---
title: "Physicochemical drivers of intramuscular depot formation for long-acting injectable suspensions"
id: "pubmed-42442543"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42442543"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42442543/"
doi: "10.1016/j.jconrel.2026.115177"
published_at: "2026-09-10T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Physicochemical drivers of intramuscular depot formation for long-acting injectable suspensions
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42442543
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42442543/)
- **DOI:** [10.1016/j.jconrel.2026.115177](https://doi.org/10.1016%2Fj.jconrel.2026.115177)
- **Published At:** 2026-09-10T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The study examines mechanistic factors that govern intramuscular depot formation and drug release for **long-acting injectable (LAI)** suspensions, using Depo‑Provera® (medroxyprogesterone acetate) and Q1/Q2 equivalent formulations as models. - Polymer excipient differences were identified: polyethylene glycol (**PEG3350**) from two suppliers showed distinct molecular weight and polydispersity that influenced particle–polymer agglomeration strength. - Molecular-scale excipient variation and drug surface chemistry combined to alter agglomerate strength, which in turn affected both in vitro and in vivo release behavior. - In vivo experiments in female New Zealand White rabbits demonstrated formulation-dependent depot morphology and excipient retention; some depots retained >60% PEG3350 after 14 days and appeared gel-like, while others were granular with reduced PEG retention. - Scanning electron microscopy (SEM) showed two dominant depot evolution patterns: compact depots with primarily surface dissolution that preserved particle morphology, and loosely packed granular depots that dissolved both at the surface and core, reducing particle size and changing morphology. - Differential scanning calorimetry (DSC) indicated that formulations with manufacturing differences retained medroxyprogesterone acetate crystallinity; formulations with formulation differences showed reduced melting points consistent with plasticization and hydration. - Depot morphology affected local tissue response: compact depots induced macrophage accumulation at the periphery, whereas granular depots permitted deeper macrophage infiltration and elicited a stronger inflammatory response. - Co-administration of dexamethasone microspheres attenuated inflammation and lowered CD68-positive cell density across formulations. - No clear correlation between particle size and in vivo drug release was observed under the study conditions; instead, a potential association emerged between **depot structure**, local immune response, and drug release kinetics. - The authors highlight depot microstructure and tissue interactions as key determinants of LAI in vivo performance, emphasizing the interplay of physicochemical and physiological factors in sustained-release suspensions.
## Clinical Analysis & Structured Key Points
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Epub 2026 Jul 13. # Mechanistic understanding of LAI suspension intramuscular depot formation: A physicochemical perspective [Nilesh Malavia](https://pubmed.ncbi.nlm.nih.gov/?term=Malavia+N&cauthor_id=42442543)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-1 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA."), [Quanying Bao](https://pubmed.ncbi.nlm.nih.gov/?term=Bao+Q&cauthor_id=42442543)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-1 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA."), [Daniela Amaral Silva](https://pubmed.ncbi.nlm.nih.gov/?term=Silva+DA&cauthor_id=42442543)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-2 "Simulations Plus, Lancaster, CA, USA."), [Khondoker Alam](https://pubmed.ncbi.nlm.nih.gov/?term=Alam+K&cauthor_id=42442543)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-3 "Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA."), [Yan Wang](https://pubmed.ncbi.nlm.nih.gov/?term=Wang+Y&cauthor_id=42442543)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-3 "Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA."), [Viera Lukacova](https://pubmed.ncbi.nlm.nih.gov/?term=Lukacova+V&cauthor_id=42442543)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-2 "Simulations Plus, Lancaster, CA, USA."), [Diane J Burgess](https://pubmed.ncbi.nlm.nih.gov/?term=Burgess+DJ&cauthor_id=42442543)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#full-view-affiliation-4 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu.") Affiliations Expand ### Affiliations * 1 University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. * 2 Simulations Plus, Lancaster, CA, USA. * 3 Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. * 4 University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu. * PMID: **42442543** * DOI: [ 10.1016/j.jconrel.2026.115177 ](https://doi.org/10.1016/j.jconrel.2026.115177) Item in Clipboard # Mechanistic understanding of LAI suspension intramuscular depot formation: A physicochemical perspective Nilesh Malavia et al. J Control Release. 