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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

178
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...
178
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

191
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,...
191
In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

172
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...
172
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

196
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...
196
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

250
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...
250
Noncompartmental Analysis: Mean Transit, Absorption and Dissolution Time01:02

Noncompartmental Analysis: Mean Transit, Absorption and Dissolution Time

321
When drugs are administered extravascularly, a comprehensive evaluation through noncompartmental analysis becomes imperative. This analytical approach considers various parameters that play a crucial role in understanding the pharmacokinetics of these drugs.
One of the key parameters is the mean transit time (MTT), which refers to the total duration required for drug molecules to transit through the body. MTT is determined by calculating the ratio of the area under the moment curve to the area...
321

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Related Experiment Video

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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug

Zhongmei Chi1, Irfan Azhar1, Habib Khan1

  • 1Faculty of Chemistry, Northeast Normal University, 5268 Renmin Street, Changchun, Jilin, 130024, P.R. China.

Scientific Reports
|November 21, 2019
PubMed
Summary

This study introduces an automated dissolution testing method using sequential analysis and capillary electrophoresis for accurate drug analysis. The novel system enables simultaneous testing of multiple ingredients, improving pharmaceutical quality control.

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Dissolution testing is crucial for pharmaceutical research, development, and quality control.
  • Accurate dissolution profiling of active ingredients from drug tablets presents separation and detection challenges.

Purpose of the Study:

  • To develop a novel, non-manual-operation method for automatic dissolution testing of drug tablets.
  • To combine program-controlled sequential analysis with high-speed capillary electrophoresis for efficient separation and detection.

Main Methods:

  • Implemented a program-controlled sequential analysis system.
  • Integrated high-speed capillary electrophoresis for active ingredient separation.
  • Validated the method using real drug tablets.

Main Results:

  • Demonstrated the feasibility and performance of the automated dissolution testing system.
  • Achieved excellent repeatability and accuracy in drug dissolution testing.
  • Successfully performed simultaneous dissolution testing of multiple ingredients, avoiding matrix interferences.

Conclusions:

  • The proposed automated method offers a valuable tool for pharmaceutical research and drug regulation.
  • The system enhances efficiency and accuracy in dissolution testing.
  • Potential applications include quality control and regulatory evaluation of drug products.