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Related Concept Videos

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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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

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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 Product Performance: In Vitro–In Vivo Correlation01:20

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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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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 experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
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Comparison of In-Vitro and In-Vivo Drug Release of Dexamethasone/PLGA Intravitreal Implants Using Two In-Vitro

Coleman Johnson1, Esther Maier1, Aanya Bhalla1

  • 1Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, Austin, Texas 78712, United States.

Molecular Pharmaceutics
|October 29, 2025
PubMed
Summary

Two in vitro release tests (IVRTs) for poly(lactic-co-glycolic acid) (PLGA) implants were compared. A saline-based IVRT better predicted in vivo drug release in rabbits, while a phosphate-buffered saline (PBS) IVRT better simulated implant degradation.

Keywords:
OZURDEXdexamethasonein vivo releaseintravitreal implantpoly(lactic-co-glycolic acid) (PLGA)

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Area of Science:

  • Biomaterials Science
  • Drug Delivery
  • Pharmacokinetics

Background:

  • Poly(lactic-co-glycolic acid) (PLGA) implants are complex drug delivery systems.
  • In vitro release tests (IVRTs) aim to predict in vivo drug release but can yield different results based on medium composition.
  • Biorelevance and biopredictiveness are key considerations when designing IVRTs for formulation development and bioequivalence testing.

Purpose of the Study:

  • To assess the biorelevance and biopredictiveness of two IVRTs for dexamethasone/PLGA intravitreal implants.
  • The IVRTs differed only in release medium: unbuffered saline versus phosphate-buffered saline (PBS) at pH 7.4.
  • To investigate the mechanistic differences in implant degradation between IVRTs and in vivo.

Main Methods:

  • Two PLGA implant formulations were tested in saline and PBS IVRTs.
  • In vivo drug release and ocular pharmacokinetics were evaluated in New Zealand White rabbits.
  • Implant degradation (PLGA molecular weight) was measured in vitro and in vivo using gel permeation chromatography.

Main Results:

  • Saline IVRT showed similar release profiles for both formulations (~28 days); PBS IVRT showed different profiles (~4 months).
  • In vivo release in rabbits lasted 21-28 days, closely matching the saline IVRT.
  • PBS IVRT better simulated in vivo surface erosion; saline IVRT better simulated in vivo bulk erosion.

Conclusions:

  • The saline-based IVRT is suitable for predicting rabbit in vivo release of these PLGA implants.
  • The PBS-based IVRT may be preferred for highly sensitive discriminatory testing due to better simulation of degradation.
  • IVRT design must consider the specific application and desired predictive outcome for PLGA drug delivery systems.