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Stability, Dose Uniformity, and Palatability of Three Counterterrorism Drugs—Human Subject and Electronic Tongue Studies

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Purpose

These studies evaluated the ability of common household food and drink products to mask the bitter taste of three selected anti-terrorism drugs.

Methods

Three anti-terrorism drugs (doxycycline, ciprofloxacin hydrochloride, and potassium iodide) were mixed with a variety of common household food and drinks, and healthy adult volunteers evaluated the resulting taste and aftertaste. In parallel, the ASTREE Electronic Tongue was used to evaluate taste combinations. Stability of the mixtures over time was monitored, as was the dosage uniformity across preparations.

Results

Foods and drinks were identified that satisfactorily masked the bitter flavor of each drug. Dose uniformity and stability were also acceptable over the range studied, although some combinations were significantly less stable than others. The electronic tongue was able to differentiate between tastes, but ranked masking agents in a different order than human volunteers.

Conclusions

Doxycycline, potassium iodide, and ciprofloxacin, which are stockpiled in solid tablet form, can conveniently be prepared into more palatable formulations, using common household foods and drinks. The electronic tongue can be used to perform an initial screening for palatability.

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Abbreviations

ATW:

average tablet weight

DI:

discrimination index

Cipro:

ciprofloxacin hydrochloride

FDA:

Food and Drug Administration

GLM:

general linear models

KI:

potassium iodide

PCA:

principle component analysis

RSD:

relative standard deviation

USP:

United States Pharmacopeia

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Acknowledgments

The authors would like to thank Ajaz Hussain, Daniel Briggs, Alan Carlin, Christopher Ellison, Joseph Hanig, Robbe Lyon, Arzu Selen, John Strong, Chuck Anello, Donna Volpe, and Anna Wokovich. The authors also would like to thank the FDA RIHSC members for their timely action and many constructive comments.

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Authors and Affiliations

  1. Food and Drug Administration, 5515 Security Lane, Rockville, Maryland, 20852, USA

    Nakissa Sadrieh

  2. Food and Drug Administration, 1114 Market Street, St. Louis, Missouri, 63101, USA

    James Brower, William Doub, Terry Moore, John Reepmeyer, Duckhee Toler & Lucinda Buhse

  3. Food and Drug Administration, 7500 Standish Place, Rockville, Maryland, 20850, USA

    Lawrence Yu & Rosemary Roberts

  4. University of Tennessee, 874 Union Avenue, Memphis, Tennessee, 38163, USA

    Arthur Straughn

  5. Food and Drug Administration, 12720 Twinbrook Parkway, Building 3, Rockville, Maryland, 20857, USA

    Stella Machado & Donald J. Schuirmann

  6. Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20857, USA

    Frank Pelsor & Moheb Nasr

  7. Alpha-MOS, 20 Avenue Didier Daurat, 31400, Toulouse, France

    Emmanuelle Saint Martin

  8. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland, 20903, USA

    Agnes Nguyenpho

Authors
  1. Nakissa Sadrieh
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  2. James Brower
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  3. Lawrence Yu
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  4. William Doub
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  5. Arthur Straughn
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  6. Stella Machado
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  7. Frank Pelsor
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  8. Emmanuelle Saint Martin
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  9. Terry Moore
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  10. John Reepmeyer
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  11. Duckhee Toler
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  12. Agnes Nguyenpho
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  13. Rosemary Roberts
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  14. Donald J. Schuirmann
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  15. Moheb Nasr
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  16. Lucinda Buhse
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Corresponding author

Correspondence to William Doub.

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Sadrieh, N., Brower, J., Yu, L. et al. Stability, Dose Uniformity, and Palatability of Three Counterterrorism Drugs—Human Subject and Electronic Tongue Studies. Pharm Res 22, 1747–1756 (2005). https://doi.org/10.1007/s11095-005-6387-x

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  • DOI: https://doi.org/10.1007/s11095-005-6387-x

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