WO2020163463A9

WO2020163463A9 - Dose feedback mechanisms and assemblies for user feedback

Info

Publication number: WO2020163463A9
Application number: PCT/US2020/016774
Authority: WO
Inventors: Xian-Ming Zeng; Imran Shaikh; Abhishek Gupta
Original assignee: Lupin Inc.
Priority date: 2019-02-06
Filing date: 2020-02-05
Publication date: 2020-09-17
Also published as: WO2020163463A1

Abstract

The present disclosure relates to a medicament dispenser for dispensing medicament. The dispenser may be for use in dispensing medicament in a liquid, pressurized aerosol, pre-filled container and in any medicament dispenser where dose related feedback is required. Mechanisms and assemblies provide dose related feedback to the user of the medicament dispenser and the physical interfaces and attributes associated with providing such feedback. The present disclosure also relates to dose feedback assemblies that can be adapted to various form factors, various individual components and elements of the container-closure system, and/or various target user interfaces. The dispenser is suited for dispensing propellant based pressurized inhalation aerosols for oral and/or nasal delivery; aqueous or non-aqueous systems for oral and/or nasal delivery; liquid dispensers for nasal delivery, multi-dose pre-filled syringes or pens; or dispensers for intra-muscular or subcutaneous delivery and powders for pulmonary administration and tablets, capsules, pellets or agglomerates for oral administration. The dispenser may dispense a propellant based pressurized inhalation aerosol comprising one or more active pharmaceutical ingredient(s)(API) and optionally, one or more propellant, cosolvent, solubilizer, emulsifier, surfactant, salt, acid and micronized or non-micronized pharmaceutically acceptable carrier(s) and/or excipient(s), wherein the dispensing process includes a press and breathe type or breath actuated or other multi-step operation medicament dispensers.

Description

DOSE FEEDBACK MECHANISMS AND ASSEMBLIES FOR USER FEEDBACK

FIELD

[001] The present disclosure relates to a medicament dispenser for dispensing medicament Mechanisms and assemblies provide dose related feedback to die user of die medicament dispenser and die physical interfaces and attributes associated with providing such feedback.

BACKGROUND

[002] Dose indicator or counters are useful in a wide variety of applications, and are especially important in the field of medicament dispensen where an accurate determination of the number of doses of medicament remaining in a medicament container might otherwise be difficult to obtain. Examples of such a medical dispenser includes liquid, pressurized aerosol, pro-filled containers and in any medicament dispenser where dose related feedback is required, c.g., pressurized metered-dose inhaler (pMDI), dry powder inhaler (DPI), pro-filled container, tablet/capsule dispenser, etc.

[003] Metered dose inhalers (MDI) are devices that deliver a specific amount of medication to the lungs, in the form of a short burst of aerosolized medicine that is usually self-administered by the patient via inhalation. Metered-dose inhalers include pressurized metered-dose inhalers and dry-powder inhalers. Generally, pMDIs include three major components: an aerosol canister where the formulation resides for administration to the lungs, a metering valve which is disposed in the canister and which allows a metered quantity of the formulation to be dispensed with each actuation, and an actuator which holds the canister and allows the patient to operate the device and directs the aerosol into the patient's lungs. Dry powder inhalers are devices that deliver a specific amount of medication to the lungs in the form of dry powder.

[004] Metered dose inhalers are used in order to administer an accurate dose of medicament A more recent development is die so-called“breath actuated inhalerf which delivers a dose of drug through a mouthpiece in response to inhalation by the user. BAIs are preferred in circumstances where the coordination between user inhalation and manual depression of the aerosol canister is imperfect For example, children have difficulty synchronizing actuation of the MDI with inhalation. Sometimes patients breathe out before inhalation is complete. [005] Unfortunately, one of the drawbacks of self-administration from conventional inhalers is that they provide no convenient way for patients to track the number of doses remaining in the canister at any given time. Thus, the illusion is created that the inhaler is still capable of providing useful doses of medicament simply because the canister contains liquid. This is potentially hazardous for the user since dosing becomes unreliable.

[006] Thus, integration of dose -counting mechanisms into MDI drug products enables users to assess how many doses remain in the obscured canister. It is recommended that manufacturers integrate a dose-counting device into new MDIs as either a numerical countdown indicating the number of remaining doses or as color-coding indicating the device should not be used.

[007] U.S. Pat. No. 5,349,945 includes a counting device for aerosol dispensers with a rotatable display means having a rack of teeth which is driven by a ratchet during the dispensing of a medicament dose. Each tooth on the rack corresponds to a single dose. However, miscounting might occur with one poor tooth. This requires all of the teeth in the rack to be perfect.

[008] U.S. Pat. No. 5,988,496 describes a device for counting doses of substance issued by a dispenser. The device includes a first count wheel and second count wheel mounted to rotate about a common axis of rotation. The first count wheel includes a drive tongue that is movable between a rest position, in which it does not cooperate with the second count wheel, and a drive position, in which it cooperates with the second count wheel to cause it to rotate about the common axis of rotation. The drive tongue is forced into position by action of a cam. Such device might possess difficulty in robust transfer and distribution of motion upon actuation.

[009] Although such devices have provided the advantage of being able to provide some measure of the number of doses of medicament dispensed from a container and/or the number of doses remaining therein, there remains room for improvement. In particular, it has proven difficult to provide dose counters that reliably“count” the release of medicament doses from containers. Moreover, there is also regulatory pressure to minimize the number of false counts. Naturally, there is a need to develop a dose feedback mechanism that is efficient and robust.

[010] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgement or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavor to which this specification relates. SUMMARY:

[011] The present disclosure provides for mechanisms and assemblies for providing dose related feedback to the user of the medicament dispenser and the physical interfaces and attributes associated with providing such feedback. The dispenser may dispense medicament in a liquid, pressurized aerosol, pie-filled container, or in any medicament dispenser where dose related feedback is required. The present disclosure also relates dose feedback assemblies that can be adapted to various form factors, various individual components and elements of the container- closure system, and/or various target user interfaces. The dispenser is suited for dispensing propellant based pressurized inhalation aerosols for oral and/or nasal delivery; aqueous or non- aqueous systems for oral and/or nasal delivery; liquid dispensers for nasal delivery and powders for pulmonary administration and tablets, capsules, pellets or agglomerates for oral administration; or pre-filled syringes or pens or dispensers for intra-muscular or subcutaneous delivery. The dispenser may dispense a propellant-based pressurized inhalation aerosol comprising one or more active pharmaceutical ingredient(sXAPI) and optionally, one or more propellant, cosolvent, solubilizer, emulsifier, surfactant, salt, acid and micronized or non-micronized pharmaceutically acceptable carriers) and/or excipient(s), wherein the dispensing process includes a press and breathe-type or breath-actuated or other multi-step operation medicament dispensers. The present disclosure also relates to dry powder inhaler-type devices comprising one or more active pharmaceutical ingredients) and optionally, one or more micronized or non-micronized pharmaceutically acceptable carrier(s) and/or excipient(s) wherein the dispensing process includes multi-step operation medicament dispensers such as open, dispense, and close.

[012] In some embodiments, the mechanism of actuation leads to change in the number of doses (increment or decrement) and provides dose related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[013] In some embodiments, the mechanism of actuation leads to change in the number of doses (increment or decrement) and also leads to the exhaustion/evacuation of the contents of the primary packaging to provide dose-related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser. [014] In some embodiments, the dose count feedback is provided through a dose indicator assembly, wherein dose feedback mechanism includes a mechanism by which the dose-related (e.g., number remaining, number consumed, and/or life-cycle of the product) visual feedback (e.g., readout) is provided to the use.

[015] In some embodiments, the dose feedback mechanism is provided through a dose indicator assembly which further comprises dose indicating means.

[016] In some embodiments, the dose feedback mechanism is provided through a dose indicator assembly including wheel(s), disk(s), printed tape, a belt, or a scroll.

[017] In some embodiments, a‘window’ (or interface or display) provides the dose-related (e.g., number remaining, number consumed, and/or life-cycle of the product) visual feedback (e.g., readout) to the user of the medicament dispenser.

[018] In some embodiments, the dose feedback mechanism ranges from numbers‘0’ to‘999’ which are displayed synchronously, collectively, and simultaneously with single or multiple components of the dose indicator assembly through the window (or interface or display).

[019] In some embodiments, a large window (or interface or display) displays the individual digits (e.g., numerical feedback) in a vertical or horizontal orientation and provides for the dose related (e.g., number remaining, number consumed, and/or life-cycle of the product) visual feedback (e.g., read-out) to the user of the medicament dispenser.

[020] In some embodiments, the dose feedback mechanism includes a dose indicator assembly having one or more dose indicator wheels.

[021] In some embodiments, the dose feedback mechanism includes simultaneous and collective read-out of the digits (e.g., numerical feedback) imprinted or etched or pasted or embossed on one or more dose-indicator wheels of dose-indicating means through the window (or interface or display).

[022] In some embodiments, the dose feedback mechanism includes at least two dose indicator wheels in a concentric, planar, and co-axial (e.g., same axis of rotation) orientation; a non- concentric and non-planar orientation; a concentric, co-planar, and co-axial orientation; overlapping orientation; or non-overlapping orientation. The dose feedback mechanism provides a simultaneous and collective read-out of the digits (e.g., numerical feedback) imprinted or etched or pasted or embossed on one or more dose-indicator wheels of dose-indicating means through the window (or interface or display). [023] In some embodiments, the dose feedback mechanism includes at least two dose-indicator wheels in a co-axial orientation (e.g., same axis of rotation); non-concentric and non-planar orientation; or concentric, co-planar, and co-axial orientation. The dose feedback mechanism also provides collective read-out of the digits (e.g., numerical feedback) imprinted or etched or pasted or embossed on one or more dose indicator wheels of dose indicating means through the window (or interface or display).

[024] In some embodiments, the dose feedback mechanism includes one or more dose indicator wheels that move synchronously and simultaneously with the movement of the primary packaging and provides collective read-out of the digits (e.g., numerical feedback) that are imprinted or etched or pasted or embossed on the one or more dose indicator wheels through the window (or interface or display).

