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Related Concept Videos

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: 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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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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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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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Formation of Dispersible Taohong Siwu Tablets
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Development and Validation Of A Discriminatory Dissolution Method for Portioned Moist Snuff and Snus.

Ziyaur Rahman1, Eman M Mohamed2, Sathish Dharani1

  • 1Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USA.

Journal of Pharmaceutical Sciences
|December 3, 2021
PubMed
Summary
This summary is machine-generated.

A new dissolution testing method effectively differentiates smokeless tobacco products (STP), specifically moist snuff and snus. This quality control test ensures product consistency and distinctiveness.

Keywords:
DissolutionMoist snuff and snusNicotineRelease mechanismSmokeless tobacco products

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Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics
  • Tobacco Science

Background:

  • Smokeless tobacco products (STP) require robust quality control measures.
  • Moist snuff and snus are distinct subcategories of STP with varying nicotine delivery.
  • Accurate methods are needed to assess nicotine dissolution from these products.

Purpose of the Study:

  • To develop and validate a dissolution testing method for portioned moist snuff and snus.
  • To establish discriminatory criteria for assessing nicotine release profiles.
  • To ensure the method's suitability as a quality control test for STP.

Main Methods:

  • Utilized USP Apparatus 4 for method development and validation.
  • Assessed method performance using nicotine dissolution plateau time, profile differences, RSD, and f1/f2 similarity/dissimilarity factors.
  • Tested nine different moist snuff and snus products.

Main Results:

  • Identified 200 ml volume and 8 ml/min flow rate as discriminatory parameters.
  • Observed wide variations in nicotine dissolution (2.0-19.6 mg/pouch at 60 min) across products.
  • Confirmed method's discriminatory power with f1 > 15 and f2 < 50, showing distinct product profiles.

Conclusions:

  • The developed dissolution method is discriminatory and suitable for quality control.
  • The method can effectively differentiate between various moist snuff and snus products.
  • This validates a reliable approach for assessing nicotine release in smokeless tobacco.