Optison

DRUG DESCRIPTION

OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is a sterile non-pyrogenic suspension of microspheres of human serum albumin with perflutren for contrast enhancement during the indicated ultrasound imaging procedures. The vial contains a clear liquid lower layer and a white upper layer that, after resuspension by gentle mixing, provides a homogeneous, opaque, milky-white suspension for intravenous injection.

Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-perflutren with a molecular weight of 188, an empirical formula of C3F8 and it has the following structural formula:

OPTISON (Perflutren Protein-Type A Microspheres) Structural Formula Illustration

Each mL of OPTISON (perflutren protein-type a microspheres) contains 5.0-8.0x108 protein-type A microspheres, 10 mg Albumin Human, USP, 0.22 ?± 0.11mg/mL N-acetyltryptophan, and 0.12 mg caprylic0.11 acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas. The pH is adjusted to 6.4-7.4. The protein in the microsphere shell makes up approximately 5?­7% (w/w) of the total protein in the liquid. The microsphere particle size parameters are listed in Table 1.

Table 1: Microsphere Particle Size Parameters

Mean diameter (range) 3.0-4.5?µm (max. 32.0?µm)
Percent less than 10?µm 95%


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