Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

Ishimoto, Hayato; Kano, Manabu; Sugiyama, Hirokazu; Takeuchi, Hirofumi; Terada, Katsuhide; Aoyama, Atsushi; Shoda, Takuji; Demizu, Yosuke; Shimamura, Jinen; Yokoyama, Reiji; Miyamoto, Yuji; Hasegawa, Koji; Serizawa, Masaru; Unosawa, Kazuomi; Osaki, Kazuo; Asai, Naochika; Matsuda, Yoshihiro

doi:10.1248/cpb.c20-00824

Cited by 4 publications

(4 citation statements)

References 16 publications

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“…QbD principle is a useful tool for establishing the control strategies for continuous manufacturing, as it provides the basic concepts and scheme for control model construction [71]. To establish variable rate process control strategies for solid oral dosage forms in continuous manufacturing, a comprehensive and systematic methodology was established for improving process understanding and control strategy for TSWG, followed by the QbD principle [72].…”

Section: Process Controlmentioning

confidence: 99%

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Zhao

Tian

2023

Biomedicines

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Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and applications. To improve both the product quality and process efficiency, the process understanding is critical. This article reviews the recent work in process understanding and optimization for TSWG. Various aspects of the progress in TSWG like process model construction, process monitoring method development, and the strategy of process control for TSWG have been thoroughly analyzed and discussed. The process modeling technique including the empirical model, the mechanistic model, and the hybrid model in the TSWG process are presented to increase the knowledge of the granulation process, and the influence of process parameters involved in granulation process on granule properties by experimental study are highlighted. The study analyzed several process monitoring tools and the associated technologies used to monitor granule attributes. In addition, control strategies based on process analytical technology (PAT) are presented as a reference to enhance product quality and ensure the applicability and capability of continuous manufacturing (CM) processes. Furthermore, this article aims to review the current research progress in an effort to make recommendations for further research in process understanding and development of TSWG.

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Section: Process Controlmentioning

confidence: 99%

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Zhao

Tian

2023

Biomedicines

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“…Formulations through QbD: Case Studies and Risk Assessment Ishimoto et al have developed a continuous manufacturing control process for oral solid dosage drugs. Despite the differences between continuous and batch manufacturing methods, the approach used in standard production batch manufacturing, including drug development, process transfer, method management and quality control, can be successfully applied in continuous manufacturing [27].…”

Section: Advancements In Pharmaceuticalmentioning

confidence: 99%

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

Azeeze,

Nunavath,

Singh

et al. 2023

Drug Res (Stuttg)

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The pharmaceutical industry has embraced the quality-by-design (QbD) approach as a promising development, formulation and manufacturing strategy. QbD provides a systematic and science-based framework for designing and producing high-quality products, with a particular focus on identifying, assessing and controlling risks throughout the development process. This review aims to assess the benefits of implementing QbD in pharmaceutical processes, evaluate its impact on regulatory compliance and explore its potential to enhance drug product quality. The primary objective of this review is to evaluate the influence of QbD on pharmaceutical development and manufacturing processes. It also seeks to examine the regulatory requirements associated with the implementation of QbD and highlight the advantages of this approach in terms of product quality and cost-effectiveness. Additionally, the review aims to explore the potential of QbD in improving the safety and efficacy of drug products. The QbD approach holds tremendous potential to revolutionize the pharmaceutical industry by optimizing drug development & manufacturing processes, reducing costs and enhancing product quality and consistency. However, implementing QbD requires a comprehensive understanding of the underlying science, as well as strict adherence to regulatory requirements in drug development and manufacturing. In conclusion, by embracing the QbD approach, the pharmaceutical industry can ensure the production of safe, effective and regulation-compliant products while simultaneously improving process efficiency. This strategic shift toward QbD represents a pivotal step in advancing pharmaceutical research and manufacturing capabilities, ultimately benefiting both the industry and more importantly, patients worldwide.

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“…Examples of how control strategies can be developed are given in detail in a paper from the AMED group (see Section 8.2.10 ). Note that in this paper, they reverse the numbering of the control strategy levels [ 47 ] and for a twin-screw wet granulation CM process in a paper by Pauli et al [ 48 ].…”

Section: Quality Considerations Of CM Processesmentioning

confidence: 99%

“…One of the main benefits of CM is the relative ease (compared to a batch process) in which the batch size can be modified [ 47 ] by:…”

Section: Quality Considerations Of CM Processesmentioning

confidence: 99%

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Wahlich¹

2021

Pharmaceutics

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Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.

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Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

Cited by 4 publications

References 16 publications

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

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