Ipqc and fpqc test for suppositories
- 1. IPQC and FPQC Test for suppositories Prepared by Arpit Rajaram Suralkar M Pharm 1st year (Quality Assurance)
- 2. • Evaluation of Suppositories The prepared suppositories were evaluated for official and unofficial parameters viz weight variation, content uniformity, hardness, Liquefaction time and temperature, dissolution test, disintegration and Macro-melting range test. The tests were carried out in triplicate • 1. Weight Variation : All the suppositories (made by the respective bases), were weighed and average weight was calculated. Then all the suppositories were individually weighed and the variation from the average was calculated. No suppositories should deviate from average weight by more than 5% except two which may deviate not more than 7.5 %.
- 3. • 2. Hardness (fracture point) Hardness of the prepared suppositories was tested using Monsanto hardness tester model. The weight required for suppository to collapse was taken as measure of hardness of the suppository. Hardness test or fracture point test was carried to determine the tensile strength of the suppositories to access whether they will be able to withstand the hazards of packing and transporting. • 3. Disintegration Test The disintegration test was performed on six suppositories of each type using USP tablet disintegration (Electro lab, ED 2L) test apparatus. 160ml of distilled water was used as medium at 37 ℃. Suppositories prepared with water soluble bases the time required for complete disintegration and in case of oily bases, the time required for complete Disintegration of suppository was determined
- 4. • 4. Macro Melting Range Test For macro melting range test the formulation was filled to about 1cm height in capillary tubes of 10 cm length and dipped in a beaker containing water. The temperature was raised slowly and the temperature at which the mass liquefies was recorded • 5. Liquefaction Time & Temperature For Liquefaction time and temperature was done using fabricated instrument. A big pipette was taken having a narrow opening on one side and broad opening on another side. The pipette was dipped in hot water maintained at 37 ℃. So that narrow end faces toward hot water. The sample suppository was introduced from the top of the pipette through broad end and carefully pushed down its length until it reaches narrow end. A glass rod was then inserted so that it rests over the suppository. The temperature at which the glass rods just come down was noted that represents the liquefaction temperature. The time at which glass rod reaches to narrow end after complete melting of suppositories represents the liquefaction time .
- 5. • 6. Drug Content For determination of drug content the suppositories were dissolved in 100 ml phosphate buffer of pH 7.4 by stirring through magnetic stirrer slowly at 37 ℃ for 1 hr. After the solution was filtered; and the filtrate was diluted suitably and absorbance was measured against blank at 371nm. • 7 Dissolution Test In vitro dissolution studies of lornoxicam suppositories were carried out in USP tablet dissolution test apparatus (Electro lab-TDT 08L) employing a rotating basket apparatus (Type I) at 100 rpm and using 500 ml of phosphate buffer (pH 7.4) at 37±0.5 ℃ as dissolution medium. One suppository was used in each test. At predetermined time intervals 5 ml sample were withdrawn by means of syringe fitted with a pre filter then filtered through watman filter paper. The volume withdrawn at each interval was replaced was replaced with same quantity of fresh dissolution medium and maintained at 37±0.5 ℃. The sample were analyzed for drug release by measuring the absorbance at 371 nm using UVvisible spectrophotometer after suitable withdrawn sample cumulative percent of lornoxicam released was calculated and plotted against time. All the studies were run in triplicate (n=3).
- 6. • 8. Stability studies Short term stability studies were performed at a room temperature and refrigeration temperature (4 ℃ ) was kept for 6 w on the promising formulation. The suppositories were individually wrapped in aluminum foil and packed in cardboard boxes. Sample are taken after 6 w for drug content estimation and dissolution test also performed to determine the drug release profile .