PISGAH FOREST, N.C., June 30 /PRNewswire/ -- Pisgah Labs, Inc., a drug product development company and an active pharmaceutical ingredient manufacturer, is pleased to announce the May 18, 2010 issuance of US Patent 7,718,649. This patent culminates several years of work and investment by Pisgah Labs, Inc. (http://www.pisgahlabs.com) to demystify the physical states of Imipramine Pamoate drug substances. The patent also covers methods of manufacturing, purifying and use of the drug in pharmaceutical preparations and marks the first allowance in a related series of applications pending before the United States Patent and Trademark Office (USPTO) (http://www.uspto.gov/main/patents.htm).
Further, Pisgah will soon file on its discoveries regarding abuse-deterrent formulations for the treatment of Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD). In the past few years the Food and Drug Administration (FDA) (http://www.fda.gov) has assertively engaged pharmaceutical companies to address America's drug abuse epidemic as guided by the FDA's Risk Evaluation and Mitigation Strategy (REMS) initiative. Pisgah's patent filing regarding AD(H)D drugs is timely given the significant abuse of this disorder's treatment medications. FDA has announced a 2-day public meeting to obtain input from stakeholders who have raised concerns about the impact of REMS on the healthcare system including prescribers, pharmacists and other affected stakeholders (http://www.fda.gov/Drugs/NewsEvents/ucm210201.htm).
The industry's challenge is to provide medically necessary products such as ADHD medications yet impede abuse. Pisgah's technology enables the drug to perform properly when used for the intended medical purpose, yet perform poorly when abused or misused. In addition to basic abuse deterrent features, Pisgah has refined their technology to yield products which are unaffected by alcohol consumption. Pisgah's technology is also applicable to a host of opioid controlled substances. Since the technology relies on salt formation, essentially any controlled substance containing a basic nitrogen will succumb to conversion to an abuse deterrent form. Therefore, a predictable product development cycle for abuse deterrent products is available to narcotics such as oxycodone, hydrocodone, morphine, oxymorphone, hydromorphone and methadone.
Law enforcement and supply chain security are also addressed within Pisgah's technology. The platform affords a forensic methodology for addressing drug trafficking, diversion, counterfeiting and crime scene analysis by imparting a track-and-trace capability. This feature covers the actual active ingredient, and formulations can be adjusted to provide a chemical "fingerprint" for a specific manufacturer. A simple analysis will be sufficient for the DEA to determine if the drug was illegally diverted (and from where) or for Customs to determine if the drug is a counterfeit. It would appear Pisgah's multi-level, abuse deterrent platform is a promising route to alleviating drug abuse which continues to increase at an alarming rate in America.
Pisgah's technology is based on new salt forms of active ingredients exhibiting well-known patient safety and efficacy. However, the new salts demonstrate medicatious release when used as intended, but the salt lacks sufficient solubility in the mucosal membranes and won't afford the "high" when abused. This feature also complicates the extraction of the active ingredient from the formulated dosage, and unlike other products on the market, crushing the tablet has no effect on releasing the controlled substance (for abuse).
Pisgah has advanced their technology platform to the final dose product development stage in preparation for FDA regulatory filings. Currently, Pisgah is seeking partnerships or licensing agreements to rapidly introduce these important products, which will improve patient safety and health for all Americans.
SOURCE Pisgah Labs, Inc.