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  InhalerUSPTO Application #: 20060021616Title: Inhaler Abstract: A dry powder inhaler device (DPI) is disclosed. When a user activates the inhaler, the DPI is capable of delivering a dry powder dose directly from a medicament container, loaded into the DPI. A method is also disclosed for delivering a dry powder medicament dose directly from a container to a user of a DPI, whereby a sealing foil of the container is being slit open concurrently with aerosolizing and entraining of the powder in the dose into the inhaled air. (end of abstract) Agent: Oblon, Spivak, Mcclelland, Maier & Neustadt, P.C. - Alexandria, VA, US Inventor: Mattias Myrman USPTO Applicaton #: 20060021616 - Class: 128203150 (USPTO) Related Patent Categories: Surgery, Respiratory Method Or Device, Means For Mixing Treating Agent With Respiratory Gas, Particulate Treating Agent Carried By Breathed Gas The Patent Description & Claims data below is from USPTO Patent Application 20060021616. Brief Patent Description - Full Patent Description - Patent Application Claims
REFERENCE TO PRIOR APPLICATIONS [0001] This application claims priority to Swedish patent application SE0401453-6 filed Jun. 7, 2004, incorporated herein by reference. TECHNICAL FIELD [0002] The present invention relates to a dry powder inhaler device for metered dry powder medicament doses, and particularly to a single dose inhaler. In a preferred embodiment the inhaler is one relying on a user providing a necessary action/force in order to deliver a selected dose made available in the inhaler. [0003] Additional advantages and other features of the present invention will be set forth in part in the description that follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from the practice of the present invention. The advantages of the present invention may be realized and obtained as particularly pointed out in the appended claims. As will be realized, the present invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the present invention. The description is to be regarded as illustrative in nature, and not as restrictive. BACKGROUND [0004] The dosing of drugs is carried out in a number of different ways in the medical service today. Within health care there is a rapidly growing interest in the possibility of administering medication drugs as a powder directly to the airways and lungs of a patient by means of an inhaler in order to obtain an effective, quick and user-friendly delivery of such substances. Because the efficacy of inhaled doses often are much higher than e.g. orally administered capsules, the inhalation doses need only be a fraction of the medicament powder mass in an oral capsule. Thus, there is an increasing demand for medicament compositions and small and exact inhalation doses of dry powder with low relative standard deviation (RSD). The doses should be available in different sizes, such that they can be easily selected by a user and administered by a dry powder inhaler device. [0005] The active substance in dry powder form, suitable for inhalation needs to be finely divided so that the majority by mass of particles in the powder is between 1 and 5 .mu.m in aerodynamic diameter (AD). Powder particles larger than 5 .mu.m tend not to deposit in the lung, when inhaled, but to stick in the mouth and upper airways where they are medicinally wasted and may even cause adverse side effects. [0006] In WO 02/00280 A2 and U.S. Pat. No. 6,655,381 B2, an inhaler comprising a magazine holding a rigid unitary magazine including a plurality of integral reservoirs is described. Each reservoir will hold a pre-metered dose of dry powder sealed with a foil. [0007] In WO 03/66470 A1, GB 02 385 020 A, and WO 03/15857 A1 an inhaler using compartments to hold the pharmaceutical formulation is described. The compartments have a first and a second face that will be sealed with a foil. A separate part inside each compartment is designed to rupture the foil before inhalation and the documents discuss weakening special sections in the foil to make the opening easier and more reliable. [0008] In WO 01/30430 A1 a dosage unit for dry powder medicaments is described. The dosage unit is possible to incorporate into a dry powder inhaler such as the one described in WO 02/00279, the dosage unit having a slidable chamber in a sleeve and an openable closure member possible to fit into the dry powder inhaler device. The dosage unit is described to have a cover of substantially the same diameter as the sleeve or being of a frangible material. A separate part inside the device will then push the cover open or rupture the frangible material. [0009] In U.S. 2002/0033176 A1 a dry powder medicament inhalator is described, which is possible to load with a medicament cartridge. The inhalator uses an inhalation activated flow-diverting means for triggering the delivery of the medicament using a lancet to penetrate the medicament cartridge. [0010] Metered dose inhalers of prior art, as in the above examples, often leave the powder dose exposed to the surrounding atmosphere for a long time. This depends on the inhaler design and the design of the dose container. Barrier properties of the container embodiments are not discussed, leaving the question unanswered of how adequate protection is secured of the fine particle dose of the enclosed medicament during transportation, storing and in-use. [0011] Thus, there is a need for improved dry powder medicament doses loaded in high integrity dose containers adapted for insertion into dry powder inhalers guaranteeing consistent high quality administration of such doses. INHALER DRAWBACKS COMMON IN PRIOR ART [0012] In prior art, opening of a container for a metered dose to make the dose accessible for inhalation inside a DPI is accomplished in many different ways. If dose capsules are used then e.g. the capsule is split in two and the content poured out in an intermediate area in the DPI from where the powder is later aerosolized. Another common method is to punch one or more holes in the capsule, blow air into the capsule and optionally vibrate the capsule such that the powder in the dose can be aerosolized and sucked out of the capsule. In the case of a blister container, the cover foil can be peeled off such that the dose is made available directly from the open blister or else poured out in an intermediate area for inhalation. [0013] A prior art container or capsule is thus opened in a first step and aerosolizing is begun in a second step. The time between step 1 and step 2 is different from one DPI to the next, depending on the deployed technical solution, but in many cases the period is not defined and can be anything up to minutes and hours depending on the actions of the user. This is not acceptable from a medical point of view if the dosage can be detrimentally affected by being exposed to the environment inside or outside of the DPI. [0014] Yet another drawback of prior art containers is that the stream of air sucked in to aerosolize the dose attacks all of the powder in the dose at the same time, so that the shearing power of the air stream is distributed over a large area where the dose is stored and the aggregates and particles in the dose are arbitrarily subjected to very different, uncontrolled shearing forces depending on how the powder and particle clusters in the dose are distributed relative the air stream. Most of the powder in the dose is delivered instantaneously with no control of the timing. Where holes are made in the container, e.g. a capsule or a blister, by a sharp, pointed tool or needle, edges of the broken container material will bend inwards towards the dose and the edges may then disturb the flow of air into the container, such that some parts of the dose are not properly aerosolized and de-aggregated. [0015] In some cases all of the powder in the dose is not subjected to the same power of shearing stress because the airflow is unevenly distributed across or through the dose. This tends to further hamper the delivered fine particle dose and raise the proportion of retained powder in the container. [0016] Another problem is incident to aerosolizing a dose in a prior art container and that is that the speed of the aerosolizing air stream starts at zero when the aerosolization process begins. The consequence is that most of the dose is quickly sucked up in aggregated form and the aggregates cannot then be completely de-aggregated during the transport through the air channel of the DPI before entering the airways of the user. [0017] Because of these drawbacks a high degree of de-aggregation is difficult to achieve consistently, and the delivered fine particle dose is relatively small as a percentage of the metered dose. SUMMARY [0018] The present invention, on the other hand, solves these problems. In a preferred embodiment of the present invention, when applied to a suitably designed dry powder inhaler device (DPI), a certain suction power must first be applied to a mouthpiece of the DPI, before e.g. a valve opens to let air into the appropriate air channel in the DPI and further into a suction nozzle connected to the mouthpiece. This ensures that a fairly high air speed begins to build up around the inlet aperture of the suction nozzle. A seal opening operation is released simultaneously with opening of the air valve, but there is an interval before the opener contacts and penetrates the seal at one end of the container. In a relative motion, opener vs. container, the seal is gradually slit open and simultaneously folded away. The suction nozzle follows the opener in its track, but before the suction nozzle reaches the nearest dose particles inside the container, the air speed into the inlet aperture of the suction nozzle has already accelerated to a high speed, sufficient to de-aggregate the powder aggregates that are accessed a moment later. Following the opener closely in its track the powder in the dose is gradually aerosolized and de-aggregated at the same time. Keeping the distance constant between the inlet aperture of the suction nozzle and the dose bed, i.e. the container bottom, ensures that the shearing power of the air stream going into the nozzle is evenly distributed and therefore used to its full potential in aerosolizing and de-aggregating all of the powder in the dose, regardless of where the powder is located on the dose bed of the container, presuming that the dose is in the area covered by the nozzle motion. Retention is minimized. The time period between exposing the dose to the atmosphere and delivering the dose to the airways of a user is clearly extremely short, normally only fractions of a second, ensuring that the dose is as unaffected as possible by the surrounding atmosphere, when inhaled. [0019] The folded edges of the cut seal may be folded back in the original position by the DPI, which closes, at least partially, the container so that any powder retained in the container does not fall out into the mechanisms of the DPI or into an air channel, where the powder may affect the operation of the DPI or present a risk to the user. Continue reading... Full patent description for Inhaler Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Inhaler patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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