HICON Oral solution Ref.[10419] Active ingredients: Sodium iodide ¹³¹I

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

HICON, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq of no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10.

The concentrated solution provided with HICON is used for the preparation of sodium iodide I 131 capsules or sodium iodide I 131 solution of varying strengths for oral administration for therapy.

Sodium iodide I 131 solution is designated chemically as Na 131I and has a molecular weight of 153.99. Hard gelatin capsules, provided for the preparation of the sodium iodide I 131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.

11.1 Physical Characteristics

Iodine I-131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days. The principal radiation emissions are listed in Table 4.

Table 4. Principal Radiation Emission Data from Decay of Sodium Iodide I 131:

Radiation Mean % per
Disintegration 		Mean Energy
(keV)
Beta-1 2.1% 69.4
Beta-3 7.2% 96.6
Beta-4 89.4% 191.6
Gamma-7 6.1% 284.3
Gamma-14 81.2% 364.5
Gamma-18 7.1% 637.0

11.2 External Radiation

The specific gamma-ray constant for iodide I 131 is 4.26 × 10-13 C·m2·kg-1·MBq-1·s-1 (2.2 R·cm2/mCi·hr). The first half-value thickness of lead (Pb) for iodide I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodide I 131 that results from interposition of various thicknesses of Pb is shown in Table 5. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.

Table 5. Radiation Attenuation of Iodine I 131 by Lead Shielding:

Shield Thickness
(Pb) cm 		Coefficient of Attenuation
0.27 0.5
0.56 0.25
0.99 10 -1
2.59 10 -2
4.53 10 -3

To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 6.

Table 6. Physical Decay Chart: Iodine I-131 Half-Life 8.04 days:

Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining
0* 1.000 11 .388 22 .151
1 .918 12 .356 23 .138
2 .842 13 .327 24 .127
3 .773 14 .300 25 .116
4 .709 15 .275 26 .107
5 .651 16 .253 27 .098
6 .597 17 .232 28 .090
7 .548 18 .213 29 .083
8 .503 19 .195 30 .076
9 .461 20 .179   
10 .423 21 .164   

* Calibration time

Dosage Forms and Strengths

HICON is available in 1 mL size, clear vials containing a colorless, aqueous, concentrated Sodium Iodide I 131 Solution [9,250 MBq, 18,500 MBq, and 37,000 MBq at time of calibration] for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic. Refer to Table 2 for the radioactivity and volume in each vial. Large gelatin capsules (empty) and small gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON for the preparation of sodium iodide I 131 capsules, therapeutic.

Table 2. HICON Concentrated Sodium Iodide I 131 Solution:

Total Radioactivity/Vial
MBq 		Solution Volume
(mL)/Vial
9,250 (250 mCi) 0.25
18,500 (500 mCi) 0.5
37,000 (1000 mCi) 1

* At time of calibration.
How Supplied

HICON is supplied in 1 mL clear vials that contain approximately 37,000 MBq (250 mCi), 18,500 MBq (500 mCi), and 37,000 MBq (1,000 mCi) at the time of calibration.

HICON:

NDC Volume of Concentrated SolutionTotal Radioactivity per Vial
65174-880-25 0.25 mL 9,250 <MBq (250 mCi)
65174-880-50 0.50 mL 18,500 MBq (500 mCi)
65174-880-00 1 mL 37,000 MBq (1,000 mCi)

A minimum of one blister package of 10 empty large hard gelatin capsules and a minimum of one blister package of 10 small hard gelatin capsules containing approximately 300 mg of dibasic sodium phosphate anhydrous as the absorbing buffer are supplied along with HICON for the preparation of sodium iodide I 131 capsules, therapeutic.

Drugs

Drug Countries
HICON United States
 
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