dissolution testing apparatus

A PRESENTAITON ON

DISSOLUTION TESTING APPARATUS

Prepared bySourav Kar6th Sem, Div-IIRoll No-1427704097Mentor: Dr. Gopa Roy BiswasNSHM Institute Of Pharmaceutical Technology

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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Classification Of Dissolution Apparatus

U.S.P I.P B.P E.P

TYPE 1 Basket Apparatus

Paddle Apparatus

Basket Apparatus

PaddleApparatus

TYPE 2 PaddleApparatus

Basket Apparatus

PaddleApparatus

BasketApparatus

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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Classification Of Dissolution Apparatus

• USP Dissolution Apparatus (Non-Off icial ):

1. Rotating Bottle Apparatus

2. Diffusion Cell

3. Peristalsis Cell

4. Intrinsic Dissolution Method

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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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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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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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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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DISSOLUTION APPARATUS-4 (FLOW

THROUGH CELL)

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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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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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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

holderconstant temp water bath

Commonly Used Dissolution Media

1. Purified water2. Dilute acid (0.001N – 0.1N HCl)3. Stimulated gastric fluid4. Stimulated intestinal fluid5. Surfactants (e.g. Polysorbate, SLS)6. Aqueous buffers (pH 5-7)

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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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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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