Enhanced Mechanical Qualification of the Dissolution Apparatus and the Chinese Pharmacopeia
To ensure your dissolution apparatus is in proper working condition, a qualification procedure must be performed. A key element is the measurement of the physical parameter, regardless of which procedure is used [USP PVT or enhanced mechanical qualification (eMQ)]. The adoption of eMQ continues to spread around the globe. The Chinese FDA (now known as the National Medical Product Administration) recently published its recommended specifications. The 280-DS software now incorporates these guidelines for companies that chose to adhere to these guidelines.
Dissolution Testing of Oral Suspensions:
What Needs to be Considered
Oral suspensions present unique dissolution testing challenges, because they are typically dosed as a liquid preparation containing solid particles dispersed in the liquid. Therefore, you should address the following considerations in your dissolution method: