Abstract
The purpose of this study was to evaluate through animal experiments the safety of novel, stearylamine-based cationic emulsion as ocular drug vehicle. A sub-chronic toxicity in rabbit eye was conducted following one single drop (50mcL) thrice-daily topical instillations of the cationic emulsion and normal saline solution for 21 days. A sub-acute systemic toxicity examination in rats was followed with 0.2 mL daily intravenous infusion of the emulsion and marketed control Intralipid 10% for 28 days. Regardless of the formulations instilled, rabbit eye did not show any inflammatory response except a slight conjunctival redness according to Baldwin's scale. Abnormal high values in some of the blood biochemical parameters were noticed in parts of female and male rats of control Intralipid 10% and test stearylamine-based cationic emulsion, respectively. However, opposite sex of the rats treated with control and test formulations elicited an almost normal range in the studied blood biochemical parameters. It suggests the use of stearylamine-based cationic emulsion for ocular topical delivery of lipophilic drugs.
Original language | English |
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Pages (from-to) | 635-642 |
Number of pages | 8 |
Journal | Indian Drugs |
Volume | 45 |
Issue number | 8 |
State | Published - Aug 2008 |
Keywords
- Emulsion
- Hematology
- Ocular tolerance
- Stearylamine