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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 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 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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Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
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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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Related Experiment Video

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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
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Accelerated in vitro release testing method for naltrexone loaded PLGA microspheres.

Janki V Andhariya1, Stephanie Choi2, Yan Wang2

  • 1Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, CT, 06269, USA.

International Journal of Pharmaceutics
|February 4, 2017
PubMed
Summary

A new accelerated release testing method using USP apparatus 4 was developed for naltrexone microspheres. This method is reproducible, discriminatory, and correlates well with real-time data, serving as a fast quality control tool.

Keywords:
Accelerated in vitro release testingCompositionally equivalentNaltrexonePLGA microspheresUSP apparatus 4

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Analytical Chemistry

Background:

  • Naltrexone microspheres are used for long-acting parenteral delivery.
  • Developing a rapid and reliable quality control method for drug release is crucial.
  • Existing methods may not be sufficiently efficient for accelerated testing.

Purpose of the Study:

  • To develop a discriminatory and reproducible accelerated in vitro release testing method for naltrexone loaded polymeric microspheres.
  • To compare the performance of sample-and-separate versus USP apparatus 4 methods.
  • To establish correlation between accelerated and real-time release profiles.

Main Methods:

  • In vitro release testing of naltrexone microspheres (Vivitrol®) using sample-and-separate and USP apparatus 4.
  • Drug stability studies with frequent media replacement and antioxidant addition.
  • Accelerated release testing at 45°C and real-time testing at 37°C.
  • Assessment of method discriminatory ability using microspheres with varied release characteristics.

Main Results:

  • The USP apparatus 4 method demonstrated higher reproducibility compared to the sample-and-separate method.
  • Accelerated release profiles using USP apparatus 4 were obtained within seven days and correlated well with real-time profiles.
  • The developed method successfully distinguished between naltrexone microspheres with different release profiles.
  • A linear correlation was observed between real-time and accelerated release profiles.

Conclusions:

  • The developed accelerated USP apparatus 4 release method is a suitable fast quality control tool for long-acting naltrexone PLGA microspheres.
  • The method is reproducible, discriminatory, and provides reliable accelerated release data.
  • The observed correlation suggests similar release mechanisms under real-time and accelerated conditions.