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Related Concept Videos

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

In Vitro Drug Release Testing: Overview, Development and Validation

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...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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

In Vitro Drug Dissolution: Compendial Testing Models II

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

In Vitro Drug Dissolution: Alternative Methods

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...
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

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 adhering...
Modified-Release Drug Delivery Systems: Drug Release Characteristics01:22

Modified-Release Drug Delivery Systems: Drug Release Characteristics

Drug release from modified-release dosage forms is designed to achieve specific therapeutic effects by controlling the rate and extent of drug release. The classification of these drug release systems is based on key pharmacokinetic assumptions: drug disposition follows first-order kinetics, drug release is the rate-limiting step in absorption, and the released drug is rapidly and completely absorbed.There are four major models of drug release patterns. The first model is the slow zero-order...

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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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In vitro release method development for Onivyde® using Agilent NanoDis® system.

Ji Li1, Vivian Juang1, Ziyi Lu1

  • 1Department of Pharmaceutical Sciences and the Biointerfaces Institute, University of Michigan. Ann Arbor, MI 48109, USA.

International Journal of Pharmaceutics
|June 27, 2025
PubMed
Summary

A new in vitro release test (IVRT) for Onivyde® (irinotecan liposomal injection) ensures quality for generic pancreatic cancer treatments. This optimized method supports bioequivalence and regulatory approval.

Keywords:
In vitro releaseIrinotecanLiposomesNanoDis systemOnivyde®

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Oncology Therapeutics

Background:

  • Onivyde® (irinotecan liposomal injection) is a key treatment for metastatic pancreatic cancer, utilizing the enhanced permeability and retention (EPR) effect.
  • Approaching patent expiration necessitates the development of reliable quality control methods for emerging generic formulations.

Purpose of the Study:

  • To develop and optimize an in vitro release test (IVRT) for Onivyde® to ensure product quality and bioequivalence.
  • To establish a method capable of differentiating formulations and assessing batch consistency for generic irinotecan liposomal injections.

Main Methods:

  • Utilized the Agilent NanoDis® system, integrating tangential flow filtration with standard dissolution equipment.
  • Systematically evaluated key parameters: filter material, molecular weight cut-offs (MWCOs), medium composition and pH, and paddle speed.
  • Tested method's ability to detect formulation variations under stress conditions and differentiate drug mixtures.

Main Results:

  • An optimized IVRT method was successfully developed for Onivyde®.
  • The method demonstrated effectiveness in identifying variations in stressed formulations.
  • The IVRT successfully assessed batch consistency and differentiated mixtures of liposomal irinotecan and free drug.

Conclusions:

  • The optimized IVRT is crucial for ensuring the quality and bioequivalence of generic Onivyde® formulations.
  • This method will support regulatory approval processes and guarantee consistent therapeutic performance of generic pancreatic cancer treatments.