What are the different types of dissolution testing apparatus?
What are the different types of dissolution testing apparatus?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
How does dissolution test work?
Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product.
Why dissolution test is important?
Dissolution testing is an important tool for characterizing the performance of oral solid dosage forms. Its significance is based on the fact that for a drug to be effective, it must first be released from the product and dissolve in the gastrointestinal fluids before absorption into the bloodstream can happen.
What do we know about dissolution testing for oral suspensions?
For oral suspensions, little information is available in the literature about the dissolution testing conditions, such as insertion and collection of the sample, influence of the system agitation, and others. In 1995, the first monograph including suspension dissolution testing was published in the United States Pharmacopeia (USP) 23.
How many suspension monographs include the liquiddissolution test?
Dissolution testing was mentioned in one suspension monograph in Brazilian Pharmacopoeia 4th edition (2005) which was excluded in the 5th edition (2010). In USP 36 (2013), 12 suspension monographs include the test. Currently, 13 NDA, 17 ANDA and 9 similar oral suspensions are registered in Anvisa.
What are the different types of drug suspension for dissolution?
With regard to dissolution, there are at least three products which have dissolution specifications. These products include phenytoin suspension, carbamazepine suspension, and sulfamethoxazole and trimethoprim suspension.
What is the role of dissolution testing in pharmacokinetics?
Dissolution testing conducted in physiological similar conditions is an useful tool in predicting issues related to pharmacokinetics, may indicate bioequivalence between certain products as solid oral dosage forms, and is employed to optimize the development and ensure the quality of drug formulations.