[025] In some embodiments, the dose feedback mechanism includes one or more dose indicator wheels that move synchronously and simultaneously with the movement of the primary packaging and with the aid of one or more stationary and rotating wheels or shafts and provides collective read-out of the digits (e.g., numerical feedback) that are imprinted or etched or pasted or embossed on the one or more substrates through the window (or interface or display).

[026] In some embodiments, the dose feedback mechanism includes one or more dose indicator wheels that move synchronously and simultaneously with the movement of the primary packaging and with the aid of one or more stationary and rotating wheels or shafts and provides collective read-out of the digits (e.g., numerical feedback) that are imprinted or etched or pasted or embossed on the one or more substrates through the window (or interface or display).

[027] In some embodiments, the dose feedback mechanism includes two or more dose indicator wheels in a concentric and planar orientation or concentric and non-planar orientation with a simultaneous and collective read-out of the digits (e.g., numerical feedback) imprinted or etched or pasted or embossed on one or more dose indicator wheels through the window (or interface or display).

[028] In some embodiments, the dose feedback mechanism includes two or more dose indicator wheels that are in a concentric, coaxial (e.g., same axis of rotation) orientation; planar or non- planar orientation with respect to each other; connected directly or indirectly to each other; and/or with a simultaneous and collective read-out of the digits (e.g., numerical feedback) imprinted or etched or pasted or embossed on the one or more dose indicator wheels through the window (or interface or display).

[029] In some embodiments, the dose feedback mechanism includes two or more dose indicator wheels that are in a concentric, coaxial (e.g., same axis of rotation) orientation, or in a planar or non-planar orientation with respect to each other. The two or more dose indicator wheels may be connected directly or indirectly to each other. All dose indicator wheels may move in the same direction; wherein at least two wheels move in the opposite direction with respect to each other. A simultaneous and collective read-out of the digits (e.g., numerical feedback) imprinted, etched, pasted, or embossed on the one or more dose indicator wheels is visible through the window (or interface or display).

[030] In some embodiments, the dose feedback mechanism includes two or more dose indicator wheels moving synchronously, collectively, and simultaneously with the operation of the medicament dispenser and provides for the dose-related (e.g., number remaining, number consumed, and/or life-cycle of the product) visual feedback (e.g., read-out) to the user of the medicament dispenser.

[031] In some embodiments, the dose feedback mechanism includes one or more dose indicator wheels with units digits, including tens and/or hundreds digits imprinted or etched or pasted or embossed on the dose indicator wheels.

[032] In some embodiments, the dose feedback mechanism includes the synchronous, collective, and simultaneous readout of one or more wheels representing the units digits, the tens digits and/or the hundreds digits through the window (or interface or display) of the medicament dispenser.

[033] In some embodiments, the dose feedback mechanism includes the operation of two or more linear racks of dose indicator assembly transforming motion from actuation/operation of the medicament dispenser to the dose feedback mechanism of the medicament dispenser.

[034] In some embodiments, the rectilinear motion of the primary packaging of the medicament dispenser during the actuation/operation of the medicament dispenser is converted to rotational motion of the dose feedback mechanism.

[035] In some embodiments, the rectilinear motion of the mechanism for actuation/operation of the medicament dispenser is mechanically converted to rectilinear motion for the operation of the dose feedback mechanism and wherein said rectilinear motion is further converted to the rotational motion of the dose feedback mechanism of the medicament dispenser. [036] In some embodiments, the rotational motion of the mechanism for operating/opening/actuating the medicament dispenser is mechanically converted to rectilinear motion which further converted into the rotational motion of the dose feedback mechanism of the medicament dispenser.

[037] In some embodiments, the dose feedback mechanism is directly connected to the mechanism of operating/opening/actuating the medicament dispenser.

[038] In some embodiments, the dose feedback mechanism includes a scroll having an ascending or descending read-outs, printed or etched or embossed or colored thereon.

[039] In some embodiments, the dose feedback mechanism includes a scroll that moves synchronously and simultaneously with the movement of the primary packaging and provides read-out printed or etched or embossed or colored thereon through the window (or interface or display).

[040] In some embodiments, the dose feedback mechanism includes a scroll that moves synchronously and simultaneously with the movement of the primary packaging and with the aid of one or more wheels or shafts and provide read-out printed or etched or embossed or colored thereon through the window (or interface or display).

[041] In some embodiments, the dose feedback mechanism includes two or more linear racks having teeth, two or more pinions, one or more dummy wheels, one or more locks to prevent the reverse rotation of the wheels, and/or a dose indicating means for providing a dose-related visual feedback to the user of the medicament dispenser.

[042] In some embodiments, the dose feedback mechanism includes two or more linear racks having teeth wherein rectilinear motion of the linear racks is converted into rotational motion through two or more pinions independently. The dose feedback mechanism may also include one or more dummy wheels; one or more locks to prevent the reverse rotation of the wheels, and/or a dose indicating means for providing a dose related visual feedback to the user of the medicament dispenser wherein it comprises one or more dose indicator wheels arranged to provide a count ranging from numbers‘0’ to‘999’. The pinions rotate the dummy wheel and dose indicator wheel to provide the synchronous, collective, and simultaneous read-out of the count.

[043] In some embodiments, the dose feedback mechanism includes two or more linear racks having ratchets wherein rectilinear motion of the linear racks is converted into rotational motion through two or more pinions independently. The dose feedback mechanism may also include one or more dummy wheels, one or more locks to prevent the reverse rotation of the wheels; and/or a dose indicating means for providing a dose-related visual feedback to the user of the medicament dispenser wherein it includes a scroll to provide a count ranging from‘0’ to‘200’. The pinions rotate the dummy wheel and driving roller thereby moving the scroll to provide the read-out of the count.

[044] In some embodiments, a dose indicator assembly includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, and/or a dose indicating means for providing a dose-related visual feedback to the user of the medicament dispenser.

[045] In some embodiments, a dose indicator assembly includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, and/or a dose indicating means comprising of dose indicator wheels or a scroll for providing a dose-related visual feedback to the user of the medicament dispenser.

[046] In some embodiments, the dose feedback mechanism includes the actuator, the dose indicator assembly, the balancer, and/or the window.

[047] In some embodiments, the dose feedback mechanism includes the actuator, the dose indicator assembly which further includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, a dose indicating means for providing a dose-related visual feedback to the user of the medicament dispense, the balancer, and/or the window.

[048] In some embodiments, the dose feedback mechanism includes two or more linear racks that allow for an efficient and robust transfer and distribution of motion from the actuation/operation of the medicament dispenser to and within the dose feedback mechanism. The dose feedback mechanism also allows for relative serial reduction of the unit count of doses remaining in the medicament dispenser.

[049] In some embodiments, the dose feedback mechanism includes two or more linear racks that prevent an inadvertent miss in the transfer and distribution of motion of the primary packaging within the dose feedback mechanism and prevents a false higher remaining dose count within the medicament dispenser.

[050] In some embodiments, the dose feedback mechanism includes two or more linear racks that prevent an inadvertent partial movement of one or more dose indicator wheels or a scroll. [051] In some embodiments, the dose feedback mechanism provides features to prevent reverse movement of dose indicating means in the medicament dispenser.

[052] In some embodiments, the dose feedback mechanism provides features that lend its utility in a reusable dose feedback mechanism and in a separable cartridge or cassette for re-use and reloading of the medicament dispenser.

[053] In some embodiments, the dose feedback mechanism includes a mechanical dose indicating mechanism and an electronic dose indicating mechanism that operate in a synchronous, collective, tandem, and redundant manner.

[054] In some embodiments, the material of construction of the components of the dose feedback mechanism includes acrylonitrile butadiene styrene (ABS), polycarbonate/acrylonitrile butadiene styrene terpolymer blend (PC/ABS), Polyoxymethylene (POM), nylon, stainless steel and/or silicone rubber.

[055] In some embodiments, the material of construction of the components of the dose feedback mechanism includes acrylonitrile butadiene styrene (ABS), polycarbonate/acrylonitrile butadiene styrene terpolymer blend (PC/ABS), Polyoxymethylene (POM) and/or nylon.

[056] In some embodiments, the dose feedback mechanism also provides for complete dose lockout and complete operation lock-out features after all doses in the medicament dispenser are dispensed and the medicament dispenser is exhausted.

BRIEF DESCRIPTION OF DRAWINGS

[057] Fig. 1 A shows an isometric view of an embodiment of the medicament dispenser.

[058] Fig. IB shows a partial-exploded isometric view of a different embodiment of the medicament dispenser.

[059] Fig. 2A shows an exploded view of a medicament dispenser showing a first embodiment of a dose indicator assembly.

[060] Fig. 2B shows an exploded view of a medicament dispenser showing a second embodiment of a dose indicator assembly.

[061] Fig. 3 A shows an actuator and the first embodiment of the dose indicator assembly assembled together. [062] Fig. 3B shows an actuator and the second embodiment of the dose indicator assembly assembled together.

[063] fig. 4A shows the view of a window displaying the count of the first embodiment of the dose indicator assembly.

[064] Fig. 4B shows the view of a window displaying the count of the second embodiment of the dose indicator assembly.

[065] figs. 5A and 5B show top isometric views of a medicament dispenser.

[066] fig. 6A shows a top isometric view of an actuator showing assembled half moon balancer.

[067] fig. 6B shows a top isometric view of an actuator showing a disk type balancer.

[068] Fig. 7A shows a sectional view showing the actuator, half-moon balancer, and the first embodiment of the dose indicator assembly.

[069] Fig. 7B shows a sectional view showing the actuator, disk type balancer, and the second embodiment of the dose indicator assembly.

[070] Fig. 8 shows the half moon balancer.

[071] Fig. 9 show a disk type balancer.

[072] Fig. 10A shows an arrangement of the first embodiment of the dose indicator assembly and the half-moon balancer.

[073] Fig. 10B shows an arrangement of the second embodiment of the dose indicator assembly and the disk type balancer.

[074] Fig. 11 shows the first embodiment of the dose indicator assembly.

[075] Fig. 12 shows the second embodiment of the dose indicator assembly.

