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

d-related drug products such as Synthroid®, Unithroid®, Levothroid®, Levolet® and Levoxyl®. The very low dosage needed for therapeutic effect was susceptible to potency degradation during and after manufacturing, and the low dosage challenged manufacturing techniques for provision of a uniform tablet-to-tablet dosage. Endocrinologists know a patient being treated for hypothyroidism could experience the complete range of dosing -- from an ineffective dose to an overdose -- principally due to the instability of levothyroxine (T4) or liothyronine (T3).

In response to the potency variability, manufacturers employed various formulation techniques to improve the stability of these delicate and sensitive active ingredients. Regulatory mandates can typically only serve as patches to inherent problems when invention is required to completely resolve a serious problem. The FDA's effort to narrow the release specification for these products defined an outcome, but not a means by which the desired result could be routinely obtained. Not surprisingly, the industry has remained handicapped with product quality often jeopardized. At the root of the stability and potency issue was a need to improve the inherent stability of the active ingredients prior to their formulation into dosage products.

Fortunately, Pisgah Labs has prepared thyroid hormone active ingredients in salt forms which exhibit unprecedented stability. Since the improved stability occurs at the active ingredient level, formulation demands are significantly lessened. With improved active ingredient stability, the formulation and manufacturing requirements are comparatively uncomplicated and can principally address the dosage and batch-to-batch uniformity.  

Pisgah Labs is currently employing this and related technologies in drug product development activities which enhance the physical and chemical performance features of existing active ingredients and drug produc
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SOURCE Pisgah Labs, Inc.
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