View of IMPROVING PATIENT COMPLIANCE: FORMULATING AND EVALUATING GLICLAZIDE FAST-DISSOLVING TABLETS

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VOLUME: 08, Issue 04, Paper id-IJIERM-VIII-IV, August 2021 170

INTERNATIONAL JOURNAL OF INNOVATION IN ENGINEERING RESEARCH & MANAGEMENT ISSN: 2348-4918 Peer Reviewed and Refereed Journal

IMPROVING PATIENT COMPLIANCE: FORMULATING AND EVALUATING GLICLAZIDE FAST-DISSOLVING TABLETS

Thejovathi B

Assoc. Professor, Department of Pharmaceutics, Princeton College of Pharmacy, Hyderabad, Telangana, India

Nandru Ramya

Asst. Professor, Department of Pharmaceutics, Princeton College of Pharmacy, Hyderabad, Telangana, India

Abstract- The development of a gliclazide tablet that dissolves quickly for rapid action was the goal of this study. The method of direct compression was modified to make the tablets that dissolve quickly. Post-compression parameters like hardness, disintegration time, weight variation, friability, wetting time, water absorption ratio, and mouth feel are evaluated for each formulation. Using a panel scale, human volunteers were recruited to test the mouth feel. The superdisintegrants were used to make a variety of formulations in three different concentrations: 3%, 5%, and 10%. In-vitro dissolution studies were used to select the formulations for various concentrations based on disintegration time, hardness, and wetting time.

Superdisintegrants showed good hardness and less d.t at 10% concentration, according to the findings. This could be because of crosspovidone's secondary burst effect, high wicking, and capillary action, as well as the gelling tendency and slow water uptake of tablets containing sodium starch glycolate and crosscarmellose sodium. Hardness was found to be 5 kg/cm2, 5.14 kg/cm2, and 4.2 kg/cm2 for formulation at a 10% concentration, and disintegration time was found to be approximately 6 seconds, 11.5 seconds, and 8.9 seconds, respectively. Based on these data, the formulation sd9 with 10% crospovidone was chosen as the best one.

Keywords: Fast dissolving tablet, crosspovidone, sodium starch glycolate, crosscarmellose sodium, superdisintegrant.

1 INTRODUCTION

The desire to offer patients a more conventional method of taking their medications led to the development of the concept of the Mouth Dissolving Drug Delivery System. Many patients have trouble swallowing tablets and hard gelatin capsules. As a result, they don't follow prescriptions, which leads to a lot of non-compliance and ineffective treatment. Without the use of water, the Fast Dissolving Tablet rapidly dissolves or dissolves in saliva.

Some tablets are truly fast-dissolving

tablets 1-5 because they are designed to dissolve in saliva extremely quickly—within a few seconds. Others are referred to as "fast disintegrating"

tablets because they contain ingredients that speed up the rate at which the tablet dissolves in the mouth. These tablets may take up to a minute to completely dissolve. This tablet dissolves instantly when swallowed, releasing the medication, which dissolves or disperses in saliva.

As saliva descends into the stomach, some drugs are absorbed from the

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mouth, pharynx, and oesophagus.

The drug's bioavailability is significantly higher in these situations than in conventional tablet dosage forms. The Fast Dissolving Tablet is a novel dosage form that stands out from more conventional forms in several ways. Through pre-gastric absorption from the mouth, pharynx, and esophagus, the tablet's disintegration in the mouth may enhance the drug's clinical effect.

Because of this, first-pass metabolism is avoided, resulting in an increase in bioavailability.

2 DESIRED CRITERIA FOR FAST DISSOLVING TABLET

The mouth-dissolving tablet should:

 Not necessitate swallowing water; rather, it should dissolve or disintegrate in the mouth in a matter of seconds.

 Compatibility with taste masking

 Portability without concern for fragility

 Feel good in the mouth.

3 EVALUATION OF FAST DISSOLVING TABLET 7-10

Variation in weight: The purpose of the weight variation test is to guarantee that all tablets in a batch weigh the same. The average and total weight of 20 tablets from each formulation were determined.

