EP2739334A1 - Inhalateur de poudre - Google Patents

Inhalateur de poudre

Info

Publication number
EP2739334A1
EP2739334A1 EP11807852.6A EP11807852A EP2739334A1 EP 2739334 A1 EP2739334 A1 EP 2739334A1 EP 11807852 A EP11807852 A EP 11807852A EP 2739334 A1 EP2739334 A1 EP 2739334A1
Authority
EP
European Patent Office
Prior art keywords
capsule
passage
improvement
fact
mouthpiece
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11807852.6A
Other languages
German (de)
English (en)
Inventor
Victor Esteve
Eric Zembrod
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Emphasys Importadora Exportadora e Distribuidora Ltda
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2739334A1 publication Critical patent/EP2739334A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001—Particle size control
    • A61M11/003—Particle size control by passing the aerosol trough sieves or filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0035—Piercing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033—Details of the piercing or cutting means
    • A61M15/0041—Details of the piercing or cutting means with movable piercing or cutting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008—Electronic counters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/14—Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • This Invention addresses technical and functional enhancements introduced into an inhaler of the type developed particularly for use with inhalable powdered medications prepared in capsules containing a single dose.
  • This device is widely used to inhale medications for the treatment of respiratory problems, where each capsule may hold a single dose or not.
  • the known devices generally present their respective innovative characteristics, although in most cases these characteristics are incorporated in the basic parts, such as the compartment for inserting a single dose capsule containing powdered medication; means for perforating the capsule at two opposite points at least, means for two opposing points at least, forming small openings that form outlets for the powdered medication; structure for the air inflow created by aspiration channeling this flow to a breakdown chamber and the consequent blending thereof with the air flow; and a mouthpiece structure for inhaling the air flow with the medication.
  • the single dose capsule has practically resulted in the establishment of a standard device that allows the powdered medication to be inhaled efficiently from a capsule, allowing its use in different types of treatments for respiratory problems, many of them chronic and widespread, including asthma, bronchitis and Chronic Obstructive Pulmonary Disease (COPD).
  • COPD Chronic Obstructive Pulmonary Disease
  • Rigid gelatin or HPMC capsules containing excipients and micronized active substances, either individually or in combination, are used in these inhalers.
  • the known devices for inhaling powdered medications prepared in capsules work with the capsules held in a receptacle as taught in, for example, EP1350532A2 and US3906950A; or loose in a breakdown chamber with dimensions that are large enough to subject the capsule to specific movements, as taught in, for example, in documents: BRP10415711A, BRP10501263A, BRP10710078, EP0911047A1 , US5048514A, WO2004052435A1 , WO2005044353A1 , WO2006051300A1 , WO2007116002A1 , CA2391466C, EP1270034A2, US3991761A, US7284552B2 and WO2005113042A1.
  • Dry powdered formulations prepared in capsules consist mainly of a blend of lactose and micronized active substances that must be broken down during inhalation in order to allow the release of the dose with an efficient percentage of fine breathable fractions, or breathable fraction (considered as particles smaller than 4.6 ⁇ micra).
  • the breathable fraction is the percentage of the formulation reaching the lower portion of the lung, determining the efficacy of the product. For dry powder inhalers with capsules, this percentage may vary between 15% and 50%; however, the percentage values found for registered products if deemed efficient, acknowledged as innovative or as market benchmarks.
  • One of the parameters for analyzing the characteristics of a powdered medication inhaler is through its flow resistance, which determines the air volumes entering the inhaler in L/min (liters per minute). This volumetric flow may be calculated by using flow resistance at a specific inhalatory pressure in kPa (or pressure drop).
  • the 4kPa parameter is mentioned as this is given by the European pharmacopeia and USP as the inhalatory pressure parameter (pressure drop) to be used for adjusting equipment and for in vitro analyses of formulations in powder inhalers.
  • inhalers that work in a stable manner with greater inhalatory resistance (pressure drop), meaning at less than 60L/min entering the inhaler at a pressure of 4kPa.
