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In-Use Photostability Practice and Regulatory Evaluation for Pharmaceutical Products in an Age of Light-Emitting Diode Light Sources.
- Source :
-
Journal of pharmaceutical sciences [J Pharm Sci] 2019 Mar; Vol. 108 (3), pp. 1172-1176. Date of Electronic Publication: 2018 Oct 10. - Publication Year :
- 2019
-
Abstract
- This article describes how the increased use of energy-efficient solid-state light sources (e.g., light-emitting diode [LED]-based illumination) in hospitals, pharmacies, and at home can help alleviate concerns of photodegradation for pharmaceuticals. LED light sources, unlike fluorescent ones, do not have spurious spectral contributions <400 nm. Because photostability is primarily evaluated in the International Council of Harmonization Q1B tests with older fluorescent bulb standards (International Organization for Standardization 10977), the amount of photodegradation observed can over-predict what happens in reality, as products are increasingly being stored and used in environments fitted with LED bulbs. Because photodegradation is premised on light absorption by a compound of interest (or a photosensitizer), one can use the overlap between the spectral distribution of a light source and the absorption spectra of a given compound to estimate if photodegradation is a possibility. Based on the absorption spectra of a sample of 150 pharmaceutical compounds in development, only 15% would meet the required overlap to be a candidate to undergo direct photodegradation in the presence of LED lights, against a baseline of 55% of compounds that would, when considering regular fluorescent lights. Biological drug products such as peptides and monoclonal antibodies are also expected to benefit from the use of more efficient solid-state lighting.<br /> (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Antibodies, Monoclonal chemistry
Antibodies, Monoclonal radiation effects
Biological Products chemistry
Biological Products radiation effects
Facility Design and Construction instrumentation
Facility Design and Construction legislation & jurisprudence
Facility Design and Construction standards
Lighting legislation & jurisprudence
Lighting standards
Pharmaceutical Preparations radiation effects
Ultraviolet Rays adverse effects
Drug Stability
Lighting instrumentation
Pharmaceutical Preparations chemistry
Photolysis radiation effects
Semiconductors
Subjects
Details
- Language :
- English
- ISSN :
- 1520-6017
- Volume :
- 108
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of pharmaceutical sciences
- Publication Type :
- Academic Journal
- Accession number :
- 30315811
- Full Text :
- https://doi.org/10.1016/j.xphs.2018.10.003