LEVULAN ® KERASTICK TM
(aminolevulinic acid HCl) for Topical Solution, 20%, contains the hydrochloride
salt of 5-aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone.
Aminolevulinic acid HCl (ALA HCl) is a white to off-white, odorless crystalline
solid that is very soluble in water, slightly soluble in methanol and
ethanol, and practically insoluble in chloroform, hexane and mineral oil.
The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride
(MW = 167.59).
The LEVULAN ® KERASTICK TM
for Topical Solution applicator is a two component system consisting of
a plastic tube containing two sealed glass ampules and an applicator tip.
One ampule contains 1.5 mL of solution vehicle comprising alcohol USP
(ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and
polyethylene glycol. The other ampule contains 354 mg of ALA HCl as a
dry solid. The applicator tube is enclosed in a protective cardboard sleeve
and cap. The 20% topical solution is prepared just prior to the time of
use by breaking the ampules and mixing the contents by shaking the LEVULAN
KERASTICK applicator. The term "ALA HCl" refers to unformulated active
ingredient, "LEVULAN KERASTICK for Topical Solution" refers to the drug
product in its unmixed state, "LEVULAN KERASTICK Topical Solution" refers
to the mixed drug product (in the applicator tube or after application),
and "LEVULAN KERASTICK" refers to the applicator only.