Inhaler for basic pharmaceutical agents and method for the production thereof

Abstract

A device for the administration of basic active agents, such as nicotine, to the human or animal body. The active agents are administered by inhalation. The device comprises a first preparation containing a nicotine base or / and a further basic active agent and, a second or further preparations. At least one preparation contains at least one volatile acid suitable for inhalation.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a National Stage application of International Application No. PCT / EP2004 / 012947, filed on Nov. 16, 2004, which claims priority of German application number 103 56 925.1, filed on Dec. 5, 2003. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention relates to devices for administering basic active agents, in particular nicotine, to the human or animal body by inhalation. The invention further relates to methods for producing such devices, as well as the use of such devices for smoking cessation or for smokeless satisfaction of the craving for nicotine in cases of situational necessity. [0004] 2. Description of the Prior Art [0005] Nicotine inhalers for administration of nicotine via the air inhaled during inspiration have been known for several years (e.g. U.S. Pat. No. 4,917,120 and U.S. Pat. No. 5,167,242). For some years nicotine inhalers have also been available on the market as smoking ...

AI Technical Summary

Benefits of technology

[0006] It was therefore the object of the invention to provide a nicotine inhaler which enables absorption of nicotine via the respiratory passages and causes as little irritation and is as intense as possible.

[0028] The devices according to the invention can be produced in a simple manner and at low cost by using formed parts produced by deep-drawing. A preferred material suitable for this purpose is a polyester material provided with a coating that is impermeable to the basic agent, especially to nicotine. Suitable for this purpose is, above all, a copolymer of acrylonitrile and methacrylate (Barex®; BP). A polyethylene terephthalate-Barex laminate sheet is used with preference.

[0031] The recesses forming the air supply channels in the formed part or formed parts may be configured, by providing additional bulges (which may likewise be produced by deep-drawing), such that the vaporisation rate of the respective volatile component can be geometrically limited. This measure results in an additional possibility of accomplishing the preferred delivery of active agent base and acid in equimolar quantities.

[0041] In a further preferred embodiment, the inhalation device is covered, after production thereof, with a peelable protective layer impermeable to the basic agent(s). This protective layer will be removed only shortly before use, by the user himself By means of the protective layer which has been applied a compartment containing the basic active substance(s), and a compartment containing the acid(s) are formed, both compartments being separated from one another in a substantially gas-tight manner and being sealed from the ambient air. In this manner, premature reaction and ageing of the ingredients is prevented. Only after the protective layer has been removed can an exchange of gas again take place between the two compartments.

Problems solved by technology

The latter nicotine inhaler is, however, not widely used since with this device only small amounts of nicotine become effective when inhaling.

This is due, in particular, to fundamental deficiencies of the known inhaler technologies and the tolerance that can be achieved with these technologies.

In particular, the locally irritating effects on the mucous membranes of the respiratory passages, caused by the alkaline properties of nicotine, are disadvantageous since they cause an urge to cough, which results in a decreased absorption of the nicotine vapours released by the inhaler.

Images