DISSOLUTION Apparatus

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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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Goals of predictive dissolution test

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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PADDLE OVER DISK

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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MEDIA FOR DISSOLUTION

POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM VOLUME DEAERATION EXAMPLES OF TYPICAL MEDIA

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STANDARD VOLUMES Paddle: 900/1000ml

Basket: 1-4 lit. Reciprocating cylinder: 200-250ml Paddle over Disk: 900ml

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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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EXAMPLES OF TYPICAL MEDIA

WATER PHOSHATE BUFFER, BORATE BUFER

BUFFERS OF pH RANGE 1.2 TO 7.5

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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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Dissolution test for tablets

tablets or capsules taken orally remain one of the most effective means of treatment available. The effectiveness of such dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. The rate of dissolution of the tablet or capsule is therefore crucial. One of the problems facing the pharmaceutical industry is to optimise the amount of drug available to the body, i.e. its bioavailability. Inadequacies in bioavailability can mean that the treatment is ineffective and at worst potentially dangerous (toxic overdose). Drug release in the human body can be measured in-vivo by measuring the plasma or urine concentrations in the subject concerned. However, there are certain obvious impracticalities involved in employing such techniques on a routine basis. These difficulties have led to the introduction of official in-vitro tests which are now rigorously and comprehensively defined in the respective Pharmacopoeia.
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Dissolution test for tablets

. The principle function of the dissolution test may be summarised as
follows: Optimisation 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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Dissolution test for suppositories

Testing for the rate of individual release of drug substance from suppositories has always posed a difficult problem owing to melting deformation dispersion in the dissolution medium In early testing is carried out by a simple placement in a beaker containing a medium In an effort to control the variation in a mass medium interface various. like Wire mess basket or membrane
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Tabular form
Name of the dosage Capsule APPARA TUS Rpm Refer to USP

standard volume

Temp

II (Paddle)

50

Water 900 (deaerated) Water 900

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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NAME OF THE DOSAGE

APPARAT US

RPM

Refer to USP

STANDAR D VOLUME

TEMP

Tablet Tablet Capsule (Extended Release)

I Paddle II (Paddle) II (Paddle)

50 50 75

Refer to USP 0.1 N HCl

900 900

5,10,15 5, 10, 15, 20 and 30 1, 2, 5, 7, 9, 12 and 14 hours

Acetate 900 Buffer, pH 4.5 with 2.2% Tween 20 Refer to USP 1000 900

Tablet Capsule

II Basket I (Basket) 100

10, 15 10, 20, 30 and 45

3% SLS in water, pH 9.6 www.bpharmstuf.com

Factors effecting dissolution

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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