Evaluation of tablets and capsule

QC of Tablets and capsule

1. EVALUATION OF SOLID DOSAGE FORM (TABLETS AND CAPSULE)

2. DEFINATION OF TABLET: Tablets are solid unit dosage form containing therap eutically active ingredient with or without excipient prepared either by molding or by compression method. DEFINATION OF CAPSULE: Capsule is solid unit dosage form, contains cap and body, API with or without excipients (in the form of powder, pellets, plugs, granules) is filled in the body and further sealed by cap DISINTEGRATION TEST: Disintegration test apparatus I.P: Basket and rack assembly. Six cylindrical glass tube 77.5( +/- 2.5 )mm long , Internal diameter 21.5 mm, thickness of wall 2mm. Covered with upper plate having 6 holes, diameter of holes is same as that of diameter of tubes. At lower plate stainless steel sieve is present (size # 10)

3. 28-32 cycles per min. Tube covers distance of 50-60 mm during upward and downward movement . Discs are added to avoid floating of tablets. Beaker having 1000 ml capacity. The volume of liquid should be such that the wire mesh at its highest point is at least 2.5 cm below the surface of liquid and at its lower point is 2.5 cm above the bottom of beaker Temperature maintained at 37(+/- 2) degree C. (same apparatus for capsule disintegration Test ) PROCEDURE: perform test on 6 tablets/ capsules If more than 2 tablets/capsules fails the test, then perform test on another 12 tablets/ capsules Out of 18 tablets/ capsules 16 tablets should pass the test

4. DISINTEGRATION TEST APPARATUS

5. LIMITS FOR DISINTEGRATION TEST FOR TABLETS: Type of tablet medium Temperature (degree c) limit Uncoated tablet Water/buffer 37(+/-2) 15 min (I.P,B.P) 30 min (USP) Film coated Water 37(+/-2) 30 Min (I.P, B.P) Sugar coated Water/ 0.1 N HCL 37(+/-2) 60 min (I.P, B.P) Dispersible tablet water 25(+/-1) 3 min (I.P, B.P) Effervescent tablet water 25(+/-1) 5 min (I.P, B.P) Enteric coated tablet 0.1 M HCL, Phosphate buffer pH 6.8 37(+/-2) 2hr in HCL (no disintegration) 1 hr in buffer (disintegration) (I.P, B.P) 1 hr in HCL (no disintegration) 2 hr in buffer( disintegration) (USP)

6. LIMITS FOR CAPSULES: Types of capsule Medium Temperature( degree c) Time limit ( i.P ) Hard gelatin Water/buffer 37(+/-2) 30 min Soft gelatin Water 37(+/-2) 60 min Enteric coated 0.1 M HCL , phosphate buffer pH 6.8 37(+/-2) 2 hr in HCL (no disintegration) 1 hr in buffer (disintegration)

7. DISSOLUTION TEST OF TABLETS AND CAPSULES: DISSOLUTION TEST APPARATUS: USP APPARATUS : TYPE I : Basket type TYPE II: Paddle type IP APPARATUS : TYPE I : Paddle type TYPE II : Basket type APPARATUS AS PER IP: TYPE I : PADDLE TYPE The part of assembly that comes in contact with medium should be made up of stainless steel and should be inert. IT CONSISTS OF: CYLINDRICAL VESSEL: Made up borosilicate glass CAPACITY: 1000 ml Have hemispherical bottom. INTERNAL DIAMETER: 98-106 mm

8. PADDLE TYPE STIRRER BASKET TYPE STIRRER

9. Upper rim is fitted with lid which has many opening one of which is central. Motor regulates speed of paddle within 4% deviation. The Lower Edge of the blade should be 23-27 mm from inside bottom of vessel. Temperature of water bath is 36.5-37.5. The liquid is kept in constant motion during test. TYPE II: BASKET TYPE Paddle is replaced by basket. Basket contains 2 parts top part is attached to the shaft. It is fitted with 3 spring clips. The preparation under examination is introduced from lower part of basket. Lower detachable part of basket is made up of welded steam cloth wire having 0.254 mm diameter and 0.381 mm square opening. Basket is plated with gold layer 2.5 micrometer thick for use with acidic media. The distance between basket and inside bottom of the vessel should be 23-27 mm

10. LIMITS FOR DISSOLUTION TEST FOR TABLETS/CAPSULES: No. of tablets/ capsules limit 6 Tablets/capsules Average should be equal to Q or more than Q. individual tablet/capsule should not less than Q+5%. IF NOT SO. 6 Tablets/capsules Average should be equal to Q or more than Q. Individual tablet/capsule should not be less than Q-15%. IF NOT SO 12Tablets/capsules Average should be equal to Q or more than Q. 2 Tablets/capsule can be less than Q-15% but individual tablet/capsule should not be less than Q-25% Q stands for dissolution rate

11. CONTENT UNIFORMITY TEST FOR TABLETS AND CAPSULES : Select 30 tablets/capsules randomly. Perform assay on first 10 tablets/capsules if more than one tablet/capsule fails the test then perform test on another 20 tablets/capsules. out of 30 tablets/capsules 29 tablets/capsules should pass the test. No of tablets/capsules limits 10 tablets/capsules 9 tablets/capsules should be (+/- 15%) 10 th tablet/capsules can be (+/-25%) If not so 20 tablets/capsules All 20 tablets/capsules should be (+/-15%) PROCEDURE:

12. Weight variation test for tablets: Select 20 tablets randomly Weigh them individually Find average weight Out of 20 tablets 18 tablet should pass the test. Weight of tablet in mg Deviation allowed 80mg or less 10% 80-250 mg 7.5% More than 250 mg 5% Weight of tablets in mg Deviation allowed 130mg or less 10% 130-324mg 7.5% More than 324mg 5% AS PER I.P: AS PER USP: PROCEDURE:

13. WEIGHT VARIATION TEST FOR CAPSULE: FOR HARD GELATIN CAPSULE : Select 20 capsules randomly. Weigh each filled capsule individually and take weight of capsule after removing the content. Find out net weight (net wet= weight of filled capsule-weight of empty capsule) Find out average net weight of 20 capsule. Find out upper limit and lower limit Out of 20 capsules 18 capsules should be in the limit. FOR SOFT GELATIN CAPSULE: Select 20 capsules randomly. Weigh each filled capsule individually. Open capsule by making cut on it remove all content, wash with water, allow shell to dry. Take weight of dry shell. Find out net weight of 20 capsule. Find out upper limit and lower limit Out of 20 capsules 18 capsules should be in the limit.

14. Limits of weight variation test for capsules: Average weight of capsules Deviation allowed 300mg or less 10% More than 300 mg 7.5% FRIABILITY TEST FOR TABLETS: Select 20 tablets randomly weigh them. Put in Roche friabilator and allow to rotate at 25 rpm for 4 min. Take weight of tablets after test Find out percent loss by formula: (Initial weight-final weight/initial weight)*10 The percent loss should not be more than 1%

15. MOISTURE PERMEATION TEST FOR CAPSULES: Capsules packed with colored pellet. Exposed packed unit to known relative humidity for specific time. Observe desiccant pellet for color change. Any change in the color indicates absorption of moisture. Difference between the pretest weight and weight after the test indicates amount of moisture absorbed by the capsule. PROCEDURE:

16. Thank you….! Prepared By: Kajal.S.Barge (17D02) T.Y.B.Pharmacy