How dissolution test is performed?
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell.
How do you test a capsule for dissolution?
The capsule dissolution process involves three stages: (1) rupture of the capsule shell, (2) release and dispersion of the capsule fill material, and (3) dissolution of the active ingredient(s) in the medium.
What are dissolution tests designed for?
Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product.
What are the types of dissolution?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
What is f2 value in dissolution?
An average difference of 10% at all measured time points results in a f2 value of 50. FDA has set a public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles.
What is the best method of dissolution testing for generic products?
For immediate-release (IR) generic products, dissolution testing using a single method may be sufficient. For ER products, if a USP method is available then dissolution testing recommendations are based on the product formulation and number of strengths to be marketed.
Is there a USP method for the dissolution testing of Dr products?
If there is no USP method, then for all the strengths of a DR product the DBE recommends that dissolution testing should be conducted under acidic conditions (pH 1.2) for 2 h followed by neutral medium (e.g., pH 6.8). In general, DR products should display acid resistance under the dissolution testing conditions (8,9).
What is a dissolution test?
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell.
What is the best way to test the strength of dissolution?
If a USP method is available then dissolution should be conducted using that method. If there is no USP method, then for all the strengths of a DR product the DBE recommends that dissolution testing should be conducted under acidic conditions (pH 1.2) for 2 h followed by neutral medium (e.g., pH 6.8).