Therapeutic dry powder preparation

#The present invention relates to the use of inhaled drugs in treatment of human disorders and presents a therapeutic dry powder preparation and a method and a system for de-aggregation and dispersal into air of the preparation forming a medicinal formulation in connection with an administration to a user inhaling through a dry powder inhaler device, the powder comprising at least one pharmacologically active substance in the form of a finely divided dry powder.

#The dosing of drugs is carried out in a number of different ways in the medical service today. For a number of reasons, such as local treatment of lung diseases, replacement of injection therapy and for rapid onset of action, there is a large interest in administering drugs to the lungs of a patient. A number of different devices have been developed in order to deliver drugs to the lung,; e.g. pressurized aerosols (pMDIs), nebulisers and dry powder inhalers (DPIs).

#While inhalation of drugs already is well established for local treatment of lung diseases such as asthma, much research is going on to utilize the lung as a feasible entry into the body of systemically acting drugs. For locally acting drugs, the preferred deposition of the drug in the lung depends on the localization of the particular disorder and depositions in the upper as well as the lower airways are of interest. For systemic delivery of the medication, a deep lung deposition of the drug is preferred and usually necessary for maximum efficiency. With deep lung should be understood the peripheral lung and alveoli, where direct transport of active substance to the blood can take place.

#The invention, together with further objects and advantages thereof, may best be understood by referring to the following detailed description taken together with the accompanying drawings, in which:

#FIG. 1 illustrates in top and side views a metered dose formed as a strip on a target area of a non-perforated substrate member;

#FIG. 2 illustrates in top and side views another metered dose formed as a strip on a target area of a non-perforated substrate member;

#The present invention discloses a dose of a therapeutic dry powder preparation as a medication powder, prepared in advance for inhalation, which becomes highly de-aggregated and entrained in inhalation air when applied to a powder Air-razor method of de-aggregating and dispersing the powder particles into air.

#The medication powder comprises one or more pharmacologically active substances, such as proteins or peptides, and optionally one or more excipients. In the document the terms “powder” or “medication powder” are used to signify the substance in the form of dry powder, which is the subject of de-aggregation and dispersal into air by the disclosed invention and intended for deposition at a selected target area, the site of action, of a user's airways. Optional excipients may or may not de-aggregate in a similar way as the active pharmacological substance, depending on the design of the powder. For example, an ordered mixture comprises an excipient characterized by particles considerably larger than those of the pharmacologically active substance. Further examples of pharmacologically active substances in dry powder formulations, which are of interest for an administration by inhalation are the following:

#Ketobemidone, Fentanyl, Buprenorfin, Hydromorfon, Ondansetron, Granisetron, Tropisetron, Scopolamin, Naratriptan, Zolmitriptan, Almotriptan, Dihydroergotamin, Somatropin, Calcitonin, Erythopoietin, Follicle stimulating hormone (FSH), Insulin, Interferons (alfa and beta), Parathyroid hormone, alfa-1-antitrypsin, LHRH agonist.