CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin
E1 (PGE1) and is designated
chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid.
The molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting
point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms
(mcg) per 100 milliliter double distilled water.
The structural formula of alprostadil is represented below:
CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber
syringe system. The system includes a glass cartridge which contains sterile,
freeze-dried alprostadil in the front chamber and sterile bacteriostatic
water for injection in the rear chamber. The alprostadil is reconstituted
with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE
is available in two strengths for intracavernosal administration:
10 microgram - The reconstituted solution has a volume of 0.64
mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil,
324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium
citrate, and 4.45 mg of benzyl alcohol.
20 microgram - The reconstituted solution has a volume of 0.64
mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil,
649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium
citrate, and 4.45 mg of benzyl alcohol.
When necessary, the pH of the alprostadil for injection was adjusted
with hydrochloric acid and/or sodium hydroxide before lyophilization.