[076] Figs. 13A and 13B show an exploded view of the first embodiment of the dose indicator assembly and its operation.

[077] Figs. 14A and 14B show an exploded view of the second embodiment of the dose indicator assembly and its operation.

[078] Fig. 15 shows an isometric view of a mount of the first embodiment of the dose indicator assembly.

[079] Fig. 16 shows an isometric view of a mount of the second embodiment of the dose indicator assembly.

[080] Fig. 17 shows an isometric view of a unit wheel. [081] Figs. 18A and 18B show isometric views of a tens wheel.

[082] Fig. 19 shows an isometric view of a hundreds wheel.

[083] Figs. 20A and 20B show isometric views of a pinion and linear rack, respectively.

[084] Figs. 21A and 21B show different isometric views of a dummy wheel of the first embodiment of the dose indicator assembly.

[085] Fig. 22A and 22B show different isometric views of dummy wheel of the second embodiment of the dose indicator assembly.

[086] Fig. 23 shows an isometric view of a spring.

[087] Fig. 24 shows an isometric view of a tens interim drive gear.

[088] Fig. 25 shows an isometric view of a hundreds interim drive gear.

[089] Fig. 26 shows an isometric view of a driving roller.

[090] Fig. 27 shows an isometric view of a driven roller.

[091] Figs. 28 A and 28B show a scroll of the second embodiment of the dose indicator assembly and its representation.

[092] Figs.29-40 show the operating cycle of the first embodiment of the dose indicator assembly with initial dose count of 999 doses along with the operation of tens and hundreds wheel.

[093] Figs.41-46 show the operating cycle of the first embodiment of the dose indicator assembly with initial dose count of 120 doses along with the operating cycle of dose feedback mechanism when the dose count reaches to 100 doses.

[094] Figs. 47-49 show the operating cycle of the second embodiment of the dose indicator assembly with initial dose count of 200 doses.

[095] Fig 50 show a bar type balancer.

[096] Fig. 51 shows arrangements of the actuator and the bar type balancer.

[097] Fig. 52 is a sectional view showing the actuator, the bar type balancer, and the first embodiment of the dose indicator assembly.

[098] Fig. 53 shows arrangements of the first embodiment of the dose indicator assembly and the bar type balancer.

[099] Fig. 54 show another type of the disk type balancer

[100] Fig. 55 show another type of the half moon type balancer

[101] Fig. 56 shows an embodiment of a dry powder inhaler device. [102] fig. 57 shows an example of a dose indicator assembly that is compatible with the dry powder inhaler.

[103] fig. 58 shows an exploded view of the dose indicator assembly and the dry powder inhaler.

[104] figs. 59A, 59B and 59C show components of another bar type balancer suitable for dry powder inhaler.

[105] figs. 60A-66 show the operating cycle of another embodiment of dose feedback mechanism with initial dose count of 999 doses.

DETAILED DESCRIPTION:

[106] The present disclosure provides for mechanisms and assemblies for providing dose related feedback to the user of the medicament dispenser and the physical interfaces and attributes associated with providing such feedback.

[107] A medicament dispensers, as disclosed herein, have a variety of structural configurations and can be used for dispensing liquids, powders, tablets, capsules, pellets or pucks, or mixtures thereof for nasal, pulmonary or oral administration. In particular, the medicament dispensers can be used to dispense a liquid comprising one or more active pharmaceutical ingredient(s)(API) and optionally, one or more pharmaceutically acceptable carrier(s) and/or excipient(s). The dispenser may dispense a propellant based pressurized inhalation aerosol comprising one or more active pharmaceutical ingredient(s)(API) and optionally, one or more propellant, cosolvent, solubilizer, emulsifier, surfactant, salt, acid, and micronized or non-micronized pharmaceutically acceptable carriers) and/or excipient(s), wherein the dispensing process includes a press-and-breathe type, breath-actuated, or other multi-step operation medicament dispensers. Further, the present disclosure relates to dispensing powdered medicament wherein the dispensing process includes a press-and-breathe type or breath-actuated or other multi-step operation medicament dispensers.

[108] One or more active pharmaceutical ingredient(s) (APIs) that can be used can be selected from analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodium salt), ketotifen or nedocromil (e.g. as the sodium salt); antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g., methapyrilene; anti--infammatories, e.g., beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. as the

propionate ester), flunisolide, budesonide, rofleponide, mometasone e.g. as the furcate ester), ciclesonide, triamcinolone (e.g. as the acetonide) or 6a,9a-difluoro-l ip-hydroxy- 16a-methyl-3 - oxo- 17a. -propionyloxy-androsta-1, 4-diene- 17P-carbothioic acid S-(2-oxo-tetrahydro-furan-3- yl) ester; antitussives, e.g., noscapine; bronchodilators, e.g., albuterol (e.g. as free base or sulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g. as hydrobromide), formoterol (e.g. as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (e.g. as acetate), reproterol (e.g. as hydrochloride), rimiterol, terbutaline (e.g. as sulphate), isoetharine, tulobuterol or 4- hydroxy-7-[2-[[2-[[3-(2- phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)- benzothiazolone; adenosine 2a agonists, e.g. 2R,3R,4S,5R)-2-[6-Amino-2-(l S- hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2- ethyl-2H-tetrazol-5-yl)-tetrahydro- furan-3,4-diol (e.g. as maleate);. a4 integrin inhibitors e.g. (2S)-3-[4-({[4- (aminocarbonyl)-l-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S-)-4-methyl-2-{[2-(2 methylphenoxy)acetyl]amino}pentanoyl)amino]propanoic acid (e.g. as free acid or potassium salt), diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium (e.g. as bromide), tiotropium, atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines, e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, e.g., insulin or glucagon; vaccines, diagnostics, and gene therapies. 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

[109] The term“dose feedback mechanism” includes the mechanism by which the dose related (e.g., number remaining, number consumed, and/or life-cycle of the product) visual feedback (e.g., read-out) is provided to the user.

[110] In some embodiments, the dose feedback mechanism includes the actuator, the dose indicator assembly, the balancer, and the window.

[111] An actuator houses a dose indicator assembly, the canister, bottle or medicament carrier (such as reel of blisters) containing the formulation, the balancer, and the window. The actuator may come in various sizes and shapes. The actuator may contain two linear rack guides that allow for the linear racks on the dose indicator assembly to move in a rectilinear motion during the operation/actuation of the medicament dispenser. [112] The rectilinear motion means a straight line motion. A body is said to experience rectilinear motion if any two particles of the body travel the same distance along two parallel straight lines with uniform velocity. The rectilinear motion may constitute reciprocal motion.

[113] In some embodiments, the dose feedback mechanism includes the dose indicator assembly having a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means for providing a dose related visual feedback to the user of the medicament dispenser.

[114] The mount holds and locates all the components of the dose indicator assembly and has one or more features such as mount groove, mount shaft, interim gear pins, rack motion space left, rack motion space right, wheel lock left and wheel lock right to prevent reverse rotation of the wheels or a scroll. The mount groove holds the counter/roller shaft.

[115] A“linear rack” includes a linear gear bar and has teeth for engagement. A linear rack has an arrangement to attach a spring to assist the return movement of the linear rack after actuation/operation.

[116] A“pinion” includes a circular gear and has teeth and radially placed driving studs. The pinion may have ratchets. The ratchets may be present on the circumference (e.g., circumferentially placed) or along the radius (e.g., radially placed) of the pinion.

[117] In general, a linear rack and pinion are a pair of gears which convert rectilinear motion into rotational motion and vice versa.

[118] The term“ratchet” includes a type of gear or arrangement of teeth in such way that it allows continuous linear or rotary motion in only one direction while preventing motion in the opposite direction.

[119] A dummy wheel may have radial ratchets. A dummy wheel may have a key hole or gear(s). The dummy wheel may have slits on its surface. The slits and wheel prevent the reverse rotation of the dummy wheels.

[120] A dose indicating means includes dose indicator wheel(s), disk(s), printed tape, belt, or a scroll.

[121] As used herein, the terms wheel or disks can be used interchangeably and printed tape, belt, or a scroll can be used interchangeably.

[122] A dose indicating means which includes dose indicator wheels including one to three dose indicator wheels. The dose indicator wheels each representing the units digits, the tens digits, and/or the hundreds digits. Each dose indicator wheel is imprinted, etched, pasted, or embossed to provide visual information in the form of digits. The dose indicator wheels are arranged in a concentric, planar, and co-axial (e.g., same axis of rotation) orientation; non-concentric and non- planar orientation; or concentric, co-planar and co-axial orientation. The wheels may be in an overlapping or non-overlapping configuration for providing a count ranging from numbers‘0’ to ‘999’ which are displayed synchronously, collectively, and simultaneously with single or multiple components of the dose indicating means wherein the numbers‘0’ to‘999’ are displayed in a vertical and/or horizontal orientation. At least one of the dose indicator wheels rotates independently of the other. The dose indicator wheels may have one or more studs, gears, and/or ratchets. The dose indicator wheels have slits on their surface. The slits and wheel prevent the reverse rotation of the dose indicator wheels. The wheels may be interconnected to each other via interim gears such as tens interim drive gear and hundreds interim drive gear.

[123] A dose indicating means includes a scroll having ascending or descending read-outs, printed, etched, embossed, or colored thereon.

[124] The primary packaging in case of MDI refers to a bottle, canister or actuator, and its components such as mouth piece cover.

[125] The balancer transfer distributes and equalizes the force of primary packaging on the linear racks. The balancer resides on top of the two linear rack of the dose indicator assembly. The rectilinear or rotational motion of the primary packaging material, (e.g., canister, bottle or cover) is transferred to the dose indicator assembly via the balancer. The balancer can have different shapes such as disc type, half moon, and/or bar type.

[126] The balancer may have one or more slot(s) for linear racks. The balancer may further have a guide for guiding the movement of the balancer. In some embodiments, the balancer may include the cam drive, long link, transverse link, actuation link, long link guide, and/or transverse link guide bar.

[127] In some embodiments, a dose indicator assembly includes the mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, and/or a dose indicating means for providing a dose-related visual feedback to the user of the medicament dispenser.