  • inhaler in order to ensure efficiency for the inhaler, it should ideally present high inhalatory resistance with air flow less than 60L/min entering the inhaler at a pressure of 4kPa, which does not occur with inhalers whose capsule spins horizontally during inhalation, as exemplified in patents: BRP10501263A, BRP10710078, CA2391466C, EP1270034A2, US3991761A, US7284552B2 and WO2005113042A1.
  • these inhalers also have the characteristic of lower inhalatory resistance, allowing an inflow of 80L/min or more into the inhaler at a pressure of 4kPa.
  • inhalers with greater inhalatory resistance are probably prompted by the weaker pulmonary capacity of patients affected by respiratory diseases. In these cases, is recommendable to offer inhalers that allow the dose to be released with the desired respiratory fraction, even for users with less pulmonary capacity.
  • an inhaler is desirable that can ensure air flow stability at different inhalatory flow configurations of less than 60lJmin, at a pressure of 4kPa.
  • Dry powder inhalers that operate with the capsule inserted into a compartment or a chamber where the capsule is vertical, such as those described in patents: BRP10415711A, EP0911047A1 , US5048514A, W02004052435A1 , W02005044353A1 , W02006051300A1 , W02007116002A1 and US3906950A, are generally designed to operate with greater inhalatory resistance, although their individual construction characteristics may present differences in efficiency in releasing the dose and the resulting pulmonary deposition profile.
  • the formulation release profile of the capsule compartment is also influenced by the manner and site where the capsule is opened. Normally, dry powder inhalers use needles or pins to pierce the capsule at its ends. This is designed to ensure that the air flow also penetrates the capsule through a vortex, encouraging the creation of the spray in the chamber housing of the capsule, resulting in a mixture of the air with the inhalant substance that flows through the mouth piece, and from there to the lungs.
  • Some powdered inhalers with greater inhalatory resistance such as for example, those described in documents W02005/044353 and W02004/052435A1 , have the capsule perforated on the side, and work with the capsule in a vertical position, presenting a pulmonary deposition profile differing from those that work with the capsule in a horizontal position and with less inhalatory resistance.
  • Another purpose of the invention is to provide means that allow the capsule itself to serve a real air flow control valve and concomitantly, this effect also causes repetitive impacts of the capsule against the walls of its chamber in order to improve the outflow of the powder and its breakdown, in order to achieve a specific percentage of fine breathable fraction (particles smaller than 4.6 ⁇ micra), which would enhance the efficacy of the medication or even bring its level of efficacy up to a specific benchmark standard.
  • the inhaler has been improved in its air / powder mixture chamber, more specifically at the air flow outlet and, in order to do so, a passage was introduced in the roof of this chamber with specific geometry, carefully dimensioned, normally rectangular, which constitutes an outlet for the inhalant, with the length of this outlet also being preferably equal to the length of the cylindrical part of the capsule (except rims) and its width is approximately 1/3 or less than its diameter.
  • this opening is fitted with a sieve-like structure at an appropriate mesh, in order to retain possible particles whose dimensions are not appropriate for inhalation.
  • the capsule is subject to a variety of rotating and rectilinear movements in the vertical or horizontal positions, consequently leading to the affirmation that, as the air flow enters the inhaler, the capsule rotates horizontally like a propeller and is concomitantly moved outwards and downwards, hitting the bottom and roof of its chamber.
  • a specific effect occurs, because as a given movement, the capsule and the outlet are aligned, thus producing a valve effect, meaning that the capsule is practically sucked into the rectangular outlet and at this moment the airflow is reduced for a fraction of a second, due to the rotation of the capsule, thus defining a new standard of functioning through which the air outlet from the capsule chamber is blocked intermittently during inhalation.
  • This improvement is presented in an alternative form for the release of inhalable powdered formulations with a more efficient pulmonary deposition profile for an inhaler that functions with the capsule in a horizontal position.
  • This invention describes an improvement in construction for a version of a powder inhaler that functions with a capsule subject to a horizontal rotating movement, which offers an efficient powder release profile with high inhalatory resistance, in contrast to the standard model for dry powder inhalers that work with the capsule in a horizontal position and with lower inhalatory pressure.
