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:
- 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:
| Type | Indian Pharmacopoeia (I.P) | USP | British Pharmacopoeia (B.P) | European Pharmacopoeia(Ph. Eur./ E.P) | Japanese Pharmacopoeia (J.P) |
| Apparatus I | Paddle | Basket | Basket | Basket | Basket |
| Apparatus II | Basket | Paddle | Paddle | Paddle | Paddle |
| Apparatus III | NA | Reciprocating cylinder | Flow-through cell | Reciprocating cylinder | Flow-through cell |
| Apparatus IV | NA | Flow-through cell | NA | Flow-through cell | NA |
| Apparatus V | NA | Paddle over disk | NA | NA | NA |
| Apparatus VI | NA | Cylinder | NA | NA | NA |
| Apparatus VII | NA | Reciprocating disk | NA | NA | NA |
| Apparatus VIII | NA | (Non-USP-NF) | NA | NA | NA |
| Apparatus IX | NA | (Non-USP-NF) | NA | NA | NA |
USP Type Dissolution Apparatus & Use:
| Type | Name | Used For |
| Apparatus I | Basket | Tablets |
| Apparatus II | Paddle | Tablets. capsules modified drug products |
| Apparatus III | Reciprocating cylinder | Extended-release drug products. |
| Apparatus IV | Flow-through cell | Drug products containing low-water-soluble drug |
| Apparatus V | Paddle over disk | Transdermal drug products. |
| Apparatus VI | Cylinder | Transdermal drug products. |
| Apparatus VII | Reciprocating disk | Extended-release drug products |
| Apparatus VIII | (Non-USP-NF) | Extended-release drug products (beads). |
| Apparatus IX | (Non-USP-NF) | Ointments, creams, transdermal drug products. |
| Apparatus I | Rotating basket | Tablets |
| Apparatus II | Paddle | Tablets. capsules modified drug products |
| Apparatus III | Reciprocating cylinder | Extended-release drug products. |
Type of Sinkers:
1. Japanese Sinker
2. Spiral or Coil Sinker
3. 3 Prong Sinker
4. Basket Sinker
5. Breath Film Sinker
6. Sotax Style Sinker
7. O ring sinkers
8. Sinker for Alfuzosin Hydrochloride
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