December 20, 2012—(Pisgah Forest, NC), Pisgah Laboratories, Inc., (www.Pisgahlabs.com) an innovative pharmaceutical development company located in Western North Carolina may have some relief for those who regularly fall victim to the cough, cold and allergy season. Pisgah recently received US Patent 8,334,322 from the United States Patent and Trademark Office (www.uspto.gov) for innovative, abuse deterrent forms of pseudoephedrine and ephedrine. The issued patent was for their application entitled, “Salts of Physiologically Active and Psychoactive Alkaloids and Amines Simultaneously Exhibiting Bioavailability and Abuse Resistance” whose underlying application covers a breadth of related active pharmaceutical ingredients (APIs) that are often subject to drug abuse.
Pseudoephedrine and Ephedrine, Common Ingredients for Methamphetamine Production
But what does pseudoephedrine have to do with drug abuse? Pseudoephedrine, found in popular decongestants and allergy medicines, is a very safe and effective drug and once was readily available to the consumer market without prescription. Unfortunately, pseudoephedrine is the preferred precursor for the illicit preparation of “crystal meth” (methamphetamine). Of course, the headlines are filled with society’s ills emanating from the scourge of methamphetamine abuse. Not surprisingly, the government’s response principally consisted of bureaucratic impediments to the legitimate availability and use of this compound in products such as Sudafed®. Without question, methamphetamine drug abuse creates hell on earth, but while Mexican drug cartels bring thousands of pounds of purified methamphetamine across our southern border, the small-time “meth cooks” prepare the illicit material from pseudoephedrine products which otherwise serve a genuine need in society. As laws were implemented, the law-abiding citizenry was subjected to additional scrutiny and even deprived of needed medications. Ultimately, pseudoephedrine products that were normally available over-the-counter (OTC) were placed behind the counter further impeding access to reasonable treatment for sinus, cough, cold and allergy symptoms.
Pisgah’s innovation cannot bolster the political will of spineless politicians to secure our southern border from the large-scale terrorism inflicted by Mexican drug cartels through illicit drugs. However, Pisgah’s pseudoephedrine addresses the drug’s potential for abuse at the drug substance level prior to formulation into a dosage form. Using chemistry, Pisgah has modified the active ingredient, pseudoephedrine, to remove the properties which enable ease of abuse. The illicit meth labs must first isolate the pseudoephedrine from the dosage form before its conversion to methamphetamine. This extraction process is quite easy in most cases, but Pisgah identified how to chemically modify the active so as to retain its medical properties while eliminating the likelihood of extraction and conversion.
One may begin to see why this complex discussion was provided for a rather common, over-the-counter product—which, today, isn’t as common or available for legitimate use. Now, with Pisgah’s innovation, product development efforts may be directed toward a valuable and needed drug product containing pseudoephedrine which isn’t susceptible to abuse—and particularly abuse by its conversion to methamphetamine. Similarly, and at the time of this release, Pisgah Laboratories is developing an abuse deterrent hydrocodone product using a comparable methodology. Here too, the active ingredient, hydrocodone, is first chemically modified to impart the abuse deterrent properties prior to its incorporation into a dosage form.
As Pisgah continues its development and business path, tangible accomplishments such as patent allowances and FDA product filings are becoming routine occurrences With these successes, the company believes collaborative efforts and licensing from its patent portfolio to product-hungry branding partners will accelerate the development of drug products particularly in the treatment areas of pain management, attention deficit hyperactivity disorder, and obesity.