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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Noncompartmental analyses offer an alternative method for describing drug pharmacokinetics without relying on a specific compartmental model. In this approach, the drug's pharmacokinetics are assumed to be linear, with the terminal phase log-linear. This assumption allows for simplified analysis and interpretation of the drug's behavior in the body.
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Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
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Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes.

Wenhui Yang1, Wuxi Qian2, Zhihong Yuan1

  • 1State Key Laboratory of Chemical Engineering, Department of Chemical Engineering, Tsinghua University, Beijing 100084, China.

Chinese Journal of Chemical Engineering
|January 16, 2023
PubMed
Summary
This summary is machine-generated.

Flexibility analysis is crucial for continuous pharmaceutical manufacturing, ensuring process robustness against variations. This review overviews methods to assess and enhance the adaptability of pharmaceutical production for better quality and economic performance.

Keywords:
Continuous manufacturingFlexibilityModelOptimizationPharmaceuticalsUncertainty

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Process Engineering
  • Process Systems Engineering

Background:

  • Continuous pharmaceutical manufacturing offers quality assurance, risk mitigation, and economic benefits, especially highlighted during the COVID-19 pandemic.
  • Flexibility analysis quantifies a chemical process's ability to operate effectively despite uncertain parameter variations.
  • Assessing process flexibility is vital for robust and adaptable pharmaceutical production systems.

Purpose of the Study:

  • To provide a comprehensive overview of flexibility analysis for continuous pharmaceutical manufacturing processes.
  • To systematically review the state-of-the-art, including concept evolution, mathematical models, solution strategies, and applications.
  • To identify future challenges and developments in flexibility analysis for active pharmaceutical ingredient (API) and integrated continuous manufacturing.

Main Methods:

  • Systematic literature review of flexibility analysis in chemical processes.
  • Overview of mathematical formulations and solution strategies for flexibility assessment.
  • Examination of applications in downstream dosage form manufacturing and future directions for API and integrated processes.

Main Results:

  • The paper systematically reviews the evolution, methodologies, and applications of flexibility analysis in chemical and pharmaceutical processes.
  • Recent advancements in flexibility/feasibility analysis for downstream dosage form manufacturing are discussed.
  • Key challenges and future research directions for flexibility analysis in API and integrated continuous manufacturing are identified.

Conclusions:

  • Flexibility analysis is a critical tool for ensuring the robustness and economic viability of continuous pharmaceutical manufacturing.
  • The review provides a foundation for understanding current capabilities and highlights the need for further research in advanced manufacturing scenarios.
  • Addressing identified challenges will be essential for optimizing novel continuous manufacturing processes for pharmaceuticals.