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Review

Central Composite Design: An Optimization Tool for Developing Pharmaceutical Formulations

Sruthi Somadasan1, Gopinath Subramaniyan1★, Meriton Stanly Athisayaraj2, Satheesh Kumar Sukumaran3★ Corresponding author

  1. 1Department of Pharmaceutics, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai, Tamil Nadu, INDIA.
  2. 2Department of Community Medicine, Sri Ramachandra Medical College and Research Institute, SRIHER (DU), Porur, Chennai, Tamil Nadu, INDIA.
  3. 3Department of Pharmaceutics, SNS college of Pharmacy and Health Sciences, SNS Kalvinagar, Kurumbalayam, Saravanampatti, Coimbatore, Tamil Nadu, INDIA.

CORRESPONDENCE

Gopinath Subramaniyan

Department of Pharmaceutics, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai, Tamil Nadu, INDIA.

drsgopinathsriramachandra@ gmail.com

Received: 10-04-2024; Revised: 20-04-2024; Accepted: 15-05-2024.

Volume 16, Issue 3 · pp. 400–409 · PUBLISHED · DOI: 10.5530/jyp.2024.16.52

View on JYP original site ↗

ABSTRACT

Design and optimization are pivotal in a pharmaceutical company's formulation and manufacturing process. Various approaches and methodologies are employed in formulation design. A quantitative adjustment to a component, ingredient, or process variable is made while maintaining control over other independent components to monitor their influence on quality attributes. However, investigating these components together poses challenges, potentially leading to misinterpretation of experimental results. To resolve this, simultaneous design and development process modification can be achieved using the design of experiment methodologies, such as Central Composite Design (CCD). CCD effectively evaluates the interaction effects of numerous elements on product quality and outcomes. It has been successfully applied across various studies to develop and enhance formulations. This review provides insights into CCD, including its varieties, a comparison with other experimental designs, applications in pharmaceutical formulation, experimental design data analysis, optimization techniques, benefits and advantages, case studies, integration with Quality by Design (QbD) and regulatory considerations.

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    Somadasan, S., Subramaniyan, G., Athisayaraj, M. S., & Sukumaran, S. K. (). Central Composite Design: An Optimization Tool for Developing Pharmaceutical Formulations. Journal of Young Pharmacists, 16(3), 400–409. https://doi.org/10.5530/jyp.2024.16.52