Additionally, the weight variation and individual tablet weights were accurately determined.

Hardness: The strength of a tablet can be gauged by its hardness. The tablet is put to the test by measuring the force required to break it across.

The force is expressed in kilograms,

and for uncoated tablets, a hardness of 3-5 kg/cm2 is considered adequate.

Using a Monsanto hardness tester, the hardness of ten tablets from each formulation was determined.

Test of friability: Friability is the weight loss of a tablet inside its container as a result of the surface's removal of fine particles. The tablet's ability to withstand abrasion during packaging, handling, and transport is assessed through a friability test. The tablets' friability was assessed using a Roche friabilator. Weighing 20 tablets from each formulation, we placed them in a Roche friabilator for four minutes at 25 rpm. The tablets were once more weighed and dedusted.

Once more, the percentage of weight loss was determined.

Test for disintegration: Six glass tubes that were "3 long, open at the top, and held against 10" screens at the bottom end of the basket rack assembly served as the USP device for resting disintegration. Each tube contains one tablet, and the basket rack is poisoned in a 1 liter beaker of distilled water at 37 degrees Celsius so that the tablets don't touch the liquid as they move upward and don't touch the bottom of the beaker more than 2.5 centimeters.

Wetting time

A straightforward method was used to measure the tablets' wetting time. A petridish containing three milliliters of a solution containing 0.2% w/v methylene blue contained five 10 cm- diameter circular tissue papers. On the tissue paper's surface, a tablet was carefully placed. The wetting time was recorded as the amount of time it

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took for the tablets' upper surface to turn blue.

4 MATERIALS AND METHODS

Sun Pharma, Baroda, India, presented a sample of gliclazide as a gift. A gift sample of Ac-Di-Sol, sodium starch glycolate, and crosspovidone was obtained from Signet Chemicals Mumbai. Aerosil, Magnesium Stearate, Sodium Saccharin, and tartaric acid were all commercially sourced analytical grade materials.

Cross carmellose, cross povidone, and sodium starch glycolate were used as disintegrants in the current study to make Gliclazide fast dissolving tablets at three, five, and ten percent concentrations, respectively. The direct compression method was used to prepare nine formulations in total.

the information that was gathered regarding post-compression parameters like hardness, friability, variation in weight, and drug content;

time for in-vitro wetting and disintegration. For each formulation, the hardness was found to be between 3.9 and 5.14 kg/cm2, which indicates that the material has good mechanical strength and can withstand physical and mechanical stress while being handled. The IP limits are met because the friability values in all formulations are less than one percent. The percentage weight variation of all the tablets was within the pharmacopoeial limits, so they all passed the weight variation test. All of the tablets had the same weight and low standard deviations, indicating that the drug, disintegrants, and excipients were mixed well. All of the tablets' in-vitro wetting and disintegration times met the requirements for fast-dissolving

tablets and were found to be within the recommended ranges. The in-vitro disintegration time was found to be between 6 and 39 s, while the in-vitro wetting time was found to be between 4 and 33 s. Formulations containing SSG, SD9, and CCM, SD8 (both ten percent), on the other hand, produced formulations with minimum D.T. of 8.9 seconds and minimum DT of 11.5 seconds, respectively. As a result, superdisintegrants produced less D.T.

and demonstrated good hardness at ten percent concentration. This could be because of the secondary burst effect and high wicking and capillary action of CPV, as well as the gelling tendency and slow water uptake of tablets with SSG and CCM rather than CPV. Super disintegrant's faster disintegration can be attributed to the increased hydrodynamic pressure and swelling that result from the increased rate and extent of water uptake.

5 CONCLUSION

Utilizing super disintegrants, Gliclazide's fast-dissolving tablets were developed. The mixture that was made through direct compression using a drug to crosspovidone ratio of 10 percent had ideal and repeatable characteristics, including a disintegration time of 6 seconds.

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