  • FIGURE 1 represents an isometric view showing the inhaler with the cap displaced and the capsule receptacle in position in order to receive the capsule;
  • FIGURE 2 shows a view in elevation presenting the inhaler in cross section;
  • FIGURE 3 illustrates the cross section view indicated in the previous FIGURE, highlighting the construction details of the 5 breakdown chamber
  • FIGURE 4 is another view in elevation showing the inhaler in cross section; however, in this view the device is in the action position for perforating the ends of the capsule;
  • FIGURE 5 displays a set of views illustrating the l o functioning of the equipment as a whole
  • FIGURES 6A, 6B, 7A and 7B reproduce the cross sections indicated therein, showing details of the flow guide tube
  • FIGURES 8A, 8B, 9A and 9B are respectively a perspective and a lower view highlighting the restrictive passage of the flow 15 guide tube with the sieve-like structure-like structure;
  • FIGURE 10 shows in diagram form the behavior of the capsule during the functioning of the known device
  • FIGURE 11 represents a diagram view of the behavior of the capsule in the inhaler, according to this invention.
  • FIGURES 12 and 13 show cross sections, highlighting a specific characteristic of the flow guide tube, whose upper end serves as an indicator of when the capsule is perforated, in order to form radial openings around its ends;
  • FIGURE 14 illustrates a view in cross section and 25 two enlarged details, highlighting the construction of the primary intake point for the inhalation air flow
  • FIGURES 15 and 16 show, respectively, a side view and a cross section, highlighting an alternative type of construction for the primary intake point of the inhalation air flow;
  • FIGURES 17 and 18 display cross sections highlighting an optional construction or the flow guide tube with a rim at its upper end;
  • FIGURE 19 reproduces a view in cross section showing a dimensional characteristic of the breakdown chamber
  • FIGURES 20 and 21 show, respectively, a front view and an isometric view, highlighting an optional characteristic for the construction of the inhaler, making previsions for transparent parts that allow an inside view to ensure the correct positioning of the capsule before it is opened or perforated.
  • FIGURES 22 to 25 present isometric views at different angles, with and without cross sections, showing details of the alternative internal and external construction of the tube; and FIGURES 26 to 29 show isometric and side views at different angles, highlighting the capsule receptacle and its construction variant.
  • this Improvement of a Powder Inhaler is applicable to a type that has been developed especially for use solely with inhalable powdered medications prepared in capsules containing a single dose, such as that taught in documents W02007/098870 (BRP10710078), consisting of: - base housing (1 ) with a cross section that is normally oval and completely hollow;
  • capsule housing (C) containing powdered inhalant medication, and means for such capsule receptacle to return to the initial position aligned with the longitudinal axis of the base housing (1);
  • a moveable mouthpiece (4) affixed on the upper part of the base housing (1), with this mouthpiece having a cap on the outside (5), while on the inside it can also be connected to the base housing, and also has the means to be moved vertically downwards or outwards including a helical spring (6), that functions in cooperation, allowing this mouthpiece to run vertically downwards and upwards, with the former responding to manual pressure that exceeds the strength of the spring (6), and the return movement upwards is due to the force of this helical spring (6);
  • the above-mentioned mouthpiece (4) also has means to establish an inward air flow from outside and is hollow in order to do so, forming a vertical passage (9) for the inhalant, whose lower end is connected to the capsule receptacle (2) which, above the slot-in cradle (3), has a wider portion that constitutes the breakdown chamber (10), cylindrical, with a diameter slightly larger than the length of the capsule (C), and also has a tangential secondary air intake point (11) positioned between the walls of the capsule receptacle (2) and the base housing (1) which in turn has one or two primary air intake points (12), with a pocket forming between them (13) which improves the stability of the air flow created when the patient breathes in during the inhalation process.
  • the inhalation process begins when the snap-in capsule receptacle (2) is packed with a capsule (C) containing powdered medication.
  • the capsule (C) slots smoothly into the cradle (3), avoiding movement.
