Application of miniaturized near-infrared spectroscopy for quality control of extemporaneous orodispersible films.

Autor: Foo WC; Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore 117543. Electronic address: wenchin.foo@u.nus.edu., Widjaja E; AbbVie Singapore Pte. Ltd., Singapore 138588., Khong YM; AbbVie Singapore Pte. Ltd., Singapore 138588., Gokhale R; AbbVie Singapore Pte. Ltd., Singapore 138588. Electronic address: rajeev.gokhale@roquette.com., Chan SY; Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore 117543. Electronic address: phacsy@nus.edu.sg.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2018 Feb 20; Vol. 150, pp. 191-198. Date of Electronic Publication: 2017 Dec 22.
DOI: 10.1016/j.jpba.2017.11.068
Abstrakt: Extemporaneous oral preparations are routinely compounded in the pharmacy due to a lack of suitable formulations for special populations. Such small-scale pharmacy preparations also present an avenue for individualized pharmacotherapy. Orodispersible films (ODF) have increasingly been evaluated as a suitable dosage form for extemporaneous oral preparations. Nevertheless, as with all other extemporaneous preparations, safety and quality remain a concern. Although the United States Pharmacopeia (USP) recommends analytical testing of compounded preparations for quality assurance, pharmaceutical assays are typically not routinely performed for such non-sterile pharmacy preparations, due to the complexity and high cost of conventional assay methods such as high performance liquid chromatography (HPLC). Spectroscopic methods including Raman, infrared and near-infrared spectroscopy have been successfully applied as quality control tools in the industry. The state-of-art benchtop spectrometers used in those studies have the advantage of superior resolution and performance, but are not suitable for use in a small-scale pharmacy setting. In this study, we investigated the application of a miniaturized near infrared (NIR) spectrometer as a quality control tool for identification and quantification of drug content in extemporaneous ODFs. Miniaturized near infrared (NIR) spectroscopy is suitable for small-scale pharmacy applications in view of its small size, portability, simple user interface, rapid measurement and real-time prediction results. Nevertheless, the challenge with miniaturized NIR spectroscopy is its lower resolution compared to state-of-art benchtop equipment. We have successfully developed NIR spectroscopy calibration models for identification of ODFs containing five different drugs, and quantification of drug content in ODFs containing 2-10mg ondansetron (OND). The qualitative model for drug identification produced 100% prediction accuracy. The quantitative model to predict OND drug content in ODFs was divided into two calibrations for improved accuracy: Calibration I and II covered the 2-4mg and 4-10mg ranges respectively. Validation was performed for method accuracy, linearity and precision. In conclusion, this study demonstrates the feasibility of miniaturized NIR spectroscopy as a quality control tool for small-scale, pharmacy preparations. Due to its non-destructive nature, every dosage unit can be tested thus affording positive impact on patient safety.
(Copyright © 2017 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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