Abstract:
:Pharmaceutical scientists are often asked to assess the impact of modifications to the illumination in the manufacturing and product packaging environment on product quality. To assess the impact of switching light sources, four model compounds were exposed to standard fluorescent light, LED, and "yellow light" and the extent of drug photodegradation was determined. Photodegradation under LED light is generally reduced compared to fluorescent light and is often predictable if the UV-Vis absorption spectrum of the active pharmaceutical ingredient (API) and the spectral power distribution emitted by the various light sources overlap. However, lack of noticeable spectral overlap does not ensure absence of API photodegradation and may require additional assessment for selection of appropriate lighting conditions. A detailed evaluation of the API and solid formulation absorbance was performed to assess degradation risk for Compound A and Vitamin D3 when exposed to LED light. The light budget was established for Compound A, spanning all stages of the manufacturing process, under different illumination conditions to enable a complex supply chain. The results also demonstrate that while LEDs used in manufacturing areas are generally "better" compared to fluorescent lights, they are not replacing yellow lights for compounds sensitive to visible light.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Wasylaschuk W,Pierce B,Geng X,Socia A,Kim D,Wuelfing WP,Abend Adoi
10.1016/j.xphs.2020.07.020subject
Has Abstractpub_date
2020-11-01 00:00:00pages
3360-3369issue
11eissn
0022-3549issn
1520-6017pii
S0022-3549(20)30386-5journal_volume
109pub_type
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