Design and characterization of gastro-retentive floating tablets of alendronate sodium

Ram Parkash Ram; Ajeet Pal Singh; Amar Pal Singh

doi:10.47957/ijpda.v13i4.669

Authors

Ram Parkash Ram Department of Pharmaceutics, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.
Ajeet Pal Singh Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.
Amar Pal Singh Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India

DOI:

https://doi.org/10.47957/ijpda.v13i4.669

Keywords:

Gastro retention, alendronate sodium, Carbopol 934P, HPMC 4KM, Na-CMC, GRDF

Abstract

Objective: This study aimed to formulate and evaluate gastro?retentive floating tablets (GRDF) of alendronate sodium to enhance its oral bioavailability by prolonging gastric residence time and providing controlled drug release.

Methods: Combinations of hydroxypropyl methylcellulose (HPMC K4M), sodium carboxymethyl cellulose (Na CMC), and carbopol 934P as polymers, as well as sodium bicarbonate as a gas producing agent, GRDF tablets containing 50 mg alendronate sodium were made by direct compression. In vitro dissolution in simulated gastric fluid, buoyancy lag time and duration, swelling index, flow properties (angle of repose, bulk/tapped density, Carr's index, Hausner ratio), and physical parameters (thickness, hardness, friability, weight variation, and drug content) were assessed for the formulations (A1–A7). The compatibility of the medication and excipient was evaluated using FT IR and DSC analyses.

Results: The drug content (95.71–107.18%) and physical characteristics of all formulations were satisfactory. There was no discernible drug–polymer interaction, according to FT IR and DSC. The kind and concentration of the polymer affected the swelling index and floating ability; HPMC K4M considerably extended flotation and regulated drug release. Formulation A7 had the greatest swelling index (191%), longest floating duration (>12 hours), smallest floating lag time (48 seconds), and sustained drug release (~71% in 12 hours). Carbopol 934P had an impact on swelling and release rate, whereas the amount of sodium bicarbonate altered buoyancy lag time.

Conclusion: Optimised alendronate sodium GRDF tablets have good physicochemical properties, gastrointestinal retention, and drug release. HPMC K4M, Na CMC, and sodium bicarbonate increased floating and controlled release, indicating alendronate bioavailability might be improved.

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Author Biographies

Ram Parkash Ram, Department of Pharmaceutics, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.

Department of Pharmaceutics, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.

Ajeet Pal Singh, Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.

Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India.

Amar Pal Singh, Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India

Department of Pharmacology, St. Soldier Institute of Pharmacy, Lidhran Campus, Behind NIT (R.E.C.), Jalandhar –Amritsar by pass, NH-1, Jalandhar -144011, Punjab, India

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