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  • Effect of Natural Polymer and Excipients on Gastro Retentive Behavior of Floating Ranitidine Tablet

  • 1Research Scholar, Department of Pharmacy, University Institute of Pharmacy
    2Associate Professor, Faculty of Pharmacy, University Institute of Pharmacy
    3Professor& Principal, Faculty of Pharmacy, University Institute of Pharmacy
     

Abstract

The current study was designed for the preparation of a gastro-retentive floating tablet of Ranitidine HCL by using combination of natural polymer Tara gum and synthetic polymer hydroxyl propyl methyl cellulose in an attempt to delay its gastric retention time and the side effects which occurs in marketed preparataion. The tablet was manufactured by the direct compression method. The outcome of varying concentrations of HPMC, Tara gum with sodium bicarbonate and citric acid for gas generating agent and magnesium stearate and talc. The preparation was augmented on the basis of adequate tablet qualities, total duration of floating, floating lag time, and in vitro drug release. The prepared tablet was found to have optimal hardness, low friability, consistent weight uniformity, and thickness. Dissolution study and floating lag time result indicated that formulation F6 showed better and controlled release of a drug. The floating lag time was 03min 30second and the total floating time was 6 hours. FTIR spectroscopy studies showed no interaction between the used polymer and the drug. The result indicated that a combination of synthetic and natural polymers reduces side effects and shows the best result[4,5].

Keywords

Ranitidine HCL, Tara Gum, HPMC, Floating tablet

Introduction

Gastric emptying for dosage forms is a highly variable process, specifically for those dosage forms that have a stomach stay for more than that of conventionally prepared dosage forms. For controlled release, drugs were designed in such dosage form to drug release at the programmed rate for maintaining the particular concentration of drug-specific time period with minimal side effects. The gastric retentive system is so formulated in an attempt to retain GIT for a longer time period ultimately enhancing the retention time of the drugs in the gastric region hence increasing their potential for absorption. Many different approaches are available that protect gastric retention, including a floating drug delivery system. A floating system, a dense density- controlled them, increases the retention time of a drug in GIT. For this, we use several approaches like muco-adhesion, gas generating, high-density, and low-density systems [1,2]. Floating improves the efficacy of tablets by controlling the rate of drug release and reducing dose frequency. Floating systems can be either non-effervescent or effervescent floating drug delivery systems. The effervescent approach utilizes various polymers in providing the floating drug delivery system Hydroxy propyl methyl cellulose is a cellulose ether polymer of non-ionic nature. It may be fibrous or in granular powder form which is soluble in cold water and is. In soluble in hot water (Higuchi&Hussain,1978). HPMC has been in use as a tablet binder, as a film coater, and also to produce matrix tablets of extended-release. It is also  used  for  the synthesis of the oral controlled drug delivery system. It has excellent characteristics of compression and good swelling properties, which helps in the formation of a gel layer (external) that further control the release of the drug [4]. Floating effervescent tablets of Ranitidine HCl were formulated in this study. Pre-compression parameters such as repose angle, tapped density, bulk density, and compressibility index and after- compression parameters such as thickness, weight variation, friability, hardness, drug content, and in vitro drug release were investigated. Dissolution studies were performedin0.1N HCl solution. Moreover, FTIR was performed to investigate the drug-polymer interaction.

MATERIALS AND METHOD

    • Chemicals: Hydroxy propyl methyl cellulose, Tartaric acid, Tara gum, Lactose, Talc (glidant) Magnesium stearate (lubricant) & sodium bicarbonate. Moreover, Hydrochloric acid, and were also procured by Merck, as the drug Ranitidine HCl. All chemicals were of analytical grades.
    • Instruments: UV spectrophotometer (shimedzu 1800), paddle (Apparatus II) dissolution apparatus, analytical weighing balance, Erweka hardness tester, vernier calipers, Roche Friabillator, and single punch tablet compression machine.
  1.  Experimental Work
  • Extraction and purification of Tara Gum: The Tara gum was extracted from Tara seed.
  • Charaterization of Tara gum: The purified and dried extracted powder was evaluated for its micromeritis properties preformulation studies, solubility studies, swelling index, and loss on drying shown in table no.01

Extraction and purification of Tara gum:

  • 1.8 kg of fresh pods from C. Spinosa dried under air flow in solar oven at 35ºC.
  • Ground down and to obtain 0.9 kg of plant material.
  • The plant material was extracted with ethanol (96% 4.5L) in recirculation percolator (2 times per days) over 10 days.
  • The ethanol crude extract (8gm) was concentrated under vacuum trapped on silica gel and removed excess humidity at 25ºC.
  • Afterwards, the ethanol extract was fractionated with the following solvents: petroleum ether(150ml); chloroform(200ml) ethanol; (200ml) and water (200ml)
  • The pure Tara gum was oven dried

Table No. 01: Physiochemical Characterization of Tara gum

S. No.

Parameter

Result{N=3}

1.

Loss on drying

12%

2.

Swelling index

18

3.

Solubility

Soluble in cold and hot water & insoluble in ethanol

4

Bulk density

0.42

5.

Tapped density

0.59

6.

Compressibility index

17.85

7.

Hausner’s ratio

1.12

8.

Angle of repose

20º.52

9.

Percentage yield

20%

7. 2 Preformulation Parameter:

• Organoleptic properties

The sample of Ranitidine was identified for color, odor and taste which were found to be same as that standard parameters.

Table No. 02: Organoleptic properties of Ranitidine HCl

S. No.

Parameter

Sample

1

Color

Brownish

2

Form

Crystalline powder

3

Odor

Odorless

4

Test

Bitter

Identification of Drug

  • By UV Spectroscopy: 10 mg drug dissolve in 100 ml of 0.1N HCL it’s an obtained stock solution of 100micrograms/ml. Then from the stock solution, 10 ml of solution is taken and the volume is made up to 100 ml with 0.1 N HCL solution and scanned under UV between 200 to 400 nm wavelength.

Reference

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Photo
Abhisek Kumar Patel
Corresponding author

Research Scholar, Department of Pharmacy, University Institute of Pharmacy

Photo
Jeevan Patel
Co-author

Associate Professor, Faculty of Pharmacy, University Institute of Pharmacy

Photo
Sudha Vengurlekar
Co-author

Professor& Principal, Faculty of Pharmacy, University Institute of Pharmacy

Photo
Sachin Kumar Jain
Co-author

Professor& Principal, Faculty of Pharmacy, University Institute of Pharmacy

Abhisek Kumar Patel*, Jeevan Patel, Sudha Vengurlekar, Sachin Kumar Jain, Effect of Natural Polymer and Excipients on Gastro Retentive Behavior of Floating Ranitidine Tablet, Int. J. Sci. R. Tech., 2026, 3 (3), 11-20. https://doi.org/10.5281/zenodo.18852130

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