[128] In some embodiments, a dose indicator assembly includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means which includes dose indicator wheels comprising of one or more dose indicator wheels for providing a dose-related visual feedback to the user of the medicament dispenser.

[129] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, and/or a dose indicating means which includes one or more dose indicator wheels for providing a dose related visual feedback to the user of the medicament dispenser.

[130] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means which includes one or more dose indicator wheels for providing a dose related visual feedback to the user of the medicament dispenser. The pinion, dummy wheel, and/or dose indicator wheels are coaxial.

[131] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount includes a mount groove, mount shaft, rack motion space left, rack motion space right, wheel lock left, and/or wheel lock right; two or more linear racks having teeth; two or more pinions; one or more dummy wheels; and/or a dose indicating means which includes one or more dose indicator wheels each representing the units digits, the tens digits, and/or the hundreds digits for providing a dose related visual feedback to the user of the medicament dispenser. The pinion, dummy wheel, and/or dose indicator wheels are coaxial. The mount shaft holds the interim drive gear for the tens wheel.

[132] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount including a mount groove, mount shaft, rack motion space left, rack motion space right, wheel lock left and/or wheel lock right; two or more linear racks having teeth; two or more pinions; one or more dummy wheel; and/or a dose indicating means which includes one or more dose indicator wheels each representing the units digits, the tens digits, and/or the hundreds digits for providing a dose related visual feedback to the user of the medicament dispenser. The pinion, dummy wheel, and/or dose indicator wheels are coaxial. The mount shaft holds the interim drive gear for the tens wheel. Two or more linear racks prevent an inadvertent miss in the transfer and distribution of motion of the primary packaging within the dose feedback mechanism and prevent a false higher remaining dose count within the medicament dispenser.

[133] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount including a mount groove, mount shaft, interim gear pins, rack motion space left, rack motion space right, wheel lock left, and/or wheel lock right; linear rack left and/or linear rack right having teeth; spring left and/or spring right; pinion left and/or pinion right; a dummy wheel; and/or a dose indicating means which includes dose indicator wheels comprising of one or more dose indicator wheels each representing the units digits, the tens digits, and/or the hundreds digits for providing a dose related visual feedback to the user of the medicament dispenser. The pinion, dummy wheel, and/or dose indicator wheels are coaxial. The mount shaft holds the interim drive gear for the tens wheel.

[134] In some embodiments, when the primary packaging, e.g., canister or bottle are depressed to actuate/operate the medicament dispenser the motion is transferred to the linear rack left, and the linear rack right which moves both of them in downward direction, simultaneously and synchronously. The motion of the linear rack left is transferred to the pinion left and the motion of the linear rack right is transferred to the pinion right, allowing them to rotate. The pinion left and the pinion right have the radially placed driving studs that drive the units wheel and the dummy wheel. The rotation of the dummy wheel leads to rotation of the tens wheel via the tens interim drive gear, which further rotates the hundreds wheel via hundreds interim drive gear. Thus, the units wheel rotates independently of the tens wheel and hundreds wheel. The spring left and spring right assist in the return movement of the linear rack left and linear rack right after actuation/operation. The radial ratchets and slits of the unit wheel and dummy wheel together with the wheel lock and prevent the reverse rotation of the wheels during the return movement of the linear racks. The unit wheel rotates every time upon actuation/operation. The tens wheel rotates once every ten actuation/operation. The hundreds wheel rotates once every 100 actuation/operation. The mechanism of actuation leads to change in the number of doses (increment or decrement) and provides dose-related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[135] When the primary packaging, (e.g., cover 100 of dry powder inhaler) is opened to actuate/operate the medicament dispenser the motion is transferred to the linear rack left and the linear rack right which moves both of them in downward direction, simultaneously and synchronously. The motion of the linear rack left is transferred to the pinion left and the motion of the linear rack right is transferred to the pinion right allowing them to rotate. The pinion left and the pinion right have the radially placed driving studs that drive the units wheel and the dummy wheel. The rotation of the dummy wheel leads to rotation of the tens wheel via the tens interim drive gear which further rotates the hundreds wheel via the hundreds interim drive gear. Thus, the units wheel rotates independently of the tens wheel and the hundreds wheel. The spring left and spring right assist in the return movement of the linear rack left and linear rack right after actuation/operation. The radial ratchets and slits of the unit wheel and dummy wheel together with the wheel lock prevent the reverse rotation of the wheels during the return movement of the linear racks. The unit wheel rotates every time upon actuation/operation. The tens wheel rotates once every ten actuation/operation. The hundreds wheel rotates once every 100 actuation/operation. The mechanism of actuation leads to change in the number of doses (increment or decrement) and provides dose-related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[136] In some embodiments, the dose feedback mechanism includes the dose indicator assembly which includes: a mount, two or more linear racks at least partially disposed within the mount, two or more pinions configured to convert rectilinear motion of the two or more linear racks to rotary motion, one or more dummy wheels interfacing with at least one of the two or more pinions, and

[137] a dose indicating means for providing a dose related visual feedback to the user of the medicament dispenser.

[138] In some embodiments a dose indicator assembly includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means which includes a scroll for providing a dose-related visual feedback to the user of the medicament dispenser.

[139] In some embodiments, the dose feedback mechanism includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means which includes a scroll for providing a dose-related visual feedback to the user of the medicament dispenser.

[140] In some embodiments, the dose feedback mechanism includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, and/or a dose indicating means which includes a scroll for providing a dose related visual feedback to the user of the medicament dispenser. The pinion and dummy wheels may be coaxial.

[141] In some embodiments, the dose feedback mechanism includes a mount comprising a mount groove, mount shaft, rack motion space left, rack motion space right, wheel lock left and/or wheel lock right; two or more linear racks having teeth; two or more pinions; one or more dummy wheels; and/or a dose indicating means which includes a scroll wound around the driven roller for providing a dose related visual feedback to the user of the medicament dispenser. The pinion(s) and dummy wheel(s) may be coaxial. The mount shaft holds the driven roller.

[142] In some embodiments, the dose feedback mechanism includes: a mount comprising a mount groove, mount shaft, rack motion space left, rack motion space right, wheel lock left and/or wheel lock right; two or more linear racks having teeth; two or more pinions; one or more dummy wheels; and/or a dose indicating means which includes a scroll wound around the driven roller for providing a dose related visual feedback to the user of the medicament dispenser. The pinion(s) and dummy wheel(s) may be coaxial. The mount shaft holds the driven roller. Two or more linear racks prevent an inadvertent miss in the transfer and distribution of motion of the primary packaging within the dose feedback mechanism and prevent a false higher remaining dose count within the medicament dispenser.

[143] In some embodiments, the dose feedback mechanism includes: a mount comprising a mount groove, mount shaft, rack motion space left, rack motion space right, wheel lock left and/or wheel lock right; linear rack left and/or linear rack right having teeth; spring left and/or spring right; pinion left and/or pinion right; a dummy wheel; a driving roller having hollow shaft; and/or a dose indicating means which includes a scroll wound around the driven roller for providing a dose related visual feedback to the user of the medicament dispenser by moving over the driving roller hollow shaft from the driven roller during each actuation/operation of the medicament dispenser. The pinions, dummy wheel, and/or a driving roller may be coaxial. The mount shaft holds the driven roller.

[144] The driving roller having hollow shaft may have key on the hallow shaft. The key engages with the key hole of the dummy wheel. The driving roller have radial ratchets. The driving roller have slits on its surface. The slits and wheel lock prevents the reverse rotation of the driving roller.

[145] The driven roller have driven roller shaft guides that are located on each side of the driven roller. The driven roller shaft guides support and guide the scroll wounded around driven roller.

[146] In some embodiments, when the primary packaging, e.g., canister or bottle are depressed to actuate/operate the medicament dispenser the motion is transferred to the linear rack left and the linear rack right, which moves both of them in downward direction, simultaneously and synchronously. The motion of the linear rack left is transferred to the pinion left and the motion of the linear rack right is transferred to the pinion right allowing them to rotate. The pinion left and the pinion right have the radially placed driving studs that drive a driving roller the dummy wheel, which leads to advancement of a scroll on the driving roller hollow shaft of the driving roller. The spring left and spring right assist in the return movement of the linear rack left and linear rack right after actuation/operation. The radial ratchets and slits of the driving roller and dummy wheel together with the wheel lock prevent the reverse rotation of the wheels during the return movement of the linear racks. The scroll moves upon every actuation or operation. The mechanism of actuation leads to change in the number of doses (increment or decrement) and provides dose related feedback (e.g number remaining; number consumed and/or life-cycle of the product) to the user of the medicament dispenser.

[147] When the primary packaging, e.g., cover 100 of dry powder inhaler is opened to actuate/operate the medicament dispenser the motion is transferred to the linear rack left and the linear rack right, which moves both of them in downward direction, simultaneously and synchronously. The motion of the linear rack left is transferred to the pinion left and the motion of the linear rack right is transferred to the pinion right allowing them to rotate. The pinion left and the pinion right have the radially placed driving studs that drive a driving roller and the dummy wheel, which leads to advancement of a scroll on the driving roller hollow shaft of the driving roller. The spring left and spring right assist in the return movement of the linear rack left and linear rack right after actuation/operation. The radial ratchets and slits of the driving roller and dummy wheel together with the wheel lock prevent the reverse rotation of the wheels during the return movement of the linear racks. The scroll moves upon every actuation or operation. The mechanism of actuation leads to change in the number of doses (increment or decrement) and provides dose related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[148] In some embodiments, the dose feedback mechanism includes: the actuator; the dose indicator assembly which includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, a dose indicating means for providing a dose related visual feedback to the user of the medicament dispenser; the balancer; and/or the window for displaying the change in the number of doses (increment or decrement) and provides dose related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser. [149] In some embodiments, the dose feedback mechanism includes the actuator; the dose indicator assembly which includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheels, a dose indicating means which includes dose indicator wheels comprising one or more dose indicator wheels for providing a dose related visual feedback to the user of the medicament dispenser; the balancer; and/or the window for displaying the change in the number of doses (increment or decrement) and provides dose related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[150] In some embodiments, the dose feedback mechanism includes: the actuator; the dose indicator assembly which includes a mount, two or more linear racks having teeth, two or more pinions, one or more dummy wheel, and/or a dose indicating means which includes a scroll for providing a dose related visual feedback to the user of the medicament dispenser; the balancer; and the window for displaying the change in the number of doses (increment or decrement) and provides dose related feedback (e.g., number remaining, number consumed, and/or life-cycle of the product) to the user of the medicament dispenser.