  • the capsule receptacle (2) is snapped back into its original position (closed)
  • the capsule remains in a stable position so that the opening device (7) can be brought into action by pressing the mouthpiece (4) through its surrounding shoulder, while the needles (8) move downwards and radially perforate the ends of the capsule (C), forming openings (S) for the outflow of the powdered medication, which occurs only when the user breaths in through the mouthpiece.
  • Such aspiration results in an airflow that runs through the primary intake point (12), the air pocket (13) and the secondary intake point (11 ) tangentially reaching the interior of the breakdown chamber (10), where the vortex effect causes an outflow from the capsule (C) in its cradle, (3) at which time it starts to spin and, due to the restrictions of the chamber (10), during this spinning movement it nevertheless remains in a horizontal position.
  • the capsule movements allow the outflow of the powder that it holds, allowing the air/powder mixture to be formed by the vortex in the chamber (10), which can flow out along the conduit (9) and reach the lungs of the user.
  • FIGURE 10 shows in a diagram the behavior of the capsule (C) in a known device where (F) is the air flow and (T) is the outlet passage to the air / powder mixture.
  • centrifugal force (G) moves the powder towards the outlets at the ends of the capsules 0493
  • an IMPROVEMENT OF A POWDER INHALER is characterized by the fact that the passage (14) for the air / powder mixture located between the conduit (9) and the chamber (10) is restricted and has a geometry that is long enough to cause such effects on the capsule (C) while it spins in the chamber (10) during inhalation: a) intermittent block valve - obstruction of the passage (14) by the capsule (C), more precisely by its cylindrical part, briefly and intermittently, with such obstruction of the passage (14) being repeated at every half turn (180°) of the capsule or when it is aligned with the passage (14); and b) breakdown of the powder in the capsule (C) during its impact against the roof of the breakdown chamber (10), which occurs through suction whenever the capsule (C) is aligned with the passage (14).
  • the passage (14) is normally rectangular.
  • the dimensions of the passage (14) are proportional to the dimensions of the capsule (C), with the length of this being preferably smaller than or equal to the length of the cylindrical part of the capsule (C), while the width is around 1/3 or less than the diameter of the capsule (C).
  • the passage (14) includes a sieve-like structure (15) for trapping any fragments that might be inhaled, such as those from the capsule itself.
  • the passage (14) is configured at the lower end of the flow guide tube (16), centralized and housed on the inner side of the mouthpiece (4), where its height is defined by two functional parts (P1 and P2), with the second or upper part fitting into this mouthpiece (4), while the lower part (P2) narrows inwards (17) and outwards (18), internally and externally, helping form the passage (14) positioned above the sieve-like structured 5) which, in turn, constitutes the roof of the breakdown chamber (10).
  • the inner passage (9) of the tube (16) presents a cross section with an area equivalent of between one quarter and three times the diameter of the capsule (C), regardless of whether such cross section is circular or not, or whether such passage (9) narrows or not.
  • the external diameter or size of the flow guide tube (16) must fit tightly against the inner side of the vertical neck (19) that, in addition to forming an integral part for being firmly affixed to the mouthpiece structure (4) and base (1), also presents external details that serve as a runner guiding the vertical movement of the mouthpiece (4) and its piercing device (7).
  • a preparation of the inhaler illustrated in FIGURE 5, is the same as that described previously, while the air flow entering this device follows the same path and, once in the breakdown chamber (10), the capsule (C) spins in a horizontal position, meaning its longitudinal axis is in a horizontal position. This rotation causes centrifugal acceleration in the powdered medication that it contains and consequently it moves towards the end of the capsule towards the openings (S) pierced by the needles, (8), where the air flow of these openings produce an effect similar to the venturi effect, meaning that the powder consequently leaves the capsule and blends with the air, moving out through the passage (14) and the longer conduit (9) in order to progress to the lungs of the user.
  • FIGURE 11 presents a diagram showing the behavior of the capsule (C) with the improvement in question, through which it may ascertained that when the capsule (C) is driven through the passage (14) by the movement generated by the air vortex in the chamber (10) this passage (14) alters the behavior of the capsule (C), which is spinning horizontally, meaning along its longitudinal axis (E) in a horizontal position.
