Dissolution Testing Apparatus

Dissolution Testing Apparatus

1. A PRESENTAITON ON
DISSOLUTION
TESTING APPARATUS
Prepared by
Sourav Kar
6
th
Sem, Div-II
Roll No-1427704097
Mentor: Dr. Gopa Roy Biswas
NSHM Institute Of Pharmaceutical
Technology

2. Definition
Dissolution is the process by which a solid solute enters in to
a solution i.e. , mass transfer from solid surface to liquid phase.
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3. Classification Of Dissolution Apparatus
U.S.P I.P B.P E.P
TYPE 1 Basket
Apparatus
Paddle
Apparatus
Basket
Apparatus
Paddle
Apparatus
TYPE 2 Paddle
Apparatus
Basket
Apparatus
Paddle
Apparatus
Basket
Apparatus
TYPE 3 Reciprocating
Cylinder
Flow Through
Cell
Flow Through
Cell
TYPE 4 Flow Through
Cell
TYPE 5 Paddle Over
Disk
TYPE 6 Rotating
Cylinder
TYPE 7 Reciprocating
Holder
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4. Classification Of Dissolution Apparatus
•USP Dissolution Apparatus (Non-Official):
1.Rotating Bottle Apparatus
2.Diffusion Cell
3.Peristalsis Cell
4.Intrinsic Dissolution Method
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5. DISSOLUTION APPARATUS-1
(ROTATING BASKET)
DESIGN:
Vessel: -Made of borosilicate glass.
-Semi hemispherical bottom
-Capacity 1000ml
Shaft : -Stainless steel 316
-Speed 50-100 rpm.
Water bath :-Maintained at 37±0.5ºC
Dosage form is kept in basket.
USE: Tablets, capsules, floating dosage forms.
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6. DISSOLUTION APPARATUS-2
(PADDLE)
DESIGN:
Vessel: -Same as basket apparatus
Shaft: - Fused with blade at bottom
Stirring elements:- Coated with teflon
For laboratory purpose
stainless steel is used
Rotation Speed:- 25-50 rpm
Water-bath: -Maintains at 37±0.5°C
Sinkers : -Platinum wire used to prevent
tablet/capsule from floating.
Dosage form should remain at the bottom center of vessel
USE: Orally disintegrating tablets, Chewable tablets etc.
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7. DISSOLUTION APPARATUS-3
(RECIPROCATING CYLINDER)
DESIGN:
Vessel: -Set of cylindrical flat bottom glass vessels
-Set of reciprocating cylinders
-stainless steel fittings.
Agitation type: -Reciprocating
(Upward & downward)
Volume of dissolution medium:-200-250ml
Water bath:- Maintain at 37±0.5°C
Dosage form is placed in cylinder
USE: Tablets, beads, controlled and
extended release formulations.
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8. DISSOLUTION APPARATUS-4 (FLOW
THROUGH CELL)
DESIGN:
Reservoir :- For dissolution medium
Pump :- Forces dissolution medium through cell (upward
direction)
-Flow rate 10-100ml/min
-Laminar flow is maintained
-Centrifugal pumps are not recommended
Water bath:- Maintained at 37±0.5°C
USE: Low solubility drugs, micro particulate, implants,
suppositories, controlled release formulations.
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9. DISSOLUTION APPARATUS-4 (FLOW
THROUGH CELL)
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10. DISSOLUTION APPARATUS-5 (PADDLE-
OVER-DISK)
DESIGN:
Vessel & Shaft:- Same as paddle apparatus
Rotation Speed:- 25-50 rpm
Sample holder:-disk assembly that holds
product in such a way that release surface
is parallel with paddle blade
-Distance 25 ± 2 mm
-Samples are drawn between
surface of the medium &
the top of the paddle blade
Temperature:32 ± 0.5°C
USE: Transdermal products, emulsions.
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11. DISSOLUTION APPARATUS-6 (ROTATING
CYLINDER)
DESIGN:
Vessel:- Same as of basket apparatus
Shaft & Cylinder:- Stainless steel
Sample :- Mounted to cuprophan (inner porous cellulosic material)
an entire system is adhered to cylinder.
- Dosage unit is placed in cylinder and release from side out.
Rotation Speed:- 25-50 rpm
Water-bath: maintained at 32±0.5°C
USE:
Mainly transdermal products
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12. DISSOLUTION APPARATUS-7
(RECIPROCATING-HOLDER)
DESIGN:
Vessel:- A set of cylindrical vessels connected to
each other
Volume of dissolution medium 50-200 ml

Shaft
Holder:- Spring holder/ Reciprocating disk/
Teflon cylinder/ Acrylic rod
Sample : - Placed on holders
Agitation:- Reciprocating frequency 30 cycle/sec
Water-bath:- Maintained at 32±0.5°C
USE:
Controlled release dosage form, non disintegrating oral formulations.
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dissolution medium
shaft
holder
constant temp
water bath

13. Commonly Used Dissolution Media
1.Purified water
2.Dilute acid (0.001N – 0.1N HCl)
3.Stimulated gastric fluid
4.Stimulated intestinal fluid
5.Surfactants (e.g. Polysorbate, SLS)
6.Aqueous buffers (pH 5-7)
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14. CONCLUSION
Dissolution research started to develop in 1897 when Noyes
and Whitney derived their equation in the course of their
dissolution studies on benzoic acid and lead chloride.
 The goal of dissolution testing is to assure the
pharmaceutical quality of the product (manufacturing of
product, release property & biopharmaceutical characteristics
e.g. rate and extent of absorption).
Dissolution testing is a routine work for pharmaceutical
quality control for oral solid dosage forms like tablets,
capsules and transdermal drug delivery systems.
The science of dissolution testing is developing every day.
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15. REFERENCES
D.M.Brahmankar, S Jaiswal, “Biopharmaceutics
and
Pharmacokinetics A Treatise”, Vallabh
Prakashan, 3rd

Edition, pg: 330-333.
V.U Banakar et all, “Pharmaceutical Dissolution
Testing”,
Markcel Daken, pg: 4,16,57,136,137.
The Science And Practice of Pharmacy by
REMINGTON ,Mack Pub Co. , 19th Edition,
pg: 594,
601,602.
USP Asian Edition, 2005, pg: 2303-2310.
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