Abstract

Objective: The main aim of the present research work was to formulate fast dissolving tablets of famotidine by direct compression method and to evaluate the effect of synthetic super disintegrating agent on drug release pattern.
 Methods: The fast dissolving tablets were prepared by using crospovidone, croscarmellose sodium, sodium starch glycolate as superdisintegrants (2, 4 and 6 %w/w), mannitol 20 % and microcrystalline cellulose (44, 46 and 48 % w/w) as a directly compressible vehicle. All the prepared tablets were evaluated for hardness, friability, drug content uniformity, weight variation, disintegrating time, wetting time and in vitro drug release studies.
 Results: All the prepared fast dissolving tablets formulations were within the Pharmacopoeial standards limits. Based on in vitro drug release studies (>90 % within 30 min), the optimised formulations were optimised tested for the short term stability (at 40 ˚C/75% RH for 3 mo) and drug excipient interaction (fourier transform infrared spectroscopy).
 Conclusion: Hence, formulation prepared with 6 % w/w of crosspovidine and 44 % w/w of microcrystalline cellulose as emerged as the overall best formulation (>90 % within 30 min) compared to marketed product (>70 % within 30 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro drug release (p<0.05).

Highlights

  • Oral routes of drug administration is the most popular route for systemic effects due to its ease of ingestion, pain, avoidance, versatility and most importantly patient compliance

  • As a competitive inhibitor of histamine H2-receptors located on the basolateral membrane of the parietal cell, famotidine reduces basal and nocturnal gastric acid secretion, resulting in a reduction in gastric volume, acidity, and amount of gastric acid released in response to various stimuli

  • Fasting dissolving tablets (FDTs) of famotidine were prepared by using synthetic superdisintegrants such as crosspovidone, cross carmellose sodium and sodium starch glycolate

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Summary

Introduction

Oral routes of drug administration is the most popular route for systemic effects due to its ease of ingestion, pain, avoidance, versatility and most importantly patient compliance. Famotidine is metabolized in the liver to famotidine S-oxide (S-famotidine). They inhibit gastric acid secretion stimulated by food, betazole, pentagastrin, caffeine, insulin and physiological vagal reflex. Famotidine is better option for the development of immediate release tablets [5, 6]. The purpose of the present research work was to develop and characterize immediate release tablets of famotidine using various synthetic superdisintegrants such as crospovidone (CP), croscarmellose sodium (CCS), sodium starch glycolate (SSG) with mannitol to release the medicament and mask bitter taste [7,8,9]. Fasting dissolving tablets (FDTs) helps in immediate release of medicament, leading to an increase in bioavailability of the drug and quick onset of pharmacological action can take place [10,11,12,13,14]

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