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Related Concept Videos

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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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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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 Release Testing: Overview, Development and Validation01:10

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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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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.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
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Nifedipine Release From Extended-Release Solid Oral Formulations Using In Vitro Dissolution Testing Under Simulated

Zongming Gao1, Li Tian1, Jason D Rodriguez1

  • 1Division of Pharmaceutical Analysis, Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110.

Journal of Pharmaceutical Sciences
|April 3, 2020
PubMed
Summary

Simulated gastrointestinal contractions impact nifedipine release from extended-release oral products. Polymer matrix formulations showed poor drug release control under simulated gastrointestinal contractions exceeding 100g force.

Keywords:
Controlled/extended releaseDissolution testingGastrointestinal compressionIn vitro model(s)Solid oral formulation

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Area of Science:

  • Pharmacology
  • Pharmaceutics
  • Biomedical Engineering

Background:

  • Drug release from extended-release solid oral dosage forms is crucial for bioavailability.
  • Predictive dissolution testing is essential for establishing clinically relevant quality standards.
  • Understanding the impact of gastrointestinal (GI) physiological conditions on drug release is vital for formulation development.

Purpose of the Study:

  • To investigate the effect of simulated gastrointestinal (GI) contractions on nifedipine release from two extended-release oral formulations.
  • To evaluate the performance of different extended-release drug delivery systems under mechanical stress.

Main Methods:

  • Utilized an in-house dissolution system to simulate varying levels of GI contractions.
  • Monitored mechanical property changes of drug formulations during dissolution testing.
  • Tested a 60 mg nifedipine osmotic pump product (Product A) and two polymer matrix-based products (Products B and C).

Main Results:

  • Polymer matrix-based formulations (Products B and C) demonstrated a failure in controlled release when simulated GI contraction force exceeded 100 g.
  • Product A (osmotic pump) performance under simulated GI contractions was not explicitly detailed but implied to be more robust than polymer matrices.
  • The study highlights formulation-dependent responses to mechanical stimuli.

Conclusions:

  • Simulated GI contractions can significantly affect drug release profiles of extended-release oral products.
  • The developed in-house method is potentially valuable for assessing the in vivo performance of polymer matrix-based products.
  • This approach aids in identifying potential formulation-related interactions with the GI tract.