Developing a quality by design approach to model tablet dissolution testing: an industrial case study

Yekpe, Ketsia; Abatzoglou, Nicolas; Gosselin, Ryan; Sharkawi, Tahmer; Simard, Jean-Sébastien; Cournoyer, Antoine

doi:10.1080/10837450.2017.1392566

Cited by 12 publications

(9 citation statements)

References 17 publications

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“…As can be seen in Table 1, in the rest of the world the QbD methodology has been extended to different areas of the pharmaceutical discipline, such as: Excipient development, analytical methods, dissolution tests, stability studies, bioequivalence studies, clinical trials, and others [66][67][68][69]. All the previously mentioned and described examples have allowed advances in the academy, pharmaceutical development, and the regulatory environment, moving from empirical processes to research based on science and risk control [70,71].…”

Section: Quality By Design Approach For Industrial Pharmacy In the Ac...mentioning

confidence: 99%

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Henríquez¹,

Murillo-Castillo²,

Ramírez-Arguedas³

et al. 2022

Preprint

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The aim of this review is to present the Quality by Design (QbD) model as a suitable methodology to perform research in the academic Costa Rican institutions that teach Pharmacy. Pubmed, Science Direct, and Google Scholar databases were screened for original and review papers, as well as short communications published not more than 10 years ago. Publications were screened by title and abstract. Relevant references were used to develop three important themes: The University’s Research Model in Costa Rica, QbD Model, and QbD as a Research Methodology for Industrial Pharmacy in the Academy. In this sense, the QbD model is a great methodology for carrying out research projects regarding Pharmaceutical Sciences but especially for Drug Development. Academic research based on this model enables training and developing practical, scientific, and leadership skills in pharmacy students. The generated knowledge can be shared in the classrooms, which represents an ideal environment to communicate their research results and to foster collaborative work between researchers, professors, and students. The participation of all these actors allows a high level of commitment to research work, which benefits the scientific advancement of the university and society. It is important to visualize the student body as potential key actors in the research process, encouraging in them the desire to become trained scientific researchers who want to pursue a career in the academy, giving continuity to it.

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Section: Quality By Design Approach For Industrial Pharmacy In the Ac...mentioning

confidence: 99%

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Henríquez¹,

Murillo-Castillo²,

Ramírez-Arguedas³

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…12 Due to the sensitivity of this technique to many chemical and physical attributes, it is possible to extract information about the properties of a large variety of tablets from the NIR spectra by chemometrics, which can consequently be utilized to predict the dissolution profile. 3 Currently, several studies have reported the effect of compression forces, 13 formulation composition, 14 particle size 15 and lubrication time 16 on dissolution using NIR spectroscopy. In addition, thus far, NIR spectroscopy has also been used for monitoring different manufacturing processes such as blending, 17 tableting, 18 and coating.…”

Section: Introductionmentioning

confidence: 99%

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Wang

Zhang

et al. 2023

New J. Chem.

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“…This issue has received more attention in recent years due to the emphasis on the use of the concept of quality by design (QbD) by the U.S. Food and Drug Administration (FDA). With the QbD initiative, routine quality control tests, such as dissolution testing (DT) performed after the production process, can be reduced or even stopped if the influencing parameters are controlled [ 13 ]. This goal can be achieved by conducting experiments or simulating the drug release process from a drug delivery system.…”

Section: Introductionmentioning

confidence: 99%

“…For example, in the research carried out by Barmpalexis et al, using neural network techniques, linear regression, and higher-order regressions, they were able to accurately predict responses such as mean dissolution time, maximum solvent absorption, and several other responses based on the combination ratio of four substances in drug production [ 18 ]. Studies such as Yekpe et al’s study with emphasis on the importance of tablet surface hardness and tablet coating weight on the drug release rate [ 13 ] and Frankiewicz and Sznitowska’s study with emphasis on the importance of production temperature and coating spray pressure on the tablet on the drug release rate [ 19 ] are studies with this type of modeling approach.…”

Section: Introductionmentioning

confidence: 99%

“…Most of the studies conducted in this field are related to the effect of drug formulation [ 13 , 30 , 31 , 32 ] or the effect of appearance properties or characteristics related to drug production, such as tablet coating weight, porosity, dimensions of particles, the pressure of the tablet compression machine, or many other properties [ 31 , 32 , 33 ]. One of the factors that can affect the release rate is the geometry of the matrix.…”

Section: Introductionmentioning

confidence: 99%

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Tablet Geometry Effect on the Drug Release Profile from a Hydrogel-Based Drug Delivery System

Mohseni-Motlagh,

Dolatabadi,

Baniassadi

et al. 2023

Pharmaceutics

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In order to achieve the optimal level of effectiveness and safety of drugs, it is necessary to control the drug release rate. Therefore, it is important to discover the factors affecting release profile from a drug delivery system. Geometry is one of these effective factors for a tablet-shaped drug delivery system. In this study, an attempt has been made to answer a general question of how the geometry of a tablet can affect the drug release profile. For this purpose, the drug release process of theophylline from two hundred HPMC-based tablets, which are categorized into eight groups of common geometries in the production of oral tablets, was simulated using finite element analysis. The analysis of the results of these simulations was carried out using statistical methods including partial least squares regression and ANOVA tests. The results showed that it is possible to predict the drug release profile by knowing the geometry type and dimensions of a tablet without performing numerous dissolution tests. Another result was that, although in many previous studies the difference in the drug release profile from several tablets with different geometries was interpreted only by variables related to the surface, the results showed that regardless of the type of geometry and its dimensions, it is not possible to have an accurate prediction of the drug release profile. Also, the results showed that without any change in the dose of the drug and the ingredients of the tablet and only because of the difference in geometry type, the tablets significantly differ in release profile. This occurred in such a way that, for example, the release time of the entire drug mass from two tablets with the same mass and materials but different geometries can be different by about seven times.

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Developing a quality by design approach to model tablet dissolution testing: an industrial case study

Cited by 12 publications

References 17 publications

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Tablet Geometry Effect on the Drug Release Profile from a Hydrogel-Based Drug Delivery System

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