was used to compare the formulations.
Results: All three formulations met pharmacopeial specifications for both pre- and
post-compression properties. FTIR spectroscopy confirmed the absence of any
significant drug-excipient interactions in all formulations. The orally disintegrating
tablet containing 5% Musa paradisiaca powder was the best formulation, exhibiting
the lowest wetting time (76.33±7.77 s), disintegration time (78.00±3.6 s), and the
highest water absorption ratio (106.47%±2.65%). Also, this formulation achieved a
high drug release rate of 95.8% in five minutes. Statistical analysis revealed a
significant difference (p<0.05) between the formulations for wetting time, water
absorption ratio, and disintegration time. A three-month stability study showed that
the drug content remained within pharmacopeial limits at 95.79%, confirming the
formulation's stability.
Conclusion: Dehydrated Musa paradisiaca powder is a potential super disintegrant
for orally disintegrating metformin tablets, offering a promising and cost-effective
alternative to synthetic disintegrants.
