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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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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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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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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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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Drug Dissolution: Requirements and Profile Comparison01:14

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Trends-process analytical technology in solid oral dosage manufacturing.

Liang Zhong1, Lele Gao1, Lian Li1

  • 1School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|June 23, 2020
PubMed
Summary
This summary is machine-generated.

Process Analytical Technology (PAT) enhances pharmaceutical quality. This review details PAT tools for monitoring and controlling solid oral dosage manufacturing to improve drug quality for researchers and manufacturers.

Keywords:
ChemometricsCritical quality attributesProcess analytical technologiesProcess controlSolid oral dosage forms

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Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Quality Control

Background:

  • Pharmaceutical quality is critical for drug safety and efficacy.
  • The US Food and Drug Administration (FDA) introduced Process Analytical Technology (PAT) in 2004.
  • PAT offers significant opportunities to enhance pharmaceutical development, manufacturing, and quality assurance.

Purpose of the Study:

  • To review various Process Analytical Technology (PAT) tools.
  • To focus on PAT applications for solid oral dosage manufacturing.
  • To provide information for improving drug quality monitoring and control.

Main Methods:

  • Literature review of Process Analytical Technology (PAT) tools.
  • Analysis of PAT applications in solid oral dosage manufacturing.
  • Synthesis of information for researchers and manufacturers.

Main Results:

  • Identification of diverse PAT tools applicable to solid oral dosage production.
  • Demonstration of PAT's role in real-time quality monitoring.
  • Highlighting PAT's potential for process optimization and control.

Conclusions:

  • Process Analytical Technology (PAT) is essential for ensuring pharmaceutical quality.
  • Implementing PAT tools can significantly improve the manufacturing of solid oral dosage forms.
  • This review serves as a guide for leveraging PAT to enhance drug quality.