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Dissolution Apparatus
Dissolution Apparatus
WHAT IS DISSOLUTION?
the process by which a solid or liquid forms a homogeneous mixture with a solvent
Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form
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To accessing therapeutic efficacy. Monitoring batch to batch consistency. High cost of in vitro dissolution test. Assessment of bioequivalence.
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FUNCTIONS OF DISSOLUTION
Optimization of therapeutic effectiveness during product development and stability assessment Routine assessment of production quality to ensure uniformity between production lots Assessment of bioequivalence, that is to say, production of the same biological availability from discrete batches of products from one or different manufacturers Prediction of in-vivo availability, i.e. bioavailability (where applicable)
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TYPES OF APPARATUS
BASKET APPARATUS PADDLE APPARATUS RECIPROCATING CYLINDER
FLOW-THROUGH CELL
PADDLE OVER DISK CYLINDER
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BASKET
a) Vessel :-Made up of borosilicate glass -Semi hemispherical bottom Capacity 1000ml b) Shaft : -Stainless steel 316 -Rotates smoothly without significance wobble c) Basket :- Stainless steel 316 -Gold coatings up to 0.0001 inch d)Waterbath : Maintained at 370.5c Use: Capsules,tablets,delayed release, suppositories,floating dosage forms
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PADDLE APPARATUS
METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT COMPRISING OF SINGLE ENTITY SINKERS (A SMALL, LOOSE PIECE OF NON-REACTIVE MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO AVOID FLOATING
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RECIPROCATING CYLINDER
1.Vessel:Cylindrical flat bottom glass vessel 2.Agitation type: Reciprocating Generally 5-35 rpm 3.Volume of dissolution fluids :200250 ml 4.Water bath: Maintain at 370.5c Use : Extended release
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FLOW-THROUGH CELL
1.Reservoir:For dissolution medium
2.Pump:-Forces dissolution medium through cell -holding a sample -Flow rate 10-100 ml/min Laminar flow is maintained peristaltic/centrifugal pumps are not recommended
3.Water bath: Maintain at 370.5c Major advantage : -to maintain sink conditions -Large volume dissolution media is used.
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1.Vessel 2.Shaft: 3.Stirring elements 4.Sample holder : -Disk assembly that hold the product in such a way that release surface is parallel with paddle. -Paddle is directly attached over disk assembly . -Samples are drawn away b/w the surface of medium and top of paddle blade. 5.Volume:900ml 6.Temperature:32 c
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SHAFT
POSITIONED IN SUCH A WAY THAT ITS AXIS IS NOT MORE THAN 2MM FROM VERTICAL AXIS OF THE VESSEL SHOULD ROTATE SMOOTHLY WITHOUT SIGNIFICANT WOBBLE
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POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM VOLUME DEAERATION EXAMPLES OF TYPICAL MEDIA
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DEAERATION
AIR BUBBLES CAN : INTERFERE WITH THE RESULT CAN CAUSE PARTICLES TO CLING TO THE APPARATUS AND VESSEL WALLS DEAERATION CAN BE DONE BY: HEATING FILTERING VACUUM
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FILTERS
USED TO PREVENT UNDISSOLVED DRUG PARTICLES FROM ENTERING THE ANALYTICAL SAMPLE USED TO REMOVE INSOLUBLE EXCIPIENTS WHICH MAY CAUSE TURBIDITY PORE SIZE MAY RANGE FROM 0.45 TO 70 m
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SAMPLING
MANUAL : USING PLASTIC OR GLASS SYRINGE, A STAINLESS STEEL CANNULA AUTOSAMPLING : BEST FOR SEVERAL TIME POINTS CAN BE SEMI OR FULLY AUTOMATIC
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TIME POINTS
FOR IMMEDIATE RELEASE : 15 TO 60 MINS FOR EXTENDED RELEASE : AT LEAST THREE TEST TIME POINTS ARE SELECTED
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Tabular form
Name of the dosage Capsule APPARA TUS Rpm Refer to USP
standard volume
Temp
II (Paddle)
50
10, 20, 30, 45 and 60 10, 20, 30, 45 and 60 10, 15, 30, 45, and 60 15, 20, 30 10, 20, 30.
Capsule
I (Basket)
100
Tablet
II (Paddle)
50
Water
900
Tablet Tablet
II Paddle I basket
50 100
water water
900/1000 1000
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APPARAT US
RPM
Refer to USP
STANDAR D VOLUME
TEMP
50 50 75
900 900
Acetate 900 Buffer, pH 4.5 with 2.2% Tween 20 Refer to USP 1000 900
Tablet Capsule
nature of the solvent and solute temperature (and to a small degree pressure) degree of undersaturation presence of mixing interfacial surface area presence of inhibitors (e.g., a substance adsorbed on the surface).
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CONCLUSION
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REFERENCE
USP NF IP1996 Industrial pharmacy BY Lacchmann Liebermann www.dissolutiontech.com
www.usp.org
www.aapspharmaceutica.com www.authorstream.com
pharmtech.findpharma.com
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QUERIES..??
Q U E R I E S
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