Electronic breath actuated droplet delivery systems with dose metering capabilities, inhalation topography methods, and related methods of use

Abstract

Methods, devices and systems are provided wherein compositions are delivered to the pulmonary system of an intended user via inhalation in a controlled manner and at a desired doses and/or amounts, e.g., within a desired dosage window and/or inhalation topography. In certain embodiments, dosage windows and/or inhalation topography may be used, e.g., to provide for controlled cessation of use or to provide a desired therapeutic window.

What is claimed: 
     
         1 . A method for controlling the dose and/or amount of a composition for delivery to the pulmonary system of a user via inhalation, the method comprising:
 receiving, at a computing system based on user input, a request for a desired dose or amount of at least one agent or ingredient of a composition for delivery to the pulmonary system of a user via inhalation;   at the computing system and in response to receiving the request, determining inhalation delivery device operating parameters to provide the requested desired dose or amount of at least one agent or ingredient of a composition for delivery to the pulmonary system of a user via inhalation;   generating, at the computing system, instructions for activation and operation of an inhalation delivery device to provide the requested desired dose or amount based on the determined inhalation delivery device operating parameters; and   transmitting the instructions from the computing system to an ejector mechanism of an inhalation delivery device for execution at the inhalation delivery device to provide for activation and operation of the inhalation delivery device upon use to thereby control the dose and/or amount of the at least one agent or ingredient of a composition for delivery to the pulmonary system of user via inhalation.   
     
     
         2 . The method of  claim 1 , wherein the request for a desired dose or amount comprises an inhalation topography to achieve a desired dosing regimen. 
     
     
         3 . The method of  claim 2 , wherein the inhalation topography facilitates cessation of use. 
     
     
         4 . The method of  claim 2 , wherein the inhalation topography gradually reduces the dose or amount over time to thereby facilitate cessation of use. 
     
     
         5 . The method of  claim 2 , wherein the inhalation topography includes an initial bolus dose at an initial loading dose, followed by maintenance doses at reduced dose. 
     
     
         6 . The method of  claim 1 , wherein the request includes independently selected doses and/or amounts at least two agents or ingredients such that instructions are provided to the inhalation delivery device to independently control the dose and/or amount of each of said at least two agents or ingredients separately. 
     
     
         7 . The method of  claim 1 , wherein the composition comprises nicotine, and the method comprises controlling the dose or amount of nicotine for delivery to the pulmonary system of a user via inhalation. 
     
     
         8 . The method of  claim 8 , wherein the composition further comprises a flavoring, and the request includes independently selected doses and/or amounts for nicotine and the flavoring such that instructions are provided to the inhalation delivery device to independently control the dose and/or amount of each of nicotine and the flavoring separately. 
     
     
         9 . The method of  claim 1 , wherein the computing system is a user computing device, and the user input is received via a user interface of the user computing device. 
     
     
         10 . The method of  claim 1 , wherein an inhalation delivery device comprises the computing system, and the user input is received via a user interface of the inhalation delivery device, via input from user inhalation flowrates, or a combination thereof. 
     
     
         11 . The method of  claim 10 , wherein the user interface of the inhalation delivery device comprises user input buttons, an LCD touchscreen, or combinations thereof. 
     
     
         12 . A computing system comprising:
 one or more processors; and   a memory storing instructions executable by the one or more processors, wherein, when executed by the one or more processors, the instructions cause the one or more processors to:
 receive, based on user input, a request for a desired dose or amount of at least one agent or ingredient of a composition for delivery to the pulmonary system of a user via inhalation; 
 determine inhalation delivery device operating parameters to provide the requested desired dose or amount of at least one agent or ingredient of a composition for delivery to the pulmonary system of a user via inhalation; 
 generate instructions for activation and operation of an inhalation delivery device to provide the requested desired dose or amount based on the determined inhalation delivery device operating parameters; and 
 transmit the instructions to an ejector mechanism of an inhalation delivery device for execution at the inhalation delivery device to provide for activation and operation of the inhalation delivery device upon use to thereby control the dose and/or amount of the at least one agent or ingredient of a composition for delivery to the pulmonary system of user via inhalation. 
   
     
     
         13 . The system of  12 , wherein the request for a desired dose or amount comprises an inhalation topography to achieve a desired dosing regimen. 
     
     
         14 . The system of  claim 13 , wherein the inhalation topography facilitates cessation of use. 
     
     
         15 . The system of  claim 13 , wherein the inhalation topography gradually reduces the dose or amount over time to thereby facilitate cessation of use. 
     
     
         16 . The system of  claim 13 , wherein the inhalation topography includes an initial bolus dose at an initial loading dose, followed by maintenance doses at reduced dose. 
     
     
         17 . The system of  12 , wherein the computing system is a user computing device, and the user input is received via a user interface of the user computing device. 
     
     
         18 . The system of  12 , wherein an inhalation delivery device comprises the computing system, and the user input is received via a user interface of the inhalation delivery device, via input from user inhalation flowrates, or a combination thereof. 
     
     
         19 . The system of  claim 18 , wherein the user interface of the inhalation delivery device comprises user input buttons, an LCD touchscreen, or combinations thereof. 
     
     
         20 . A method of displaying historical data of use of an inhalation delivery device, the method comprising:
 receiving, at a user computing device from a user interface, a request for historical data associated with use of an inhalation delivery device to deliver an inhaled composition, the historical data comprising an element selected from: number of doses administered, dosages and amounts administered, average inhalation topography, and combinations thereof;   transmitting, from the user computing device to an inhalation delivery device, the request for historical data;   receiving, at the user computing device from the inhalation delivery device, the requested historical data;   generating, at the user computing device, graphical data for rendering and displaying a report of the requested historical data;   rendering the graphical data, at the user computing device; and   displaying a report on a display of the user computing device, the report including graphical elements including the historical data.   
     
     
         21 . The method of  claim 20 , wherein the displaying of historical data of use of an inhalation delivery device facilities the cessation of use. 
     
     
         22 . The method of  claim 20 , wherein rendering the graphical data further includes displaying changes in dosage amounts over time to illustrate reductions or increases in use of the inhalation delivery device. 
     
     
         23 . The method of  claim 20  further comprising:
 receiving a selection of a graphical element of the report at the user computing device; 
 generating, in response to receiving the selection, additional graphical data related to the selected graphical element; 
 rendering the additional graphical data, at the user computing device; and 
 displaying a report on a display of the user computing device, the report including additional graphical data related to the selected graphical element. 
 
     
     
         24 . The method of  claim 23 , wherein the report comprises education information related to cessation of use.