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

• SHAFTwww.bpharmstuf.com

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 37±0.5⁰c

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 :200-250 ml 4.Water bath: Maintain at 37±0.5 c⁰

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 37±0.5⁰c 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 ⁰c

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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 µm

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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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. 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).

Dissolution test for tablets

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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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Name of the dosage

 APPARATUS

 R p m Refer to USP 

 standard 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  II Paddle  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

 APPARATUS

 RPM Refer to USP 

 STANDARD VOLUME

 TEMP

Tablet   I Paddle  50 Refer to USP 

 900  5,10,15

Tablet  II (Paddle)  50  0.1 N HCl 

900  5, 10, 15, 20 and 30 

Capsule (Extended Release) 

II (Paddle)  75  Acetate Buffer, pH 4.5 with 2.2% Tween 20 

900  1, 2, 5, 7, 9, 12 and 14 hours 

Tablet  II Basket   Refer to USP 

 1000  10, 15

Capsule  I (Basket)  100  3% SLS in water, pH 9.6 

900  10, 20, 30 and 45 

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• 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).

Factors effecting dissolution

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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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Q U E R I E S

QUERIES..??

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