A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods

Huang, Jun; Goolcharran, Chimanlall; Ghosh, Krishnendu

doi:10.1016/j.ejpb.2010.12.012

Cited by 47 publications

(18 citation statements)

References 21 publications

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“…For product formulation, the optimization literature primarily focuses on artificial neural networks (ANNs), response surface methods (RSM) and multivariate methods [153]. This use of surrogate models is in accordance with FDA QbD guidance, which suggests the use of design space enabling tools (i.e., design of experiments (DoE) and statistical models) for product design [5,138,154,155]. Many instances of formulation optimization point to ANNs as the surrogate method for optimization, primarily because of its effectiveness to use and learn from available experimental datasets [133].…”

Section: Product Formulationmentioning

confidence: 99%

Optimization Methodologies for the Production of Pharmaceutical Products

Escotet‐Espinoza

Rogers

Ierapetritou

2016

Methods in Pharmacology and Toxicology

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Finding the most beneficial conditions during the development of a given product or process is among one of the top goals for both scientist and engineers across all industries. In the pharmaceutical industry, as global competition increases and there is a higher demand for accessible quality products, it is important to focus on the improvement of product development and manufacturing. Optimization methodologies can greatly aid the production of pharmaceutical products by providing a systematic framework to process improvement. In this review, general concepts regarding the implementation of optimization methods are introduced along with examples of their application in pharmaceutical manufacturing process design and formulation development. An overview of optimization methodologies used for the improvement of batch and continuous pharmaceutical manufacturing is presented. Challenges in the application of optimization methods in pharmaceutical manufacturing are discussed along with a future outlook of the field and its place in pharmaceutical process and product design. Overall the review points to optimization as a critical component in the design of improved and effective pharmaceutical products, in alignment with the common goals of both regulatory agencies and industry.

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Section: Product Formulationmentioning

confidence: 99%

Optimization Methodologies for the Production of Pharmaceutical Products

Escotet‐Espinoza

Rogers

Ierapetritou

2016

Methods in Pharmacology and Toxicology

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“…Fundamental understanding of physical and chemical mechanisms underpinning any physical change is essential to achieve robust drug formulation development [105]. This should be part of any Quality by Design (QbD) drug‐development strategy, with the systematic evaluation of the drug substance, excipients and manufacture processes [106]. In one example, the changes of tablet thickness and hardness were related to the dehydration‐hydration cycle of a drug substance hydrate during secondary manufacturing [107].…”

Section: Regulatory Perspectivesmentioning

confidence: 99%

The solid-state continuum: a perspective on the interrelationships between different solid-state forms in drug substance and drug product

Elder

Patterson

Holm

2014

Journal of Pharmacy and Pharmacology

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Objective The objective of the review is to provide an overview of the nomenclature used in the solid-state continuum and relate these to the development of drug substances and drug products. Key findings The importance of a rational approach to solid-state form selection, including integrated decision making (ensuring equal weight is given to the needs of the drug substance and the drug product), is vital for the effective development of a drug candidate. For example, how do secondary processing considerations influence the selection of drug substance solid-state form and resulting formulation, and how can drug substance solid-state form be used to optimise secondary processing? Further, the potential use of 'crystal' engineering to optimise stability, purity and optical resolutions, and the linked regulatory requirements, will be discussed. Summary The nomenclature used in the solid-state continuum, which contains a large number of different crystalline and non-crystalline forms, for example, amorphous systems, was reviewed. Further, the significant role of the drug substance within the solid oral dose form from a physicochemical perspective was covered.

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“…Although these studies guide to design a reasonable process, they do not specify a complete implementation of the continuous life-cycle improvement of the process. Statistical methodologies such as analysis of variance (ANOVA), principal component analysis (PCA), and partial least square (PLS) are proposed to predict the likelihood or root causes of quality deviation (Gilabert, Roch, Camanas, Hernandez, & Sagrado, 2004;Gunther, Conner, & Seborg, 2009;Huang, Goolcharran, & Ghosh, 2011;Wu, White, & Khan, 2011). These methodologies are useful in determining a possible scenario to explain a quality deviation.…”

Section: Introductionmentioning

confidence: 98%