[151] The presence of two or more linear racks prevents an inadvertent miss in the transfer and distribution of motion of the primary packaging within the dose feedback mechanism and prevents a false higher remaining dose count within the medicament dispenser.

[152] The presence of two or more linear racks allows for an efficient and robust transfer and distribution of motion from the actuation/operation of the medicament dispenser to and within the dose feedback mechanism and allows for relative serial reduction in the unit count of doses remaining in the medicament dispenser.

[153] It is intended that the scope of the present disclosure should not be limited by any particular embodiment described herein. While various embodiments have been described above, it should be noted that they have been presented by way of example only, and not limitation. Numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein without departing from the spirit or scope of the invention.

[154] Figs. 1 A and IB show types of actuators 36 for metered dose inhalers having a window 48. A can 56 or bottle 65 to be inserted in to an actuator. [155] Figs. 2A and 2B show exploded views of the medicament dispenser showing actuator 36, different dose indicator assemblies 57, different dose indicator assembly covers 58, and window

48.

[156] Figs. 3A and 3B show assembled views of the actuator 36 and the different dose indicator assemblies 57.

[157] Figs. 4A and 4B shows the view of window 48 displaying the count of the different dose indicator assemblies 57 through the window 48.

[158] Figs. 5A and 5B shows top isometric view of an actuator 36 showing two linear rack guides 37 for linear rack left 2 and linear rack right 3, and an actuator slot for balancer 40. The linear rack left 2 and linear rack right 3 passes through the linear rack guides 37.

[159] The dose indicator assembly 57 shown in Figs. 1A, 2A, and 3A provides a dose feedback mechanism ranging from numbers‘0’ to‘999’ which are displayed synchronously, collectively and simultaneously through the window 48. The actuator 36 includes two linear rack guides 37 that allow for the linear rack left 2 and the linear rack right 3 on the dose indicator assembly 57 to move in a rectilinear motion during the operation/actuation of the medicament dispenser. The balancer 38, 41, or 43 (see Figs. 8, 9, 50, 54 and 55) resides on top of the two linear rack guides

37 of the actuator 36 and the dose indicator assembly 57. The rectilinear motion of the canister 56 or bottle 65 within the body of the actuator 36 is transferred to the dose indicator assembly 57 via the balancer 38, 41, or 43. The operation/actuation of the medicament dispenser includes rectilinear motion of the canister 56 or bottle 65 within the body of the actuator 36 transferred to the linear rack left 2 and the linear rack right 3 on the dose indicator assembly 57 via the balancer 38, 41 or 43.

[160] Figs. 6A and 6B show actuators having a half moon type balancer 38 and a disc type balancer 43, respectively. The figs also show the balancer slots for linear rack 66.

[161] Figs. 7A and 7B are sectional views showing the actuator 36 with a half moon type balancer

38 and a disc type balancer 43, respectively, different dose indicator assemblies 57, linear rack right 3, linear rack guides 37 and actuator slot 40 for balancer.

[162] Fig. 8 show half moon type balancer 38 having balancer half-moon guide 39, balancer slot for linear rack 66. The balancer half-moon guide 39 on the balancer half-moon 38 moves within the actuator slot for balancer 40 and provides support during the rectilinear motion of the balancer under the pressure from die canister 56 or battle 65 (refer fig. 7A). The balancer 38 serves the functions of providing a dynamic guide for the canister 56 or bottle 65, and the transfer, distribution, and equalization of the force on die linear rack left 2 and the linear rack right 3 of the dose indicator assembly 57 from die rectilinear motion of the canister 56 or bottle 65. This efficient and consistent transfer of force from die motion of the canister 56 or bottle 65 to the dose indicator assembly 57 allows for a consistent and efficient operation of the dose indicator assembly 57 and prevents an inadvertent miss in the change in dose count during the actuation/operation of the medicament dispenser.

[163] Fig. 9 show disc type balancer 43 having balancer slot for linear racks 66. The balancer disk 43 is located on top of the dose indicator assembly 57 provides for a circumferential balancer within the body of the actuator (refer figs. 6B and 7B). The balancer 43 serves the functions of providing a dynamic guide for the canister 56 or bottle 65, and transfers» distributes» and equalizes force on the linear rack left 2 and the linear rack right 3 of the dose indicator assembly 57 from the rectilinear motion of the canister 56 or bottle 65. This efficient and consistent transfer of force from the motion of the canister 56 or bottle 65 to the dose indicator assembly 57 allows for a consistent and efficient operation of the dose indicator assembly 57 and prevents an inadvertent miss in the change in dose count during the actuation/operation of the medicament dispenser.

[164] Figs. 10A and 10B show various possible arrangements of different dose indicator assemblies 57 and the half moon type balancer 38 or the disc type balancer 43, respectively. The tip of liner rack fits into die balancer slots for liner rack 66.

[165] Fig. 11 shows a dose indicator assembly. The figure shows mount 1, linear rack left 2, linear rack right 3, pinion left 4, pinion right 5, counter/roller wheel shaft 10, units wheel 6, tens wheel 7, hundreds wheel 8, dummy wheel 9, tens interim drive gear 11, spring left 59, and/or spring right 60. The dose indicator assembly 57 includes mount 1, linear rack left 2, linear rack right 3, pinion left 4, pinion right 5, units wheel 6, tens wheel 7, hundreds wheel 8, dummy wheel 9, countex/roller shaft 10, tens interim drive gear 11, hundreds interim drive gear 12, spring left 59, and/or spring right 60. The mount 1 holds and locates all the components of the dose indicator assembly and has features mount groove 29, mount shaft 30, interim gear pins 31, rack motion space left 32, rack motion space right 33, wheel lock left 34 and wheel lock right 35 (refer fig. 15). This dose indicator set-up which provides the dose feedback mechanism indudes the dose indicator assembly 57 with a four wheel set-up, e.g., units wheel 6, tens wheel 7, hundreds wheel 8 and dummy wheel 9. This dose indicator set-up allows for a three digit (units) read-out and feedback on dose numbers in a medicament dispenser ranging from‘0’ to‘999’. Depending upon the medicament dispenser configuration and number of doses required a units wheel set-up only with three dummy wheels can be used to provide feedback from‘0’ to‘9’; a units and tens wheel set-up can be used with two dummy wheels to provide feedback from‘0’ to‘99’ and a units, tens and hundreds wheel set-up with one dummy wheel can be used to provide feedback from‘0’ to ‘999’. The digits (units) of the wheels can be laser etched, printed, or pasted as pre-printed substrate. The two linear rack set-up, e.g., linear rack left 2 and linear rack right 3 provide a rectilinear motion. The two linear rack set-up allows for an efficient and robust transfer and distribution of motion from the actuation/opening of the medicament dispenser to and within the core dose indicator assembly 57 and allows for relative serial reduction in the unit count of doses remaining in the medicament dispenser. The two linear rack set-up prevents an inadvertent miss in the transfer and distribution of motion within the dose indictor assembly 57 and a false higher remaining dose count within the medicament dispenser. The two linear rack set-up also prevents an inadvertent partial movement of the units wheel 6 and/or tens wheel 7 and/or hundreds wheel 8. The spring left 59 and spring right 60 assist in the return movement of the linear rack left 2 and linear rack right 3 after actuation/operation. The pinion left 4, pinion right 5 are the main drivers of the dose counter mechanism in the rotational motion. They convert the rectilinear motion of the linear rack right 2 and linear rack left 3 to the rotary motion. The tens interim drive gear 11 is located on the mount shaft 30 of the mount 1 and is always in contact with the tens wheel 7 via the tens wheel gear 26 (refer fig. 18). The tens interim driver gear 11 drives the tens wheel 7 when it comes in contact with the dummy wheel gears 25 (refer fig. 2 IB) on the dummy wheel 9. The hundreds interim drive gear 12 is located on the interim gear pins 31 of the mount 1 and is always in contact with the hundreds wheel 8 via the hundreds wheel gear 28 (refer fig. 19) on the hundreds wheel 8. The hundreds interim driver gear 12 drives the hundreds wheel 8 when it comes in contact with the tens wheel drive gears 27 (refer fig. 18) on the tens wheel 7. The dummy wheel 9 rotates synchronously with the units wheel 6 and allows for the rotation of the tens wheel 7. The tens interim driver gear 11 is always in contact with the tens wheel 7 but only comes in contact with the dummy wheel 9 via the dummy wheel gear 25 (refer fig. 21B) after every 10 actuation/operations (e.g., when the dummy wheel 9 completes 10 rotational increments). The mount 1 provides for a stationery fixture that holds all the moving components of the dose indicator assembly 57.

[166] Fig. 12 shows dose indicator assembly of another embodiment. The figure shows the dose indicator assembly 57 includes mount 1, linear rack left 2, linear rack right 3, pinion left 4, pinion right 5, driving roller 13, dummy wheel 9, counter/roller shaft 10, driven roller 16, driving roller hollow shaft 44 (also refer fig. 26), mount shaft 30, dummy wheel key hole 46, driving roller key 47 (also refer fig. 26), driven roller shaft guides 67, the scroll 55, the spring left 59, and/or the spring right 60. The mount 1 holds and locates all the components of the dose indicator assembly and has features mount groove 29, rack motion space left 32, rack motion space right 33, wheel lock left 34, and/or wheel lock right 35 (refer fig. 16). The mount groove 29 holds and locates the counter/roller shaft 10 and prevents any motion of the counter/roller shaft 10. The pinion left 4, pinion right 5, dummy wheel 9 and the driving roller 13 rotate about the counter/roller shaft 10 and are locked in place on the mount groove 29 of the mount 1. The mount shaft 30 locates the driven roller 16. The rack motion space left 32, rack motion space right 33, allow room for the reciprocal motion of the linear rack left 2 and the linear rack right 3. The wheel lock left 34 and wheel lock right 35 prevent the reverse rotation of the driving roller 13 and the dummy wheel 9 through slits 14 (refer figs. 22 and 26), respectively. This dose indicator set-up allows for a three digit (units) read-out and feedback on dose numbers in a medicament dispenser ranging from‘0’ to‘200’ via a printed, etched, embossed, or colored scroll 55.

