Category: Drug Dissolution

Post Views: 77

Often, one hears such announcements, i.e., FDA approves, concerning drugs and drug products from the FDA and other similar regulatory authorities. People, including physicians, assume that the FDA independently evaluates the products and that the claims (safe and effective) are based on scientific studies or evidence.

Unfortunately, it is not true.

An approved drug product does not mean it is safe and effective, but it only means that it complies with the FDA requirements for putting its label or stamp for approval. In short, approval is for compliance mostly with arbitrary standards and requirements that do not reflect the products’ quality (by extension, safety and efficacy). Prove me wrong!

(more…)
Post Views: 22
medicine, healthcare and pharmacy concept – different pills and capsules of drugs

A drug dissolution test is a test used to establish the quality of a pharmaceutical product, such as a tablet or capsule. This test is conducted because the drug (often called active ingredient) needs to be released from the product for its absorption into the blood to elicit its therapeutic effect.

The test is conducted in place of a clinical test/study called bioavailability or bioequivalence, a pharmacology/pharmacokinetic study type. The test is the backbone of quality assessment of all tablet and capsule products. It is a requirement of worldwide authorities, including the FDA, Health Canada, etc., and pharmacopeias such as USP, BP, EP, etc.

(more…)
Post Views: 11

Years ago, I suggested a simple convolution approach using MS Excel Spreadsheet to predict blood/plasma drug levels from drug dissolution results. Several successful applications of such an approach have been published. A simple yet revolutionary approach! The model spreadsheet may be obtained from here.

Details of the approach are described in the publication (Saeed Qureshi (author), In Vitro-In Vivo Correlation (IVIVC) and Determining Drug Concentrations in Blood from Dissolution Testing – A Simple and Practical Approach, The Open Drug Delivery Journal, 2010, 4: 38-47 (link).

Obtain a copy of Helpful Notes (link) for pharmaceutical drug dissolution testing with several examples of using this (convolution) technique, along with articles describing the testing, its issues, and suggested solutions.