METFORMIN ADORNED BILAYER TABLETS FOR TYPE Ⅱ DIABETES MANAGEMENT: FORMULATION DEVELOPMENT AND CHARACTERIZATION

Atif Khattak; Shefaat Ullah Shah; Pervaiz Akhtar Shah; Sheikh Abdur Rashid; Hashmat Ullah; Hadia Gul; Saima Mahmood; Mudassar Mazher; Rabia Baloch; Sidra Mumtaz

doi:10.53555/jptcp.v31i4.6048

Atif Khattak
Shefaat Ullah Shah
Pervaiz Akhtar Shah
Sheikh Abdur Rashid
Hashmat Ullah
Hadia Gul
Saima Mahmood
Mudassar Mazher
Rabia Baloch
Sidra Mumtaz

Keywords

Diabetes mellitus, bilayer tablet, Carbopol, direct compression, in-vitro drug release

Abstract

Diabetes mellitus is a chronic metabolic disorder and its management requires uninterrupted drug administration, as failure to show the compliance results in fatal consequences. This study was executed to develop, optimize and characterize metformin HCl adorned bilayer tablets which underwent initial burst release in the stomach followed by a sustained release pattern to meet the once daily requirements for patients acceptability. Metformin HCl is scheduled to be taken three times a day due to having reduced half-life of 2-6 h. Therefore, its development into bilayer tablets having both immediate (IR) and sustained release (SR) layers would be clearly beneficial in reducing the frequency of administration as well as patients compliance. The immediate release layer anticipated the initial burst release in the stomach to quickly produce the antidiabetic effect with subsequent persistent extended action generated by controlled release layer. Direct compression method was used to fabricate bilayer tablets of metformin HCl by incorporating numerous polymers (HPMC K4M, carbopol and chitosan) in varied concentrations. The drug and polymeric admixtures were assessed for compatibility through FTIR and results revealed no interactions among the drug and various polymers. The flow parameters were found to be within the acceptable official range. After compression into bilayer tablets different physico -chemical tests were performed. All the tests were found to be consistent with official limits. The results of in-vitro data showed biphasic release pattern with the release from IR layer within 15 minutes and up to 24 h controlled drug release from SR layer. MT3 was chosen as an optimized formulation batch based on the results of in-vitro controlled drug release, physico-chemical tests and stability profiles. Kinetic model fitting of the release data of formulations (MT1-MT9) demonstrated Fickian diffusion mechanism with zero order kinetics (n<0.5). There was no statistical significant difference found for cumulative drug release of IR layer (p>0.05), however, for SR layer a significant difference was observed for the cumulative amount of drug release (p<0.05). Thus, the anticipated results revealed the potential of carbopol polymer for assuring the biphasic release of metformin HCl.

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Published

Apr 30, 2024

DOI: https://doi.org/10.53555/jptcp.v31i4.6048

How to Cite

Atif Khattak, Shefaat Ullah Shah, Pervaiz Akhtar Shah, Sheikh Abdur Rashid, Hashmat Ullah, Hadia Gul, Saima Mahmood, Mudassar Mazher, Rabia Baloch, & Sidra Mumtaz. (2024). METFORMIN ADORNED BILAYER TABLETS FOR TYPE Ⅱ DIABETES MANAGEMENT: FORMULATION DEVELOPMENT AND CHARACTERIZATION. Journal of Population Therapeutics and Clinical Pharmacology, 31(4), 1952-1967. https://doi.org/10.53555/jptcp.v31i4.6048

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Vol. 31 No. 4 (2024): JPTCP

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