Escolar Documentos
Profissional Documentos
Cultura Documentos
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)Basket Apparatus (B)Paddle Apparatus. Conditions used for (A) &(B) are same as in case for BP
Coated Tablet
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 Specimens withdrawn with a tolerance of 2% of the stated time (B) Reciprocating Cylinder: (C) Flow through Cell: Same condition as in Basket and Paddle Apparatus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
--------
--------
--------
-----
------
-----------
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
---------
--------
-------
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.
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