Dissolution Testing Apparatus

1. A PRESENTAITON ON
DISSOLUTION
TESTING APPARATUS
Prepared by
Sourav Kar
6th
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.
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