5 Jun 〈〉 DISSOLUTION This general chapter is harmonized with the correspond- tional USP text, and therefore not part of the harmonized. How should the level L2 from Acceptance Table 2 in the USP General Chapter > Dissolution be applied for this time point? A To apply the levels L2 and L3. Q Typically, the rotation speed for USP Apparatus 2 is between 25 and 75 rpm. Can we This information is in the USP General Chapter > Dissolution.

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This is the reason for not considering the presence of cross-linking as a signifi- cant change.

Questions and Answers May

The large volume available in the open-loop configuration makes this apparatus useful in testing extend-ed-release implants or products with poorly soluble drugs. The text does not address dissolution profiles. Is this qualification mandatory? If peak vessels are going to be used, it is necessary to demonstrate that they bring an advantage to the method that cannot dissolition achieved with the standard apparatus.

How should a dissolution method be developed for this kind of product? From that data, you might discover a possible dissolution medium. At the end dlssolution the process with dissolution data in hand, you will still need to justify the conditions chosen. You can see the list of references in the Dissolution Toolkit, http: The observation of lower dissolution results when bubbles form on the tablets or baskets is not unexpected because the bubbles will retard the transfer of dissolved drug from the solution inside the basket to the bulk medium and could also occlude the dissolving tablet surface reducing mass transfer there.

A Not as far as we know.

Questions and Answers May 2017

The same logic should be applied to the other time gwneral and to level L3. Shear is at a minimal level in the region below the tip of the paddle shaft. We would like to know if we could use other types of baskets such as the mesh basket in the dissolution testing?

We are working with a fixed combination product, and one of the drug substances has very low solubility in aqueous solvents. There are several cases where the product was approved without taking sample volume into consideration e. Q What should be the maximum volume that can be sampled during dissolution?


Which one should be used, the one in the monograph or the one in the general chapter? Or should we use mL of medium and consider the actual volume of mL in the calculations? The information available in the literature regarding all aspects of cross-linking in gelatin capsules is very extensive.

The most appropriate sampling procedure needs to be evaluated genearl a case-by-case approach.

It should be the smallest amount possible to minimize the interference in the results, and it depends on the quantitative procedure used to quantify the amount of drug substance released. William Brown sup Margareth Marques The following questions have been submitted by readers of Dissolution Technologies. The USP Dissolution Toolkit recommends a frequency of six months for routine operational qualification and also disssolution that it is done on installing, relocating, or repairing the apparatus.

As the size and shape of the sinker may have a big impact in disoslution dissolution profile, it has to be selected in a case-by-case approach. However, if the testing is performed for other purposes, sampling will depend on the purpose of the test. Differences between the paddle and basket include the formation and maintenance of a cone under the disintegrating tablets paddles and the ability of the disintegrated material to exit the basket upon reaching a mesh size.

Q Dissolution testers have a number of configurations with vessel positions in most cases. A There are no limits for the dissollution of solution with- drawn during the dissolution test.

In some cases more discriminative dissolution methods are developed when sink conditions are not met. Q We hired a vendor to do the mechanical verification of our dissolution equipment.

Q We received an inspection by the local regulatory agency, and the inspectors recommended that we do mechanical qualification before dissolutkon dissolution test.

However, for the later stages of the test, the average of the units tested must not be less than Q. If dissolution at a reasonable level cannot be achieved, then it is possible that the addition of a surfactant to the medium may be needed.


This means that in some situations, the analytical procedure used in the assay of the active ingredient in the dosage form may not be suitable to be used in the dissolution test. There are some situations where centrifugation is the choice even if it is not the best method.

Typically, an amount of pellets equivalent to the target capsule contents will be tested. Some level of physiological relevance as well as discriminatory power are important aspects of a dissolu-tion method.

For the two-stage procedure, if the criteria after stage 1 are not met, six additional tablets are tested. However, the underlying issue in your question can be answered simply by noting that the dissolution rates are what they are.

If surfactants need to be added to the dissolution medium, it is necessary to justify the type and the concentration of the surfactant used. The description of the setup of the disintegration test, if followed, will prevent the gendral of the tops of the tubes.

If this approach is acceptable, which acceptance criteria would apply in this situation, Acceptance Table 1 for the individual unit dose results or Acceptance Table for a Pooled Sample using the gfneral of the individual results instead of the pooled-sample result?

An additional PVT will be necessary in this case. Which controls should be done before running each dissolution test? A Gendral developing a dissolution test or when evaluating the suitability of a dissolution test from the literature from a paper or pharmacopeial monographthe dissolution procedure must be evaluated for the appropriateness to the formulation under study.

Do we need to take into account the 5 mL of sample? Why should a dissolution method be developed? If testing in multiple tubes is done, the dosage form should be contained within chaptef mesh at the bottom. In both situations, bubble formation was observed.