Title of Invention

A DRY POWDER INHALER FOR LUNG THERAPY

Abstract

This dry powder inhaler has a smaller longer air flow tube, with a front air inlet with appropriate hole for slow, deep inhalation. The air inlet leads to a baffle having one or more holes for air to blow and spray t11e drug deposited in a drug deposit area. The drug, deposit area receives the drug from a hole on the air tube. The drug is blown and sprayed back through the mouthpiece into the wind passages as the air is drawn through the inhaler. The drug can be deposited by a drug enclosed between two films of a drug cartridge wound on a spool and the films when seperated, drops the drug on to the drug deposit area. The films are pulled apart by another spool that seperates the films, both spools being synchronously operated. The air tube, drug film and spools are enclosed along with the air tube.. The drug is deposited through the hole in the air tube or in the cartridge type, the spools are moved to separate and drop the drug in the drug deposit area, the long mouth piece is kept in mouth, air is sucked, the sucked air escaping through the holes in the baffle blow and spray the drug at back of throat for easy flow into wind pipes and lungs for good relief. The inhaler gives, with delivery of spray at the back of throat and not outside mouth as now, has no mouth wastage, and reliably delivers drugs to lungs for good effect even for children and elderly persons!

Full Text

A DRY POWDER INHALER FOR LUNG THERAPY Technical Field This invention in general relates to human necessities. More particularly this invention relates to medical equipments. Precisely this invention relates to a novel kind of dry powder inhaler for successfully delivering drugs to lungs where the drug is absorbed and works, producing relief State of Art in stress, only 15%efricient, leading to poor relief The new inhaler helps to spray and deliver into lungs correctly. Existing dry powder inhalers are of the single dose or multidose type .In all the existing dry powder inhalers the dry powder is dropped on to a site in the air path of the inhaler outside the lips, from where the powder is sucked. The sucking of dry powder from outside the lips is difficult and wastes the drug as mouth coating. The following description gives critical examination of the inhalers known in the art. It also discusses the shortcomings of the conventional dry powder inhaler. Further in order to over come the problem associated with prior art inhalers, the invention offers the solution to overcome the impediments in the consfruction and the process of using the inhaler. Constraints in the conventional dry powder devices are as follows: 1 .The drug has to be sucked from outside the mouth needing more force. 2. Spray starts outside the lip, diverges and spreads wasting spray into mouth. 3. Larger Air Inlet which produces ^hallow, fast inhalation and allows little time for drug deposition in the lungs. 4. Large Mouth Piece which is difficult for children and elderly to hold in mouth 5. Mouth Wastage due to combination of above factors. 6. Sucked air only carries big particles, that do not form a uniform mist. Accordingly the object of the invention is to identify the problem associated with the conventional dry powder inhalers. An extensive search has been carried out using the internet and related patent specifications were studied. Since the present invention is radically different in lower mouth coating, deep mouth spray formation, a baffle before the drug deposit area, structure, function and result, the inventor is unable to site any patent specification out of the available databases. The invention is directed to a novel type of inhaler which is most effective for children and aged who may not be in a position to suck [deep and vigorously ] and create the spray leading to poor utilization of the inhaler. Further the invention is addressed to the process of using the new inhaler. Accordingly it is the primary object of the inve^.lion to invent a novel inhaler which is unique in design and construction, working and use. It is another object of the invention to indicate a novel process by virtue of which, the inhaler c?n be effectively utilized. It is another object of this invention is to invent a novel inhaler which has a lower suction mechanism which helps to deposit the drug correctly. It is another object of this invention is to invent a novel inhaler which allows slow and deep inspiration of air, which gives more time for spray creation and spread of spray deeply into the lungs for better drug deposit and relief Further objects of the invention will be clear from the ensuing description. Summary of the invention : The new dry powder inhaler comprising of a smaller air inlet with an appropriate hole, the said air inlet leads to a baffle with one or more holes, the said hole leads to a drug deposit area [which on its top has a hole to drop the drug or in multi dose model a plastic illm with drug that can be pulled apart],the said drug spray escapes