Title of Invention

AN IMPROVED DEVICE FOR ADMINISTERING ORALLY OR NASALLY METERED MEDICINAL COMPOSITION BY INHALATION

Abstract

An improved device for metered administration of medicament by inhalation orally comprising: a) a housing with an opening closing means pivotally attached for receiving a circular cartridge of medicament; b) said cartridge having a plurality of diskettes along its circumference to hold a predetermined quantity of medicament; c) each such diskette being sealed by a pierceable sepling means; d) a member for piercing the said sealing means and thereby penetrating into the said diskette; e) said piercing member being a hollow cylindrical part in fluid communication with an inhalation nozzle means containing a partition whereby upon piercing and inhalation by user, the incoming air stream on one side of the partition, lifts the medicament along with, before reaching the said nozzle means wherein f) said housing has a view window at a location below the said nozzle means to enable the user to ascertain the evacuation of medicament from the diskette pierced for use.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10] AN IMPROVED DEVICE FOR ADMINISTERING ORALLY OR NASALLY METERED MEDICINAL COMPOSITION BY INHALATION; ORIGINAL 681/MUMNP/2003 GRANTED 13-4-2004 CIPLA LIMITED, A COMPANY INCORPORATED UNDER THE INDIAN COMPANIES ACT, 1913, WHOSE ADDRESS IS 289, BELLASIS ROAD, MUMBAI CENTRAL, MUMBAI - 400 018, MAHARASHTRA, INDIA. THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES AND ASCERTAINS THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BEPERFOMED. TITLE An Improved device for metered administration of medicament by inhalation. FIELD OF INVENTION This invention relates to an improved device for administering orally metered dose of medicinal composition by inhalation. For patients suffering from asthma or similar recurring type of diseases, administration of medicinal preparations by inhalation orally is found to be more effective than administration of medicines by intravenous or intra¬muscular administrations. The patients suffering from asthma or similar diseases are advised self-administration of medicinal preparations by inhalation any time throughout the day when they get breathing inconvenience. Therefore, various devices for self-administration of metered dose of medicinal compositions by inhalation are already in existence, which can be carried by the patients conveniently. PRIOR ART In a measure to explain one of the prior art applications, reference is hereby made to the German publication DE 19704849A describing one such inhaler device using a tubular piercing member to pierce a cartridge of medicament. The tubular piercing member has a conical piercing tip with a plurality of holes for entry of the medicament. However this device suffers from the following drawbacks : (i). facility to judge the evacuation of medicament from cavity, upon inhalation, by user; ii). lack of sufficient fluid flow technology to ensure efficient delivery of medicament upon inhalation. It is, therefore, the foremost objective of the present invention to obviate the above drawbacks in the known such inhaler device containing medicament cartridge pierced open by a tubular piercing member. This invention provides an inhaler device containing cartridge loaded with multiple doses of metered medicinal composition, and facility for the user to visualize the evacuation of the medicament from cavity upon inhalation. The device also adds to its part, a simple and economical construction for making it available to a common man at an affordable price. With the above object in mind, this invention provides an inhaler device containing cartridge loaded with multiple doses of metered medicinal composition, comprising of a container formed of a circular lower chamber, an upper chamber in the form of a lid and a cartridge having multiple cavities with opening ends facing towards the lid. The lid has a tubular piercing member, which is in fluid communication with a nozzle. The fluid communication connecting the medicament to the mouthpiece is defined by a pathway preferably contains geometry, which is capable of increasing, or decreasing the velocity of the medicament inhaled for use, depending on the kind of the medicament formulation used. The nozzle is adapted for inhalation by mouth. The container has a view window below the nozzle, to enable the user to ascertain the evacuation of medicament from the cavity upon inhalation. The tubular piercing member and a lever exposed on the top end of the lid and configured to operate the piercing member are connected to a common fulcrum. The piercing member has a vertical baffle oriented diametrical to its hollow interior. In operative configuration, the piercing member remains inserted into the cavity loaded with medicinal . composition, and the free end of the lever remains lifted-up. A kinob with individual openings at its side walls, is welded to the upper portion of the tubular piercing member. The knob is pressed down by finger, to make the piercing member penetrate into the cavity of medicament. The container has an opening on sidewall for rotating the cartridge in clockwise rotation. The cavities in the cartridge are divided by projections extending radially. Every time at least one projection penetrates through the opening on the sidewall and remains exposed to rotate the cartridge in clockwise rotation. A ratchet mechanism comprising of zig-zag projections is provided in the cartridge. One slope of every zig-zag