Effect of Different Binding Agents on the Properties of Tablets...pharmacyteach

Effect of Different Binding Agents on the Properties of  Tablets

APPARATUS: 

Mortar and pestle, beaker, sieve no 10, tablet punching machine, hot air oven. 

CHEMICALS: 

Paracetamol, Hydroxy propyl methyl cellulose, advice, polyvinyl pyrrolidone, 

isopropyl alcohol, magnesium stearate, talc, starch, acacia, gelatin

EQUIPMENT: 

Tablet punching machine, hot air oven, cone mixer, horizontal mixer, weighing 

balance

THEORY

Paracetamol has analgesic and antipyretic properties but it has no useful anti-inflammatory properties. Paracetamol is readily absorbed from the gastrointestinal tract. Paracetamol is categorized under BCS classification II Binders or adhesives are materials that are added either dry or as a liquid form during wet granulation to form granules or to promote cohesive compact for directly compressed tablets. Tablet binders are the substances that are used to cause the adhesion of powder particles in tablet granulation. The different binders in common use include starch mucilage, acacia, and tragacanth solution (10-20%), gelatin solution, cellulose derivative, polyvinylpyrrolidone.

PROCEDURE

Five different binding agents will be used and five different formulations will be made 

F1 – 5% starch as binding agent 

F2 – 5% HPMC in water as a binding agent 

F3 – 10% acacia as binding agent 

F4 – 10% gelatin as binding agent 

F5 – 10% polyvinyl pyrrolidone as a binding agent.

The different formulations will be granulated by passing through no 10 mesh size sieve. The 

granules will be dried at 55ᵒC. After drying, dry screening of granules will be done using no 14-size sieves.This will be followed by the addition of the remaining half of the starch, talc, and magnesium stearate. These will be then compressed to form tablets on flat rounded punches on a 10-station rotary tablet machine.

FORMULA

Weight of Tablet 50 mg/Tablet

* Paracetamol-------------------------------50 mg

* Starch (binder) ---------------------------3.6 mg

* Magnesium stearate (lubricant) --------2.5 mg

* Primojel (disintegrant) -------------------2 mg

* Starch (binder) ----------------------------35 mg

* Avicel (diluents/binder) ----------------56.9 mg

EVALUATION OF TABLETS 

1. Hardness Test: 

Tablet hardness will be measured using the Monsanto hardness test apparatus. 

2. Weight Variation Test: 

20 tablets are weighed individually. Calculate the average weight and individual weight is compared with the average weight. 

3. Friability Test: 

Friability is a measure of the mechanical strength of the tablet. If a tablet has more friability it may not remain intact during packaging, transport, Pre-weighed, or handling. Roche friability is used to determine the friability by following 28 procedures. Pre weighed tablets are placed in the friability. Friabilator consists of a plastic chamber that revolves at 25 rpm, dropping those tablets at a distance of 6 inches with each revolution. The tablets are rotated in the friability for at least 4 minutes. At the end of test, tablets are dusted and reweighed; the loss in the weight of the tablet is the measure of friability and is expressed in percentage as: 

% Friability = 1‐ (loss in weight / Initial weight) X 100 

4. Assay: 

20 tablets are powdered and weighed. A quantity of powder equivalent to about 0.15g of paracetamol is accurately weighed and 50ml of 0.1M sodium hydroxide, diluted with 100ml of water, and shaken for 15 mins and added sufficient water to produce 250ml. They are mixed filtered and diluted 10ml of the filtrate to 100ml with water. To 10ml of resulting solution 10ml of 0.1M sodium hydroxide are added and diluted to 100ml with water and mixed. The absorbance of the resulting solution at the maximum at about 257nm was measured by using UV-Visible spectroscopy.

5. Disintegration Study Experimental conditions will be: 

Medium: water Speed: 30cycles/minute 

Temperature: 37±0.5ᵒC One tablet will be added into each of the 6 tubes of the apparatus and the assembly will be suspended in a beaker containing water and time required to disintegrate each tablet will be noted. From this average disintegration time was determined. 

6. Dissolution Study: 

The study will be carried out using Type-2 Paddle type USP apparatus. The set condition will be 

900ml of 6.8pH phosphate buffer, at 50 rpm, 37ᵒC for 45 minutes, 5ml of samples were withdrawn 

at time intervals of 5, 15, 30, 45 minutes, which will be replaced by fresh equal volume of 

dissolution medium, 29 the sample will be diluted suitably, assayed at 249nm by using UV-Visible 

spectroscopy. The calibration curve will be used to determine the drug concentration per ml. The 

amount of drug release was calculated using calibration curve method. 

Amount of drug release = 𝑐𝑜𝑛𝑐.×𝑣𝑜𝑙.𝑜𝑓.𝑑𝑖𝑠𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛𝑚𝑒𝑑𝑖𝑢𝑚×𝑑𝑖𝑙𝑓𝑎𝑐𝑡𝑜𝑟 1000 

Percentage drug release = 𝑎𝑚𝑜𝑢𝑛𝑡𝑜𝑓𝑑𝑟𝑢𝑔𝑟𝑒𝑙𝑒𝑎𝑠𝑒𝑠𝑡𝑟𝑒𝑛𝑔𝑡ℎ x 100 

Paracetamol tablets using 5% starch, 5% HPMC, 10% Gelatin, 10% polyvinyl pyrrollidone as 

binding agents will be prepared and evaluate each of the formulation.