through a back mouthpiece into the lungs. The drug with the desired drugs and cxipicnts is used for release of spray. Statement of Drawings: These and other objects and features of the invention will become more apparent upon perusal of following description taken in conjunction with accompanying drawings wherein: Figure 1 shows in elevation the constructional details of conventional inhaler. Figure 2 shows the various components of the novel inhaler according to invention. Figure 3 shows the exploded view of the novel inhaler. Figure 4 shows the mechanism and spread of the drug mist originating from the novel inhaler inside the mouth. Figure 5 shows another embodiment of the invention with a multiple doses. DESCRIPTION OF PREFERRED EMBODIMENTS The following specification describes salient features of invention, the melliod of construction, the method of use and the advantages of the novel invention. The novel inhaler has smaller air inlet with a cover, to develop deep, longer inspiration. The air inlet leads to a baffle with one or more holes and leads to a drug deposit area [which has the needed drug]. This leads to a longer mouthpiece. The mouthpiece directs the spray into wind passages and lungs for better effect. The novel inhaler according to the invention is filled with the drug in the drug deposit area and kept in mouth, ?ir is sucked in through the air inlet, the drug is now released as a spray at the back of mouth piece which travels to lungs for better effect. The novel inhaler according to invention is better because of slow, deeper inspiration, longer mouth piece for maximal lung deposit. Special feature of the invention is that it is an easy inhaler with improved spray useful for inhalation therapy. Existing inhalers spray the mouth, need larger suction effort as the drug is sucked from outside the lips from a longer distance (difficult for kids and aged) and do not facilitate deep inspiration for drug spread in the lungs. The novel inhaler according to invention gives a spray with lower suction force spray (now made easy for kids 8c aged), directs more spray into wind passages and promotes longer and deeper inspiration for the spray to spread to all areas of the lungs. One of the salient feature of the invention is that the novel inhaler according to invention has a narrower air flow pipe comprising of a smaller air inlet [ for slow, deep inspiration] as the air is sucked, a spray formed by the baffle holes leads to the back mouthpiece (also longer for avoiding mouth coating). The same volume of air sucked through a smaller area takes longer time. The chest muscles also work deeper for forceful inhalation and spread of drugs. The dry powder inhaler creates the correct spray before maximal inspiration, smaller air inlet delays and deepens inspiration, and the longer mouthpiece correctly sprays into throat and wind pipes leading to lungs. The converttional single dose inhaler [rotainhaler] fig.l. consists of a body (1) with a large air inlet (2) at the top in which the drug capsule (3) is placed. The body has at its other end has a large area short mouth piece (4). The body on its inside has a spray area which receives the drug capsule . To use, the drug capsule is kept and broken and the mouth piece (4) is kept in mouth. Air is inhaled. Inhalation is shallow and fast as the mouthpiece area is large.. There is wastage of spray in the mouth as the spray is released outside the lip level and diverges, coating mouth. Children and elderly persons do not suck well to create a deep spray release. There is less response to the drug and device. The device has not been improved for decades. The object of the invention is to overcome the inherent defect in the device. To this end the new invention is addressed. Existing multi dose devices have the drug doses in a reservoir that feed the drug on to a blowing area [outside the lips] needing more suction and mouth coating that needs to be washed away by water! The new inhaler comprises of an air suction tube preferably of transparent plastic or metal fig.2.and fig.3.. At the front is the air inlet (1), the air inlet leads to a baffle (2)with one or more holes (3). At the back of this hole is the drug deposit area (4), which leads to the long mouthpiece (6). Another hole in the inhaler (5) helps to drop the drug on the drug deposit area. This hole is covered by a lid (10).. The mouthpiece (6) is long and has markings for adjustment of lips to throat distance, releasing the spray at back of throat! The drug is inserted in the hole (5) of the inhaler. As the air is sucked the inhaler resonates, creating a faint audible musical sound allowing a long pleasant inhalation! The novel device alerts the user to trigger the device in inspiration, does not spray into mouth, novely directs flow of mist maximally to air passages delivering correct doses, and is safe for children, aged, even in disorientation! The novel device"s mouthpiece is kept between the lips after drug is deposited.. The air inlet orifice allows air to be