57121870 Dissolution Apparatus

7/31/2019 57121870 Dissolution Apparatus

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DISSOLUTION

Apparatus

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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

SHAFTwww.bpharmstuf.com


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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:Cylindricalflat bottom glassvessel

2.Agitation type: -Reciprocating -Generally 5-35 rpm

3.Volume ofdissolution fluids :200-250 ml 4.Water bath:Maintain at 370.5c

Use : Extendedrelease

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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 volumedissolution 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 surfaceis 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 PARTICLESFROM 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 arecertain 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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. The principle function of the dissolution test may be summarised asfollows:

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 samebiological availability from discrete batches of products from one or

different manufacturers.

Prediction of in-vivo availability, i.e. bioavailability (where applicable).

Dissolution test for tablets

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Dissolution test for suppositories

Testing for the rate of individual release of drugsubstance 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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T b l f


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Name ofthedosage

APPARA

TUSR p m Refer to

USPstandard

volume

Temp

Capsule II (Paddle) 50 Water(deaerated)

900 10, 20, 30,45 and 60

Capsule I (Basket) 100 Water 900 10, 20, 30,45 and 60

Tablet II (Paddle) 50 Water 900 10, 15, 30,45, and 60

Tablet IIPaddle 50 water 900/1000 15, 20, 30

Tablet I basket 100 water 1000 10, 20, 30.

Tabular form

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NAME OF THE

DOSAGE

APPARAT

USRPM Refer to

USPSTANDAR

D VOLUME

TEMP

Tablet I Paddle 50 Refer toUSP

900 5,10,15

Tablet II (Paddle) 50 0.1 NHCl

900 5, 10, 15,20 and 30

Capsule

(Extended

Release)

II (Paddle) 75 AcetateBuffer,

pH 4.5

with 2.2%

Tween 20

900 1, 2, 5, 7, 9,12 and 14

hours

Tablet IIBasket Refer toUSP

1000 10, 15

Capsule I (Basket) 100 3% SLSin water,

pH 9.6

900 10, 20, 30and 45

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CONCLUSION

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REFERENCE

USP NF

IP1996

Industrial pharmacyBYLacchmann Liebermann

www.dissolutiontech.com

www.usp.org

www.aapspharmaceutica.com

www.authorstream.compharmtech.findpharma.com

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Q U E R I E S

QUERIES..??

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57121870 Dissolution Apparatus