Friability tester

Vibrator sifter with number 60 sieve of Vinsyst makes of model MA-134-102, tablet compression machine of Karnavati Engineering make, model Rimek 02007103, Vernier caliper, Monsanto hardness tester, friability tester (Roche), disintegration apparatus, USP TYPE-2 (paddle type) dissolution apparatus, and UV-visible spectrophotometer of Agilent makes. All instruments and equipment used during the manufacturing of ketoprofen FDT were qualified, calibrated, and maintained before use.
Prospective process validation for the manufacture of ketoprofen FDT was carried out with three consecutive batches and the batches were labeled as batch 1, batch 2, and batch 3.

The prepared tablets were characterized for different post compression parameters such as weight variation, hardness, % friability, thickness, wetting time, drug content and disintegration time. The hardness of the tablets was assessed with the help of Monsanto hardness tester. It was done by taking the average value of any three tablets from every batch. Friability was tested by taking 20 tablets and placing the weighed tablets in the friability chamber (Roche friability tester) for 4 min at 25±1 rpm, and then percentage of the weight loss was determined. Disintegration test was performed in phosphate buffer of pH 6.8 at 37 ± 1 °C. 15 Thickness of tablets was determined using vernier caliper (Mitutoyo Dial Thickness Gauge, Mitutoyo, Japan). Wetting time was recorded by taking 10 ml of phosphate buffer pH 6.8 in petridish, over this fourfold tissue paper was placed and a tablet was carefully placed over this. Time required for a tablet to wet was recorded as wetting time. For determination of drug content ten tablets from each formulation batch was taken randomly and triturated to fine powder. Weight of powder equivalent to 150mg was taken in phosphate buffer pH 6.8 and assayed for drug content uniformity using double beam UV -visible spectrophotometer at λ max 325 nm.

Friability was determined using a Roche Friability tester which revolves at a speed of 25 rpm, dropping the tablets at a distance of 6 inches in each revolution. A sample of pre-weighed tablets (10 tablets for each batch) was placed in the Friability tester and allowed to rotate for 4 min. The tablets were de-dusted and then weighed.
The procedure was carried out three times for each batch. Friability values were determined as percent weight loss.