could you please tell the dissolution limit of prolong release teblets as per ip, since its not mentioned in general chapters
Any release that are not conventional means which is modified to release the drug from the matrix at desired time intervals are generally termed as modified, prolonged, delayed and other releases.
In case of these formulations the specifications are not set as single Q point release but are different. These specifications are generally matched with the reference product profiles in different medias.
The general thumb rules used to set the time points for these drug products are
- The initial time point, which shows the control of drug release from the formulation matrix and no burst or dose dumping, is observed. Generally a release around 15 to 20 % of the drug dissolved with respect to the labeled amount.
- The mid time point, this generally shows the profile characteristic generally a release around 50 % of the drug dissolved with respect to the labeled amount.
- The final or end time point, where the drug dissolved is around or above 80 to 85 % of the drug dissolved with respect to the labeled amount. This is to show the drug release from the formulation matrix is achieved or achievable.
The time points are to be properly selected with proper release range, and one should be able to justify for their selections during setting of the specification and filing.
While developing the dissolutions methods initially and during multimedia dissolution stage one must select as many time points as possible to evaluate the curve of the drug dissolution from the matrix and calculation of the similarity factors (f2).
Hope this helps your query