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Pisgah Labs' Invention Improves Safety of Thyroid Hormones
Date:8/17/2010

PISGAH FOREST, N.C., Aug. 17 /PRNewswire/ -- Today, Pisgah Labs, Inc. (http://www.pisgahlabs.com) received a Notice of Allowance from the United States Patent and Trademark office (http://www.uspto.gov) for an important new technology patent addressing global stability problems of thyroid hormone drugs. According to the FDA (http://www.fda.gov): "Thyroid hormones effect protein, lipid, and carbohydrate metabolism, growth and development. Orally administered levothyroxine sodium is used as replacement therapy in conditions characterized by diminished or absent thyroid function, such as cretinism, myxedema, nontoxic goiter, or hypothyroidism. Levothyroxine sodium may be used to suppress the secretion of thyrotropin in the management of simple nonendemic goiter, chronic lymphocytic thyroiditis, and thyroid cancer."

The shelf life of important treatments, particularly for prescription drugs, is a factor that affects all patients. A medication past its expiry date has been shown to have decreased potency to the extent it may no longer exhibit therapeutic value. Drug product manufacturers in conjunction with the FDA routinely perform and monitor the stability of formulated drug products and of the active ingredients used to make those drug products. In the case of the thyroid hormones, the stability of the existing commercial drugs is inherently lacking and formulation techniques do little to correct the deficiency. Current manufacturers have responded to the FDA's insistence for safe and efficacious medications, but breakthrough technology was, until now, unavailable.

Further, the criticality of drug product stability and associated shelf life is obviously very important and well-exemplified when considering the low-dose requirements of the thyroid hormone drugs. During the past decade, the FDA implemented rigorous potency standards for thyroi
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SOURCE Pisgah Labs, Inc.
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