Drug Dissolution Apparatus II USP (Paddle)

By: Mitul Shah | Views: 41538 | Date: 24-Mar-2011

The paddle apparatus (Apparatus II) consists of a special, coated paddle that minimizes turbulence due to stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled40 speed.

Drug Dissolution Apparatus II USP (Paddle)

The paddle apparatus (Apparatus II) consists of a special, coated paddle that minimizes turbulence due to stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled40 speed.

The tablet or capsule is placed into the round-bottom dissolution flask, which minimizes turbulence of the dissolution medium. The apparatus is housed in a constant-temperature water hall maintained at 370C, similar to the rotating-basket method.

The position and alignment of the paddle are specified in the USP. The paddle method is very sensitive to tilting. Improper alignment may drastically affect the dissolution results with some drug products.

The same set of dissolution calibration standards is used to check the equipment before tests are run. The most common operating speed for Apparatus II are 50 rpm for solid oral dosage forms and 25 rpm for suspensions.

Apparatus II is generally preferred for tablets. A sinker, such as a few turns of platinum wire. may be used to prevent a capsule or tablet from floating.

A sinker may also be used for film coated tablets that stick to the vessel walls or help position the tablet or capsule under the paddle (Gray et al, 2001). The sinker should not alter the dissolution characteristics of the dosage form.




Figure 8, USP paddle apparatus
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