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Related Concept Videos

Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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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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In Vitro Drug Dissolution: Alternative Methods01:17

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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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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

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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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Theories of Dissolution: Diffusion Layer Model01:15

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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
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A new biorelevant dissolution method for orodispersible films.

Raphael Krampe1, Daniel Sieber1, Miriam Pein-Hackelbusch1

  • 1Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitätsstraße 1, 40225 Düsseldorf, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|October 31, 2015
PubMed
Summary

A new biorelevant dissolution setup for orodispersible films (ODFs) reveals slower initial drug release compared to conventional methods. Simulating oral conditions like saliva flow and tongue movement significantly impacts ketoprofen (KTP) release profiles.

Keywords:
Biorelevant methodDissolution testingIn-line measurementKetoprofenOrodispersible films

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Biopharmaceutics

Background:

  • Orodispersible films (ODFs) require understanding dissolution under oral conditions, which differ significantly from standard testing.
  • Pharmacopoeial dissolution methods do not fully replicate the dynamic environment of the oral cavity.

Purpose of the Study:

  • To develop a novel biorelevant dissolution setup for ODFs that mimics oral cavity conditions.
  • To evaluate the dissolution behavior of ketoprofen (KTP) ODFs using this new setup.

Main Methods:

  • Development of a biorelevant dissolution apparatus simulating tongue movement, saliva flow, low fluid volume, and saliva composition.
  • Comparison of KTP ODF dissolution profiles obtained from the new setup versus conventional methods.
  • Investigation of the impact of simulated saliva flow and mechanical force on KTP release.

Main Results:

  • The new biorelevant method showed significantly slower initial KTP release from ODFs (27.47% in 100s) compared to conventional methods (59.29-82.55%).
  • Simulating saliva flow or mechanical force individually resulted in 2-3 times higher KTP release (18.78%, 14.18%) than without considering these parameters (6.76%).

Conclusions:

  • The developed biorelevant dissolution setup provides a more realistic assessment of ODF performance in the oral cavity.
  • Simulated in vivo conditions critically influence drug release from ODFs, highlighting limitations of current standard dissolution tests.
  • Further research is needed to correlate these biorelevant data with actual in vivo performance for predicting ODF drug release.