Aquasol A (Vitamin A Palmitate) - Description and Clinical Pharmacology

water-miscible vitamin A Palmitate

50,000 USP Units

(15 mg retinol/mL)

R_x only

with 0.5% chlorobutanol as preservative; 12% polysorbate 80, 0.1% citric acid, and sodium hydroxide to adjust pH.

THIS IS A STERILE PRODUCT FOR INTRAMUSCULAR INJECTION

DESCRIPTION

AQUASOL A ^® Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C₂₀H₃₀O) in the form of vitamin A palmitate, a light yellow to amber oil. The structural formula of retinol is:

Ordinarily oil-soluble, the vitamin A in this product has been water solubilized by special processingOil-soluble vitamin A water solubilized with polysorbate 80 and is available in a water solution for intramuscular injection.

One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of beta-carotene.

CLINICAL PHARMACOLOGY

Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation. Vitamin A prevents retardation of growth and preserves the epithelial cells’ integrity. Normal adult liver storage is sufficient to satisfy two years’ requirements of vitamin A.

Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chylomicron fraction of the lymph. Vitamin A is stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80–300 Units per 100 mL (plasma range is 30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL.The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.