FDA Sets New Dissolution Specifications for IR Drugs

Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released July 31.

The proposal applies to solid orally administered Class 1 (high solubility/high permeability) and Class 3 (high solubility/low permeability). It excludes drugs, such as rescue medications, where speedy absorption into the plasma is critical and more extensive testing is required.

While dissolution should be used as the primary testing method, drugmakers may use disintegration testing as an alternative if the product does not dissolve within a specified time. The disintegration test requires the product to completely disintegrate within five minutes, the FDA says.

The guideline will supersede the 1997 guidance on Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Applicants should continue to refer to the 1997 guidance for Class 2 and 4 substances, which are low-solubility versions of high- and low-permeability drugs.

Comments are due by Oct. 2. Read the draft guidance here: www.fdanews.com/7-15-IR-Guidance.pdf. — Jonathon Shacat



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