Dissolution of Prednisone Tablets in the Presence of an Arch-Shaped Fiber Optic Probe in a USP Dissolution Testing Apparatus 2

Zhang, Yiran; Bredael, Gerard; Armenante, Piero M.

doi:10.1002/jps.23651

Cited by 16 publications

(4 citation statements)

References 35 publications

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“…There is already available instrumentation commercially to carry out dissolution testing according to the requirements of the directives from the pharmacopoeias (EP, USP, and FIP) [21]. These instruments have a fraction collector for the sample, which is further evaluated by UV or HPLC [22].…”

Section: Analytical Applicationsmentioning

confidence: 99%

Ion-selective electrodes for the determination of l-carnitine. Application in dissolution testing of a dietary supplement

et al. 2014

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L-Carnitine selective electrodes were developed using polymeric membranes containing a lipophilic cation exchanger (potassium tetrakis[3,5-bis(trifluoromethyl) phenyl]borate) and plasticized with three different plasticizers: bis(2-ethylhexyl) sebacate, tricresyl phosphate, and 2-nitrophenyl octyl ether. The response of the electrodes was evaluated in terms of calibration parameters (slope, limit of detection, and linear range), reproducibility, selectivity profile, and pH influence. The electrodes were applied to the dissolution testing of a dietary supplement containing L-carnitine in water and in HCl (pH = 3) by direct potentiometric monitoring.

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Section: Analytical Applicationsmentioning

confidence: 99%

Ion-selective electrodes for the determination of l-carnitine. Application in dissolution testing of a dietary supplement

et al. 2014

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“…35,36 There is a "dead zone" immediately underneath the paddle, and consequently, the tablet/capsule position may be a critical factor to the dissolution results, leading to increased variability. Over the years, there have been several attempts to address these intrinsic design flaws, for example, PEAK vessels, 37 tilted vessels, 38 crescent-shaped spindles, 39 "mega" paddle, 40 metal strips, 41 permanent in-line probes acting as baffles, 42 and the offcenter paddle. 43 However, none of these approaches have gained general support across industry, pharmacopoeias, academia, or the regulators due to deficiencies of each design.…”

Section: Understanding the Constraints Of The Standard Qc Dissolutionmentioning

confidence: 99%

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Grady

Elder²,

Webster

et al. 2018

Journal of Pharmaceutical Sciences

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This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and beyond. Over the past 3 decades, dissolution testing has evolved from a routine and straightforward test as a component of end-product release into a comprehensive set of tools that the developer can deploy at various stages of the product life cycle. The definitions of commonly used dissolution approaches, how they relate to one another and how they may be applied in modern drug development, and life cycle management is described in this article. Specifically, this article discusses the purpose, advantages, and limitations of quality control, biorelevant, and clinically relevant dissolution methods.

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“…Zhang et al demonstrated the effects of the introduction of an optic probe to the paddle apparatus (38). Tablet dissolution generally increased when the probe is present, which is likely due to two effects.…”

Section: Presence Of Probementioning

confidence: 99%

Characterization and Simulation of Hydrodynamics in the Paddle, Basket and Flow-Through Dissolution Testing Apparatuses - A Review

Todaro¹,

Pearsons²,

Grove³

et al. 2017

Dissolution Technol.

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Fluid velocity local to the dissolving surface will affect the dissolution rate. It is difficult to anticipate what local fluid velocities are present within compendial dissolution apparatuses from set flow rates or stirring rates. A range of qualitative and quantitative velocimetric techniques are available to assess and characterize hydrodynamics. These methods are frequently used in combination with computational fluid dynamics simulations to characterize and simulate hydrodynamics. Dosage form location and motion varies between apparatuses, and the presence of the dosage form itself can impact local hydrodynamics. Each apparatus described has identified hydrodynamic features which may also vary with agitation rate. This review describes the methods used to simulate and characterize hydrodynamics and summarizes some of the main findings from studies investigating hydrodynamics in the paddle, basket, and flowthrough dissolution apparatuses.

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Dissolution of Prednisone Tablets in the Presence of an Arch-Shaped Fiber Optic Probe in a USP Dissolution Testing Apparatus 2

Cited by 16 publications

References 35 publications

Ion-selective electrodes for the determination of l-carnitine. Application in dissolution testing of a dietary supplement

Ion-selective electrodes for the determination of l-carnitine. Application in dissolution testing of a dietary supplement

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Characterization and Simulation of Hydrodynamics in the Paddle, Basket and Flow-Through Dissolution Testing Apparatuses - A Review

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