Evidence map›Paper›PMID 41791460›Full record

ArticleJournal of controlled release : official journal of the Controlled Release Society2026

A systematic approach to develop and characterize a compositionally equivalent buprenorphine in situ forming implant (Sublocade®).

Surendra Poudel, Rudra Pangeni, Ziyu Huo, Dale Farkas, Semih Gulec, Qiangnan Zhang, Maria Lasaosa, Rong Tong, F Gerard Moeller, Qi Li and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of controlled release : official journal of the Controlled Release Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Surendra PoudelDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.
Rudra PangeniDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.
Ziyu HuoDepartment of Chemical engineering, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.
Dale FarkasDepartment of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA 23220, USA.
Semih GulecMaterials Characterization, Anton Paar Inc., Richmond, VA 23298, USA.
Qiangnan ZhangOffice of Research and Standards, Office of Generic Drugs, CDER, U.S. Food and Drug Administration, Silver Springs, MD 20993, USA.
Maria LasaosaDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.
Rong TongDepartment of Chemical engineering, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.
F Gerard MoellerDepartment of Pharmacology and Toxicology, Virginia Commonwealth University, Richmond, VA 23298, USA.
Qi LiOffice of Research and Standards, Office of Generic Drugs, CDER, U.S. Food and Drug Administration, Silver Springs, MD 20993, USA.
Yan WangOffice of Research and Standards, Office of Generic Drugs, CDER, U.S. Food and Drug Administration, Silver Springs, MD 20993, USA.
Bin QinOffice of Research and Standards, Office of Generic Drugs, CDER, U.S. Food and Drug Administration, Silver Springs, MD 20993, USA.
Matthew S HalquistDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.
Qingguo XuDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA; Department of Ophthalmology, Department of Biomedical Engineering, Department of Pediatrics, Center for Pharmaceutical Engineering, Center for Drug Discovery, and Massey Cancer Center, Virginia Commonwealth University, Richmond, VA 23298, USA. Electronic address: qxu@vcu.edu.

Funding

Local Administration of Particle-Anchored Cytokines as a Safe and Effective Cancer ImmunotherapyR21CA287324 · NCI · VIRGINIA POLYTECHNIC INST AND ST UNIV · PI TONG, RONG · 2024 to 2024
$380k
FDA HHS 75F40123C00196NCI NIH HHS R21 CA287324
6 · The paper itself

Abstract

Sublocade® is a PLGA-based in situ forming implant designed for the sustained delivery of buprenorphine, a partial mu-opioid receptor agonist, with a monthly dosing regimen for the treatment of moderate to severe opioid use disorder (OUD). Unlike other suspension-based in situ forming implants, where the drug crystals are dispersed within the Atrigel® system, Sublocade® is a true solution-based in situ forming implant, as buprenorphine is fully dissolved in the Atrigel® system. The heterogeneous nature of PLGA and the lack of compendial in vitro release testing methods present challenges for the development of generic alternatives, limiting treatment accessibility during the opioid crisis. This study focuses on the comprehensive characterization of Sublocade® and the development of a compositionally equivalent, reverse-engineered buprenorphine in situ forming implant (BUP-ISFI). Advanced analytical methods were employed to establish key PLGA attributes, including molecular weight, lactide/glycolide (L/G) ratio, end group, and blockiness from Sublocade®, which was key in developing reverse-engineered BUP-ISFI. Solid-state characterization techniques revealed a heterogeneous distribution of precipitated drug crystals within the solidified implant. An in-house PVA thin-film-assisted cylindrical adapter in UPS 2 dissolution apparatus achieved a reproducible drug release and was able to discriminate any changes in formulation with different PLGA molecular weight, end group and L/G ratio. Sublocade® and reverse-engineered BUP-ISFI had similar in vitro drug release profiles and demonstrated similar pharmacokinetic profile and drug absorption. This study provides valuable insights into PLGA purification, characterization and in vitro/in vivo evaluation of solution-based in situ forming implants, which is essential for the development of generic products.

Indexed as

Analgesics, OpioidBuprenorphinePolylactic Acid-Polyglycolic Acid CopolymerAnimalsDelayed-Action PreparationsDrug ImplantsDrug LiberationAnalgesics, OpioidBuprenorphineDelayed-Action PreparationsDrug ImplantsPolylactic Acid-Polyglycolic Acid CopolymerGeneric formulation developmentIn vitro release testingLong-acting injectableOpioid use disorderPLGAReverse engineeringSustained release formulation

Identifiers

PMID41791460
PMCPMC13231472

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.