[167] Figs. 13A and 13B show an exploded view of the dose indicator assembly 57 and its operation. The dose indicator assembly 57 includes mount 1, linear rack left 2, linear rack right 3, pinion left 4, pinion right 5, units wheel 6, tens wheel 7, hundreds wheel 8, dummy wheel 9, counter/roller shaft 10, tens interim drive gear 11, hundreds interim drive gear 12, spring left 59, and/or spring right 60. The mount 1 holds and locates all the components of the core dose indicator assembly and has a mount groove 29, mount shaft 30, interim gear pins 31, rack motion space left 32, rack motion space right 33, wheel lock left 34 and wheel lock right 35. The mount groove 29 holds and locates the counter/roller shaft 10 and prevents any motion. The mount shaft 30 locates the interim drive gear 11 while the interim gear pins 31 locates the hundreds interim drive gear 12. The rack motion space left 32 and rack motion space right 33 allow room for the reciprocal motion of the linear rack left 2, and linear rack right 3. The spring left 59 and spring right 60 compress when the canister 56 or bottle 65 are depressed either by the press-and breathe operation of the user or the activation of the breath triggered actuation mechanism, both resulting in downward rectilinear motion of the canister 56 or bottle 65 and remain in the state of compression as long as the canister 56 or bottle 65 are depressed. When the canister 56 or bottle 65 are not depressed and return back to their original state, spring left 59 and spring right 60 un-compress and move the linear rack left 2 and linear rack right 3 vertically to their original state. The pinions 4 and 5 rotate both clockwise and counter-clockwise due to the to-and-fro motion of the linear racks 2 and 3. When the linear rack left 2 and the linear rack right 3 move in a downward motion, simultaneously and synchronously, the pinion left 4 and the pinion right 5 move in a clock-wise motion. When the linear rack left 2 and the linear rack right 3 move in an upward motion, simultaneously and synchronously, the pinion left 4 and the pinion right 5 move in a counter-clockwise motion. The wheel lock left 34 and wheel lock right 35 prevent the reverse rotation of the units wheel 6 and the dummy wheel 9 through the slits 14 (refer figs. 21 and 17), respectively. The units wheel 6 has radial ratchets 24 (refer fig. 21). The units wheel 6 is driven by the driving studs 23 located on the pinion left 4 (refer fig. 20 A). The driving studs 23 ride over the radial ratchets 24 of units wheel 6 during the reverse rotation of pinion left 4. The radial ratchet 24 and slits 14 of unit wheel 6 (refer fig. 17) together with the wheel lock left 34 prevent the reverse rotation of the units wheel 6. The tens wheel 7 has tens wheel gear 26 and tens wheel driver gear 27 (refer fig. 18). The tens wheel 7 is driven by the dummy wheel gears 25 (refer fig. 21B) located on the dummy wheel 9 via the tens interim drive gear 11. The tens interim drive gear 11 is always in contact with the tens wheel gear 26 and rotates every ten doses. The tens wheel 7 also drives the hundreds wheel 9 via the tens wheel drive gears 27 and the hundreds interim gear 12. The hundreds wheel 8 has hundreds wheel gear 28 (refer fig. 19). The hundreds wheel 8 is driven by the tens wheel 7 via tens wheel drive gear 27 and the hundreds interim gear 12. The hundreds interim gear 12 is always in contact with the hundreds wheel 8 via the hundreds wheel gear 28 and rotates every 100 doses or one complete rotation of the tens wheel 7. The dummy wheel 9 has radial ratchets 24, dummy wheel gears 25, and/or slits 14. The dummy wheel 9 is driven by the driving studs 23 located on the pinion right 5 (refer fig. 20A). The driving studs 23 on the pinion right 5 rides over the radial ratchets 24 of the dummy wheel 9 during the reverse rotation of the pinion right 5. The radial ratchet 24 and slits 14 on the dummy wheel 9 (refer fig. 21) together with the wheel lock right 35 prevent the reverse rotation of the dummy wheel 9. The dummy wheel gears 25 drive the tens interim gear 11 to rotate the tens wheel 7 after every ten doses. The dummy wheel 9 moves synchronously with the units wheel 6 since the driving mechanism on both side of the dose indicator assembly 57 and mount 1 include: linear rack right 3 and pinion right 5 on the right side are identical to linear rack left 2 and pinion left 4 on the left side. Springs 59 and 60 are identical and are located in the rack motion space left 32 and rack motion space right 33 of the mount 1.

[168] Figs. 14A and 14B show an exploded view of another embodiment of the dose indicator assembly and its operation. The pinion 4 drives the driving roller 13 and the pinion 5 drives the dummy wheel 9 which leads to advancement of scroll on the driving roller hollow shaft 44 of the driving roller 13 to the driven roller 16. The pinion left 4, pinion right 5 have driving studs 23 that ride over the radial ratchets 24 of the driving roller 13 and the dummy wheel 9, respectively. The pinion left 4 and the pinion right 5 can rotate in both directions as a result of the rectilinear motion of the linear rack left 2 and the linear rack right 3 in upward and downward direction. The dummy wheel 9 bears the radial ratchets 24 on one side that contact with the pinion right 5. The radial ratchets 24 and slit 14 along with the wheel lock right 35 prevent the reverse motion of the dummy wheel 9. The dummy wheel 9 includes a dummy wheel key hole 46 which keys into the driving roller key 47 of the driving roller 13. The dummy wheel 9 moves synchronously with the driving roller 13 due to similar driving mechanisms including the linear rack left 2, linear rack right 3, pinion left 4 and pinion right 5 on each side of the assembly. The driving roller hollow shaft 44 rides over the counter/ roller shaft 10. The driving roller key 47 rotates the dummy wheel 9 via the dummy wheel key hole 46. The driven roller 16 rotates about the mount shaft 30 which is fixed on the mount 1. Initially the scroll 55 is wound around the driven roller 16 and is supported by the driven roller shaft guides 67 that are located on each side of the driven roller 16. The other end of the scroll 55 is fixed on the driving roller hollow shaft 44 of the driving roller 13. During each actuation/operation of the medicament dispenser the driving roller hollow shaft 44 of the driving roller 13 rotates incrementally, thereby moving the scroll 55 over driven roller 16 and displaying the dose count through the window 48 on the actuator 36. The two linear rack set-up, e.g., linear rack left 2 and linear rack right 3, allows for an efficient and robust transfer and distribution of motion from the actuation/opening of the medicament dispenser to and within the dose indicator assembly 57 and allows for relative serial reduction in the unit count of doses remaining in the medicament dispenser. The two linear rack set-up prevents an inadvertent miss in the transfer and distribution of motion within the dose indictor assembly 57 and a false higher remaining dose count within the medicament dispenser. The two linear rack set-up also prevents an inadvertent partial movement of the scroll 55. The spring left 59 and spring right 60 assist in the return movement of the linear rack left 2 and the linear rack right 3 after actuation/operation.

[169] Fig. 15 shows an isometric view of mount 1 of an embodiment. The mount 1 has mount groove 29, mount shaft 30, interim gear pins 31, rack motion space left 32, rack motion space right 33, wheel lock left 34, and/or wheel lock right 35

[170] Fig. 16 shows an isometric view of mount 1 of another embodiment. The mount 1 has mount groove 29, mount shaft 30, rack motion space left 32, rack motion space right 33, wheel lock left 34, and/or wheel lock right 35.

[171] Fig. 17 is an isometric view of unit wheel 6. The figure shows radial ratchets 24 and slits 14. The unit wheels have radial ratchets 24 for engagement with the pinion. The slits 14 on the unit wheels engages with the wheel lock 34.

[172] Figs. 18A and 18B show isometric views of tens wheel 7. The tens wheel has the slits 14, the tens wheel gear 26, and tens wheel drive gear 27.

[173] Fig. 19 is an isometric view of hundreds wheel 8 showing hundreds wheel gear 28 and slits

14.

[174] Fig. 20A is an isometric view of pinion 4 or 5 showing driving studs 23.

[175] Fig. 20B is an isometric view of linear rack.

[176] Figs. 21A and 21B show different isometric view of dummy wheel 9. The dummy wheel 9 showing slits 14, radial ratchets 24 and dummy wheel gear 25.

[177] Figs. 22A and 22B shows different isometric view of dummy wheel 9 of another embodiment. The dummy wheel 9 showing slits 14, radial ratchets 24, and/or dummy wheel key hole 46.

[178] Fig. 23 is an isometric view of spring 59 or 60.

[179] Fig. 24 is an isometric view of tens interim drive gear 11.

[180] Fig. 25 is an isometric view of hundreds interim drive gear 12.

[181] Fig. 26 is an isometric view of driving roller 13. The driving roller includes slits 14, radial ratchets 24, driving roller hollow shaft 44, and/or driving roller key 47.

[182] Fig. 27 is an isometric view of driven roller 16 showing driven roller shaft guides 67. The driven roller shaft guides 67 maintain the scroll 55 in its position.

