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  • United States Pharmacopoeia 2009 (Usp)

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    Mahesh Chokshi
    133 vizualizări3 pagini
    The document compares disintegration testing methods for various oral solid dosage forms like capsules, tablets, etc. as described in three pharmacopoeias - Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP). All three use similar apparatus and process, but vary in terms of test conditions like medium, time periods and acceptance criteria for different dosage forms.

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    The document compares disintegration testing methods for various oral solid dosage forms like capsules, tablets, etc. as described in three pharmacopoeias - Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP). All three use similar apparatus and process, but vary in terms of test conditions like medium, time periods and acceptance criteria for different dosage forms.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca XLS, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    133 vizualizări3 pagini

    United States Pharmacopoeia 2009 (Usp)

    Încărcat de

    Mahesh Chokshi
    The document compares disintegration testing methods for various oral solid dosage forms like capsules, tablets, etc. as described in three pharmacopoeias - Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP). All three use similar apparatus and process, but vary in terms of test conditions like medium, time periods and acceptance criteria for different dosage forms.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca XLS, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    din 3

     

    FORMULATION INDIAN PHARMACOPOEIA 1996 (IP) BRITISH PHARMACOPOEIA 2009 (BP) UNITED STATES PHARMACOPOEIA 2009 (USP)

    Hard gelatin capsules Uses disintegration apparatus with 250ml Uses disintegration apparatus with water R Same as uncoated tablets. Use a circular
    or 1 L of specified medium at 37+-2OC & for or specified liquid medium, add a metal cloth mesh of diameter 0.60-0.655mm &
    specified time as per monograph. If 1-2 fail, disc to prevent capsule from floating & 1.8-2.2mm square mesh size. No palpable
    repeat for 12 different units. 16 out of 18 operate for 30 min. or as per monograph. If material to remain on the mesh.
    indicate test is affirmative. 1-2 fail, repeat for 12 different units. 16 out
    of 18 indicate test is affirmative.

    Soft gelatin capsules Uses disintegration apparatus with 250ml Uses disintegration apparatus with water R Same as uncoated tablets. Use a circular
    or 1 L of specified medium at 37+-2OC & for or specified liquid medium, add a metal cloth mesh of diameter 0.60-0.655mm &
    specified time as per monograph. If 1-2 fail, disc to prevent capsule from floating & 1.8-2.2mm square mesh size. No palpable
    repeat for 12 different units. 16 out of 18 operate for 30 min. or as per monograph. If material to remain on the mesh.
    indicate test is affirmative. 1-2 fail, repeat for 12 different units. 16 out
    of 18 indicate test is affirmative.

    Modified release capsules Disintegration testnot applicable Disintegration testnot applicable Disintegration testnot applicable
    Gastro resistant capsules Uses disintegration apparatus with 250ml Uses disintegration apparatus with 0.1 M -NA-
    or 1 L of specified medium at 37+-2OC & for HCl at 37+-2OC for 2-3 hrs (nlt 1 hour), if
    specified time as per monograph. If 1-2 fail, there is no cracking or breaking, continue
    repeat for 12 different units. 16 out of 18 with phosphate buffer, pH 6.8 at same
    indicate test is affirmative. 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.

    Suppositories Uses disintegration apparatus for Uses disintegration apparatus with water R -NA-
    suppositories/pessaries Uses 4 L of or specified liquid medium & for 30 min. for
    specified medium at 37+-2OC & for suppositories with fatty base and for 60
    specified time as per monograph. If 1-2 fail, min. for suppositories with water soluble
    repeat for 12 different units. 16 out of 18 base. If 1-2 fail, repeat for 12 different
    indicate test is affirmative. units. 16 out of 18 indicate test is
    affirmative.

    Rectal capsules -NA- -NA-


    Uncoated tablets Uses disintegration apparatus with 250ml Uses disintegration apparatus Uses liquid Uses disintegration apparatus with
    or 1 L of specified medium & for specified medium water R or specified medium for 15 specified liquid medium & for specified time
    time as per monograph. If 1-2 fail, repeat min. If 1-2 fail, repeat for 12 different units. as per monograph. If 1-2 fail, repeat for 12
    for 12 different units. 16 out of 18 indicate 16 out of 18 indicate test is affirmative. different units. 16 out of 18 indicate test is
    test is affirmative. affirmative.
    Chewable tablets -NA- Disintegration testnot 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 Same as uncoated tablets. Uses
    or specified liquid medium & for 60 min., if disintegration apparatus with specified
    there is no cracking of coat; continue by liquid medium & for specified time as per
    replacing the medium with 0.1 M HCl for monograph. If 1-2 fail, repeat for 12
    specified time as per monograph. If 1-2 fail, different units. 16 out of 18 indicate test is
    repeat for 12 different units. 16 out of 18 affirmative.
    indicate test is affirmative.

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

    Gastro resistant tablets Uses disintegration apparatus with 250ml Uses disintegration apparatus with 0.1 M Uses disintegration apparatus with
    (Enteric Coated) or 1 L of specified medium & for specified HCl at 37+-2OC for 2-3 hrs (nlt 1 hour), if stimulated gastric fluid TS at 37+-2OC for 1
    time as per monograph. If 1-2 fail, repeat there is no cracking or breaking of coat, hour, if there is no cracking or breaking of
    for 12 different units. 16 out of 18 indicate continue with phosphate buffer, pH 6.8 at coat, continue with stimulated intestinal
    test is affirmative. same temperature for 1 hour or as per fluid at same temperature for specified time
    monograph.  If 1-2 fail, repeat for 12 as per monograph.  If 1-2 fail, repeat for 12
    different units. 16 out of 18 indicate test is different units. 16 out of 18 indicate test is
    affirmative. affirmative.

    Modified release tablets Disintegration testnot applicable Disintegration testnot applicable Disintegration testnot applicable
    Effervescent tablets -NA- A total of 6 units tested Uses 200ml of -NA-
    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.

    Soluble tablets -NA- Uses disintegration apparatus Uses liquid -NA-


    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.
    Dispersible tablets -NA- Uses disintegration apparatus Uses liquid -NA-
    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.
    Oral lyophilisates -NA- 1 unit in a beaker of 200ml water R at 15- -NA-
    25OC. Disintegrates within 3 min. Repeated
    for total 6 units. Sample accepted if all
    pass.

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