Quality control measurement science: Point-of-care opioid compounding and personalized pain management
- 1National Institute of Standards and Technology, Materials Measurement Science Division
- 2College of Osteopathic Medicine
- 3Lake Erie College of Osteopathic Medicine
Abstract
Traditional "one-size-fits-all" pharmacotherapy often fails to address the complex, highly individualized needs of patients undergoing opioid tapering, pain management, and withdrawal. While distributed and point-of-care (POC) additive manufacturing—such as 3D printing, semisolid extrusion, and drop-on-demand (DoD) deposition—enable agile, patient-specific dosing and multi-drug formulations, they introduce critical quality control (QC) challenges in facilities that often lack extensive laboratory infrastructure. We employed a quality by design (QbD) approach to identify the critical relationships between input materials, process parameters, and critical quality attributes (CQAs) and investigated a tiered series of atline, inline, and final-product QC measurement technologies for personalized pain management and opioid-tapering therapies. Using precision DoD liquid dispensers, various tunable dosage forms were produced, including injectable saline solutions, semi-solid extruded tablets, and oral films. These vehicles carried full and partial opioid agonists, opioid antagonists, and adjuvant withdrawal medications (fentanyl, buprenorphine, methadone, oxycodone, naloxone, diphenhydramine, promethazine, and 2 bupivacaine). The performance, speed, and selectivity of four analytical techniques were explored: microdrop UV-Vis spectroscopy, liquid chromatography-UV (LC-UV), handheld Raman spectroscopy, and chromatography-free direct analysis in real time triple quadrupole mass spectrometry (DART-TQ-MS). We characterized and quantified each manufactured dosage form by either single-point calibration (i.e., against a reference standard [RS] or quality control standard) or linear least squares regression. Analytical control strategies for quality control require balancing throughput, analytical capabilities and limitations, and specific medicine considerations. This work defined robust metrological pathways for safe, compliant, and personalized point-ofcare pharmaceutical production, bridging clinical pain management and opioid tapering guidelines with manufacturing quality assurance.
Related
- Dataset-level reliability and quality control for metallurgical data structured with large language models
- Machine Learning and Corona Effect Coupling, a New Tool for Water Quality Control: Highlighting the Impact of Microwaves on Water Samples
- Influence of pH, Alcohol Structure, and Temperature on Lenalidomide Alcoholysis with Implications for Pharmaceutical Quality Control
- Generative and Foundation-Model Artificial Intelligence in Food Safety Analysis, Authenticity Identification, and Quality Control: A Systematic Review of Validation and Decision Readiness.
- Platelet membrane-coated nanoparticles: Bioengineering principles, quality control, and translational opportunities
BibTeX
@misc{forbes2026quality,
title = {{Quality control measurement science: Point-of-care opioid compounding and personalized pain management}},
author = {Thomas P. Forbes and Zainab Altamimi and Jeffrey Lawrence and Elizabeth L. Robinson},
howpublished = {ChemRxiv},
year = {2026},
month = sep,
doi = {10.26434/chemrxiv.15009149/v1},
url = {https://chemrxiv.org/doi/full/10.26434/chemrxiv.15009149/v1},
note = {CC BY-NC},
}
RIS
TY - UNPB
TI - Quality control measurement science: Point-of-care opioid compounding and personalized pain management
AU - Thomas P. Forbes
AU - Zainab Altamimi
AU - Jeffrey Lawrence
AU - Elizabeth L. Robinson
PY - 2026
DA - 2026/09/21
PB - ChemRxiv
DO - 10.26434/chemrxiv.15009149/v1
UR - https://chemrxiv.org/doi/full/10.26434/chemrxiv.15009149/v1
AB - Traditional "one-size-fits-all" pharmacotherapy often fails to address the complex, highly individualized needs of patients undergoing opioid tapering, pain management, and withdrawal. While distributed and point-of-care (POC) additive manufacturing—such as 3D printing, semisolid extrusion, and drop-on-demand (DoD) deposition—enable agile, patient-specific dosing and multi-drug formulations, they introduce critical quality control (QC) challenges in facilities that often lack extensive laboratory infrastructure. We employed a quality by design (QbD) approach to identify the critical relationships between input materials, process parameters, and critical quality attributes (CQAs) and investigated a tiered series of atline, inline, and final-product QC measurement technologies for personalized pain management and opioid-tapering therapies. Using precision DoD liquid dispensers, various tunable dosage forms were produced, including injectable saline solutions, semi-solid extruded tablets, and oral films. These vehicles carried full and partial opioid agonists, opioid antagonists, and adjuvant withdrawal medications (fentanyl, buprenorphine, methadone, oxycodone, naloxone, diphenhydramine, promethazine, and 2 bupivacaine). The performance, speed, and selectivity of four analytical techniques were explored: microdrop UV-Vis spectroscopy, liquid chromatography-UV (LC-UV), handheld Raman spectroscopy, and chromatography-free direct analysis in real time triple quadrupole mass spectrometry (DART-TQ-MS). We characterized and quantified each manufactured dosage form by either single-point calibration (i.e., against a reference standard [RS] or quality control standard) or linear least squares regression. Analytical control strategies for quality control require balancing throughput, analytical capabilities and limitations, and specific medicine considerations. This work defined robust metrological pathways for safe, compliant, and personalized point-ofcare pharmaceutical production, bridging clinical pain management and opioid tapering guidelines with manufacturing quality assurance.
ER -