The dissolution specification is defined by the amount (Q) of active substance that dissolves within a designated time frame, represented as a percentage of the content indicated on the product label.
According to the Indian Pharmacopoeia, the dissolution specification is articulated in terms of the amount (D) of active substance that dissolves in a specified duration, also represented as a percentage of the content indicated on the product label.
Traditional dosage forms (Immediate release)
In general, when evaluated under appropriate and valid testing conditions, the acceptance criteria for level S1 stipulate that a minimum of 80 percent of the active substance must be released within a designated timeframe, usually 45 minutes or less. This equates to a Q value of 75 percent.
Extended-release dosage forms (Prolonged-release)
The acceptance criteria for the dissolution test of prolonged-release dosage forms typically require 3 or more points.
The first specification point usually indicates a dissolved amount ranging from 20 percent to 30 percent.
The second specification point is established at approximately 50 percent release.
The final specification point aims to guarantee nearly complete release, which is commonly interpreted as exceeding 80 percent release.
Delayed-release dosage forms
A delayed-release dosage form can release the active substance(s) either partially or completely, depending on the formulation design, when evaluated in various dissolution media, such as acid and buffer. Gastro-resistant dosage forms necessitate a minimum of two specification points during a sequential test. In this sequential test, the first specification point indicates an upper limit and is set after 1 hour or 2 hours in an acidic medium and the second phase occurring after a predetermined testing duration in a suitable buffer solution (ideally at pH 6.8). Generally, the acceptance criteria at level B1 stipulate that a minimum of 80 percent of the active substance must be released. This equates to a Q value of 75 percent.