Abstract
Hypothyroidism is a common disease that needs to be closely treated, in order to reduce adverse symptoms and pathophysiological effects. For thyroid hormone replacement is preferred a therapy with a synthetic form of thyroxine (levothyroxine), a drug recognized by its Narrow Therapeutic Index. Generic levothyroxine can be an economic alternative for Hypothyroidism treatment.
Highlights
It is currently known that hypothyroidism is a relatively common disease, in which early diagnosis helps to reduce mortality by circulatory and cardiovascular disorders preventing progression to myxedema coma, which has high mortality
Food and Drug Administration (FDA) states that biowaiver for tablets strengths is possible only if: a) three in vivo studies, low, middle and high strength are bioequivalent; b) tablets evaluated only differ in the amount of levothyroxine sodium and filler needed to maintain the tablet weights; and c) dissolution profile are similar across tablets strengths using a f2 test [16]
The FDA guidance on bioequivalence studies using levothyroxine advises that a single dose of 0.6 mg is administered to healthy volunteers and this dose appears to be generally well tolerated
Summary
It is currently known that hypothyroidism is a relatively common disease, in which early diagnosis helps to reduce mortality by circulatory and cardiovascular disorders preventing progression to myxedema coma, which has high mortality. Iatrogenic hyperthyroidism has been associated with the development of osteoporosis and approximately 600,000 elderly patients may be at risk for bone demineralization because levothyroxine overdose [3]. To reduce this illness it is very important to have a close clinical follow-up of patients. Diagnosis and treatment of hypothyroidism restores the physical and cognitive function of patients, with a better willingness to perform daily activities [1]. Biowaiver can become an important and cost-saving tool for the development and approval of generic drugs. Alternative strategies are proposed to perform bioequivalence with this drug
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