Surgery – Liquid medicament atomizer or sprayer
Reexamination Certificate
2001-05-31
2002-11-19
Lewis, Aaron J. (Department: 3761)
Surgery
Liquid medicament atomizer or sprayer
C604S086000, C604S087000, C604S088000, C604S089000, C604S092000, C604S415000, C604S416000, C366S130000, C206S219000
Reexamination Certificate
active
06481435
ABSTRACT:
The present invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebuliser, and to a propellant-free active substance concentrate in which the active ingredient is present in highly-concentrated form for storage purposes. The cartridge according to the invention serves especially as a container for medicament formulations for use in nebulisers for production of aerosols for inhalative or nasal application, especially for use in propellant-free nebulisers.
In the International Patent Application WO91/14468 “Atomising Device and Methods” and also in WO 97/12687, cf.
FIGS. 6
a
and
6
B and the associated description, an apparatus for the propellant-free administration of a metered quantity of a fluid medicament for inhalative application is described. In such a nebuliser, a medicament solution is converted by means of high pressure into a lung-accessible aerosol and sprayed. For this kind of application, it can be necessary to decant the solutions which contain the active ingredients into containers so that only a small amount of air and gas residue is included. Containers which are suitable for this purpose, are, for example, disclosed in International Patent Application PCT/EP95/03183, to which express reference will be made for the purposes of the present invention. The containers described there are above all suitable for those medicaments which can be stored over a longer period of time in the form of an aqueous or ethanolic solution.
In order to increase the shelf-life of active ingredients in solution which break down after only a few months, DE 196 15 422 discloses a cartridge which has two chambers for the separate storage of the solvent and an active ingredient in the form of a powder or a compressed tablet. The cartridge is designed in such a way that when the cartridge is inserted in apparatus for the production of the aerosol (inhaler), the chamber which contains the active ingredient is penetrated by a canula in the inhaler, so that the active ingredient comes into contact with the solvent in the container and is dissolved. Although this cartridge for storing inhalation formulations in the aforementioned containers has many advantages, from time to time the canula of the inhaler, as specified, can become blocked when it penetrates the chamber which contains the active ingredient. For this reason, no medicament suspensions can be stored in the aforementioned chamber. Furthermore, it can not always be guaranteed that active ingredients formulated as a solid will dissolve sufficiently rapidly in the solvent, so that the desired active ingredient concentration can only be achieved with a time delay. In this way, trouble-free use of the inhaler charged with the cartridge is made difficult.
The present invention solves the aforementioned problems and also those known from the prior art in that a new two or multi-chamber cartridge (container) is provided where two or more components of the inhalation formulation can be stored separately from one another.
In particular, the invention relates to an apparatus comprising a closure-cap and a container which can be used as a cartridge (container) for nebulisers. In the cartridge, at least one active ingredient and one solvent of a therapeutic formulation specified for inhalative or nasal application can be stored separately until the cartridge is installed in the nebuliser as specified. As nebulisers, high-pressure atomisers and especially the high-pressure atomisers from WO91/14468 and WO 97/12687,
FIGS. 6
a
and
6
b
and the associated description, are particularly suitable. Here, the cartridge is shaped so that the separately-stored components can be mixed together during use of the cartridge in the inhaler without causing a blockage of the canula, so that the medicament preparation is formed, ready for use, within the shortest possible time, preferably within a few minutes and possibly within a few seconds. In the context of the present invention, it is unimportant whether the medicament formulation which is to be applied is a solution or a suspension; what is critical is that the formulation which is to be applied is a fluid formulation which can be converted by means of a nebuliser of the aforementioned type into an aerosol for inhalative or nasal application. For administration by inhaling using the inhaler described hereinbefore, however, formulations in the form of solutions are generally preferred to those in the form of suspensions.
Within the scope of this description, the expressions nebuliser, atomiser, inhaler and high-pressure atomiser, and also metering aerosol and aerosol are used as synonyms unless otherwise stated.
DESCRIPTION OF THE INVENTION
The present invention is constructed in a similar manner to the invention in the aforementioned document DE 196 15 422, to the entirety of which reference will expressly be made. As in DE 196 15 422, the cartridge according to the invention has at least two possible ways of storing formulations or ingredients of formulations: the container of the cartridge and another chamber which is preferably formed in the closure-cap of the cartridge. Some ingredients of the formulation to be administered are stored in the chamber until ready for use, while the remaining ingredients are stored in the container, including the majority of the liquid component. This liquid component contains the solvent or suspension agent, or the majority thereof, provided for administration, preferably a solvent, and optionally other components which will be specifically described more fully hereinafter. By the term “majority thereof” is meant that part of the formulation to be applied that is not already formulated together with the active substance in the chamber. In the following text, no great distinction is drawn between solvent and mixture of solvents, i.e. the term “solvent” includes a mixture of solvents, unless otherwise stated. Conversely, however, a mixture of solvents always comprises at least two fluid, chemically-different components.
Active substances can be stored in a pharmaceutically-stable manner in the abovementioned chamber over a fairly long period of time of, for example, several months or possibly years, especially active ingredients which cannot be stored in a pharmaceutically stable manner in ethanolic solutions over the aforementioned time span.
The chamber is preferably formed in the closure-cap; however, it may be located elsewhere in the cartridge, e.g. in the interior of the container.
For reasons of clarity, in the course of this description the expression “chamber” is used for both a single chamber and also for a plurality of chambers of the same type located directly adjacent to one another, unless otherwise specified.
The chamber has at least one but preferably two openings. The closure-cap is designed so that the contents of the chambers can be transferred into the interior of the chamber through the one opening which is present in every case by means of an external influence, even when the closure-cap seals the container tightly. This opening is hereinafter referred to as the inner opening.
In addition, the chamber can optionally have a further opening. In the cartridge's closed condition, a connection between the chamber and the external environment can be made by means of this opening, so that e.g. an object, such as e.g. a plunger, a stopper, a canula, a capillary or a rod can be introduced into the chamber from outside. This opening will hereinafter be referred to as the outer opening. It is expressly emphasised that the terms “inner opening” and “outer opening” purely serve to differentiate between the terms, and no direct conclusions with regards to the position or the mutual orientation of the openings are to be made. If necessary, the inner opening can also take over the function of the outer opening.
In a preferred embodiment, the chamber is characterised in that at least one of the op
Hochrainer Dieter
Zierenberg Bernd
Boehringer Ingelheim Pharma KG
Devlin Mary-Ellen M.
Lewis Aaron J.
Patel Mital
Raymond Robert P.
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