Claims for Patent: 9,016,147

Summary for Patent: 9,016,147

Title:	Apparatus and method for simulating inhalation efforts
Abstract:	An inhalation simulation system is provided for use with inhalers in particular breath-powered dry powder inhalers. The simulation system can recreate a patient\'s inhalation profile obtained with an inhaler adapted with a sensing and monitoring device for the detection of characteristic signals generated from the inhaler in use, which signals are transmitted to a computer with an algorithm which is configured to analyze the signals and generate new signals via a transmitter to actuate the inhalation simulation system component parts so that a subject\'s inhalation profile is replicated simultaneously or in real-time, or stored for later use. Methods of measuring the performance of inhalers are also provided.
Inventor(s):	Adamo; Benoit (Mount Kisko, NY), Polidoro; John M. (Coventry, CT), Overfield; Dennis (Fairfield, CT), Sahi; Carl R. (Coventry, CT), Laurenzi; Brendan (New Milford, CT), Smutney; Chad C. (Watertown, CT), Kinsey; Spencer P. (Sandy Hook, CT)
Assignee:	MannKind Corporation (Valencia, CA)
Application Number:	13/505,729
Patent Claims:	1. An inhalation simulation system comprising: an artificial anatomical head comprising a substantially accurate upper respiratory airway; a dry powder inhaler, wherein the dry powder inhaler is breath-powered; a sensor configured within said dry powder inhaler or configured to attach to said dry powder inhaler; said sensor is configured to detect an acoustic signal generated from said dry powder inhaler when said dry powder inhaler is connected to said artificial head and to transmit at least one type of signal to at least one device for analysis, storage, printing or display; a vacuum source; a power supply; a computer comprising a microprocessor, an algorithm and a display device. 2. The inhalation simulation system of claim 1, wherein said dry powder inhaler comprises a sensor and a microprocessor built within the inhaler or provided in a device attachable to the inhaler. 3. The inhalation simulation system of claim 2, wherein said dry powder inhaler device comprises a cartridge comprising a dry powder for pulmonary delivery. 4. The inhalation simulation system of claim 3, wherein the dry powder comprises diketopiperazine microparticles. 5. The inhalation simulation system of claim 3, wherein the dry powder comprises at least one active ingredient. 6. The inhalation simulation system of claim 5, wherein said at least one active ingredient comprises insulin, GLP-1, growth hormone, sumatriptan, parathyroid hormone, or analogs thereof. 7. The inhalation simulation system of claim 2, wherein said dry powder inhaler has a resistance value between about 0.065 ( kPa)/liter per minute and about 0.200 ( kPa)/liter per minute. 8. The inhalation simulation system of claim 2, wherein an analog to digital converter communicates at least one acoustic signal to a microprocessor configured to analyze and process said at least one acoustic signal. 9. The inhalation simulation system of claim 1, wherein said at least one type of signal is an amplitude of the acoustic signal, a frequency of the acoustic signal or combinations thereof. 10. The inhalation simulation system of claim 1, wherein said sensor is configured to further measure said at least one acoustic signal generated from the inhaler and transmit said signal to a receiver in a microprocessor or a computer. 11. The inhalation simulation system of claim 1, wherein said sensor is a microphone. 12. The inhalation simulation system of claim 1, wherein said sensor is configured to transmit said acoustic signal by a wireless communication mode to said at least one device. 13. The inhalation simulation system of claim 1, wherein said at least one device is an analog to digital converter. 14. The inhalation simulation system of claim 1, wherein said at least one device is a display device. 15. The inhalation simulation system of claim 14, wherein the display device is a computer monitor, a PDA or a printer. 16. The inhalation simulation system of claim 1, wherein the vacuum source is a calibrated syringe pump or a piston/cylinder device. 17. A method for simulating an inhalation maneuver by a subject, comprising: providing a first breath-powered dry powder inhaler comprising a first sensor and a first radio transmitter to the subject, wherein the first sensor is configured within said breath-powered dry powder inhaler or attached to said breath-powered dry powder inhaler; having the subject inhale through the first breath-powered dry powder inhaler to produce a pressure differential through the first breath-powered dry powder inhaler in a location near an inhalation simulation apparatus, inhalation simulation apparatus comprising: a computer with a microprocessor comprising a signal receiver and an algorithm configured to analyze and process a signal produced from the first sensor, a controller, a motor, a calibrated syringe pump, an artificial substantially accurate anatomical upper respiratory airway, and a second breath-powered dry powder inhaler attached to said artificial substantially accurate anatomical upper respiratory airway and comprising a second sensor, a second radio transmitter and a dry powder formulation; collecting at least one type of signal from flow generated in the first breath-powered dry powder inhaler; converting the signal to a first set of data from the subject's inhalation provided by the first sensor in the computer or microprocessor with said algorithm; generating a second set of signals in the computer to instruct the controller to activate the motor to move the calibrated syringe pump to generate a pressure differential equal to the pressure differential generated by the subject's inhalation; and simulating said inhalation maneuver by said subject. 18. The method of claim 17, wherein the syringe pump is connected to the artificial substantially accurate anatomical upper respiratory airway configured with a mouth connected to the second inhaler. 19. The method of claim 17, wherein the second inhaler is a dry powder inhaler adapted with a sensor and a radio transmitter. 20. The method of claim 17, wherein the second inhaler is adapted with a wireless or wired jacket comprising a microphone which can convert a sound signal into an electrical impulse configured to communicate with a radio signal receiver in a computer or microprocessor.

Details for Patent 9,016,147

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2029-11-03