Dissolution Apparatus 5x3zb
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DISSOLUTION Apparatus Visit www.bpharmstuf.com For more ppt’s & material
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
www.bpharmstuf.com
Goals of predictive dissolution test
• To accessing therapeutic efficacy. • Monitoring batch to batch consistency. • High cost of in vitro dissolution test. • Assessment of bioequivalence.
www.bpharmstuf.com
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)
www.bpharmstuf.com
TYPES OF APPARATUS • BASKET APPARATUS • PADDLE APPARATUS • RECIPROCATING CYLINDER • FLOW-THROUGH CELL • PADDLE OVER DISK • CYLINDER www.bpharmstuf.com • SHAFT
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 www.bpharmstuf.com
PADDLE APPARATUS • METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT COMPRISING OF SINGLE ENTITY • SINKERS (A SMALL, LOOSE PIECE OF NONREACTIVE MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO AVOID FLOATING
www.bpharmstuf.com
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 37±0.5⁰c Use : Extended release www.bpharmstuf.com
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.
www.bpharmstuf.com
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 • • • •
www.bpharmstuf.com
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
www.bpharmstuf.com
MEDIA FOR DISSOLUTION • POINTS TO BE ED WHILE SELECTING A MEDIUM • VOLUME • DEAERATION • EXAMPLES OF TYPICAL MEDIA
www.bpharmstuf.com
STANDARD VOLUMES Paddle: 900/1000ml Basket: 1-4 lit. Reciprocating cylinder: 200250ml Paddle over Disk: 900ml
www.bpharmstuf.com
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
www.bpharmstuf.com
EXAMPLES OF TYPICAL MEDIA • WATER • PHOSHATE BUFFER, BORATE BUFER • BUFFERS OF pH RANGE 1.2 TO 7.5
www.bpharmstuf.com
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
www.bpharmstuf.com
SAMPLING • MANUAL : USING PLASTIC OR GLASS SYRINGE, A STAINLESS STEEL CANNULA • AUTOSAMPLING : BEST FOR SEVERAL TIME POINTS CAN BE SEMI OR FULLY AUTOMATIC
www.bpharmstuf.com
TIME POINTS
• FOR IMMEDIATE RELEASE : 15 TO 60 MINS • FOR EXTENDED RELEASE : AT LEAST THREE TEST TIME POINTS ARE SELECTED
www.bpharmstuf.com
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 rigorouslywww.bpharmstuf.com and comprehensively defined in the respective Pharmacopoeia.
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 www.bpharmstuf.com applicable).
www.bpharmstuf.com
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. www.bpharmstuf.com
Tabular form
Name of APPARAT R p m the dosage US
Refer to USP
Capsule
II (Paddle)
50
Water 900 (deaerated)
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.
www.bpharmstuf.com
standard volume
Temp
NAME OF THE APPARATU RPM S DOSAGE
Refer to USP
STANDARD TEMP VOLUME
Tablet
I Paddle
50
Refer to USP
900
Tablet
II (Paddle)
50
0.1 N HCl 900
5, 10, 15, 20 and 30
Capsule (Extended Release)
II (Paddle)
75
Acetate 900 Buffer, pH 4.5 with 2.2% Tween 20
1, 2, 5, 7, 9, 12 and 14 hours
Tablet
II Basket
Refer to USP
10, 15
Capsule
I (Basket)
100
1000
3% SLS in 900 water, pH 9.6 www.bpharmstuf.com
5,10,15
10, 20, 30 and 45
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). www.bpharmstuf.com
CONCLUSION
www.bpharmstuf.com
REFERENCE •USP NF •IP1996 •Industrial pharmacy BY Lacchmann Liebermann •www.dissolutiontech.co m •www.usp.org •www.aapspharmaceutica. com •www.authorstream.com •pharmtech.findpharma.co m
www.bpharmstuf.com
QUERIES..??
