Design and Optimization of Herbal-Based Polymeric Fast Dissolving Tablets of Amlodipine Besylate Using Plantago ovata Mucilage

Pooja Sandeep Bhandare¹, Rameshwar Madhukar Ardad², SanjayKumar Patel³, Aditya Shah⁴, Devadiya Premkumar Vinod Bhai*⁵, Dr. Dhairysheel Mahadeo Ghadge⁶

¹Assistant Professor, KCT's Krishna College of Pharmacy Karad, Maharashtra. Email : pooja14511@gmail.com
²Department of Pharmaceutical Quality Assurance, D.Y. Patil College of Pharmacy, Kolhapur. Email :ramardad@rediffmail.com
³Manager, Analytical, Enzene, Inc. Email :Patelsanjay.pharma@gmail.com
⁴Associate Principal scientist, GRA Organon LLC. Email :aditya.shah1@organon.com
⁵Assistant Professor, School of Pharmacy Rai University, Ahmedabad, Gujarat. Email :premkumar.devdiya@raiuniversity.edu
⁶Gourishankar Institute of Pharmaceutical Education and Research, Limb, Email :Satara.dhairysheelsatara@gmail.com

ABSTRACT

Hypertension is a widespread chronic disorder that requires effective and patient-friendly therapeutic strategies to ensure long-term compliance. Amlodipine Besylate, a commonly prescribed calcium channel blocker for hypertension, exhibits low aqueous solubility, which may delay drug dissolution and onset of action. The present study aimed to formulate and optimize fast dissolving tablets (FDTs) of Amlodipine Besylate using isolated Plantago ovata mucilage as a natural superdisintegrants to enhance disintegration, drug release, and patient compliance. The mucilage was isolated and characterized for its suitability as a polymeric excipient, and a 2³ full factorial design was employed to optimize formulation variables, including concentrations of Plantago ovata mucilage, sodium starch glycolate, and microcrystalline cellulose. Critical quality attributes such as wetting time, disintegration time, and in-vitro drug release were evaluated, and predicted responses were compared with experimental values to assess model reliability. The optimized formulation showed a predicted wetting time of 43.71 seconds, drug release of 96.37%, and disintegration time of 76.83 seconds, while observed values were 45.62 seconds, 97.59%, and 79.28 seconds, respectively, with percentage predicted error values below 5% for all responses. These findings demonstrate that Plantago ovata mucilage is an effective natural superdisintegrants for developing patient-compliant Amlodipine Besylate FDTs, offering a biocompatible and sustainable alternative to synthetic excipients, with potential application in improved oral delivery of antihypertensive drugs...

Keywords: Hypertension; Amlodipine Besylate; Plantago ovata mucilage; Fast dissolving tablets; Optimization; Factorial design Studies

How to cite this article: Bhandare PS, Ardad RM, Patel S, Shah A, Vinod Bhai DP, Ghadge DM., Design and Optimization of Herbal-Based Polymeric Fast Dissolving Tablets of Amlodipine Besylate Using Plantago ovata Mucilage..Int J Drug Deliv Technol. 2026;16(1s): 318-324; DOI: 10.25258/ijddt.16. 318-324