  • This rotation means that, at a specific moment ( Figures 7A to 9A) the capsule is longitudinally aligned with the longitudinal axis of the passage (14).
  • This alignment triggers a sequence of effects, through which the capsule is first sucked against the passage (14), serving as a temporary block valve, although for a very brief period of time.
  • the tube (16) and the mouthpiece (4) may constitute a single part and, in order to do so, the inner part of this mouthpiece is formed by the construction details of the tube (16).
  • additional air passages running from the chamber (10) to the inside of the tube (16) are desirable in certain situations, in addition to that defined by the sieve-like structure (15) together with the narrow passage (14).
  • one or more adjacent openings (30) are positioned on the sievelike structure (15), preferably two openings, one on each side of those forming this sieve-like structure (15), with such openings (30) also positioned off the longitudinal axis of the openings that form the sieve-like structure (15) and consequently off the alignment axis between the capsule (C) and the narrow passage (14) and when this alignment occurs, the openings (20) serve as supplementary air flow passages, whereby this intermittent impact occurs with less intensity, although continuing to function in the same manner.
  • the flow guide tube (16) presents sufficient height (H) in order to comply with two conditions: a) its upper end is built in under the side of the mouthpiece (4) in compliance with a specific elevation level (C 1 ) when the above-mentioned mouthpiece (4) is in the usage position, and b) its upper end is slightly exposed, in compliance with a specific elevation level (C 2 ) when the mouthpiece (4) which at its lowest position when perforating the capsule (C), with this exposed section constituting an indicator that the capsule (C) has been perforated (opened).
  • H height
  • FIGURE 14 shows another characteristic of this improvement because, as already mentioned, in order for the inhaler to reach ideal efficiency, it must present high inhalatory resistance with a stable air flow below 60Umin entering the inhaler at a pressure of 4kPa. In order to achieve these characteristics, the breakdown chamber (10) must P T/BR2011/000493
  • each secondary air intake point (12) also has a supplementary deflector wall (20), positioned in parallel to the inner side.
  • At least one primary intake point (12) makes provision for a side wall of the base housing (1), stating that this wall (20), might or might not be supplementary, and offers almost the same desired effect.
  • the flow guide tube (16) has a truncated-cone rim (21) that opens and slides along the inner diameter of the moveable mouthpiece (4) closing the space between these parts, with this truncated- cone rim also being positioned below the upper end of the flow guide tube (16), at sufficient distance to ensure that it always remains on the inner side of the mouthpiece (4), even when this is pressed downwards to perforate or open the capsule (C), as shown in Figure 18, keeping the exposed tip in compliance with a specific elevation level (C 1 ).
  • a tangential secondary air intake point (11) moves downwards from the roof of the breakdown chamber (10) or the plan defined by the passage (14) or up to a height defined by the elevation level (B) which corresponds to preferentially one half or less of the diameter of the capsule (C) and a total height (H) slightly larger than the diameter of the above- mentioned capsule (C).
  • transparent means are addressed (22) in the capsule receptacle (2) and its outer wall (23) that are sufficient to see the capsule (C) before it is perforated or opened.
  • the transparent means are defined preferably by a window (24) in the outer wall of the capsule receptacle (2) which in turn has at least its breakdown chamber (10) including the cradle (3) made from transparent material.
  • the transparent parts confer ideal means that ensure a clear view for ascertaining the correct positioning of the capsule (C) before it is opened or perforated and, if this occurs, the upper end (elevation level C 2 ) of the tube (16) is exposed, confirming that the operation was completed correctly.
  • the lower part (P1) of this flow guide tube (16) is widened into an elliptical trunk shape (25), whose longer side fits over a modified sieve-like structure with the same shape (26) that traps fragments.
  • the longer longitudinal axis (El) of the ellipse is large enough to correspond to the length of the capsule (C), which also occurs with the transversal axis (E2) that is in turn more flexible and may vary in size, being larger, the same or smaller that the diameter of the capsule (C), simultaneously complying with the condition for forming a very narrow passage or not.
