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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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Drug Product Stability01:16

Drug Product Stability

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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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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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Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Improving tablet coating robustness by selecting critical process parameters from retrospective data.

A Galí1,2, E García-Montoya2, M Ascaso1

  • 1a Department of Pharmacy and Pharmaceutical Technology , University of Barcelona , Barcelona , Spain and.

Pharmaceutical Development and Technology
|May 29, 2015
PubMed
Summary

This study optimized pharmaceutical tablet coating by identifying critical process parameters (CPP) using retrospective data. This approach enhances process robustness and quality with minimal experimental investment.

Keywords:
Coating defectscoating optimizationcritical process parametersdesign of experimentsdesign spaceretrospective data

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Quality by Design

Background:

  • Tablet coating processes are vital in pharmaceuticals but often lack robustness, leading to quality variations.
  • Up-scaling these processes presents challenges due to parameter sensitivity and inconsistent outcomes.

Purpose of the Study:

  • To identify critical process parameters (CPP) for tablet coating using historical commercial batch data.
  • To establish a robust design of experiments (DoE) to improve coating process reliability.

Main Methods:

  • Retrospective analysis of 36 commercial tablet coating batches with varying quality results.
  • Statistical data processing using Statgraphics 5.1 software to determine CPP.

Main Results:

  • Identification of critical process parameters (CPP) influencing tablet coating quality.
  • Proposal of new, optimized working ranges for improved process control.

Conclusions:

  • Retrospective data analysis enables CPP determination and design space creation for existing pharmaceutical processes.
  • This statistical approach optimizes process robustness with minimal additional experimental cost.