2026. Show details Display options Display options Format Abstract PubMed PMID J Control Release Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22J+Control+Release%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22J+Control+Release%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) . 2026 Sep 10:397:115177. doi: 10.1016/j.jconrel.2026.115177. Epub 2026 Jul 13. ### Authors [Nilesh Malavia](https://pubmed.ncbi.nlm.nih.gov/?term=Malavia+N&cauthor_id=42442543)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-1 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA."), [Quanying Bao](https://pubmed.ncbi.nlm.nih.gov/?term=Bao+Q&cauthor_id=42442543)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-1 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA."), [Daniela Amaral Silva](https://pubmed.ncbi.nlm.nih.gov/?term=Silva+DA&cauthor_id=42442543)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-2 "Simulations Plus, Lancaster, CA, USA."), [Khondoker Alam](https://pubmed.ncbi.nlm.nih.gov/?term=Alam+K&cauthor_id=42442543)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-3 "Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA."), [Yan Wang](https://pubmed.ncbi.nlm.nih.gov/?term=Wang+Y&cauthor_id=42442543)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-3 "Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA."), [Viera Lukacova](https://pubmed.ncbi.nlm.nih.gov/?term=Lukacova+V&cauthor_id=42442543)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-2 "Simulations Plus, Lancaster, CA, USA."), [Diane J Burgess](https://pubmed.ncbi.nlm.nih.gov/?term=Burgess+DJ&cauthor_id=42442543)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42442543/#short-view-affiliation-4 "University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu.") ### Affiliations * 1 University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. * 2 Simulations Plus, Lancaster, CA, USA. * 3 Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. * 4 University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu. * PMID: **42442543** * DOI: [ 10.1016/j.jconrel.2026.115177 ](https://doi.org/10.1016/j.jconrel.2026.115177) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract Long-acting injectable (LAI) suspensions have emerged as a promising class of drug delivery systems offering sustained drug release, improved patient adherence, and reduced dosing frequency. However, their in vivo performance remains poorly understood due to the complex interplay of physicochemical and physiological factors governing depot formation at the intramuscular (IM) injection site. The present study provides a mechanistic understanding of intramuscular depot formation and drug release of Depo-Provera® (medroxyprogesterone acetate) injectable suspension and its qualitatively and quantitatively (Q1/Q2) equivalent formulations from a physicochemical perspective. Characterization of polyethylene glycol (PEG3350) polymers from two different suppliers revealed notable differences in molecular weight and polydispersity. These molecular-scale variations appeared to influence the strength of particle-polymer agglomerates, with the extent of this effect likely depending on both the polymer characteristics and the surface chemistry of the drug substance. These differing interactions subsequently contribute to variations in both in vitro and in vivo drug release behavior. In vivo studies in female New Zealand White rabbits demonstrated formulation-dependent differences in depot morphology and excipient retention. Depots formed by Depo Provera® and its Q1/Q2 equivalents with formulation differences retained more than 60% of PEG3350 after 14 days and were gel-like in appearance. Whereas, Depo Provera® Q1/Q2 equivalents with manufacturing differences showed reduced PEG retention and formed granular depots. Scanning electron microscopy (SEM) analyses further revealed distinct patterns of particle evolution: compact depots primarily underwent surface dissolution and largely preserved the particle morphology, while loosely packed granular depots dissolved from both the surface and the core, resulting in reduced particle size and altered morphology. Differential scanning calorimetry showed that medroxyprogesterone acetate in the formulations