Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US ...
A recent decision from the U.S. District Court for the District of Delaware highlights an unsuccessful, yet creative Section 101 challenge. This ...
Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor ...
In the manufacture of solid dosage forms, the rate at which the active pharmaceutical ingredient (API) is dissolved into solvents simulating the digestive tract fluids is determined with dissolution ...
The dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new ...
Drug delivery as solid dosage forms is complex with a number of factors that can noticeably influence their therapeutic benefit. The drug must be stabilized in the tablet and at the same time be ...