Cody unveils homogenous method for morphine derivatives
Hydromorphone and hydrocodone, which are among the most frequently prescribed generic products worldwide, are semi-synthetic narcotics that can be prepared by transition metal catalyzed isomerization of morphine and codeine, respectively.
Most commonly this conversion is carried out using heterogeneous catalysts on the industrial scale. However such reactions can suffer from low selectivity, produce low yields and require additional purification steps.
In contrast Cody’s approach, which is one of the few homogeneous methods to have been characterised, demonstrates improved selectivity and significantly reduces the need for post-conversion purification.
The Wyoming-headquartered firm, a subsidiary of generic drug company Lannett, recently received protection for its new method from the US Patent and Trademark Office (USPTO).
Commenting on the US Patent, Lannett CEO Arthur Bedrosian, said: "our method for preparing Hydromorphone and Hydrocodone will greatly enhance our ability to manufacture these products quickly and efficiently.
"Importantly, with minimal incremental investment, the faster manufacturing time appreciably expands our manufacturing capacity, allowing us to maximise our production assets.” He added that the firm expects its efforts in developing the new method to reap considerable rewards.
Pain management market
In addition to the US patent, Cody also received an import license from the US Drug Enforcement Administration (DEA), which further strengthens its position in the pain management market.
Bedrosian said that: “As we enter the pain management market, we take seriously our responsibilities with regard to the secure manufacture and distribution of prescription narcotics," acknowledging the major issue in opioid analgesics, namely their potential for abuse.
Although both hydromorphone and hydrocodone are subject to restrictions on prescribing and feature explicit label warnings in the US and other markets, there have been increasing problems with diversion and misuse of both products.
Last year for example a report in the journal Archives of Internal Medicine, which looked at serious adverse events reported to the US Food and Drug Administration (FDA) between 1998 and 2005, found that hydrocodone is one the drugs most often associated with fatal and non-fatal serious events.
As a result considerable research effort has been invested in developing abuse resistant products, ensuring that the already considerable market for the two active pharmaceutical ingredients (API) looks set to continue to expanding.