  • the elliptical shape of any size within the desired dimensions allows the functioning to be practically the same as already described, although fine-tuning can ensure compliance with specific pulmonary deposition standards, and performance stability with a high resistance inhalatory flow, meaning that the particles of the medication are properly broken down, forming a blend of air and powder with a stable flow, in distinct inhalatory flows of less than 60L/min at a pressure of 4kPa, in order to attain a specific percentage of fine breathable fraction (particles smaller than 4.6 ⁇ micra), thus enhancing the efficacy of the medication or bringing its level of efficacy up to a specific benchmark.
  • this flow guide tube (16) presents a modified inner passage with a spiral feature (27) like a thread that, in turn, showed through laboratory tests that this construction is desirable in order to obtain different outcomes, although maintaining the desired parameters for the breakdown of the particles of the medication and the percentage of its breathable fraction.
  • FIGURES 26 to 29 show another preferred construction for the modified tangential secondary air intake point (28) that in this case also runs downwards from the top of the upper edge of the capsule receptacle (2), where a portion of the rounded wall (29) partially covers this secondary intake point, producing a desired restrictive effect that enhances the air flow control and consequently comprises a fine-tuned adjustment to the inhalatory resistance with less than 60L/min at a pressure of 4kPa.
  • the purposes mentioned above are materialized this improvement, offering an alternative way of ensuring the efficacious release of inhalable powdered formulations through an inhaler using capsules with high inhalatory resistance and with the capsule functioning in a horizontal rotating position.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des améliorations apportées à un inhalateur de poudre, constitué d'un logement de base (1), d'un réceptacle pour capsules (2) de type à encliquetage et d'un embout buccal amovible (4), à l'intérieur duquel se trouve un dispositif (7) destiné à ouvrir la capsule (C) contenant le médicament sous la forme de poudre, contenue dans une chambre de décomposition (10), avec des points de prise d'air (11 et 12) et un orifice de sortie (14) pour l'air mélangé avec la poudre, l'orifice de sortie (14) étant intégré au conduit (9) de l'embout buccal (4) ; le passage susmentionné (14) pour le mélange air/poudre situé entre le conduit (9) et la chambre (10) est restreint et suffisamment long pour entraîner deux effets dans la capsule (C) alors qu'elle tourne dans la chambre (10) durant l'inhalation : a) l'obstruction de la valve du passage (14) par la capsule (C), plus précisément par sa partie cylindrique, brièvement et par intermittence, cette obstruction du passage (14) étant répétée chaque fois que la capsule fait une moitié de tour (180°) ou qu'elle est alignée sur le passage (14) ; et b) impact de la capsule (C) par succion contre le haut de la chambre de décomposition (10) chaque fois que la capsule est alignée sur le passage (14) et que son obstruction est totale, cet impact étant suffisant pour neutraliser la compaction de la poudre au niveau des extrémités de la capsule (C) pendant sa rotation.
EP11807852.6A 2011-08-04 2011-12-21 Inhalateur de poudre Withdrawn EP2739334A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/BR2011/000279 WO2013016784A1 (fr) 2011-08-04 2011-08-04 Inhalateur de poudre sèche
PCT/BR2011/000493 WO2013016787A1 (fr) 2011-08-04 2011-12-21 Inhalateur de poudre

Publications (1)

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EP2739334A1 true EP2739334A1 (fr) 2014-06-11

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EP11807852.6A Withdrawn EP2739334A1 (fr) 2011-08-04 2011-12-21 Inhalateur de poudre

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EP (1) EP2739334A1 (fr)
BR (1) BR112014002724A8 (fr)
WO (2) WO2013016784A1 (fr)

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EP3159030A1 (fr) 2015-10-23 2017-04-26 Presspart Manufacturing Ltd. Inhalateur de poudre sèche

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WO2016116629A1 (fr) 2015-01-23 2016-07-28 Sandoz Ag Appareil et procédé de production d'un profil de flux
PT3111978T (pt) 2015-07-03 2021-12-06 Novartis Ag Inalador adaptado para ler informação armazenada num meio de armazenamento de dados de um recipiente
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Also Published As

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BR112014002724A2 (pt) 2017-06-13
WO2013016787A1 (fr) 2013-02-07
BR112014002724A8 (pt) 2017-06-20
WO2013016784A1 (fr) 2013-02-07

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