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

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476
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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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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Formation of Dispersible Taohong Siwu Tablets
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A Novel Disintegration Tester for Solid Dosage Forms Enabling Adjustable Hydrodynamics.

Sarah Kindgen1, Regine Rach1, Thomas Nawroth1

  • 1Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University, Staudingerweg 5, 55128 Mainz, Germany.

Journal of Pharmaceutical Sciences
|July 17, 2016
PubMed
Summary
This summary is machine-generated.

A new in vitro disintegration test device simulates physiological conditions, revealing hydrodynamics significantly impact tablet disintegration times, especially in fasted-state media. This tool enhances biorelevant testing for oral dosage forms.

Keywords:
computational fluid dynamicsdisintegration testinghydrodynamicsin vitro modelsliberationtablets

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Area of Science:

  • Pharmacokinetics and Drug Delivery
  • Pharmaceutical Technology

Background:

  • Standard disintegration tests may not fully capture in vivo performance.
  • Hydrodynamic forces are critical but often overlooked in disintegration testing.
  • Physiologically relevant conditions are needed for accurate in vitro assessment.

Purpose of the Study:

  • To develop and validate a modified disintegration test device.
  • To investigate the influence of hydrodynamic conditions on oral dosage form disintegration.
  • To establish biorelevance in in vitro disintegration testing.

Main Methods:

  • Modification of the compendial PhEur/USP disintegration test device.
  • Integration of computerized numerical control for variable velocity profiles.
  • Utilisation of computational fluid dynamics (CFD) to characterize forces.
  • Proof-of-concept study with immediate-release tablets.

Main Results:

  • The modified device successfully applied physiologically relevant hydrodynamic conditions.
  • Disintegration times were significantly influenced by hydrodynamic conditions.
  • Slower disintegration observed with decreased device velocity, particularly in simulated fasted-state media.
  • Correlation found between CFD-predicted shear stress and experimental disintegration times.

Conclusions:

  • The modified disintegration test device provides biorelevant in vitro disintegration data.
  • Hydrodynamics play a crucial role in the disintegration of solid oral dosage forms.
  • This tool is valuable for optimizing drug product development and performance prediction.