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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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Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
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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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Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...
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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PLGA Nanoparticles Formed by Single- or Double-emulsion with Vitamin E-TPGS
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Published on: December 27, 2013

An Overview of In Vitro Release Methods for Long-Acting Injectable Products Based on PLGA.

Maja Lusina Kregar1,2, Iva Krtalić3, Ivana Šagud1,4

  • 1HALMED, Agency for Medicinal Products and Medical Devices of Croatia, Ksaverska Cesta 4, 10000 Zagreb, Croatia.

Methods and Protocols
|June 25, 2026
PubMed
Summary
This summary is machine-generated.

Standardized in vitro release testing methods for long-acting injectables (LAIs) are lacking. This review covers current methods for poly(lactide-co-glycolide) (PLGA)-based LAIs to aid future development and standardization.

Keywords:
PLGAbiorelevancedrug delivery systemsin vitro release testlong-acting injectables

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Biomaterials

Background:

  • Long-acting injectables (LAIs) are crucial for managing chronic diseases like schizophrenia, opioid use disorder, and HIV.
  • Poly(lactide-co-glycolide) (PLGA) is a common biodegradable polymer used in LAI formulations for diverse drug types.
  • In vitro release (IVR) testing is essential for assessing drug product performance but lacks standardization for LAIs.

Purpose of the Study:

  • To review existing compendial and non-compendial in vitro release testing methods for PLGA-based LAIs.
  • To highlight the challenges and needs for standardized IVR methodologies in LAI development.
  • To support the advancement and regulatory approval of novel LAI drug products.

Main Methods:

  • Comprehensive literature review of in vitro release testing methodologies for poly(lactide-co-glycolide) (PLGA)-based LAIs.
  • Analysis of both microsphere and in situ forming implant formulations.
  • Evaluation of compendial and non-compendial testing approaches.

Main Results:

  • A significant gap exists in standardized compendial in vitro release testing methods for LAIs.
  • Diverse formulation designs and release mechanisms necessitate tailored IVR approaches.
  • Both simple, robust methods for quality control and complex, biorelevant methods for development are utilized.

Conclusions:

  • Standardization of in vitro release testing for PLGA-based LAIs is critical for product development and regulatory processes.
  • A universal IVR method is not feasible due to formulation complexity; tailored approaches are needed.
  • This review provides a foundation for developing and standardizing future in vitro release testing methodologies for LAIs.