Jump to main content
US EPA
United States Environmental Protection Agency
Search
Search
Main menu
Environmental Topics
Laws & Regulations
About EPA
Health & Environmental Research Online (HERO)
Contact Us
Print
Feedback
Export to File
Search:
This record has one attached file:
Add More Files
Attach File(s):
Display Name for File*:
Save
Citation
Tags
HERO ID
7906916
Reference Type
Journal Article
Title
IN-VIVO SCREENING MODEL FOR EXCIPIENTS AND VEHICLES USED IN SUBCUTANEOUS INJECTIONS
Author(s)
Radwan, M
Year
1994
Is Peer Reviewed?
Yes
Journal
Drug Development and Industrial Pharmacy
ISSN:
0363-9045
EISSN:
1520-5762
Publisher
Informa Healthcare
Volume
20
Issue
17
Page Numbers
2753-2762
Language
English
DOI
10.3109/03639049409042678
Web of Science Id
WOS:A1994PE76100013
Abstract
Incorporation of an insoluble drug in Subcutaneous (SC) dosage form requires addition of a cosolvent. The use of a cosolvent may result in burning sensation and/or severe skin inflammation response after the injection. In this investigation the inflammation response of rat skin after SC administration of excipients and vehicles was demonstrated by a simple and effective in vivo technique. Four hours after SC injection, of each vehicle with or without excipients, the skin fold thickness of rat skin was measured. Among the oils tested, Planters" peanut oil showed a higher increase in skin fold thickness (25% In the mean time, the SC injection of MCT Estasan GT 80 oil resulted in an insignificant increase (< 15% A group of cosolvents prepared in sesame oil was tested in rats after SC injections. The magnitudes of the percentage increase in skin fold thickness of 10% benzyl alcohol, 10% ethyl oleate, 15% phospholipon 100, 4% ethyl alcohol, and 0.2% triethanolamine were 172, 45, 38, 31, and 31, respectively. The rest of excipients evaluated showed minor inflammation responses. Different concentrations of benzyl alcohol (1, 2, 5 and 10% v/v) in sesame oil were injected. Only the 1% benzyl alcohol produced an insignificant increase in skin fold thickness. © 1994 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
Home
Learn about HERO
Using HERO
Search HERO
Projects in HERO
Risk Assessment
Transparency & Integrity