projection is configured as a curve, and the other slope is in straight line. A stopper member is positioned facing the slope in straight line, to prevent anticlockwise rotation of the cartridge. However, the curved configuration of the adjacent projection allows clockwise rotation of the cartridge. The stopper member is located in position such that radial projection remains exposed at the middle of the opening on the sidewall, and two cavities adjacent to the exposed projection become visible. The cartridge is made of transparent material. Visibility through the container, facilitates knowing whether at least one cavity is left with for subsequent administration, or all are exhausted. DESCRIPTION OF THE INVENTION The invention will now be described with reference to the accompanying illustrative drawings, which are in no way intended to restrict the scope of the invention, and are only for the sake of clear understanding of the invention. Figure 1 is a top perspective view of assembly of the inhaler device containing cartridge loaded with multiple doses of metered medicinal composition, according to the invention. Figure 2 is a perspective view of the inhaler device, the dust cap being separated from the mouth piece. Figure 3 is the top plan of the upper chamber, i.e. lid of the inhaler device in Figures 1 and 2, the assembly of mouth adapter and dust cap being separated from the outlet nozzle. Figure 4 is a cross-sectional view of the inhaler device shown in Figures 1 and 2, the section being taken along the line 7WY in Figure 2. Figure 5 is a top plan of the lower chamber the stopper member, female interlocking constituent, opening on the sidewall, and hinge loop. Figure 6 is bottom plan of the upper chamber, i.e. lid illustrating the male interlocking member, outlet nozzle, opening on the side walls, and hinge pins. Figure 7 is a blown-up view of the piercing member, illustrating the piercing point, openings on the piercing point to establish connection with the outlet nozzle, baffle, connector for connecting to the lever, and press button. Figure 8 is the top plan of the cartridge having multiple circumferential cavities, filled with doses of medicinal composition and sealed with a pierceable blister. Figure 9 is bottom plan of the cartridge illustrating multiple radial cavities, a projection between every pair of cavities, and zig-zag inner end of cartridge. Referring to the illustrative figures 1 and 2, container 101 is formed of a circular lower chamber 102, an upper chamber 103 in the form of a lid, and a cartridge 104 having multiple cavities 105. Open ends 106 of the cavities 105 are facing towards the lid 103.107 is a tubular piercing member which communicates with an outlet nozzle 108. A view window 118 is provided at a location, below the nozzle 108, to judge the evacuation of the medicament from the cavity, upon inhalation. The tubular piercing member 107 is shown in detail in Figure 7. The piercing member is a hollow cylindrical part with a press button portion 704 at the top, an axial air suction hole 701, and a conical piercing tip 702 at the bottom. Multiple holes 706 are provided at the taper portion of the conical piercing tip 702 for entry of the medicament for delivery. The axial air suction hole 701 communicates with the inhalation nozzle 108, to lead air and medicament mixture upon inhalation by the user. This communication provides a pathway connecting medicament to the mouthpiece preferably contains geometry which is capable of increasing or decreasing the velocity of the medicament inhaled by the user, depending on the kind of the medicament formulation. The press button portion 704 is provided to apply necessary pressure with a finger, for penetration of the piercing member 107 into the cavity filled with medicament. A knob 703 with openings 707 at three of its sidewalls 709 is ultrasonically welded to the press button portion 704. A vertical baffle 708 is oriented diametrical to the axial air suction hole 701 of the tubular piercing member 107. Upon inhalation by the user through the nozzle 108, the outer air rushes through the openings 707 of the knob 703, into the axial air suction hole 701 of the tubular piercing member 107. The incoming air stream flowing towards the medicament cartridge and on one side of the baffle 708 lifts up sufficient quantity of the medicament from the cartridge, before delivery through the nozzle 108. To prevent dust accumulation, the mouth adapter 109 is provided with a dust cap 128. In the closed state of the mouth adaptor 109 by the dust cap 128, the knob 703 is restricted from being pressed down for piercing the cavity of medicament. Referring to figures 3 and 4, the outlet of nozzle 108 is provided with a mouth adapter 109 for inhalation by mouth. The piercing member 107 and a lever 110 exposed on the top end of the lid are connected to a common fulcrum 111, through a connector 121. Lever 110 operates the piercing member 107. In operative configuration of the inhaler, pressure is applied on the knob 703 by finger so that the piercing member 107 enters the cavity by piercing the sealing means on an open end of the cavity loaded with medicinal composition, and the free end of the lever 110 remains lifted-up as can be seen in Figure 4. The free end of the lever is pressed down by finger to release the piercing member from the piercing position. Referring to figures 5 and 6, the container 101 has an opening 112 through sidewalls of the lower chamber 102 and upper chamber 103. An index hole 131 is provided in the bottom surface cf the lower chamber 102 of the container 101. An indexing disc 130 with multiple color segments 132 at the periphery on one surface, is mounted at the central location within the lower chamber 102. Each color segment represents the identity of medicine stored in the cartridge. The disc is mounted such that the color of the segment when viewed from out side through the index hole, indicates to the user, the identity of the medicament stored in the cartridge. Referring to figures 8 and 9, one of the radial projections 113 dividing cavities 105 from each other, and projecting at the lower end 114 of the cartridge is exposed through the opening 112 for manually rotating the cartridge 104 to align the next filled cavity with the piercing device 107. 