Inhaler

Details Inhaler Inhaler

2001-08-09

2004-02-03

Lo, Weilun (Department: 3761)

Surgery

Liquid medicament atomizer or sprayer

C128S200160, C128S203120

Reexamination Certificate

active

06684879

ABSTRACT:

This invention relates to an inhaler for enabling delivery of an active ingredient to the nasal passages.
Conventionally, nasal inhalers are used for the supply of decongestants such as oxymetazoline and the like. The nasal passages are also a good way of supplying drugs and other medicaments into the bloodstream for treatment of ailments which are not specific to the nasal passages.
Conventional hydraulic/pump action nasal inhalers fire or eject large droplets of liquid into the nose. These droplets are polydispersed, that is they have a broad spectrum of sizes. The deposition of such droplets is primarily due to their own inertia which can lead to a very patchy distribution of the liquid. Indeed excessive deposition in one region can lead to the droplets coalescing and flowing out of a nostril or down the back of the throat which can cause an unpleasant taste or, worse, lead to detrimental side effects as a result of the drug being delivered to the digestive or pulmonary system.
It is an aim of the present invention to provide a device which enables satisfactory and efficient supply of a substance such as a medicament or other active ingredient to the nasal mucosa avoiding deposition in non-target regions such as the lungs or the stomach.
A process for producing comminuted matter known as electrohydrodynamic comminution is described in detail in, for example, GB-A-1569707. In this process, a dispersed spray or cloud of comminuted matter such as liquid droplets which are all of substantially the same size (monodispersed) is produced by subjecting liquid emerging from an outlet to an electric field.
The device described in GB-A-1569707 is large, produces highly charged droplets and is intended primarily for spraying of crops.
Inhalers have been proposed that exploit electrohydrodynamic comminution because they have the advantage, unlike conventional inhalers, of producing a monodispersed (substantially all the same size) mist or cloud of droplets so that the droplets may be targeted more accurately. However, because the conventional wisdom is that it is difficult, if not impossible, to spray electrically charged material into a cavity, previous attempts at producing inhalers using electrohydrodynamic techniques require that the comminuted matter be electrically discharged before inhalation. For example, EP-A-0234842 teaches that it is necessary to discharge the resulting comminution before inhalation to prevent it being deposited only on the wet conductive surfaces immediately inside the mouth or throat.
The present inventors have, surprisingly, found that, by a combination of electrohydrodynamic, discharging or partial discharging techniques and aerodynamic forces on the resultant comminution, an inhaler can be provided which generates by electrohydrodynamic means electrically charged comminuted matter which can be inhaled so as to deposit evenly onto the conductive inner surface of the nasal passages from whence an active ingredient carried by the comminution can be rapidly absorbed into the bloodstream without being inhaled into the pulmonary system.
In one aspect, the present invention provides an inhaler having electrohydrodynamic comminution means arranged to be activated by inhalation by a user, which facilitates entrainment of electrically charged comminuted matter into the air flow and thence into the nasal passages of the user.
In one aspect the present invention provides an inhaler having electrohydrodynamic comminution means with the electrode or electrodes of the comminution means being shielded from the user so that the user cannot make direct electrical contact with the electrodes.
In one aspect the present invention provides an inhaler wherein the material to be inhaled is electrohydrodynamically produced and the electrical charge and/or size of the comminuted material, generally droplets, are/is controlled so that the material can be deposited evenly into the nasal passages but supply to the pulmonary system or the back of the throat is prevented, thereby enabling the inhaler to be used for the supply to the nasal passages of medicaments which may produce unpleasant or undesirable effects if they were supplied to the pulmonary or digestive system.
In one aspect the present invention provides an inhaler having a supply of liquid carrying an active ingredient, means for supplying the liquid to an outlet and means for subjecting liquid issuing from the outlet to an electrical field sufficient to cause comminution of the liquid to produce electrically charged comminuted matter for inhalation by the user, the liquid or liquids being selected so as to control the manner in which active ingredient in the electrically charged comminuted matter is released when the electrically charged comminuted matter is deposited in the nasal passages. The liquid may be an oil or alcohol-based formulation allowing rapid supply of the active ingredient into the bloodstream via the surfaces of the nasal passages. As another possibility, the liquid may be such that the resulting comminuted matter has a gel-like structure enabling continued release of the active ingredient.
In one aspect the present invention provides an inhaler having means for subjecting liquid issuing from an outlet to an electric field sufficient to cause comminution of the liquid and means for causing electrically charged comminuted matter to be deposited onto the surfaces of the nasal passages. The latter means may comprise means for causing or facilitating an air flow through the inhaler which entrains the charged comminuted matter such an air flow may be generated by inhalation by a user, by artificial means such as a pump or a combination of both of these.
In one aspect, the present invention provides an inhaler having comminution means arranged to provide an electric field which has a strength which reduces rapidly in the direction of liquid flow from liquid supply means enabling liquid comminuted by the electric field to be easily entrained in an air flow path from the inhaler into a nostril of a user during use.
In one aspect, the present invention provides an inhaler having means for supplying liquid to an outlet and means for subjecting liquid issuing from the outlet to an electrical field sufficient to cause comminution of liquid issuing from the outlet, and means for generating an electrical potential at the one of the first and second electrodes most remote from the liquid outlet, said means for generating the electrical potential comprising means for generating an ion current for indirectly charging said one electrode.
In this aspect, the ion current generating means may comprise a further electrode located adjacent the one electrode and means for providing a high resistance path to earth from said one electrode. The high resistance path to earth may be provided by an actual resistor in series with said one electrode or, for example, a resistive or semiconductive coating on said one electrode. Indirect charging of said one electrode reduces the possibility of deposition of comminuted matter onto said one electrode because any electrically charged comminuted matter which approaches said one electrode will be at least partially electrically discharged by the generated ions. Furthermore, a more even deposition or greater penetration within the nasal passages should be achieved because of the at least partial discharge of some of the comminuted matter by the ion generating means.
In one aspect, the present invention provides an inhaler having means for supplying liquid to a comminution site and electrical current limiting means for limiting the supply of electrical current to the comminution site. The current-limiting means may comprise a dielectric or semi-insulating coating or sleeve or a high resistance coupled in the path from a high capacitance high voltage source to an electrode. Otherwise, a low capacitance high voltage source, such as a piezoelectric voltage source, may be used.
In one aspect, the present invention provides an inhaler capable of supplying opposite polarity comminutions to the nasa

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