sucked in inspiration! The suction of air blows and sprays the drug! The drug has the needed drug(s) with additives to spray. The mouthpiece is longer and projects into the mouth deeper as in Figure 4. This produces a mist directed to the wind pipe and not to mouth! The drug is carried to distal air passages uniformly, because of deep and slow inhalation. The increased duration of inspiration also helps in spread of drug mist. The drug is delivered better maximally, without waste, for the user for the first time in a simple manner ! The inhaler is made of plastic with the orifices, incorporated as a unit or as separate segments easily assembled. To use, after drug deposit, the mouthpiece is kept in the mouth after adjustment of lip-throat distance and inspiration started. The drug is then sprayed into wind pipes and lungs. The deeper and prolonged inspiration spreads the drug spray, to all parts of lungs, for a better effect. In figure 5, another form of invention shows the multi dose inhaler with an air inlet (1) leading to spray path. The multiple doses of the drug is held between two films and wound on a spool (7). The films are separated to drop the drug on to the drug deposit area (4). Another spool (8) draws the film and separates after pillar (9). The film is separated by poles 11 placed between the spools to drop the drugs on to the drug deposit area. The spools are worked synchronously to move the film and drop the drug on the deposit area. The baflle (2) with hole (3) creates the spray! This multi dose device also releases the spray in the back of throat with no mouth waste. A filter of paper or fabric, to remove air bacteria may be used before the spray, but after the air inlet to clean the inhaled air. The device can be modified. The air inlet can have an adjustable hole, as the person wants for prolonged deep inspiration! The drug film may be mounted as in fig. 5 in the long axis of the inhaler! The mouthpiece tubes may be made as two and adjusted on a screw or sliding mechanism. Electronic sensing and spraying is possible but will make the device costly ^nd heavy. The mouthpiece may have markings for correct back of mouth spray, A rotating rod in drug deposit area may separate and form a uniform powder mist. The term "drug formulation" means active drug (or a physiologically acceptable solvate thereof) optionally in combination with one or more other pharmacologically active agents such as other antiinflammatory agents, analgesic agents or other respiratory drugs and opliuiuilly conlaining one or more cxcipicnl.s,. The Icim "cxcipicnls" us u.icd herein means chemical agents having little or no pharmacological activity (for the quantities used) but which enhance the drug formulation or the performance of the system. For example, excipients include but are not limited to surfactants, preservatives, Havorings, antioxidants, antiaggregating agents. It will be appreciated by those skilled in the art that the drug formulation for use in the invention may, if desired, contain one or more other pharmacologically active agents. Such medicaments may be selected from any suitable drug useful in inhalation therapy. Appropriate medicaments may thus be selected from, for example, analgesics, e.g. codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g. diltiazem; antiallergics, e.g. cromoglycate, ketotifen or nedocromil; anti infectives e.g. cephalosporins, pentamidine; antihistamines, e.g. methapyrilene; anti-inllammatorics, e.g. beclomcthasonc, fluticasone propionate, flunisolide, budesonide, tipredane or triamcinolone acetonide; antitussives, e.g. noscapine; bronchodilators, e.g. salbutamol, salmeterol, albuterol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, tcrbutaiine, isoelharinc, tulobuterol, orciprenaline,or(-)-4-amino-3,5-dichloro-.alpha.[[[6-[2-(2-pyridinyI) ethoxy] hexyl] amino] me thyl] benzenemethanol; diuretics, e.g. amiloride; anticholinergics e.g. ipratropium, atropine or oxitropium; hormones, e.g. cortisone, hydrocortisone or prednisolone; xanthines e.g. aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; and therapeutic proteins and peptides, e.g. insulin or glucagon and genetic fragments. It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts (e.g. as alkali metal or amine salts or as acid addition salts) or as esters (e.g. lower alkyl esters) or as solvates (e.g. hydrates) to optimise the activity and/or stability of the medicament and/or to minimize the solubility of the medicament. Particularly preferred drug formulations for Asthma contain lluticasone propionate (or a physiologically acceptable solvate thereof) in combination with a bronchodilator such as salbulamol (e.g. as the free base or the sulphate salt) or albuterol or salmctcrol (e.g. as the xinafoate salt). Combinations for the other diseases may be used for treatment. Drug formulations for use in the invention may be free or substantially free of formulation cxcipients e,g. surfactants and cosolvents etc. Such drug formulations are advantageous since they may be substantially