115 is a flexible stopper in the lower chamber 102. One end of the stopper 115 is secured with the base of the lower chamber 102, and the other free end is configured and positioned such that it remains inserted into one of the valleys 116 of the zig-zag of inner radius of the cartridge 104. The engagement of stopper 115 with one of the valleys 116 of the zig-zag of the inner radius of the cartridge 104 forms a ratchet mechanism allowing * clockwise rotation of the cartridge 104, and operates as restraint for rotating it anti-clockwise. In accordance with a preferred embodiment of the invention, the stopper 115 is integrally formed at inside base of the lower chamber 102 of the container 101. Alternatively, the stopper 115 may be flexibly secured on the inside base of the lower chamber 102 of the container 101 with conventional means. Referring back to figure 4, lower chamber 102 and upper chamber 103 of the container 101 are provided with interlocking central male member 119 and female member 120. The interlocking formed of male member 119 and female member 120 ensures proper alignment of the chambers 102 and 103 and prevents them from lateral movement. The lower chamber 102 and upper chamber 103 are joined at hinge 122, which allows lifting the upper member 103 of the container for replacement of the cartridge 104, or for any other purpose. The lower member 102 and upper member 103 of the container 1.01 are interlocked with the help of conventional interlocking rib and groove, or the like arrangements (not shown). Referring to figure 10, one of the edges of every valley of the zig-zag projection adapted to face the stopper member 115 is configured as a straight line 123 and the opposing edge is configured as a curve 124. The WE CLAIM 1. An improved device for metered administration of medicament by inhalation orally comprising: a) a housing with an opening closing means pivotally attached for receiving a circular cartridge of medicament; b) said cartridge having a plurality of diskettes along its circumference to hold a predetermined quantity of medicament; c) each such diskette being sealed by a pierceable sepling means; d) a member for piercing the said sealing means and thereby penetrating into the said diskette; e) said piercing member being a hollow cylindrical part in fluid communication with an inhalation nozzle means containing a partition whereby upon piercing and inhalation by user, the incoming air stream on one side of the partition, lifts the medicament along with, before reaching the said nozzle means wherein f) said housing has a view window at a location below the said nozzle means to enable the user to ascertain the evacuation of medicament from the diskette pierced for use. 2) The device according to claim 1, wherein the pathway connecting the medicament to the mouthpiece preferably contains a geometry which is capable of increasing or decreasing the velocity of the medicament inhaled for use, depending on the kind of the medicament formulation used. 3) The device according to any of the foregoing claims comprises of a knob to close the upper portion of the hollow cylindrical part of the piercing member. 4) The device according to claim 3 wherein the knob has individual openings on three of its sidewalls to allow the entry of outer air into the interior of the hollow cylindrical part, upon inhalation by user. 5) The device according to claim 1 comprises of a lever connected to the piercing member. 6) The device according to claim 5 wherein the lever is connected to the piercing member so as to release the piercing member from the piercing position. 7) The device according to claim 1 wherein an opening is provided on its sidewall to enable axial rotation of the cartridge. 8) The device according to claim 1 or claim7 wherein the diskettes of the cartridge are divided by radially extending projections of which atleast one projection penetrates through the opening to enable axial rotation of the cartridge. 9) The device according to claim 1 wherein the cartridge comprises of a ratchet mechanism comprising zigzag projections of which one slope of each zigzag projection is configured as a curve and the other as a straight line. 10) ' The device according to claim 1 or claim 9 wherein the cartridge as has a stopper member positioned such that it faces the slope in a straight line to prevent anticlockwise rotation of cartridge. 11) The device according to claim 10 wherein the stopper member is located such that the radial projections remain exposed at the middle of the opening on sidewall whereby the two diskettes adjacent to the exposed projections become visible from external. 12) The device according to claim 1 wherein the cartridge is made of a transparent material. Dated this 7th day of July, 2003.

