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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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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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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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Gentamicin, an aminoglycoside antibiotic, is commonly administered via intermittent intravenous infusion to treat severe infections. An intermittent one-hour infusion of gentamicin, administered at eight-hour intervals, allows for precise control of plasma drug concentrations, minimizing toxicity while ensuring therapeutic efficacy. Pharmacokinetic principles govern the dynamics of plasma concentrations and can be mathematically described using specific equations.The plasma drug concentration...
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Integrating QbD Tools for Flexible Scale-Up Batch Size Selection for Solid Dosage Forms.

Naseem A Charoo1, Ziyaur Rahman2

  • 1Zeino Pharma FZ LLC, 703-HQ Complex-North Tower, Dubai Science Park, Dubai, United Arab Emirates; Neopharma, PO. Box 72900, Mussafah, Abu Dhabi, United Arab Emirates.

Journal of Pharmaceutical Sciences
|December 21, 2019
PubMed
Summary
This summary is machine-generated.

Current pilot scale batch size regulations for solid oral dosage forms are arbitrary. A science- and risk-based approach, integrating quality by design, is needed for flexible batch size selection during scale-up.

Keywords:
dimensionless numberspilot batchprocess analytical technologyquality by designscale upsimulatorssolid dosage forms

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Quality by Design

Background:

  • Current pilot scale batch size regulations for solid oral dosage forms are defined by regulatory agencies as 1/10th of full production or 100,000 units, whichever is larger.
  • This criterion is arbitrary and does not incorporate scientific or risk assessment principles, nor does it account for scale-up changes.
  • The current approach fails to guarantee the impact of scale-up on critical quality attributes or ensure reproducibility.

Purpose of the Study:

  • To advocate for a paradigm shift in determining pilot scale batch sizes for solid oral dosage forms.
  • To emphasize the integration of science and risk assessment principles into the scale-up process.
  • To introduce tools that can be combined with quality by design for flexible batch size selection.

Main Methods:

  • Review of current regulatory standards for pilot scale batch size determination.
  • Analysis of the limitations of the existing arbitrary criteria.
  • Exploration of quality by design (QbD) principles and associated tools for scale-up.
  • Discussion of geometric, kinematic, and dynamic considerations in scale-up.

Main Results:

  • The current regulatory approach for pilot scale batch size is scientifically unsound and arbitrary.
  • Scale-up involves complex changes not addressed by fixed batch size limits.
  • Quality by Design (QbD) offers a framework for science- and risk-based scale-up batch size selection.
  • Tools exist to integrate QbD for flexible and robust scale-up.

Conclusions:

  • The selection of scale-up batch size must be based on science and risk assessment, aligning with 21st Century Good Manufacturing Practice.
  • Scale-up should be an integral part of product development, not an isolated activity.
  • Quality by Design (QbD) integration enables flexible and scientifically justified batch size selection during scale-up, ensuring product quality and reproducibility.