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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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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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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

310
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...
310
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

384
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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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

617
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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Developing a quality by design approach to model tablet dissolution testing: an industrial case study.

Ketsia Yekpe1,2, Nicolas Abatzoglou1, Bernard Bataille2

  • 1a Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering , Université de Sherbrooke , Sherbrooke , Quebec , Canada.

Pharmaceutical Development and Technology
|November 3, 2017
PubMed
Summary

Quality by Design (QbD) modeling of tablet dissolution uses risk analysis and experimental design. This approach identifies key parameters like particle size and hardness to predict dissolution profiles, reducing the need for extensive testing.

Keywords:
Dissolution testingICH Q8 guidelinedesign of experimentsdissolution modelingquality by designrisk assessment

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Area of Science:

  • Pharmaceutical Science
  • Drug Delivery Systems
  • Process Analytical Technology

Background:

  • Tablet dissolution is a critical quality attribute for solid oral dose products.
  • Current dissolution testing methods can be resource-intensive.
  • Quality by Design (QbD) offers a systematic approach to product development and control.

Purpose of the Study:

  • To apply the Quality by Design (QbD) concept to tablet dissolution testing.
  • To propose a quality control strategy for modeling dissolution profiles.
  • To align dissolution testing with International Conference on Harmonization (ICH) guidelines.

Main Methods:

  • Performed a risk analysis to identify critical material and process parameters affecting dissolution.
  • Utilized experimental design to assess the influence of identified parameters on dissolution testing.
  • Investigated the relationship between critical parameters and dissolution profiles.

Main Results:

  • Identified active pharmaceutical ingredient particle size distribution and tablet hardness as key parameters influencing dissolution kinetics.
  • Demonstrated that Process Analytical Technology (PAT) tools can monitor these parameters to predict dissolution profiles.
  • Confirmed the feasibility of modeling dissolution profiles using the QbD approach.

Conclusions:

  • The QbD approach provides a practical and effective strategy for controlling tablet dissolution.
  • Systematic implementation of QbD can optimize pharmaceutical manufacturing processes.
  • This methodology can potentially reduce the reliance on traditional tablet dissolution testing.