Dissolution Test General

Aim: In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release data for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage (OSD) forms, and drug formulation & development, i.e., to predict in vivo drug release pattern & profiles.

There are three typical situations where dissolution testing plays a vital role:

  1. Formulation and optimization Decisions: Both the product formulation and the manufacturing process are optimized based on reaching particular dissolution targets during product development for products where dissolve performance is a critical quality attribute.
  • Equivalence Decisions: Similarity of in vitro dissolution profiles between the reference product and its generic or modified version is one of the major criteria for regulatory approval decisions during generic product development, as well as when executing post-approval processes or formulation changes.
  • Product Compliance and Release Decisions: Dissolution results are frequently one of the variables used to make product release decisions during normal manufacturing.

Dissolution Apparatus Type:

TypeIndian Pharmacopoeia (I.P)USPBritish Pharmacopoeia (B.P) European Pharmacopoeia(Ph. Eur./ E.P)  Japanese Pharmacopoeia (J.P)
Apparatus IPaddleBasketBasketBasketBasket
Apparatus IIBasketPaddlePaddlePaddlePaddle
Apparatus III NAReciprocating cylinderFlow-through cellReciprocating cylinderFlow-through cell
Apparatus IV NAFlow-through cell  NAFlow-through cell  NA
Apparatus V  NAPaddle over disk  NA  NA  NA
Apparatus VI  NACylinder  NA  NA  NA
Apparatus VII  NAReciprocating disk  NA  NA  NA
Apparatus VIII  NA(Non-USP-NF)  NA  NA  NA
Apparatus IX  NA(Non-USP-NF)  NA  NA  NA
Type Dissolution Apparatus

USP Type Dissolution Apparatus & Use:

TypeNameUsed For
Apparatus IBasketTablets
Apparatus IIPaddleTablets. capsules modified drug products
Apparatus IIIReciprocating cylinderExtended-release drug products.
Apparatus IVFlow-through cellDrug products containing low-water-soluble drug
Apparatus VPaddle over diskTransdermal drug products.
Apparatus VICylinderTransdermal drug products.
Apparatus VIIReciprocating diskExtended-release drug products
Apparatus VIII(Non-USP-NF)Extended-release drug products (beads).
Apparatus IX(Non-USP-NF)Ointments, creams, transdermal drug products.
Apparatus IRotating basketTablets
Apparatus IIPaddleTablets. capsules modified drug products
Apparatus IIIReciprocating cylinderExtended-release drug products.
USP Type Dissolution Apparatus & Use

Type of Sinkers:

1. Japanese Sinker

Japanese Sinker

2. Spiral or Coil Sinker

Spiral or Coil Sinker

3. 3 Prong Sinker

3 Prong Sinker

4. Basket Sinker

Basket Sinker

5. Breath Film Sinker

Breath Film Sinker

6. Sotax Style Sinker

Sotax Style Sinker

7. O ring sinkers

O ring sinkers

8. Sinker for Alfuzosin Hydrochloride  

Sinker for Alfuzosin Hydrochloride  

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