IN-PROCESS QUALITY CONTROL TESTS - IPQC OF TABLETS ppt

IN-PROCESS QUALITY CONTROL TESTS - IPQC OF TABLETS ppt by Akanksha puri

1. INPROCESS QUALITY CONTROL (IPQC) TEST FOR TABLETS 1 Prepared by:- Akanksha Balasaheb Puri (01) M pharmacy 1 st Year Department of Quality Assurance Techniques

2. CONTENTS INTRODUCTION IMPORTANCE TYPES OF IPQC TESTS IPQC TESTS FOR TABLETS REFERNCE 2

3. INTRODUCTION IPQC tests are tests that are carried out during the process of manufacturing or before it is completed. The function of the in-process quality control test is monitoring and if necessary adaption of the manufacturing process in order to comply with specification. IPQC is concerned with providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form. 3 INTRODUCTION

4. IMPORTANCE OF IPQC TESTS To minimize human errors. To provide accurate, specific and definite description of the procedure to be employed. Gives easier identification of the problems. Detects errors if and when it does occurs . Quality issues and unstable factors in manufacturing process Immediately takes measures to improve and ensures quality 4 IMPORTANCE

5. TYPES OF THE IPQC TESTS 5 PHYSICAL AND CHEMICAL BIOLOGIC AND MICROBIOLOGIC IDENTITY TEST QUALITY TEST PURITY TEST POTENCY TEST

6. IPQC TEST FOR TABLETS OFFICIAL TESTS WEIGHT VARIATION DISINTEGRATION DISSOLUTION DRUG CONTENT UNOFFICIAL TESTS GENERAL APPERANCE HARDNESS FRIABILITY 6

7. UNOFFICIAL TESTS GENERAL APPEARANCE - Its visual identity and all over elegance is essential for consumer acceptance for control of lot of uniformity . SHAPE SIZE COLOUR ODOUR TASTE SURFACE TEXTURE 7

8. The thickness of a tablet is the only dimensional variable related to the process. Thickness of individual tablets may be measured by a vernier calliper . Tablet thickness should be controlled within a ± 5 % variation of a standard. Thickness must be controlled to facilitate packaging. It is expressed in mm THICKNESS 8

9. HARDNESS TEST Monsanto hardness tester is used to evaluate tablet hardness tester. The tester consists of a barrel containing a compressible spring held between two plungers. The lower plunger is placed in contact with the tablet and zero reading is taken. The upper plunger is then forced against a spring by turning a threaded bolt until the tablet fractures. As the spring is compressed, a pointer rides along a gauge in the barrel to indicate the force. The force of fracture is recorded in kilogram. 9

10. FRIABILITY TEST For this test 20 tablets are weighed and placed in the friabilator and then operated at 25 rpm for 4 minutes. The tablets are then dedusted and weighed. The difference in the two weights is used to calculate friability and the value of friability is expressed in percentage. It is determined by the following formula. Friability = ( Iw – Fw )/ Iw *100% where, Iw = Total Initial weight of tablets; Fw = Total final weight of tablets. As stated by USP if conventional compressed tablets that loss less than 0.5 % to 1 % (after 100 revolutions) of their weight are generally considered acceptable . 10

11. Weight Variation Test According to the USP 20 tablets were weigh randomly and average is taken. then it is compared with upper and lower limit. UPPER LIMIT= average weight + (average weight*% error) Lower limit= average weight - (average weight*% error) The value of weight variation test is expressed in percentage. The following formula is used. Weight Variation = ( Iw – Aw )/ Aw 100% where, Iw = Individual weight of tablet Aw = Average weight of tablet. 11 OFFICIAL TEST

12. Sr no. Avg wt of tablets (mg) IP Max % difference allowed Avg wt of tablets (mg) USP 1 84mg or less 10% 130mg or less 2 84mg-250mg 7.5% 130mg-324mg 3 More than 250mg 5% 324mg or more 12

13. UNIFORMITY CONTENT Randomly select 30 tablets.10 of these are assay individually. The tablet pass the test if 9 of the tablets must contains not less than 85% and not more than 115% of the labelled content and the 10 th tablet may not contain less than 75% and more than 125% of the labeled content If the condition are not met, remaining 20 tablets assayed individually and more may fall outside the 85-115% range. 13

14. DISINTEGRATION TEST The USP disintegration apparatus consist of 6 glass tubes-3 inches long, open at the top, and held against a 10-mesh screen at the bottom end of the basket rack assembly. Temperature- 37 ± 2 °C (tablet remains 2.5 cm below the surface of the liquid on their upward movement) A standard motor driven device is used to move the basket up and down through distance of 5 to 6 cm Speed- 28 to 32 cycles per minute. Perforated plastic discs may also be used in the test. These are placed on the top of tablets and impart an abrasive action to the tablets. Operate it for 15 mins. 14

15. Sr no. TYPES IP BP USP 1 Uncoated tablet 15mins 15mins 5mins 2 Sugar coated tablet 60mins 30mins - 3 Film coated tablet 30mins 30mins - 4 Enteric coated tablet 1hr in 0.1N HCl and disintegrate in within 2hr ion mixed phosphate buffer 6.8 1-2hr 2hr 5 Effervescent/dispersible tablet <3mins <3mins <3mins 15 If any residue remains, it must have a soft mass. The tablet complies with the test according to USP, if all of the tablets have disintegrated completely. If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets. The requirement is met if not less than 16 of the total of 18 tablets tested are disintegrated.

16. DISSOLUTION TEST It is generally used to determine the percentage release from the drug. i.e breaks down into the smaller particle to get the increase surface area Types of apparatus as per IP Apparatus 1:Paddle type Apparatus 2:Basket type Conditioned maintain Speed : 25-150rpm Temperature: 37+_ 0.5 C 16

17. Sr no. Stage No. of tablet tested Acceptance criteria 1 S1 6 Each unit is not less than Q + 5 %. 2 S2 12 Average of 12 units (S1 + S2) is equal to or greater than Q, and no unit is less than Q – 15 %. 3 S3 18 Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15 %, and no unit is less than Q – 25 % 17

18. REFERENCES: https://www.slideshare.net/bharathpharmacist/ipqc-for-tablets-correctd-39635926 2.http://vikramuniv.ac.in/files/ wpcontent /uploads/B.Pharma_8_th_Sem_Ph._Analysis_IPQC_tests_Dr._Anis_Shaikh.pdf 3. https://www.slideshare.net/GOVINDYADAV28/tablets-evalution 4. Pooja Rajan * , P. Sindhuja , A REVIEW ON IN PROCESS AND FINISHED PRODUCTS QUALITY CONTROL TESTS FOR TABLETS ACCORDING TO PHARMACOPOEIAS,World Journal of Pharmacy and Pharmaceutical Sciences. 18

19. THANK YOU!! 19