taste and odour free, less irritant and less toxic than excipient-containing formulations. Thus, a preferred drug formulation consists essentially of tluticasone propionate, or a physiologically acceptable salt thereof, optionally in combination with one or more other pharmacologically active agents particularly salmeterol (e.g. in the form of the xinafoate salt). Further drug formulations for use in the invention may be free or substantially free of surfactant. The particle size of the particular (e.g., micronised) drug should be such as to permit inhalation of substantially all the drug into the lungs upon administration of the formulation and will thus be less than 100 microns, desirably less than 20 microns, and, in particular, in the range of 1-10 microns, e.g., 1-5 microns. It will be apparent to those skilled in the art that modifications to the invention described herein can readily be made without departing from the spirit of the invention. Protection is sought for all the subject matter described herein including any such modifications. Advantages of the new invention : 1. Slow and deep inhalation, as air is drawn through a smaller area of air inlet. 2. The device gives more time to spread of the spray. 3. There is an easier suction mechanism which is embodied for the first time. 4. There is no need for washing the mouth after the device is used as there is no mouth spray. 5. Useful for kids, old, who can now create the spray mechanism easily. 6. The spray is released at the back of the mouth and not outside the lip level, which easily goes into wind pipes and lungs for good effect. WE CLAIM: 1 A dry powder inhaler comprising of a long slender air tube with a front air inlet with appropriate hole for deep and long inhalation, the said air inlet leading to a baffle, the said baffle having one or holes the said baffle holes opening on to a drug deposit area, the said drug deposit area leading to a long mouth piece, the said mouth piece back spraying the drugs to lungs, the said drug deposit area gets the drug through a hole above the said drug deposit area in the single dose inhaler or through a spool that splits and deposits the drug on the said drug deposit area in the multi-dose inhaler. 2 A dry powder inhaler as claimed in claim 1, wherein the said air path has a baffle after the air inlet, but before the said drug deposit area, the said baffle has one or more holes to allow the sucked air to spray the drug back in to the air passages. 3 A dry powder inhaler as claimed in claim 1, wherein the said inhaler has a long and slender mouthpiece, the said mouthpiece having visible markings to adjust for correct positioning in back of mouth to spray into air passages. 4 A dry powder inhaler as claimed in claim 1, wherein the inhaler is made of transparent plastic for easy visibility. 5 A dry powder inhaler as claimed in claim 1, wherein the inhalation drug is single or combination of active pharmacological agents as needed. 6 A dry powder inhaler as claimed in claim 1, wherein the drug dropping hole of the single dose inhaler has a movable lid opened to drop the said drug on the drug deposit area and closed in inhalation 7.A dry powder inhaler as claimed in claim 1, wherein the multiple doses of drug or drugs is enclosed between two layers of polymer films, the said film with the drug is mounted in a rotatable spool, the said two layers separate over the drug deposit area to drop the drug on the drug deposit area, the said separated film is rolled on to another spool, the said spools being rotated synchronously to feed and drop the drug on the drug deposit area, the said films are separated between poles placed between the said spools in the multi dose inhaler. 8. A dry powder inhaler as claimed in claim 1, wherein the said active drugs are micronised particles for easy blowing, travel and deposit into the lungs for rapid relief 9. A dry powder inhaler as claimed in claim 1, wherein an air filter is placed between the said air inlet and the baffle to clean air before inhalation. 10. A dry powder inhaler as claimed in claim 1, wherein the air inlet hole is small and appropriate for slow, long deep inhalation for drug spray to spread and deposit deeply in the lungs. 11. A dry powder inhaler as claimed in claim 1, wherein the slender mouthpiece is long and projects in to back of mouth to release the spray directly into air passages of the lungs. 12. A dry powder inhaler as claimed in claim 1, wherein the small air inlet and baffle holes resonate and create an audible long sound for deep inhalation training.

Documents:

0085-mas-2002 abstract.pdf

0085-mas-2002 claims-duplicate.pdf

0085-mas-2002 claims.pdf

0085-mas-2002 correspondence-others.pdf

0085-mas-2002 correspondence-po.pdf

0085-mas-2002 description (complete)-duplicate.pdf

0085-mas-2002 description (complete).pdf

0085-mas-2002 description (provisional).pdf

0085-mas-2002 drawings-duplicate.pdf

0085-mas-2002 drawings.pdf

0085-mas-2002 form-1.pdf

0085-mas-2002 form-19.pdf

0085-mas-2002 form-5.pdf