Quality control measurement science: Point-of-care opioid compounding and personalized pain management
Year: 2026
Type: preprint
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.
Source: ChemRxiv
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7213931627