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Related Concept Videos

Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

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Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Sample Preparation for Analysis: Overview01:21

Sample Preparation for Analysis: Overview

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Sample preparation is an essential step in the analytical process. It involves preparing a sample so that it can be analyzed accurately. The goal is to extract the analyte, the substance you want to measure, from the sample while removing any components that may interfere with the analysis. Sample preparation techniques vary depending on the physical state of the sample.
Bulk or large solid samples are typically reduced in size using grinding, crushing, or milling techniques to increase the...
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

10
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

208
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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In Vitro Drug Release Testing: Overview, Development and Validation01:10

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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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PAT implementation for advanced process control in solid dosage manufacturing - A practical guide.

Stephan Sacher1, Johannes Poms1, Jakob Rehrl1

  • 1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.

International Journal of Pharmaceutics
|December 24, 2021
PubMed
Summary
This summary is machine-generated.

Advanced control strategies and in-line monitoring are crucial for continuous pharmaceutical manufacturing, moving beyond traditional testing to enable real-time release testing (RTRT) and enhance process automation.

Keywords:
Advanced process controlContinuous manufacturingControl conceptModel predictive controlPAT

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Control

Background:

  • Continuous pharmaceutical manufacturing necessitates advanced control strategies beyond traditional methods.
  • Current Process Analytical Technology (PAT) primarily focuses on process understanding and quality control for real-time release testing (RTRT).

Purpose of the Study:

  • To describe the workflow for developing an in-line monitoring strategy to support PAT-based real-time control actions.
  • To detail the integration of this strategy into solid dosage manufacturing.

Main Methods:

  • Process analysis and definition of monitoring tasks.
  • Technology assessment, selection, and process integration.
  • Development of data acquisition systems for in-line monitoring.

Main Results:

  • A comprehensive workflow for developing and integrating in-line monitoring strategies for PAT has been established.
  • The developed tools are ready for commercial-scale utilization in pharmaceutical manufacturing.

Conclusions:

  • In-line monitoring is essential for enabling advanced control and real-time control actions in continuous pharmaceutical manufacturing.
  • The integration of PAT and advanced automation is key to achieving efficient and high-quality solid dosage production.