Dissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is ...
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 ...
Advances in dissolution testing technology have been one of the biggest breakthroughs in solid dosage form testing over the last decade. The full version of this ...
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 ...
The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs. The British ...
that would penetrate the first stage of the impactor), the ex-throat dose or the Fine Particle Dose (FPD); the fraction of the dose defined as respirable on the basis of size. The dose is collected on ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation ...
FDA agents recall 100 out of 1,000 bottles of Chlorthalidone sold nationwide because they “failed dissolution specifications.” ...
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