Dissolution Apparatus Types and their Applications as Per USP

Types of Dissolution Apparatus and their Applications as Per USP

 

Drug Dissolution Testing:

In the pharmaceutical industry, drug dissolution testing is a tool which is routinely used by Quality control department to assess batch-to-batch consistency of solid oral dosage forms such as tablets and capsules. If dissolution results obtained are within the specifications, the manufactured batch is approved to release in to the market.

Dissolution testing is also widely used during drug product development,to provide critical in-vitro drug release information to predict in-vivo drug release profiles.

 

Below is the list of dissolution apparatuses as per United States Pharmacopeia (USP) General Chapter <711> Dissolution:

 

USP

Apparatus-I 

Rotating basket

Rotator Speed:

50-120 rpm

Medium Volume: 

500-4000 mL

Used for :

Immediate release, delayed release, chewable tablets, delayed release suppositories, Extended release tablets and floating dosage form

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USP-Apparatus I
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USP

Apparatus-II

Paddle

Rotator Speed:

25-50 rpm

Medium Volume: 

500-4000 mL

 

Used for :

Immediate release, orally disintegrating tablets, chewable tablets, delayed release and Extended release tablets and capsules and suspensions.

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USP-Apparatus II
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USP

Apparatus III

Reciprocating cylinder

Rotator Speed:

6-35 rpm

Medium Volume: 

250 mL (Typical)

 

 

Used for :

Controlled release formulations, Chewable tablets and beads.

USP-Apparatus III
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USP

Apparatus IV

Flow through cell

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Rotator Speed:

N/AP

Medium Volume: 

Up to 3 Lit./hour

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Used for :

Drug products containing poorly soluble API, Powders and granules, microparticles and Implants.

USP-Apparatus IV
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USP

Apparatus V

Paddle over disk

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Rotator Speed:

25-50 rpm

Medium Volume: 

500-4000 mL

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Used for :

Transdermal Patches, ointments, Floaters and Emulsions

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USP-Apparatus V
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USP

Apparatus VI

Rotating Cylinder

 

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Rotator Speed:

25-50 rpm

Medium Volume: 

500-4000 mL

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Used for :

Transdermal Patches

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USP-Apparatus VI
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 USP

Apparatus VII

Reciprocating Holder

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Rotator Speed:

30 rpm

Medium Volume: 

Variable

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 Used for :

Controlled release formulations (Transdedrmal formulations & non disintegrating oral formulations), pH profile, small volumes.

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USP-Apparatus VII
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