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Related Concept Videos

Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

126
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
126
In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

124
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...
124
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

132
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
132
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

140
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...
140
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

145
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...
145
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

174
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...
174

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In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets.

Ziye Zhou1, Chenxiang Wang1, Min Li2

  • 1Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.

Clinical Pharmacology in Drug Development
|July 25, 2020
PubMed
Summary

Generic and branded metformin extended-release (ER) tablets are bioequivalent in Chinese subjects. Both formulations demonstrated similar extended-release properties and pharmacokinetic profiles, indicating therapeutic equivalence.

Keywords:
Chinese subjectsbioequivalencedissolutionmetforminsafety

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Area of Science:

  • Pharmacology
  • Pharmaceutical Sciences

Background:

  • Metformin extended-release (ER) is a widely prescribed medication for type 2 diabetes.
  • Evaluating bioequivalence of generic formulations ensures therapeutic interchangeability with the reference branded product.

Purpose of the Study:

  • To assess the bioequivalence of a generic metformin ER tablet compared to a branded formulation in Chinese subjects.
  • To confirm comparable in vitro dissolution and in vivo pharmacokinetic profiles.

Main Methods:

  • Comparative in vitro dissolution testing of generic and branded metformin ER tablets.
  • In vivo pharmacokinetic study in Chinese subjects to determine key parameters (AUC, Cmax).
  • Safety monitoring throughout the clinical trial.

Main Results:

  • Dissolution profiles showed similar extended-release characteristics (f2 > 60.0%) for both formulations.
  • Pharmacokinetic analysis revealed no significant differences between generic and branded metformin ER.
  • 90% confidence intervals for Ln AUC and Ln Cmax fell within the bioequivalence range (80-125%).

Conclusions:

  • The generic metformin ER tablet is bioequivalent to the branded formulation in Chinese subjects.
  • The study supports the interchangeability of the generic and branded metformin ER tablets.
  • No significant safety concerns were identified during the trial.