Regulatory status on the role of <i>in vitro</i> dissolution testing in quality control and biopharmaceutics in Europe

Limberg, Jobst; Potthast, Henrike

doi:10.1002/bdd.1844

Cited by 25 publications

(15 citation statements)

References 1 publication

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“…Demonstrating the discriminatory power of the dissolution method is both challenging and important, particularly in monitoring the active pharmaceutical ingredient (API) or formulation parameters where subtle changes may affect biopharmaceutical product performance. The discriminatory power of the dissolution method is the method's ability to detect changes in the drug product (8,9).…”

Section: Figure 1 Schematic Diagram Showing Different Stages Of Drugmentioning

confidence: 99%

Development of a Discriminating Dissolution Method for Immediate-Release Soft Gelatin Capsules Containing a BCS Class II Compound

Damian¹,

Harati²,

Pathak³

et al. 2016

Dissolution Technol.

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The purpose of this study was to develop a robust dissolution procedure for liquid-filled, soft gelatin capsules (SGCs) that can distinguish small but real changes in drug product formulation. SGCs were manufactured using different ratios of fill formulations. The formulations were evaluated by performing dissolution testing on fresh capsules and capsules that were aged at different time points and conditions. USP Apparatus 1 (basket) and 2 (paddle) at rotating speeds of 50, 75, or 100 rpm were used to evaluate the release characteristics of the formulations. The model-independent method using difference factor (f1) and similarity factor (f2) was employed to compare dissolution profiles. Dissolution data showed that fill material characteristics played a major role in controlling the rate of dissolution of our drug products. The basket increased the discriminatory power of the dissolution process regardless of speed. We observed that the paddle rotation speed may impact discrimination power but not the ability of the method to discriminate. The basket was successful for the quality assessment and characterization of formulation changes of our drug products. Through understanding of drug product characteristics and evaluating parameters of dissolution testing, a methodology can be established to enable batch-to-batch evaluation.

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Section: Figure 1 Schematic Diagram Showing Different Stages Of Drugmentioning

confidence: 99%

Development of a Discriminating Dissolution Method for Immediate-Release Soft Gelatin Capsules Containing a BCS Class II Compound

Damian¹,

Harati²,

Pathak³

et al. 2016

Dissolution Technol.

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“…These instruments have a fraction collector for the sample, which is further evaluated by UV or HPLC [22]. Although the method is well established, sample collection is a critical step.…”

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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“…Many references in the last decade can be found about the concept and application of IVIVC for pharmaceutical dosage forms [25][26][27][28][29] . Academia, pharmaceutical industry and regulatory sectors have focused on the use of IVIVC for different purposes.…”

Section: Introductionmentioning

confidence: 99%

In vitro–in vivocorrelations: general concepts, methodologies and regulatory applications

González‐García

Mangas‐Sanjuán

Merino-Sanjuán

et al. 2015

Drug Development and Industrial Pharmacy

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The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo performance serving as a surrogate for an in vivo bioavailability test and to support biowaivers. Therefore, the aims of this review are: (i) to clarify the factors involved during bio-predictive dissolution method development; and (ii) the elements that may affect the mathematical analysis in order to exploit all information available. This article covers the basic aspects of dissolution media and apparatus used in the development of in vivo predictive dissolution methods, including the latest proposals in this field as well as the summary of the mathematical methods for establishing the in vitro-in vivo relationship and their scope and limitations. The incorporation of physiological relevant factors in the in vitro dissolution method is essential to get accurate in vivo predictions. Standard quality control dissolution methods do not necessarily reflect the in vivo behavior, so they rarely are useful for predicting in vivo performance. The combination of physiological based dissolution methods with physiological-based pharmacokinetics models incorporating gastrointestinal variables will lead to robust tools for drug and formulation development, nevertheless their regulatory use for biowaiver application still require harmonization of the mathematical methods proposed and more detailed recommendations about the procedures for setting up dissolution specifications.

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Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe

Cited by 25 publications

References 1 publication

Development of a Discriminating Dissolution Method for Immediate-Release Soft Gelatin Capsules Containing a BCS Class II Compound

Development of a Discriminating Dissolution Method for Immediate-Release Soft Gelatin Capsules Containing a BCS Class II Compound

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

In vitro–in vivocorrelations: general concepts, methodologies and regulatory applications

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