There is no possibility of establishing quality of products without fixing the pharmacopeial drug dissolution test!

Quality of a drug product, such as tablet and capsule, may be defined as product’s ability to release the drug in humans in expected amount and with consistently. In technical term, it is known as drug release characteristics of the product. At the manufacturing stage, this characteristic is established by conducting an in vitro test commonly known as drug dissolution/release test. The test is commonly conducted as recommended by regulatory agencies (such as FDA) and pharmacopeias (such as USP) using paddle and basket apparatuses. The quality assessment of most of the solid dosage forms, if not all, in particular tablet and capsule products is determined using this test.

The testers for this test, however, have never been validated for the intended purpose. Therefore, conclusions drawn from this test, hence quality of the products, would be invalid and false. Use caution in accepting and/or making claims about quality of products! (link)

Seek help for conducting a scientifically valid drug dissolution test and establishing quality of the drug products.

Comments are closed.

Crescent-Shaped Spindle

Now Available
Click here

Archives
Links

PharmacoMechanics