A Comparison of Dissolution Testing on Lipid Soft Gelatin Capsules Using USP Apparatus 2 and Apparatus 4

Comparison of Flow-Through Cell and Paddle Methods for Testing Vaginal Tablets Containing a Poorly Water-Soluble Drug

“…This is probably due to higher agitation rate and greater surface area of the drug-dissolution medium interface in the vessel. Similar observations were made in dissolution experiments with gelatin capsules containing a poorly water soluble amine drug [11]. In the flowthrough cell method faster release was observed in 0.1 M HCl (85.9 % in 10 min) when compared to the acetate buffer pH 5.2 with 1 % SDS (> 80 % of the drug released in 30 min).…”

“…In the flow-through cell method, there are no problems with sampling and no further filtration steps are needed as the sample solution is automatically filtered upon leaving the cell [5]. Although there are many reports in the literature describing the suitability of apparatus 4 as dissolution method for various dosage forms [10][11][12], no standard pharmacopeial tests on the use of this apparatus for non-modified release drugs are available [2,7,13]. Therefore, the aim of this study was to evaluate the usefulness of the flowthrough cell method (apparatus 4) for testing commercially available vaginal tablets containing a poorly water-soluble drug, clotrimazole, intended for immediate drug release vis-a-vis the FDA recommended paddle method [13].…”

What is a Suitable Dissolution Method for Drug Nanoparticles?

“…Previous comparative studies of different dissolution apparatus (i.e. USP and non-USP) focused mainly on tablets (24,(29)(30)(31) and capsules (25,31,32). Only a few studies have dealt with active pharmaceutical ingredients (API) in the powdered form (23,33,34), and with limited scope, involving less than three apparatus.…”

Enzymes in the Dissolution Testing of Gelatin Capsules

“…Since the early 1980s, technology has been available to permit accurate dosing and sealing of liquids into hard gelatin capsules. Current technologies allow the encapsulation of lipid solutions, suspensions, or semisolid formulations (1)(2)(3). In the presence of certain compounds such as aldehydes or when exposed to high humidity and temperature, gelatin can cross-link rendering it insoluble in aqueous solvents.…”

“…In the presence of certain compounds such as aldehydes or when exposed to high humidity and temperature, gelatin can cross-link rendering it insoluble in aqueous solvents. The presence of cross-linking will alter the in vitro dissolution behavior of the gelatin capsules; the capsule will not open and release its contents into the dissolution medium (1)(2)(3)(4)(5)(6)(7). This failure may not reflect a possible failure to dissolve in the body.…”