[183] Figs. 28A and 28B show a scroll 55 and its representation. [184] Figs. 29-40 show an illustration of the medicament dispenser with an initial dose count of ‘999’ number of doses. During operation of the medicament dispenser, the spring left 59 and spring right 60 loaded on the linear rack left 2 and the linear rack right 3, respectively, compressed when the canister 56 or bottle 65 are depressed either by the press-and breathe operation of the user or the activation of the breath triggered actuation mechanism, both resulting in downward rectilinear motion of the canister 56 or bottle 65. Due to the reciprocal movement of the linear rack left 2 and the linear rack right 3, the pinion left 4 and the pinion right 5 rotate both clockwise and counterclockwise. At this stage, the dose counter 57 reads‘999’ thereby displaying‘9’ on all units wheel 6, tens wheel 7 and hundreds wheel 8 (refer fig. 29). The units wheel 6, tens wheel 7, and hundreds wheel 8 rotate in the same direction. When the canister 56 or bottle 65 are depressed to actuate/operate the medicament dispenser the first time (once), the motion is transferred to the linear rack left 2 and the linear rack right 3 by the balancer (38, 41, 43). At this stage, the linear rack left 2 and the linear rack right 3 move in a downward motion, simultaneously and synchronously. At this stage the pinion left 4 and the pinion right 5 rotates clockwise. The pinion left 4 and the pinion right 5 having driving studs 23 further lead to clockwise movement of the units wheel 6 and the dummy wheel 9 through radial ratchets 24, respectively. At this stage the units wheel 6 move by decrementing from‘9’ to‘8’ (refer fig. 30, 31 and 32). The unit wheel 6 moves synchronously with the dummy wheel 9. At this stage the dummy wheel gear 25 on the dummy wheel 9 does not come in contact with the tens interim drive gear 11, thereby no movement of tens wheel 7 which further leads to no movement of hundreds 8 wheel. As a result, the tens wheel 7 and hundreds wheel 8 continues to displays‘9’. At the end of this actuation/operation, the dose counter will display‘998’. Once the canister 56 or bottle 65 are no longer depressed the linear rack left 2 and the linear rack right 3 move in an upward motion, simultaneously and synchronously and achieve the original position. At this stage there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer figs. 33 and 34). When the canister 56 or bottle 65 are depressed operated 9 (nine) times the units wheel 6 reads‘O’, the tens wheel 7 reads‘9’ and the hundreds wheel 8 reads‘9’. The units wheel 6 and the dummy wheel 9 move simultaneously and synchronously. At the dose count of‘990’, when the canister 56 or bottle 65 are depressed to actuate/operate the medicament dispenser, the units wheel 6 moves from‘0’ to ‘9’(refer fig. 35). At this stage dummy wheel 9 rotates the tens interim drive gear 11 and increments the tens wheel 7 from‘9’ to‘8’ via tens wheel gear 26 (refer fig. 36; hundreds wheel not shown to illustrate gear mechanism). At this stage there is no movement of the hundreds wheel 8. At this stage the dose indicator displays‘989’. Once the canister 56 or bottle 65 are no longer depressed the linear rack left 2 and the linear rack right 3 move in an upward motion, simultaneously and synchronously and achieve the original position. At this stage there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer fig. 37). When the canister 56 or bottle 65 are depressed to actuate/operate the medicament dispenser‘99’ times, the units wheel 6 reads‘O’, the tens wheel 7 reads‘0’ and the hundreds wheel 9 reads‘9’. The units wheel 6, dummy wheel 9, and tens wheel 7 move simultaneously and synchronously. At the dose count of‘900’, when the when the canister 56 or bottle 65 are depressed to actuate/operate the medicament dispenser, the units wheel 6 moves from‘0’ to‘9’ (refer fig. 38). At this stage dummy wheel 9 rotates the tens interim drive gear 11 and increments the tens wheel 7 from‘0’ to‘9’. At this stage, the tens wheel 7 comes in contact with the hundreds interim drive gear 12 and increments the hundreds wheel 8 from‘9’ to‘8’ via hundreds wheel gear 28 (refer fig. 39; units wheel not shown to illustrate gear mechanism). At this stage the dose indicator displays‘899’. ). As a result, the tens wheel 7 does not rotate each time when the dummy wheel 9 and the units wheel 6 rotate as the counts decrement from‘9’ to‘0’ on the units wheel 6. Similarly, the hundreds wheel 8 does not rotate each time when the tens wheel 7 decrements from‘9’ to‘0’ on the tens wheel 7. Every time when the canister 56 or bottle 65 are no longer depressed, the linear rack left 2 and the linear rack right 3 move in an upward motion due to the spring left 59 and spring right 60, simultaneously and synchronously and achieve the original position. At this stage there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer fig. 40).

[185] Figs. 41-46 shows the operating cycle of dose feedback mechanism with initial dose count of 120 doses. During operation of the medicament dispenser, the spring left 59 and spring right 60 loaded on the linear rack left 2 and the linear rack right 3, respectively, compressed when the canister 56 or bottle 65 are depressed either by the press-and breathe operation of the user or the activation of the breath triggered actuation mechanism, both resulting in downward rectilinear motion of the canister 56 or bottle 65. Due to the reciprocal movement of the linear rack left 2 and the linear rack right 3, the pinion left 4 and the pinion right 5 rotate both clockwise and counterclockwise. At this stage, the dose counter 57 reads‘120’ thereby displaying‘0’ on units wheel 6, ‘2’ on tens wheel 7 and‘1’ on hundreds wheel 8. The units wheel 6, tens wheel 7 and hundreds wheel 8 all rotate in the same direction. When the canister 56 or bottle 65 are depressed to actuate/operate the medicament dispenser for the first time (once), the motion is transferred to the linear rack left 2 and the linear rack right 3 by the balancer (38, 41, 43). At this stage, the linear rack left 2 and the linear rack right 3 move in a downward motion, simultaneously and synchronously. At this stage the pinion left 4 and the pinion right 5 having driving studs 23 moves clockwise and lead to clockwise movement of the units wheel 6 and the dummy wheel 9 through radial ratchets 24, respectively (refer fig. 41). At this stage the units wheel 6 move by decrementing from‘0’ to‘9’. The unit wheel 6 moves synchronously with the dummy wheel 9. When the units wheel 6 decrements from‘0’ to‘9’, the dummy wheel gear 25 on the dummy wheel 9 come in contact with the tens interim drive gear 11, thereby rotating and decrementing the tens wheel 7 from‘2’ to‘ 1’ (refer fig. 42; hundreds wheel not shown to illustrate gear mechanism). During this rotation of the tens wheel 7 from‘2’ to‘V, the tens wheel drive gear 27 of tens wheel 7 does not come in contact with the hundreds interim drive gear 12. As a result, the hundreds wheel 8 does not rotate and continues to displays‘V. At the end of this actuation/operation, the dose counter will display‘119’. Once the canister 56 or bottle 65 are no longer depressed the linear rack left 2 and the linear rack right 3 move in an upward motion due to the spring left 59 and spring right 60, simultaneously and synchronously and achieve the original position. At this stage there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer fig. 43). The dose indicator will continue to move during each successive actuation/operation by decrementing the units wheel from‘9’ to‘O’. The units wheel 6 and hence the dummy wheel 9 will not come in contact with the tens interim drive gear 11 for the next ten actuations/operations. As a result, the tens wheel 7 will continue to display‘ 1’and also the hundreds wheel 8 will continue to display‘1’. When the dose indicator reads‘100’ and the canister 56 or bottle 65 are depressed to actuate/operate at this stage, the units wheel decrements from‘0’ to‘9’ (refer fig. 44). The unit wheel 6 moves synchronously with the dummy wheel 9. When the units wheel 6 decrements from ‘0’ to‘9’, the dummy wheel gear 25 on the dummy wheel 9 come in contact with the tens interim drive gear 11 thereby rotating and decrementing the tens wheel 7 from‘0’ to‘9’ via tens wheel gear 26 (refer fig. 45; units wheel not shown to illustrate gear mechanism). When the tens wheel 7 decrements from‘0’ to‘9’, the tens wheel drive gear 27 on the tens wheel 7 come in contact with the hundreds interim drive gear 12 thereby rotating and decrementing the hundreds wheel 8 from ‘1’ to‘0’ via hundreds wheel gear 28 (refer fig. 45; units wheel not shown to illustrate gear mechanism). At the end of this actuation/operation, the dose counter displays‘099’. The core dose indicator assembly 57 will continue to operate in this manner until it reads‘000’, after which it may locks down and does not rotate anymore. Once the canister 56 or bottle 65 are no longer depressed the linear rack left 2 and the linear rack right 3 move in an upward motion due to the spring left 59 and spring right 60, simultaneously and synchronously and achieve the original position. At this stage there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer fig. 46).

[186] Figs. 47-49 show the operating cycle of another embodiment of dose feedback mechanism with initial dose count of 200 doses. During operation of the medicament dispenser, the spring left 59 and spring right 60 loaded on the linear rack left 2 and the linear rack right 3, respectively, compressed when the canister 56 or bottle 65 are depressed either by the press-and breathe operation of the user or the activation of the breath triggered actuation mechanism, both resulting in downward rectilinear motion of the canister 56 or bottle 65. Due to the reciprocal movement of the linear rack left 2 and the linear rack right 3, the pinion left 4 and the pinion right 5 rotate both clockwise and counter-clockwise. The pinion left 4 and the pinion right 5 drive studs 23 that drive over the radial ratchets 24 of the driving roller 13 and the dummy wheel 9, respectively. This causes the driving roller 13 and the dummy wheel 9 to rotate uni -directionally (clockwise) (refer figs. 47 and 48). The dummy wheel 9 is keyed to the driving roller hollow shaft 44 of the driving roller 13. The pinion left 4, the pinion right 5, and the driving roller 13 rotate about the counter/roller shaft 10 which is locked in place on the mount groove 29 of mount 1. Initially, the scroll 55 is wound around the driven roller 16. The other end of the scroll 55 is fixed on the driving roller hollow shaft 44 of the driving roller 13. During the initial the operation of the medicament dispenser, the collective, synchronous, simultaneous, rectilinear and reciprocal movement of both the balancer (38, 41, 43), the linear rack left 2 and the linear rack right 3, leads to clockwise rotation of the pinion left 4 and the pinion right 5 which leads to clockwise and unidirectional rotation of the driving roller 13 and the dummy wheel 9 which leads to advancement of scroll 55 fixed on the driving roller hollow shaft 44 of the driving roller 13. At the end of the dosing cycle when the canister 56 or bottle 65 are no longer depressed, the linear rack left 2, the linear rack right 3 and the balancer (38, 41, 43) return to their original position due to the spring left 59 and spring right 60. At this stage there is no movement of the driving roller 13, the dummy wheel 9 and hence no movement of the scroll 55 (refer fig. 49). [187] Fig 50 shows bar type balancer 41. The bar type balancer 41 includes a balancer bar surface 42. The bar type balancer 41 serves the functions of providing a dynamic guide for the canister 56 or bottle 65, and transfers, distributes, and equalizes the force on the linear rack left 2 and the linear rack right 3 of the dose indicator assembly 57 from the rectilinear motion of the canister 56 or bottle 65. This efficient and consistent transfer of force from the motion of the canister 56 or bottle 65 to the dose indicator assembly 57 allows for a consistent and efficient operation of the dose indicator assembly 57 and prevents an inadvertent miss in the change in dose count during the actuation/operation of the medicament dispenser.