with manufacturing differences maintained crystallinity, whereas those with formulation differences demonstrated reduced melting points consistent with plasticization and hydration effects. Histopathological and immunohistochemical analyses showed that depot morphology directly influenced the local tissue response. Compact depots primarily induced macrophage accumulation at the periphery. In contrast, sparse, loosely structured, granular depots allowed deeper macrophage infiltration and elicited a more pronounced inflammatory response. Co-administration of dexamethasone microspheres markedly attenuated inflammation and reduced CD68-positive cell density across the formulations. However, no clear correlation was observed between particle size and in vivo drug release under the study conditions, potentially due to confounding factors affecting systemic clearance. Instead, a potential association was identified between depot structure, local immune response, and drug release kinetics, highlighting depot morphology and tissue interactions as key determinants of the in vivo performance. **Keywords:** Biorelevant drug release testing; Correlation between physicochemical and physiological changes; Depot formation microstructure; In vivo physicochemical changes in depot; Long acting suspensions. Copyright © 2026 Elsevier B.V. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Similar articles * [ Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions. ](https://pubmed.ncbi.nlm.nih.gov/33709196/) Bao Q, Zou Y, Wang Y, Choi S, Burgess DJ.Bao Q, et al.AAPS J. 2021 Mar 11;23(2):42. doi: 10.1208/s12248-021-00566-0.AAPS J. 2021.PMID: 33709196Free PMC article. * [ The effect of macrophage and angiogenesis inhibition on the drug release and absorption from an intramuscular sustained-release paliperidone palmitate suspension. ](https://pubmed.ncbi.nlm.nih.gov/27067365/) Darville N, van Heerden M, Mariën D, De Meulder M, Rossenu S, Vermeulen A, Vynckier A, De Jonghe S, Sterkens P, Annaert P, Van den Mooter G.Darville N, et al.J Control Release. 2016 May 28;230:95-108. doi: 10.1016/j.jconrel.2016.03.041. Epub 2016 Apr 9.J Control Release. 2016.PMID: 27067365 * [ Personality Theories. ](https://pubmed.ncbi.nlm.nih.gov/42475469/) Gallios JM, Iyer V, Kaylor LE.Gallios JM, et al.2026 Jun 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan–.2026 Jun 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan–.PMID: 42475469Free Books & Documents. * [ Insights into development of long-acting injectable suspensions. ](https://pubmed.ncbi.nlm.nih.gov/41690479/) Malavia N, Burgess DJ.Malavia N, et al.J Control Release. 2026 Apr 10;392:114721. doi: 10.1016/j.jconrel.2026.114721. Epub 2026 Feb 12.J Control Release. 2026.PMID: 41690479Review. * [ Toxicology of depot medroxyprogesterone acetate. ](https://pubmed.ncbi.nlm.nih.gov/8200213/) Jordan A.Jordan A.Contraception. 1994 Mar;49(3):189-201. doi: 10.1016/0010-7824(94)90037-x.Contraception. 1994.PMID: 8200213Review. 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Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Research+Support%2C+U.S.+Gov%27t%2C+Non-P.H.S.%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Research+Support%2C+U.S.+Gov%27t%2C+Non-P.H.S.) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) ## MeSH terms * Animals Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Animals%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Animals) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) * Contraceptive Agents, Hormonal* / administration & dosage Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Contraceptive+Agents%2C+Hormonal%2Fadministration+and+dosage%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Contraceptive+Agents%2C+Hormonal) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) * Contraceptive Agents, Hormonal* / chemistry Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Contraceptive+Agents%2C+Hormonal%2Fchemistry%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Contraceptive+Agents%2C+Hormonal) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) * Delayed-Action Preparations / administration & dosage Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Delayed-Action+Preparations%2Fadministration+and+dosage%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Delayed-Action+Preparations) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543/) * Delayed-Action Preparations / chemistry Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Delayed-Action+Preparations%2Fchemistry%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Delayed-Action+Preparations) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42442543
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