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Potassium Iodide ("KI") References

Palatability Evaluations of Potassium Iodide Solid Dosage Tablets Ground and Mixed in Drinks1

Francis R. Pelsor, Nakissa Sadrieh, and Stella G. Machado.

U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.

 

ABSTRACT

Objective. To evaluate the hypothesis that the potassium iodide (KI) 130 mg tablet, once ground and mixed with appropriate drinks, could be taken orally with reasonable palatability. Methods. Thirty healthy adult male and female volunteers completed the taste study in a blinded fashion. The taste and aftertaste of the following drinks each containing KI were evaluated: water (negative control), low fat milk, low fat chocolate milk, orange juice, soda (cola, flat), and raspberry syrup. Results. Taste ranking of all six preparations, highest to lowest, was as follows: raspberry syrup, low fat chocolate milk, simple syrup, orange juice, flat cola, low fat milk, and water. The preparations of raspberry syrup, low fat chocolate milk, orange juice, and cola (flat) have acceptable taste and palatability. Conclusions. The results from this study confirm our hypothesis that the KI tablet, once ground and mixed with drinks, can have acceptable palatability. It appears that raspberry syrup has a high capacity to mask the saltiness while low fat milk has little capacity to cover the saltiness of KI.

1This work was completed through a FDA contract with the Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee, Memphis, TN 38163, Arthur B. Straughn (Principal Investigator). Stability and Dose Uniformity Evaluations of Potassium Iodide Solid Dosage Tablets mixed in Drinks

Stability and Dose Uniformity Evaluations of Potassium Iodide Solid Dosage Tablets Mixed in Drinks

James F. Brower and Terra Lipe.

U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, 1114 Market St., Room 1002, St. Louis, MO 63101.

Government stockpiles of drugs needed for bioterrorism include solid oral dosage forms. In order to give these drugs to children in an emergency, the solid dosage forms need to be ground and mixed with appropriate foods or drinks. To be effective in children, the drug/food or drug/drink mixture must have good stability and dose uniformity and have reasonable taste. For this study, stability and dose uniformity were examined for potassium iodide (KI) 130-mg tablets mixed with various drinks. Tablets were dissolved in water to yield 65 mg KI/5 mL or 32.5 mg KI/5 mL stock solutions.

Dose uniformity was determined by mixing one teaspoon of KI stock solution (65 mg/5 mL) with one teaspoon of water. Two analysts each repeated the procedure five times. The average amount (±1SD) of KI per teaspoonful (or medicinal dispensing container) was 32.0 (±2.6) mg.

The results show that the procedure for mixing KI in water is acceptable for administration of ¼ tablet (Range: 88%-112% of desired amount).

Seven-day stability in the refrigerator (2 - 8 ºC) of KI added to each of the following preparations were evaluated: water, orange juice, soda (cola), simple syrup with raspberry flavor, low fat milk, low fat chocolate milk, and infant formula. The results of recovery1 and stability testing of KI mixtures are shown in Table 1.

Table 1: Recovery and stability of KI (130 mg tablet) mixed with various drinks.

 

DrinksDose(mg)Original % Recovery% Recovery after 7 days Temperature, 2-8 ºC
Stock Solution (65 mg/5 mL) 

97.7

101.5

Water

32

102.8

102.9

Water

16

104.9

100.0

Orange Juice

32

100.4

101.4

Orange Juice

16

102.9

97.9

Soda (cola)

32

104.7

103.2

Soda (cola)

16

101.5

99.6

Raspberry Syrup

32

105.0

104.8

Raspberry Syrup

16

102.6

102.0

Low Fat Milk

32

106.1

99.9

Low Fat Milk

16

98.0

100.2

Low Fat Chocolate Milk

32

103.2

102.6

Low Fat Chocolate Milk

16

100.3

99.4

Infant Formula

32

104.6

103.0

Infant Formula

16

100.5

99.6

Good original recoveries (all >97% recovery) and 7-day stability (all >97% recovery) (Refrigerated, 2 - 8 ºC) were seen for KI tablets dissolved in water and mixed with all seven drinks.

 1 Recovery is the ratio (expressed as percent) of the amount of active drug