[188] Fig. 51 shows an arrangement of dose indicator assembly 57 and bar type balancer 41 in the actuator 36.

[189] Fig. 52 is a sectional view showing the actuator 36, bar type balancer 41, balancer bar surface 42, dose indicator assembly 57, linear rack right 3, and linear rack guides 37.

[190] Fig. 53 shows an arrangement of dose indicator assembly 57 and bar type balancer 41. The tip of linear rack fits into the balancer slots for liner rack 66.

[191] Fig54 show another type of disc type balancer 43 showing balancer slots for linear rack 66

[192] Fig 55show another type of half moon type balancer 38 showing balancer slots for liner rack 66.

[193] Fig. 56 shows a dry powder inhaler actuator 99 showing outer cover 100 and window 48.

[194] Fig. 57 shows a view of an example of a dose indicator assembly 57 and bar type balancer 45 that is compatible with the dry powder inhaler described herein. The bar type balancer 45 has cam drive 127, long link 128, transverse link 129, actuation link 130, long link guide 133 and transverse link guide bar 137. The balancer transfers, distributes, and equalizes the force of primary packaging on the linear racks.

[195] Fig. 58 shows an exploded view of the dose indicator assembly 57 and the dry powder inhaler actuator 99. The exploded view shows outer cover 100, dose indicator assembly 57, the bar type balancer 45 component cam drive 127, long link 128, transverse link 129, actuation link 130, long link guide 133, and transverse link guide bar 137.

[196] Figs. 59A, 59B and 59C show components of another bar type balancer 45 compatible with dry powder inhaler. The components of bar type balancer 45 include cam drive 127, long link 128, transverse link 129, actuation link 130, long link guide 133 and transverse link guide bar 137. The CLEAN SPECIFICATION cam drive 127 has cam surface 135 and cam gear 136. The cam drive 127 is driven by cam gears 136. The long link 128 moves in a linear motion guided by the cam surface 135. The long link 128 is attached to the transverse link 129 guided by long link guide 133 through the transverse link guide bar 137.

Transverse link 129 moves the actuation link 130 that drives the mechanism of the dose indicator assembly 57 (refer fig 57 for assembly of bar type balancer 45).

[197] figs. 60A-66 show the operating cycle of another embodiment of dose feedback mechanism with initial dose count of 999 doses. When the outer cover 100 is opened/actuated/operated the first time (once), the motion is transferred to the linear rack left 2 and the linear rack right 3 by the bar type balancer 45 including the cam drive 127, long link 128, transverse link 129, actuation link 130, long link guide 133 and transverse link guide bar 137 (refer figs. 60A, 60B and 61). At this stage, the linear rack left 2 and the linear rack right 3 move in a downward motion, simultaneously and synchronously. When the outer cover 100 is opened/actuated/operated during the operation of the medicament dispenser, it rotates the cam drive 127 via the interim driver gear 108 (refer fig. 61). The long link 128 rides over the cam surface 135 (refer fig. 59B) resulting in a linear motion of the long link 128. The transverse link 129 is attached to the long link 128 and is guided by long link guide 133 (refer fig. 61). The transverse link 129 operates the actuation link 130 that moves the linear rack left 2 and the linear rack right 3 move in a downward motion (refer fig. 61). At this stage, the dose counter 57 reads '999' thereby displaying '9' on all units wheel 6, tens wheel 7 and hundreds wheel 8. The units wheel 6, tens wheel 7 and hundreds wheel 8 all rotate in the same direction. When the outer cover 100 operated for the first time (once), the motion is transferred to the linear rack left 2 and the linear rack right 3 by the bar type balancer 45 (refer fig. 60A). At this stage, the linear rack left 2 and the linear rack right 3 move in a downward motion, simultaneously and synchronously. At this stage, the pinion left 4 and the pinion right 5 having driving studs 23 lead to clockwise movement of the units wheel 6 and the dummy wheel 9 through radial ratchets 24, respectively (refer fig. 62). At this stage, the units wheel 6 move by decrementing from '9' to '8' (refer fig. 63). The unit wheel 6 moves synchronously with the dummy wheel 9. At this stage, the dummy wheel gear 25 (not shown in fig.) on the dummy wheel 9 does not come in contact with the tens interim drive gear 11, thereby no movement of tens wheel 7 which further leads to no movement of hundreds 8 wheel. As a result, the tens wheel 7 and hundreds wheel 8 continues to displays '9'. At the end of this actuation/operation, the dose counter will display '998' (refer fig. 64). Subsequently when the dummy wheel 9 rotates and completes 10 incremental rotations, at this stage, the dummy wheel gear 25 on the dummy wheel 9 contact the tens interim drive gear 11 and cause it to rotate (not shown in fig.). The rotation of tens interim drive gear 11 leads to the rotations of the tens wheel 7 via tens wheel gears 26 (not shown in fig.). When the tens wheel 7 rotates and completes 10 incremental rotations, at this stage the tens wheel driver gear 27 on the tens wheel 7 comes in contact with the hundreds interim drive gear 12 and causes it to rotate (not shown in fig.). The rotation of the hundreds interim drive gear 12 leads to the rotation of the hundreds wheel 8 via the hundreds wheel gear 28 (not shown in fig.). The tens interim drive gear 11 is always in contact with the tens wheel 7 via the tens wheel gears 26. The tens interim drive gear 11 does not rotate until it comes in contact with the dummy wheel 9 via the dummy wheel gear 25 on the dummy wheel 9. As a result, the tens wheel 7 does not rotate each time when the dummy wheel 9 and the units wheel 6 rotate as the counts decrement from '9' to 'O' on the units wheel 6. Similarly, the hundreds interim drive gear 12 is always in contact with the hundreds wheel 8 via hundreds wheel drive gear 28. The hundreds interim drive gear 12 does not rotate until it comes in contact with the tens wheel 7 via tens wheel drive gear 27 on the tens wheel 7. As a result, the hundreds wheel 8 does not rotate each time when the tens wheel 7 decrements from '9' to 'O' on the tens wheel 7. At the end of the dosing cycle when the when cover 100 moves back to its original position (close position), the linear rack left 2, the linear rack right 3 and the balancer 45 return to their original position due to the spring left 59 and spring right 60. At this stage, there is no further movement of the units wheel 6 or dummy wheel 9 or tens wheel 7 or hundreds wheel 8 (refer figs. 65A, 65Band 66)."

Claims

Claims:

1. A dose indicator assembly comprising:

a mount;

two or more linear racks at least partially disposed within the mount;

two or more pinions configured to convert rectilinear motion of the two or more linear racks to rotary motion;

one or more dummy wheels interfacing with at least one of the two or more pinions; and a dose indicating means for providing a dose related visual feedback to the user of the medicament dispenser.

2. The dose indicator assembly according to claim 1, wherein each of the two or more linear racks comprises teeth.

3. The dose indicator assembly according to claim 1, wherein the dose indicating means provides a count ranging from numbers‘0’ to‘999’ which are displayed synchronously, collectively and simultaneously with single or multiple components of the dose indicator assembly.

4. The dose indicator assembly according to claim 3, wherein the numbers‘0’ to‘999’ are displayed in a vertical or horizontal orientation.

5. The dose indicator assembly according to claim 1, wherein the dose indicating means comprises one or more dose indicator wheels.

6. The dose indicator assembly according to claim 5, wherein the one or more dose indicator wheels comprises a units wheel, a tens wheel, and a hundreds wheel.

7. The dose indicator assembly according to claim 5, wherein the one or more dose indicator wheels are arranged in a non-concentric, co-axial configuration.

8. The dose indicator assembly according to claim 5, wherein at least one of the dose indicator wheels rotates independently of the other.

9. The dose indicator assembly according to claim 1, wherein the assembly prevents a false higher remaining or consumed dose count within the medicament dispenser.

10. The dose indicator assembly according to claim 1, wherein the dose indicating means comprises a scroll having an ascending or descending read-outs, printed, etched, embossed, or colored thereon.

11. The dose indicator assembly according to claim 1, wherein the dose indicator assembly further comprises: a mount groove, mount shaft interim gear pins, a rack motion space left, a rack motion space right, a wheel lock left and a wheel lock right to prevent reverse rotation of wheels or a scroll.

12. The dose indicator assembly according to claim 6, wherein the units wheel is rotated by one of the two or more pinions and the tens wheel is rotated by one of the one or more dummy wheels.

13. The dose indicator assembly according to claim 12, wherein the tens wheel is rotated by one of the one or more dummy wheels through tens interim gear.

14. The dose indicator assembly according to claim 13, wherein the tens wheel rotates the hundreds wheel.

15. The dose indicator assembly according to claim 14, wherein the units wheel rotates each time one of the two or more pinions rotates and the tens wheel rotate once on every tenth rotation of one of the one or more dummy wheels.

16. The dose indicator assembly according to claim 15, wherein the hundreds wheel rotates once on every tenth rotation of the tens wheel.

17. The dose indicator assembly according to claim 11, further comprising a driving roller.

18. The dose indicator assembly according to claim 17, wherein the dummy wheel and the driving roller are rotated by the two or more pinions.

19. The dose counter according to claim 17, wherein the rotation of the dummy wheel and the driving roller causes a scroll to advance over the driven roller from the driving roller providing the dose related visual feedback to the user of the medicament dispenser.