Frequently Asked Questions
What is dissolution testing?
Dissolution testing is used in drug development to determine the release rate of an active pharmaceutical ingredient in tablet or capsule form as it dissolves into a dissolution media. Drug dissolution testing is one indicator of how, and how well, a drug will work in a person’s system.
How do you perform a dissolution test?
Per the USP, “A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. USP dissolution apparatus includes 4 standardized pieces of equipment: basket, paddle, reciprocating cylinder, and flow-through cell.”
To perform drug dissolution testing, the drug to be tested is usually in solid oral dosage form (this includes modified release dosage forms and others). The desire is to obtain a dissolved active ingredient. The drug is placed into a rotating cylinder containing a dissolution medium using the “standardized apparatus” described above. The process can then be accomplished using a manual system or an instrument such as those offered by Teledyne Hanson. These instruments meet USP dissolution apparatus criteria while significantly increasing the speed and accuracy of the test. Just step away and accomplish other tasks while the paddle apparatus does the work. We stand by our products, so you don’t have to.
What is dissolution testing as per USP?
Quoting the USP, “Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution and drug release are terms used interchangeably...
“Where specified in a monograph, USP dissolution tests are legal requirements. USP training and service are designed to help you meet regulatory compliance requirements while strengthening your quality standards.” All Teledyne Hanson dissolution apparatus meet USP dissolution test apparatus requirements.