The performance of the analytical methodologies recommended by the United States Pharmacopoeia (USP) monograph (1) for dissolution testing of lansoprazole (LPZ) enteric-coated solid dosage forms (capsules/tablets) was critically evaluated. While USP adopts an essentially nonselective UV method, the British Pharmacopoeia (2) recommends a highperformance liquid chromatography (HPLC) method capabl...

A recent report suggested that some folic acid preparations available in the United States failed to meet the specifications for dissolution specified by the US Pharmacopoeia (USP), of 70 per cent drug release in the first hour of testing. The Teratology Society recommends that women of childbearing age should take a daily supplement of 400 microg folic acid when they are trying to conceive, to...

The intended purpose of this work is to develop and validate a dissolution test for betamethasone acetate and betamethasone sodium phosphate injectable suspension using a reverse-phase liquid chromatographic method. After testing sink conditions, dissolution medium and stability of the drug, the best conditions were: flow through cell of diameter 22.6 mm, 2.0 ml per minutes flow rate for 120 mi...

As shown in previous papers, mathematical simulation can be useful in the design of drug delivery systems. We present a finite-difference approximation to the drug mass transfer rate from dissolving cylindrical drug-containing compacts, consisting of alternating layers of drug and inert material. Results are compared with a recent analytical solution to the same problem and with experiment. The...

USP dissolution Apparatus 4 can have a pulsing or non-pulsing flow, with most commercial apparatus employing a pulsing flow. Overall, a low velocity flow field is present, particularly in the larger 22.6-mm diameter cell. Dissolution data, computational fluid dynamics (CFD), and imaging methods are used and discussed to investigate the effects of low velocity pulsing flow on dissolution. Local ...

Drug dissolution studies are commonly conducted using compendial methods employing USP Paddle and Basket apparatuses. In many cases, dissolution studies can be of limited benefit especially for product-dependent dissolution procedures like in extended release (ER) formulations. The high variability in dissolution testing, that is not productrelated, emphasizes the need for developing new method...

Rabeprazole sodium (RAB) dissolved in acidic media is accompanied by its degradation in the course of dissolution testing. To develop and establish the accumulative release profiles of ACIPHEX(®) Sprinkle (RAB) delayed-release capsules (ACIPHEX(®) Sprinkle) in acidic media using USP apparatus 2 (paddle apparatus) as a dissolution tester, the issues of determination of accumulative release amoun...

The WHO biowaiver procedure for BCS Class II weak acids was evaluated by running two multisource IR ibuprofen drug products (Ibuprofen, 200 mg tablets, Tatchempharmpreparaty, Russia and Ibuprofen, 200 mg tablets, Biosintez, Russia) with current Marketing Authorizations (i.e. in vivo bioequivalent) through that procedure. Risks associated with excipients interaction and therapeutic index were co...