Formulation and Evaluation of Gastro Retentive Floating Tablets of Montelukast Sodium using Natural and Synthetic Polymers

Syed Abuthahir Badusha, A (2021) Formulation and Evaluation of Gastro Retentive Floating Tablets of Montelukast Sodium using Natural and Synthetic Polymers. Masters thesis, The Erode College of Pharmacy and Research Institute, Erode.

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Abstract

The effervescent based floating drug delivery was a promising approach to achieve in vitro buoyancy. Montelukast sodium is a drug molecule used for the treatment of asthma. The present work was to formulate floating tablet of Montelukast sodium. So, the attempt was made to increase the bioavailability by increasing the gastric retention time of tablet by formulating as floating tablet. Polymers used in the formulation were HPMC K4 M, HPMC K 15 M, Xanthan gum, PVP K 30, Peanut husk, Magnesium stearate as glidants. Sodium bicarbonate and citric acid as gas generating agents. Lactose is used to provide good compression property of the tablet formulation. Talc is used as a lubricating agent. IR spectroscopy confirmed that there was no interaction between drug and polymers. All the prepared polymers were evaluated for hardness, thickness, weight variation, friability, drug content uniformity, buoyancy lag time, total floating time, swelling index, in-vitro dissolution studies and drug release kinetic studies. F1 formulation showed optimal FLT and it retained the drug release up to 12 hours with a good floating property of 14 hours. Xanthan gum, Peanut husk a natural polymer when it comes to contact with the gastric fluid, it swells and thus control the release of drug through it. Sodium bicarbonate and citric acid ratios were important for the FLT. All the formulations were subjected to four different release kinetics model, i.e., Zero order, First order, Higuchi model, Peppas model. F1, F3 formulations best fit to Higuchi model and F2, F4, F5 follows Zero order kinetics. From the studies it can be concluded that the polymers have an important role in the release of drug and thus to extend it release. Sodium bicarbonate, citric acid and Peanut husk were also needed to achieve good floating property for the tablet and also achieving good FLT. From the obtained experimental results, it was concluded that, HPMC K4 M, HPMC K15 M has a significant role in controlling the release of drug from a dosage form. From the in-vitro release studies, it was noted that in the F1 formulation the drug release was 89% which was minimum if compared to all other formulations of F2-F5 at the time period of 12 hrs. Hence the F1 formulation is concluded as the optimized formulation among the other 4 formulations. The drug release from the formulation F1 was sufficiently sustained and follows Higuchi’s kinetic release.

Item Type: Thesis (Masters)
Additional Information: Reg.No.261910556
Uncontrolled Keywords: Formulation, Evaluation, Gastro Retentive Floating Tablets, Montelukast Sodium, Natural and Synthetic Polymers.
Subjects: PHARMACY > Pharmaceutics
Depositing User: Subramani R
Date Deposited: 19 May 2023 01:59
Last Modified: 19 May 2023 01:59
URI: http://repository-tnmgrmu.ac.in/id/eprint/21265

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