Table quality control test
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I. The document discusses quality control tests that are performed on tablets to ensure they meet standards for safety, efficacy and other quality parameters. It describes tests like hardness testing, friability testing, thickness measurement, disintegration testing and dissolution testing. II. Official tests discussed include weight variation testing, disintegration testing, dissolution testing and drug content uniformity. Unofficial tests include thickness measurement, hardness testing and friability testing. III. The document provides details on the procedures, equipment and apparatus used for these various quality control tests performed on tablets.
Table quality control test
- 1. Under guidance of Dr. Rashmei Mathews Ass.Professor Dep: of pharmaceutics Presented by: Abdallah abdalmalk Email: abdallahabdalmalk@yahoo.com Phone no: 7899406897/+249 900126821 KARNATAKA COLLEGE OF PHARMACY SEMINAR TOPIC IS QUALITY CONTROL TEST OF TABLET 15/12/2019
- 2. INTRODUCTION • TABLETS can be defined as solid dosage form of medicaments with or without excipients which are prepared by compression or moulding method and intended for oral administration for local and systemic effect. • They may vary in size shape weight depending upon the medicament and it’s mode of administration.
- 3. SIGNIFICANTS OF QUALITY CONTOL TEST (QCT) I. To ensure safety , potency. Efficacy ,stability, patient acceptability and patient compliance. II.To whether a pharmaceutical tablet satisfy certain standards to claim it to be a quality drug or not . III.To check the quality parameters are within the acceptance limits or not.
- 4. QUALITY CONTROL • Quality control is a small part of QA and it is concerned with sampling, testing and documentation during manufacturing and also after completion of manufacturing. • It the monitoring process through which manufacturer measures actual quality performance, compares it with standards and find out the causes of deviation from standard to ensure quality product not once but every time. • In general term quality control refers to a procedure or a set of steps taken during the manufacturing of product to ensure that it meets requirements and the product is reproducible.
- 5. TYPES OF QUALITY CONTROL TEST 1.OFFICIAL TESTS I. Weight variation test II.Disintegration time test III.Dissolution test IV.Drug content 2.UNOFFICIAL TESTS I. Thickness II.Hardness III.Friability IV.Organoleptic characters
- 6. EQUIPMENTS USED IN THICKNESS TEST A.Micrometer: put the tablet between two anvils and read it’s Thickness by scale . It’s measured in micrometer(mm). B.Vernier caliper: tablet is placed between two jaws of Vernier caliper and measure thickness of tablet by reading scale . It’s measured in centimeter(cm).
- 7. EQUIPMENTS USED IN HARDNESS TEST a)Monsanto hardness tester b)Pfizer hardness tester c)Strong cobb hardness tester d)Erweka hardness tester
- 8. a)Monsanto hardness tester • Tablet is put between moving jaw and fixed jaw is moved and pressure is applied on tablet by means of screw knob. • The point where the tablet break down it’s recorded by means of scale. • The hardness is measured in kg/cm2
- 9. b). Pfizer hardness tester • the Pfizer tester compresses tablet between a holding anvil and a piston connected to a force-reading gauge when it’s plier-like handle are gripped. • The point where tablet gets break down it’s noted by reading gauze.
- 10. FRIABILITY TEST • It means surface erosion by certain mechanical shock and lost of martial from intact tablet. • Friability is phenomenon where the surface of the tablet is damage or shown a stir of damage due to mechanical shock. • Tablet friability is measured by the uses of Roche friabilator. • This method employed to determine physical strength of uncoated tablet upon exposure to mechanical shock and attrition.
- 11. PROCEDURE OF FRIABILITY TEST 1. Take amount of tablet say 20 tablets and take initial weight of it and put it into friabliator. 2. Now rotate the drum at 25 rpm per min or 100 rpm for 4 mins. 3. During this tablet get dropped on plastic from 6 inches it will pass through mechanical shocks. 4. After 4 minutes, calculate final weight of tablets and that of %friability. 5. %friability can be calculate by the following formula : % friability= W1-W2/W1*100 W1= weight of tablets before testing. W2= weight of tablets after testing.
- 12. DISINTEGRATION TEST • Disintegration is process in which tablet are breaks up into granular or smaller particles. • The time is taken to disintegrate the tablet and measured in a device described in USP/NF so disintegration test is measure of the time required for a group of tablets to breaks up into particles under a given set of conditions. • The test is essential for tablets intended for administration by mouth. • E.g.: lozenges, glyceryl trinitrate. PROCEDURE OF DIS INTEGRATION TEST 1. The time of one tablet is placed in each tube and the basket rack is positional in 1-L beaker of water stimulated gastric fluid or stimulated intestinal fluid at 37c such that tablet remains 2.5cm below the surface of liquid on their upward movement and descend not closer than 2.5vm from the bottom of beaker.
- 13. 2. A standard motor-driven is used to move the basket assembly contains the tablet up and down through a distance of 5-6 cm at frequency of 28-32 cycles per minutes. In this way we can note the time required to complete disappearance from glass tube.
- 14. VIDEO SHOWS DISINTERGRATION TEST
- 15. DISSOLUTION TEST • The test intended to measure the times required for a given drug in oral solid dosage form into solution under specific set of conditions and all particles to pass through mesh 10 screen. • This test performed in two ways such as : 1) In vivo dissolution test is performed in healthy living subjects. 2) In vitro dissolution test is performed in dissolutions apparatus under stimulate biological conditions. • Generally two apparatus have been using for dissolution test 1) Rotating basket apparatus 2) Rotating raddle apparatus. Fig: rotating basket apparatus
- 16. Rotating paddle apparatus: ASSEMBLY CONSIST OF : • A covered vessel • Metallic drive shaft • Stainless steel paddle • Motor • Sinker to prevent floating tablet • Water bath holding temperature at 37c - + 0.5c. • Acidic media or alkaline media.
- 17. RESOURSES • Theory and practice of industrial pharmacy by Lachman/Lieberman’s • A text book of industrial pharmacy-1 by prof.(Dr.) Mahesh Prasad and Dr. antesh kummar jha . Presented by: malk’s Son