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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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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

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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

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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Pharmacokinetic Models: Comparison and Selection Criterion01:26

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Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
163
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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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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System model driven selection of robust tablet manufacturing processes based on drug loading and formulation physical

Leah R White1, Matthew Molloy1, Robert J Shaw1

  • 1Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|February 12, 2022
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Mechanistic process modeling uses in-silico experiments to map pharmaceutical manufacturing. This study developed a system model comparing dry granulation and direct compression to optimize drug product formulation and process design.

Keywords:
Design spaceFormulation designPharmaceutical processSystem model

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Computational Modeling

Background:

  • Reducing experimental burden in pharmaceutical development is crucial.
  • Understanding the interplay between material properties, formulation, and process parameters is key.
  • In-silico experiments offer a powerful tool for process optimization.

Purpose of the Study:

  • To develop a mechanistic system model for pharmaceutical tablet manufacturing.
  • To compare dry granulation and direct compression processes.
  • To map the robust operating space by linking API properties and formulation to process parameters.

Main Methods:

  • Developed a computational framework using system models.
  • Generated process classification and design space maps.
  • Utilized the Manufacturing Classification System to define critical quality attribute constraints.

Main Results:

  • Assessed feasibility of roller compaction and direct compression for various material properties.
  • Demonstrated how system models support formulation and process design decisions.
  • Illustrated the impact of API mass fraction on the process operating space.

Conclusions:

  • Mechanistic process modeling aids robust pharmaceutical formulation and process decision-making.
  • Understanding API physical properties is vital for successful formulation and process design.
  • Models facilitate setting API property requirements for robust drug product development.