Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes

Gray, Vivian A.

doi:10.1208/s12249-018-1197-7

Cited by 38 publications

(24 citation statements)

References 21 publications

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“…If development is performed with a close eye on the in vivo performance and aligned with the biopharmaceutic risk assessment, the dissolution method could lead to clinically relevant drug products specifications (CRDPS). The present state of dissolution methods includes robust challenges to show discriminatory power for CQA (9). A discriminating method is useful, especially for a QC tool, but it could lead to specifications that may not be considered clinically relevant.…”

Section: Introductionmentioning

confidence: 99%

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

Gray¹,

Mann²,

Barker³

et al. 2020

Dissolution Technol.

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The purpose of this article is to inform the dissolution scientist of a powerful emerging tool that provides in vivo linkage to dissolution methods. This tool is physiologically based biopharmaceutics modelling (PBBM). Dissolution scientists are mostly concerned with analytical sections of drug development, so exposure to modeling and other pharmacokinetics and biopharmaceutic concepts may be uncommon. PBBM is an in-silico model that focuses on the interactions between the in vivo physiology and the formulation and drug characteristics. The principles behind PBBM is that all mechanisms related to drug release, dissolution, and diffusion from the site of administration to the site of action can be described in a mechanistic way or semi-empirical way. The integration of in vitro dissolution data in PBBM is described, including examples of software and modeling applications. The expertise needed to use the software and appropriate training is discussed. The key inputs that are expected from the dissolution scientist include an understanding of the aqueous solubility across the physiological pH range, impact of in vivo relevant bile salts and phospholipids on solubilization, and the impact of surface pH on dissolution rate. An example of an advanced in vitro system, TNO intestinal model (TIM-1), will be discussed and its importance in establishing a biorelevant understanding of dissolution behavior. PBBM can evaluate the clinical relevance of a dissolution method and justify specifications and ultimately provide an approval advantage to the sponsor. A well-supported dissolution method that provides clinically relevant drug product specifications (CRDPS) will be viewed with favor by the regulators. Therefore, the partnering of a dissolution scientist and biopharmaceutics scientist to develop PBBM is clearly an important step forward in drug development.

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Section: Introductionmentioning

confidence: 99%

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

Gray¹,

Mann²,

Barker³

et al. 2020

Dissolution Technol.

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“…It plays many important roles throughout the pharmaceutical industry, including drug product research and development, controlling and evaluating drug quality, and assessing the quality and efficacy consistency of generic drugs. In vitro dissolution testing is a primary test in the pharmaceutical industry 2–5 . In order to establish in vitro and in vivo correlations (IVIVCs) of drugs, as well as to evaluate dosages for compliant with quality standards, accurate information about dissolution kinetics (i.e., time-dependent dissolution) is strongly required 6–11 .…”

Section: Introductionmentioning

confidence: 99%

Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets

Chi

Azhar

Khan

et al. 2019

Sci Rep

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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 a challenging task to perform both high-efficient separation and high-temporal detection to achieve accurate dissolution profile of each active ingredient dissolved from a drug tablet. In our study, we report a novel non-manual-operation method for performing the automatic dissolution testing of drug tablets, by combining a program-controlled sequential analysis and high-speed capillary electrophoresis for efficient separation of active ingredients. The feasibility of the method for dissolution testing of real drug tablets as well as the performance of the proposed system has been demonstrated. The accuracy of drug dissolution testing is ensured by the excellent repeatability of the sequential analysis, as well as the similarity of the evaluation of dissolution testing. Our study show that the proposed method is capable to achieve simultaneous dissolution testing of multiple ingredients, and the matrix interferences can be avoided. Therefore it is of potential valuable applications in various fields of pharmaceutical research and drug regulation.

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“…During the 1970s, there were 12 official dissolution tests using baskets in USP monographs. The paddle apparatus followed shortly thereafter (2). During the following decades, dissolution testing has assumed more and more importance.…”

mentioning

confidence: 99%

“…The ability to properly discriminate between drug products of different quality was always an essential requirement for a dissolution method. However, whereas for a long time a method was regarded as appropriate when it could indicate differences among changes in critical material attributes and critical process parameters applied in the manufacture of the dosage form, there are ongoing efforts to strengthen the linkage to the in vivo performance of the dosage form by use of improved media, apparatus, and PBPK (2).…”

mentioning

confidence: 99%

“…As discussed in the mini-review on "Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes", if a dissolution test is both discriminatory and in vivo predictive, it is a powerful tool that alerts that there may be bioinequivalent batches produced and helps to avoid that patients receive drugs that are not fully efficacious (2).…”

mentioning

confidence: 99%

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Advancements in Dissolution Testing of Oral and Non-oral Formulations

Klein

2019

AAPS PharmSciTech

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Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes

Cited by 38 publications

References 21 publications

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets

Advancements in Dissolution Testing of Oral and Non-oral Formulations

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