For conventional tablet dosage form, what are the conditions in which disintegration results can be neglected in case of good dissolution results? please state the reference and link if possible
Hello Alaa,
generally a dissolution test is a lot more expensive to carry out than a disintegration test, therefore whenever possible, it is a wise decision (from economical point of view) to chose disintegration over dissolution.
This can be done according to Decision Trees #7: Setting Acceptance Criteria for Drug Product Dissolution as given in ICH Q6A Guideline: Specificatinos: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products.
Basically, if the dosage form is an immediate release, you have a mean to control assay through a PAT tool, then disintegration might be enough and dissolution could be neglected.
The other way around is simple, you can just show your dissolution data and say, that if disintgration is inadequate, dissolution would not meet the requirements.
ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
b) Disintegration: For rapidly dissolving (dissolution >80% in 15 minutes at pH 1.2, 4.0 and 6.8) products containing drugs which are highly soluble throughout the physiological range (dose/solubility volume < 250 mL from pH 1.2 to 6.8), disintegration may be substituted for dissolution. Disintegration testing is most appropriate when a relationship to dissolution has been established or when disintegration is shown to be more discriminating than dissolution. In such cases dissolution testing may not be necessary. It is expected that development information will be provided to support the robustness of the formulation and manufacturing process with respect to the selection of dissolution vs. disintegration testing (see Decision Tree #7(1)).
+ the link from the EMA site
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002823.pdf
Disintegration test can be deleted from FP specifications with below two justifications:
1. Disintegration test is carried out as routine in-process control test.
2. The dissolution test shows good release in short period of time (e.g. More than 80 % in 30 mins).
We have received approval with these technical justifications from MHRA, SAHPRA and other HA for our one of the products.
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