Comparison of various disssolution specification as per IP/ BP/ USP/ EP

Dosage form

BP (A)Basket Apparatus (B)Paddle Apparatus For (A) & (B) use 1000ml vessel, 36.537.7C, pH 0.05 unit, speed 5%, 252mm distance between lowest point of vessel and lowest point of rotating element. (C)Flow Through Cell Apparatus : 36.5-37.5 C, sampling at 45 mins or as specified, flowrate 5% Basket and Paddle Apparatus

IP

USP

EP (A)Basket Apparatus (B)Paddle Apparatus Same conditions for (A) & (B) as in case of BP (C)Flow through Apparatus: specifically intended for lipophilic solid dosage forms such as suppositories & soft capsules. Basket and Paddle Apparatus

Uncoated tablet

(A)Paddle Apparatus (B)Basket Apparatus. Conditions same as BP

(A)Basket Apparatus (B)Paddle Apparatus. Conditions used for (A) &(B) are same as in case for BP

Coated Tablet

Paddle and Basket Apparatus

Basket and Paddle Apparatus (A)Basket and Paddle Apparatus:Time - Test time points generally expressed in hours. Specimens withdrawn with a tolerance of 2% of the stated time (B) Reciprocating Cylinder: (C) Flow through Cell: Same condition as in Basket and Paddle Apparatus

Extended Release

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Rectal & vaginal

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Same as solid dosage form

Dosage form

BP

IP

USP (1)PADDLE OVER DISK: Paddle apparatus with SS Disk Assembly(SSDA) holding patch at the bottom of vessel, Temp 320.5 C (2)CYLINDER APPARATUS: Similar to Basket Apparatus except Basket is replaced by SS stirring element & maintain temp 32 0.5 C (3)RECIPROCATING HOLDER: Temp 32 0.5 C, applicable to coated drug delivery system, transdermal and other drug delivery system, reciprocate at a frequency of 30 cycles per min with amplitude of 2 cm or as specified in monograph, time as specified Basket and Paddle Apparatus : Time as per individual monograph. After 2 hours withdraw sample and carry out test

EP

(1)DISK ASSEMBLY METHOD: with addition of SSDA in form of a net with an aperture of 125. Rotate at 100 rpm/min Transdermal (2)ROTATING CYLINDER METHOD: Replace paddle & shaft. Rotate at 100rpm/min. (3)CELL METHOD: Rotate at 100 rpm/min . ------

Same as BP

Delayed release Tablet

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As Per U.S.P. :APPARATUS SUITABILITY TEST :-

USP REFERENCE STANDARDS FOR APPARATUS I ,II ,IV & V: USP Prednisone Tablet RS (Dissolution Calibrator ,Disintegrating) USP Salicylic acid Tablet RS (Dissolution Calibrator ,Non-disintegrating) USP REFERENCE STANDARDS FOR APPARATUS III: USP Chlorpheniramine Extended-Release Tablets RS

(Drug Release Calibrator, Single Unit) USP Theophylline Extended-Release Beads RS (Drug Release Calibrator, Multiple Unit)

FOR BASKET & PADDLE APPARATUS: AS PER USP :FOR NOMINAL CAPACITY 1L 2L 4L HEIGHT (mm) 160 to 210 280 to 300 280 to 300 INSIDE DIAMETER 98 to 106 mm 98 to 106 mm 145 to155 mm

AS PER IP , BP & EP :FOR NOMINAL CAPACITY 1L HEIGHT 168 8 mm INSIDE DIAMETER 98 to 106 mm

As Per U.S.P. : Basket apparatus is generally used for capsules. Rotated at 100 rpm/min. Paddle apparatus is generally used for tablets. Rotated at 50 or 75 rpm/min.

METHOD OF DEAERATION (USP):

Heat the medium,while stirring gently to 41 C. Immediately filter under vaccum using filter having porosity of 0.45 or less, with vigrous stirring. Continue stirring under vaccum for about 5 min.

For Conventional Dosage forms:

AS PER IP , BP , EP ,USP (FOR UNIT SAMPLE):STAGE S1 S2 S3 NUMBER TESTED 6 6 12 Each Unit NLT Q+ 5% Avg. of 12 Units ( S1 + S2 ) is Equal to OR Greater than Q, & No Unit is less than Q - 15% Avg. of 24 Units ( S1 + S2 + S3) is Equal to OR Greater than Q, & NMT 2 Units are LESS than Q - 15% & No Unit is less than Q - 25% ACCEPTANCE CRITERIA

 AS PER USP (FOR POOLED SAMPLE):STAGE S1 S2 S3 NUMBER TESTED 6 6 12 ACCEPTANCE CRITERIA Avg. AMOUNT DISSOLVED IS NLT Q + 10% Avg. AMOUNT DISSOLVED ( S1 + S2 ) IS EQUAL TO OR GREATER THAN Q + 5% Avg. AMOUNT DISSOLVED ( S1 + S2 + S3) IS EQUAL TO OR GREATER THAN Q.

REFERENCES :

INDIAN PHARMACOPOEIA -2007, P.NO.:179 to182 UNITED STATES PHARMACOPOEIA (USP XXVI), P.NO.:2155 to 2165 EUROPEAN PHARMACOPOEIA- 5.0, P.NO.:228 to 233 BRITISH PHARMACOPOEIA-1993, VOL-II,A160