Thursday, May 15, 2014

Oh, patents! Transdermal nicotine patch

Copyright © Françoise Herrmann

The NIH (National Institutes of Health) NIDA (National Institute on Drug Abuse) suggests one or a combination of three approaches to quit smoking:
  1. Behavioral (e.g.; counseling, self-help or the Department of Health 800-QUIT NOW hotline)
  2. Nicotine replacement therapies or NRTs (e.g.; nicotine patches, nicotine gum, nasal sprays, inhalers and lozenges), and
  3. Medication (e.g.; Zyban, and Chantix which blocks nicotine receptors) [NIH, Drug Facts]

Transdermal nicotine patches thus offer a nicotine replacement approach to quitting. A search for nicotine patches at the EPO yields several different patents. For example:
US4920989 and US5016652 both titled:  Method of aiding in reduction of the incidence of tobacco smoking are assigned to the University of California.They disclose transdermal patches for administration of nicotine to the bloodstream. at a rate sufficient to correspond to the nicotine level in the blood which is achieved by the normal smoking patterns of the individual”; and additionally, a combination nasal aerosol spray (in US4920989) designed:  “to provide desired sensations in the respiratory tract to which the user is accustomed from normal tobacco use.” 

The stated advantage of this form of nicotine replacement therapy, compared to nicotine gum for example, is that it is able to deliver adequate quantities of nicotine in the blood stream, without the displeasing taste of nicotine gum or the gastroinstestinal upset.

The abstract for US4920989 in included below with a patent figure drawing and a commercial figure drawing of the transdermal reservoir patch:

A method of aiding in the reduction of incidence of tobacco smoking. The method comprises applying a patch containing nicotine to the skin of a person with whom smoking reduction is desired and allowing the nicotine to transdermally migrate into the person's bloodstream to achieve a desired systemic nicotine level. The method also comprises the simultaneous administration of a nicotine containing aerosol spray to the oral cavity of the user in order to provide the desired sensations in the respiratory tract to which the user is accustomed from normal tobacco smoke. A combination of the spray and transdermal patch is also provided such that an occlusive patch is applied to the skin of the person with whom smoking reduction is desired and the nicotine containing aerosol spray is delivered to the oral cavity simultaneously with the application of the nicotine from the patch.

There are many other patents related to dosage and/or comfort of transdermal nicotine patch therapy. For example:

US5230896 titled Transdermal nicotine delivery system discloses “a novel transdermal delivery system to satisfy addicted smokers’ cravings” which offers an option to transdermal patches containing a reservoir of the drug.  The novel construction of the patch consists of a nicotine base within an acrylate polymer matrix, so that the patch is neither bulky nor conspicuous when worn.

US5603947 titled Method and device for providing nicotine replacement therapy transdermally/transbucally discloses a patch for heavy smokers which delivers an average flow rate of nicotine that exceeds the prior art delivery amounts.

There are also known disadvantages of the transdermal delivery mode, in general, and in particular for nicotine delivery (Prausnitz & Langer, 2008). For example, one of the known disadvantages is skin irritation that can be caused by the patches. This problem is addressed and patented, for example in US2013053357 titled: Skin irritant suppression and transdermal preparation which discloses delivery of an irritant suppression agent in conjunction with a drug such as nicotine, in a transdermal patch. 

US2009169606 titled Low flexural strength transdermal tobacco alkaloid patch also addresses the issue of patch comfort and the risks of leaking in transdermal reservoir technology by disclosing a patch with a high degree of flexibility (i.e. low flexural strength).

So… in the countdown to May 31 World No tobacco day – transdermal nicotine replacement patches appear as one patented option available to assist with cessation. 

NIH – Drug Facts: Cigarettes and other tobacco products   
Prausnitz, M. R. & R. Langer (2008) Transdermal delivery
Nat Biotechnology, Nov.2008, 26(11), 1261-1268

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