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Long-Acting injectable buprenorphine PLGA microparticle formulation.

Andrew Otte¹, Chad Johnson², John Garner²

¹Purdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA.

International Journal of Pharmaceutics

|July 29, 2025

Summary

This summary is machine-generated.

Researchers developed a long-acting injectable buprenorphine microparticle formulation for opioid use disorder (OUD). This new formulation provides sustained release for over three months, offering a promising treatment option for OUD management.

Keywords:

Buprenorphine Long-acting injectable Opioid use disorder PLGA microparticles S/O/W emulsion

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Area of Science:

Pharmacology
Materials Science
Drug Delivery Systems

Background:

Opioid use disorder (OUD) presents a significant global health challenge, contributing to high rates of morbidity and mortality.
Medications for OUD, such as buprenorphine, are effective in reducing illicit opioid use, overdose deaths, and healthcare expenses.
Buprenorphine's properties make it suitable for developing long-acting formulations to improve treatment adherence and outcomes.

Purpose of the Study:

To develop a novel 3-month long-acting injectable buprenorphine microparticle formulation for the treatment of OUD.
To achieve a target drug loading of 35-40% and in vivo drug release for a duration of at least 3 months.

Main Methods:

Utilized a solid-in-oil-in-water (S/O/W) emulsion technique for microparticle fabrication.
Employed poly(lactic-co-glycolic acid) (PLGA) with specific material attributes (85:15, MW = 108 kDa) at 15.2% w/v in the oil phase.
Optimized critical processing parameters, including ethyl acetate as the solvent and post-treatment with a 25% ethanolic solution for 8 hours.

Main Results:

A pharmacokinetic study in a rat model demonstrated sustained buprenorphine release.
Drug concentrations remained above 2 ng/mL for over 60 days and above 1 ng/mL for an additional 40 days.
The formulation maintained therapeutic buprenorphine levels (≥1 ng/mL) for an extended period, comparable to existing commercial options.

Conclusions:

Successfully developed a feasible long-acting injectable buprenorphine microparticle formulation using the S/O/W emulsion method.
The formulation demonstrated sustained drug release for ≥3 months, meeting the target product profile.
This long-acting formulation holds potential for improved OUD treatment management and patient adherence.