Documents:

681-mumnp-2003-abstract(7-7-2003).pdf

681-mumnp-2003-abstract(granted)-(3-4-2007).pdf

681-mumnp-2003-cancelled page(13-04-2004).pdf

681-mumnp-2003-cancelled pages(13-5-2004).pdf

681-mumnp-2003-claim(granted)-(13-04-2004).doc

681-mumnp-2003-claim(granted)-(13-04-2004).pdf

681-mumnp-2003-claims(7-7-2003).pdf

681-mumnp-2003-claims(amended)-(13-5-2004).pdf

681-mumnp-2003-claims(amended)-(7-7-2003).pdf

681-mumnp-2003-claims(complete)-(7-7-2003).pdf

681-mumnp-2003-claims(granted)-(3-4-2007).pdf

681-mumnp-2003-correspondence(29-03-2005).pdf

681-mumnp-2003-correspondence(ipo)-(31-03-2004).pdf

681-mumnp-2003-correspondence(ipo)-(6-6-2007).pdf

681-mumnp-2003-description(complete)-(7-7-2003).pdf

681-mumnp-2003-description(granted)-(3-4-2007).pdf

681-mumnp-2003-drawing(13-04-2004).pdf

681-mumnp-2003-drawing(7-7-2003).pdf

681-mumnp-2003-drawing(granted)-(3-4-2007).pdf

681-mumnp-2003-form 1(07-07-2003).pdf

681-MUMNP-2003-FORM 1(13-5-2004).pdf

681-MUMNP-2003-FORM 1(29-3-2005).pdf

681-MUMNP-2003-FORM 1(7-7-2003).pdf

681-mumnp-2003-form 19(11-07-2003).pdf

681-mumnp-2003-form 2(complete)-(7-7-2003).pdf

681-mumnp-2003-form 2(granted)-(13-04-2004).doc

681-mumnp-2003-form 2(granted)-(13-04-2004).pdf

681-mumnp-2003-form 2(granted)-(3-4-2007).pdf

681-mumnp-2003-form 2(title page)-(complete)-(7-7-2003).pdf

681-mumnp-2003-form 2(title page)-(granted)-(3-4-2007).pdf

681-mumnp-2003-form 3(05-05-2004).pdf

681-mumnp-2003-form 3(07-07-2003).pdf

681-MUMNP-2003-FORM 3(13-5-2004).pdf

681-MUMNP-2003-FORM 3(29-3-2005).pdf

681-MUMNP-2003-FORM 3(7-7-2003).pdf

681-mumnp-2003-form 5(07-07-2003).pdf

681-MUMNP-2003-FORM 5(29-3-2005).pdf

681-mumnp-2003-form 5(7-7-2003).pdf

681-MUMNP-2003-GENERAL POWER OF ATTORNEY(7-7-2003).pdf

681-mumnp-2003-pct-ipea-409(13-04-2004).pdf

681-mumnp-2003-pct-isa-210(13-04-2004).pdf

681-mumnp-2003-power of attorney(22-05-2003).pdf

681-MUMNP-2003-WO INTERNATIONAL PUBLICATION REPORT(7-7-2003).pdf

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