www.bpharmstuf.com
Q U E R I E S
www.bpharmstuf.com
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
www.bpharmstuf.com
Goals of predictive dissolution test
• To accessing therapeutic efficacy. • Monitoring batch to batch consistency. • High cost of in vitro dissolution test. • Assessment of bioequivalence.
www.bpharmstuf.com
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)
www.bpharmstuf.com
TYPES OF APPARATUS • BASKET APPARATUS • PADDLE APPARATUS • RECIPROCATING CYLINDER • FLOW-THROUGH CELL • PADDLE OVER DISK • CYLINDER www.bpharmstuf.com • SHAFT
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 www.bpharmstuf.com
PADDLE APPARATUS • METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT COMPRISING OF SINGLE ENTITY • SINKERS (A SMALL, LOOSE PIECE OF NONREACTIVE MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO AVOID FLOATING
www.bpharmstuf.com
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 37±0.5⁰c Use : Extended release www.bpharmstuf.com
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.
www.bpharmstuf.com
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 • • • •
www.bpharmstuf.com
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
www.bpharmstuf.com
MEDIA FOR DISSOLUTION • POINTS TO BE ED WHILE SELECTING A MEDIUM • VOLUME • DEAERATION • EXAMPLES OF TYPICAL MEDIA
www.bpharmstuf.com
STANDARD VOLUMES Paddle: 900/1000ml Basket: 1-4 lit. Reciprocating cylinder: 200250ml Paddle over Disk: 900ml
www.bpharmstuf.com
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
www.bpharmstuf.com
EXAMPLES OF TYPICAL MEDIA • WATER • PHOSHATE BUFFER, BORATE BUFER • BUFFERS OF pH RANGE 1.2 TO 7.5
www.bpharmstuf.com
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
www.bpharmstuf.com
SAMPLING • MANUAL : USING PLASTIC OR GLASS SYRINGE, A STAINLESS STEEL CANNULA • AUTOSAMPLING : BEST FOR SEVERAL TIME POINTS CAN BE SEMI OR FULLY AUTOMATIC
www.bpharmstuf.com
TIME POINTS
• FOR IMMEDIATE RELEASE : 15 TO 60 MINS • FOR EXTENDED RELEASE : AT LEAST THREE TEST TIME POINTS ARE SELECTED
www.bpharmstuf.com
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 rigorouslywww.bpharmstuf.com and comprehensively defined in the respective Pharmacopoeia.
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 www.bpharmstuf.com applicable).
www.bpharmstuf.com
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. www.bpharmstuf.com
Tabular form
Name of APPARAT R p m the dosage US
Refer to USP
Capsule
II (Paddle)
50
Water 900 (deaerated)
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.
www.bpharmstuf.com
standard volume
Temp
NAME OF THE APPARATU RPM S DOSAGE
Refer to USP
STANDARD TEMP VOLUME
Tablet
I Paddle
50
Refer to USP
900
Tablet
II (Paddle)
50
0.1 N HCl 900
5, 10, 15, 20 and 30
Capsule (Extended Release)
II (Paddle)
75
Acetate 900 Buffer, pH 4.5 with 2.2% Tween 20
1, 2, 5, 7, 9, 12 and 14 hours
Tablet
II Basket
Refer to USP
10, 15
Capsule
I (Basket)
100
1000
3% SLS in 900 water, pH 9.6 www.bpharmstuf.com
5,10,15
10, 20, 30 and 45
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). www.bpharmstuf.com
CONCLUSION
www.bpharmstuf.com
REFERENCE •USP NF •IP1996 •Industrial pharmacy BY Lacchmann Liebermann •www.dissolutiontech.co m •www.usp.org •www.aapspharmaceutica. com •www.authorstream.com •pharmtech.findpharma.co m
www.bpharmstuf.com
QUERIES..??
www.bpharmstuf.com
Q U E R I E S
www.bpharmstuf.com
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