Disintegration Tests : Pharmacopoeial comparison

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Disintegration Test requirements for Hard gelatin capsules,Soft gelatin capsules, Modified release capsules,Suppositories,Gastro resistant capsules etc

FORMULATION

Indian pharmacopoeia 1996 (IP)

british pharmacopoeia 2009 (BP)

united states pharmacopoeia 2009 (USP)

Hard gelatin capsules

Uses disintegration apparatus with 250ml or 1 L of specified medium at 37+-2OC & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with water R or specified liquid medium, add a metal disc to prevent capsule from floating & operate for 30 min. or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Same as uncoated tablets. Use a circular cloth mesh of diameter 0.60-0.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh.

Soft gelatin capsules

Uses disintegration apparatus with 250ml or 1 L of specified medium at 37+-2OC & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with water R or specified liquid medium, add a metal disc to prevent capsule from floating & operate for 30 min. or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Same as uncoated tablets. Use a circular cloth mesh of diameter 0.60-0.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh.

Modified release capsules

Disintegration test not applicable

Disintegration test not applicable

Disintegration test not applicable

Gastro resistant capsules

Uses disintegration apparatus with 250ml or 1 L of specified medium at 37+-2OC & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with 0.1 M HCl at 37+-2OC for 2-3 hrs (nlt 1 hour), if there is no cracking or breaking, continue with phosphate buffer, pH 6.8 at same temperature for 1 hour or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

-NA-

Suppositories

Uses disintegration apparatus for suppositories/pessaries Uses 4 L of specified medium at 37+-2OC & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with water R or specified liquid medium & for 30 min. for suppositories with fatty base and for 60 min. for suppositories with water soluble base. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

-NA-

Rectal capsules

-NA-

-NA-

Uncoated tablets

Uses disintegration apparatus with 250ml or 1 L of specified medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus Uses liquid medium water R or specified medium for 15 min. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Chewable tablets

-NA-

Disintegration test not applicable.

Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for 4 hours or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Non-film coated tablets

-NA-

Uses disintegration apparatus with water R or specified liquid medium & for 60 min., if there is no cracking of coat; continue by replacing the medium with 0.1 M HCl for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Film coated tablets

-NA-

Uses disintegration apparatus with water R or specified liquid medium & for 30 min., if there is no cracking of coat; continue by replacing the medium with 0.1 M HCl for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Gastro resistant tablets (Enteric Coated)

Uses disintegration apparatus with 250ml or 1 L of specified medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with 0.1 M HCl at 37+-2OC for 2-3 hrs (nlt 1 hour), if there is no cracking or breaking of coat, continue with phosphate buffer, pH 6.8 at same temperature for 1 hour or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Uses disintegration apparatus with stimulated gastric fluid TS at 37+-2OC for 1 hour, if there is no cracking or breaking of coat, continue with stimulated intestinal fluid at same temperature for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Modified release tablets

Disintegration test not applicable

Disintegration test not applicable

Disintegration test not applicable

Effervescent tablets

-NA-

A total of 6 units tested Uses 200ml of water R at 15-25OC. Disintegrates within 5 min. or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

-NA-

Soluble tablets

-NA-

Uses disintegration apparatus Uses liquid medium water R or specified medium. Disintegrated within 3 min. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

-NA-

Dispersible tablets

-NA-

Uses disintegration apparatus Uses liquid medium water R or specified medium. Disintegrated within 3 min. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

-NA-

Oral lyophilisates

-NA-

1 unit in a beaker of 200ml water R at 15-25OC. Disintegrates within 3 min. Repeated for total 6 units. Sample accepted if all pass.

-NA-

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References:

1) The Indian pharmacopoeia,1996

2) British pharmacopoeia,2009

3) United States NF, 2008.

About the Author

Niklesh Rao V's picture
Author: Niklesh Rao V

Comments

Santosh kumar. JH's picture

Excellent presentation.... Keep it up... Hope you continue the same in your coming blogs....

Bhushan Sonawane's picture

Hi, I want to know that how it is decided that only 6 tablets has to be taken in disintegration test? Why not more or less than six? Same ibn case of Friability , Dissolution ?

hushan Sonawane