Are multisource levothyroxine sodium tablets marketed in Egypt interchangeable?
Abstract
A clinical study was initiated in response to patients' complaints, supported by the treating physicians, of suspected differences in efficacy among multisource levothyroxine sodium tablets marketed in Egypt. The study design was a multiple dose (100μg levothyroxine sodium tablet once daily for 6 months) and involved 50 primary hypothyroidism female patients (5 equal groups). Tablets administered included five tablet batches (two brands, three origin locations) purchased from local pharmacies in Alexandria. Assessment parameters (measured on consecutive visits) included the thyroid stimulating hormone, total and free levothyroxine. Tablet dissolution rate was determined (BP/EP 2014 & USP 2014). In vitro vs in vivovs correlations were developed. Clinical and pharmaceutical data confirmed inter-brand and inter-source differences in efficacy. Correlations examined indicated potential usefulness of in vitro dissolution test in detecting poor performing levothyroxine sodium tablets during shelf life.
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The plausible explanation for the complaints may be altered disintegration and dissolution due to the use of different excipients.
“The plausible explanation may be altered disintegration and dissolution due to the use of different excipients (117).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [117]
Cites
Hollowell, J. G., Staehling, N. W., Flanders, W. D., Hannon, W. H., Gunter, E. W., Spencer, C. A., & Braverman, L. E. (2002) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.87.2.489 · Cited by 4,279 · see citing works
The Colorado Thyroid Disease Prevalence Study
Canaris, G. J., Manowitz, N. R., Mayor, G., & Ridgway, E. C. (2000) · Archives of Internal Medicine · doi:10.1001/archinte.160.4.526 · Cited by 2,824 · see citing works
THE SPECTRUM OF THYROID DISEASE IN A COMMUNITY: THE WHICKHAM SURVEY
Tunbridge, W. M. G., Evered, D. C., Hall, R., Appleton, D. R., BREWIS, M., CLARK, F., Evans, J. G., Young, E. T., Bird, T., & Smith, P. (1977) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1977.tb01340.x · Cited by 2,665 · see citing works
Jonklaas, J., Bianco, A. C., Bauer, A. J., Burman, K. D., Cappola, A. R., Celi, F. S., Cooper, D. S., Kim, B. W., Peeters, R. P., Rosenthal, M. S., et al. (2014) · Thyroid® · doi:10.1089/thy.2014.0028 · Cited by 1,928 · see citing works
Cooper, D. S. (2005) · New England Journal of Medicine · doi:10.1056/nejmra042972 · Cited by 1,008 · see citing works
Fade, J. V., Franklyn, J. A., Cross, K. W., Jones, S. C., & Sheppard, M. C. (1991) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1991.tb01739.x · Cited by 567 · see citing works
Conditions and drugs interfering with thyroxine absorption
Liwanpo, L., & Hershman, J. M. (2009) · Best Practice & Research Clinical Endocrinology & Metabolism · doi:10.1016/j.beem.2009.06.006 · Cited by 222 · see citing works
CARR, D., MCLEOD, D. T., PARRY, G., & THORNES, H. M. (1988) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1988.tb01219.x · Cited by 210 · see citing works
Okosieme, O., Gilbert, J., Abraham, P., Boelaert, K., Dayan, C., Gurnell, M., Leese, G., McCabe, C., Perros, P., Smith, V., et al. (2016) · Clinical Endocrinology · doi:10.1111/cen.12824 · Cited by 208 · see citing works
Bioequivalence of Generic and Brand-name Levothyroxine Products in the Treatment of Hypothyroidism
Dong, B. J. (1997) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1997.03540390035032 · Cited by 185 · see citing works
Principles and practice of endocrinology and metabolism
Holub, D. A. (1992) · Trends in Endocrinology and Metabolism · doi:10.1016/1043-2760(92)90115-h · Cited by 160 · see citing works
The epidemiology of thyroid diseases in the Arab world: A systematic review
Awad, S. A. S., El‐Metwally, A., Khaled, A. S., Salih, B. S., Yousef, S., Abeer, A. S., & Anna, A. (2016) · Journal of Public Health and Epidemiology · doi:10.5897/jphe2015.0713 · Cited by 93 · see citing works
Collier, J. W., Shah, R. B., Bryant, A., Habib, M. J., Khan, M. A., & Faustino, P. J. (2010) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2010.08.025 · Cited by 47 · see citing works
U.S. Food and Drug Administration's Decision Regarding Bioequivalence of Levothyroxine Sodium
American Thyroid Association, T. E. S. (2004) · Thyroid · doi:10.1089/1050725041517138 · Cited by 44 · see citing works
New questions regarding bioequivalence of levothyroxine preparations: A Clinician's response
Green, W. L. (2005) · The AAPS Journal · doi:10.1208/aapsj070107 · Cited by 32 · see citing works
Levothyroxine dosage and the limitations of current bioequivalence standards
Hennessey, J. V. (2006) · Nature Clinical Practice Endocrinology & Metabolism · doi:10.1038/ncpendmet0273 · Cited by 28 · see citing works
Volpato, N. M., Silva, R. L., Brito, A. P. P., Gonçalves, J. C. S., Vaisman, M., & Noël, F. (2004) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2004.01.006 · Cited by 24 · see citing works
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Levothyroxine: conventional and novel drug delivery formulations.
Liu, H., Li, W., Zhang, W., Sun, S., & Chen, C. (2023) · Endocrine Reviews · doi:10.1210/endrev/bnac030 · Cited by 63 · see citing works
Levothyroxine sodium pentahydrate tablets – formulation considerations
Kaur, N., & Suryanarayanan, R. (2021) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2021.08.006 · Cited by 19 · see citing works
- Authors
- Abou-Taleb, B. A., Bondok, M., Nounou, M. I., Khalafallah, N., & Khalil, S.
- Affiliations
- Pharos University in Alexandria (EG)
- Alexandria University (EG)
- University of Saint Joseph (US)
- Corresponding author
- Nounou, Mohamed Ismail
- Venue
- Annales d Endocrinologie
- Publisher
- Elsevier BV
- Published
- 2018-02
- Volume
- 79
- Issue
- 1
- Pages
- 23-29
- ISSN
- 0003-4266 (ISSN-L)
- OpenAlex
- W2778299366
- Cited by
- 7
- References
- 17
- Citations by year
- 2026: 1 · 2024: 1 · 2022: 1 · 2021: 1 · 2020: 2 · 2018: 1
- FWCI
- 0.65
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annales d Endocrinologie (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Keywords
- levothyroxine sodium, primary hypothyroidism, in vitro-in vivo correlation, tablet dissolution rate, thyroid-stimulating hormone, free thyroxine, storage stability, generic drug quality, Egypt
- MeSH terms
- Adolescent, Adult, Blood Chemical Analysis, Chromatography, High Pressure Liquid, Drug Compounding, Egypt, Female, Humans, Hypothyroidism, Middle Aged, Solubility, Tablets, Therapeutic Equivalency, Thyroid Function Tests, Thyrotropin, Thyroxine, Health Care Sector, Young Adult
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