Navigation Links
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 thyroid-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 products. In a related area of intellectual property, Pisgah has identified a platform technology for imparting abuse deterrent features to the highly abused opioid-base products such as hydrocodone, oxycodone, morphine, hydromorphone and oxymorphone. For those interested in additional information, please visit http://www.pisgahlabs.com.   Contact:Todd Stamps803-212-8224This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.


'/>"/>
SOURCE Pisgah Labs, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Canadas Michael Smith Genome Sciences Center Validates NEBNextâ„¢ DNA Sample Preparation Reagents From New England Biolabs for Use in Next Generation Sequencing
2. Sandia Labs reports first monolithic terahertz solid-state transceiver
3. BellBrook Labs Launches Groundbreaking New Microplate for High Content Chemotaxis Assays in a Stable Gradient
4. BellBrook Labs Launches Compound Profiling Services with High Content 3D Invasion Assay
5. Atacama Labs Enters Into Partnership With Excella Gmbh, Which is Part of Fareva Holding, a Top 10 Global Contract Manufacturer
6. New England Biolabs Launches NEBNext(TM) DNA Sample Prep Master Mix Set 3 for Use with SOLiD(TM) 3
7. GeoVax Labs, Inc. Reports Data on Prototype Adjuvant - Supplemented HIV Vaccine Tested in Preclinical Animal Studies
8. Wellcome Trust Sanger Institute to use NEBNext(TM) DNA Sample Preparation Reagents from New England Biolabs for Next Generation Sequencing
9. Palmer Labs Awarded U.S. Department of Energy Funding for Algae Biofuel Research
10. ECBC Delivers Mobile Labs to DRDC, Celebrates with Ribbon Cutting Ceremony
11. GeoVax Labs, Inc. Celebrates 21st World AIDS Day With Continued Clinical Trial Progress
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... December 02, 2016 , ... The ... to collaboratively developing improved chemistry, manufacturing and control technologies for the pharmaceutical ... with robust, probe-based sampling. , Online liquid chromatography analysis is becoming ...
(Date:12/2/2016)... PUNE, India , December 2, 2016 ... Billion by 2021, growing at a CAGR of 7.3% during the ... segment while hospitals and diagnostic laboratories segment accounted for the largest ... ... Complete report on global immunohistochemistry (IHC) market spread across 225 ...
(Date:11/30/2016)... -- GenomOncology today announced the appointment of Joshua F. Coleman ... Dr. Coleman will oversee clinical content development and curation ... GenomOncology software suite empowers molecular pathologists with a seamless workflow ... support, from quality control through reporting. ... , , ...
(Date:11/30/2016)... 30, 2016 Biotest Pharmaceuticals Corporation (BPC), a ... announce the addition of its newest plasma collection center ... . The 15,200 square foot state-of-the-art facility officially ... and brings the total number of BPC,s plasma collection ... , BPC,s Chief Executive Officer said "We are pleased ...
Breaking Biology Technology:
(Date:11/17/2016)... 17, 2016 Global Market Watch: Primarily ... Banks, Population-Based Banks and Academics) market is to witness a ... Biobanks shows the highest Compounded Annual Growth Rate (CAGR) of ... during the analysis period 2014-2020. North America ... followed by Europe at 9.56% respectively. ...
(Date:11/15/2016)... 2016  Synthetic Biologics, Inc. (NYSE MKT: SYN), ... the gut microbiome, today announced the pricing of ... its common stock and warrants to purchase 50,000,000 ... to the public of $1.00 per share and ... the offering, excluding the proceeds, if any from ...
(Date:11/14/2016)... , Nov. 14, 2016  Based on ... market, Frost & Sullivan recognizes FST Biometrics ... Award for Visionary Innovation Leadership. FST Biometrics ... biometric identification market by pioneering In Motion ... for instant, seamless, and non-invasive verification. This ...
Breaking Biology News(10 mins):