Apparatus, systems and related methods for dispensing and /or evaluating dry powders

• US 7,118,010 B2
• Filed: 06/26/2003
• Issued: 10/10/2006
• Est. Priority Date: 05/10/2002
• Status: Expired due to Fees

• Current Assignee: Oriel Therapeutics, Inc. (Novartis Ag)
• Original Assignee: Oriel Therapeutics, Inc. (Novartis Ag)
• Inventors: Crowder, Timothy M., Boekestein, Vanessa, Hickey, Anthony J.
• Primary Examiner(s): Nicolas, Frederick C.
• Application Number:
  US10/607,389
• Publication Number:
  US 20040050860A1
• Time in Patent Office: 1,202 Days
• Field of Search: 222/1, 222/185.1, 222/181.1, 222/198, 222201-203, 222/52, 222/63, 222/196, 222/200, 700/240, 128/203.15, 310/316.01, 310/316.02, 310/316.03, 310/317
• US Class Current: 222/1
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0005 with means for agitating the medicament
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/0075 on a disc
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: B65B 37/04 by vibratory feeders
• CPC Class Codes: B65D 88/66 using vibrating or knocking devices
• CPC Class Codes: B65G 53/66 Use of indicator or control devices, e.g. for controlling gas pressure, for controlling proportions of material and gas, for indicating or preventing jamming of material controlling the flow of coal firing systems C21B5/003

Abstract

Methods, systems, and computer program products flowably dispense meted amounts of dry powders using a flexing piezoelectric layer to transmit a vibratory signal to the dry powder to facilitate fluidic flow through a flow channel. The apparatus for dispensing dry powders can include: (a) an elongate flow channel having a width, length, and depth, the flow channel having axially spaced apart inlet and outlet ports, wherein the elongate flow channel is configured to extend in an angular orientation of between about 10–75 degrees relative to the axial direction of flow; (b) a flexible piezoelectric layer configured to overlie the flow channel so that, in operation, the piezoelectric layer is able to flex upwardly away from the lowermost portion of the underlying flow channel; and (c) a signal generator operatively associated with the piezoelectric layer, wherein, in operation, the signal generator is configured to output a signal for flexing the piezoelectric layer in the elongate flow channel.

Claims

1. A method for selecting and/or determining customizable excitation signals for dispensing dry powders, comprising the steps of:

providing an elongate flow channel having a floor of piezoelectric material;

selecting an angle of orientation for the flow channel such that at least a portion of the flow channel angularly extends in a non-vertical, non-horizontal orientation in the axial direction;

providing a quantity of a target dry powder;

outputting a vibration excitation signal having a first carrier frequency from a signal generator to the piezoelectric material;

flowing the dry powder out of the flow channel;

outputting a vibration excitation signal having a second carrier frequency from the signal generator to the piezoelectric material; and

determining a dispensing vibration excitation signal for the target dry powder that generates a repeatable or a uniform or a repeatable and uniform fluid-like substantially non-agglomerated flow output based on flow data from the first and second vibration excitation signals.

2. A method according to claim 1, further comprising adjusting the angle of orientation of the flow channel and determining a desired operational angle of orientation of the flow channel based on the angles used in the selecting and adjusting steps, the determined operational angle being below the static angle of repose of the target dry powder.

3. A method according to claim 1, further comprising repeating the steps for a second target powder.

4. A method according to claim 1, wherein the dry powder flow rate is reproducible to have variation that is less than about +/−

10%.

5. A method according to claim 1, wherein the flow rate is reproducible to have variation that is less than about +/−

5%.

6. A method according to claim 1, wherein the flow rate is reproducible to have variation that is less than about +/−

2%.

7. A method according to claim 1, wherein the flow channel is disposed in a structurally rigid flow channel member, further comprising adjusting the size of a flow orifice extending above the piezoelectric material floor and below a cover member that overlies the floor and rests on the upper portion of the flow channel member by sliding the cover member forward or rearward over the flow channel member.

8. A method according to claim 2, wherein the determining, altering and selecting steps are carried out by selecting an angle of orientation that is below the static angle of repose of the target dry powder under analysis and evaluating the flow of the dry powder at a plurality of different angles below the static angle of repose.

9. A method according to claim 1, wherein the flowing step is controllably started and stopped by the application and removal, respectively, of the excitation signal to the piezoelectric material.

10. A method according to claim 7, wherein the cover member has an elongate, axially-extending tip portion that has a downwardly extending length that varies over the axial length of the cover member to thereby project into the flow channel at different depths.

11. A method of dispensing a dry powder, comprising the steps of:

providing an elongate flow channel having a powder support floor formed of a flexible piezoelectric material and inlet and outlet ports;

directing a quantity of dry powder into the inlet port of the elongate flow channel;

vibrating the piezoelectric material with an electric excitation signal so that the piezoelectric material deflects upwardly;

flowing the dry powder out of the outlet port responsive to the vibrating step; and

adjusting the orientation angle of the elongate floor channel so that the flow channel angularly extends in a non-vertical, non-horizontal configuration and so that the outlet port is lower than the inlet port.

12. A method according to claim 11, wherein the flowing step is carried out to serially dispense dose amounts of dry pharmaceutical powder(s).

13. A method of dispensing a dry powder, comprising the steps of:

providing an elongate flow channel having a powder support floor formed of a flexible

piezoelectric material and inlet and outlet pods;

directing a quantity of dry powder into the inlet port of the elongate flow channel;

vibrating the piezoelectric material with an electric excitation signal so that the piezoelectric material deflects upwardly; and

flowing the dry powder out of the outlet port responsive to the vibrating step

wherein the flowing step is carried out to serially dispense dose amounts of dry pharmaceutical powder(s), and

wherein the flowing step is controllably started and stopped by the application and termination, respectively, of the electric excitation signal to the piezoelectric material.

14. A method of dispensing a dry powder, comprising the steps of:

providing an elongate flow channel having a powder support floor formed of a flexible piezoelectric material and inlet and outlet ports;

tensioning the piezoelectric material in the flow channel;

directing a quantity of dry powder into the inlet port of the elongate flow channel;

vibrating the piezoelectric material with an electric excitation signal so that the piezoelectric material deflects upwardly; and

flowing the dry powder out of the outlet port responsive to the vibrating step.

15. A method according to claim 14, wherein the tensioning step is carried out by securely clasping a portion of the piezoelectric material between a cover member and an underlying flow channel member and allowing the center floor portion of the piezoelectric material in the flow channel to be suspended above the bottom of the flow channel member.

16. A method according to claim 15, wherein the vibrating step comprises applying the excitation signal voltage to the underside of the piezoelectric material.

17. A method of dispensing a dry powder, comprising the steps of:

providing an elongate flow channel having a powder support floor formed of a flexible piezoelectric material and inlet and outlet ports;

directing a quantity of dry powder into the inlet port of the elongate flow channel;

vibrating the piezoelectric material with an electric excitation signal so that the piezoelectric material deflects upwardly; and

flowing the dry powder out of the outlet port responsive to the vibrating step

wherein the excitation signal has a carrier frequency and a plurality of superpositioned modulating frequencies.

18. A method according to claim 17, wherein the number of superpositioned modulating frequencies is at least three.

19. A method according to claim 18, wherein the number of superpositioned modulating frequencies is four.

20. A method according to claim 19, wherein the four modulating frequencies are in the range of between about 10–

15 Hz.

21. A method for selecting and/or determining customizable excitation signals for dispensing dry powders, comprising the steps of:

providing an elongate flow channel having a floor of piezoelectric material;

selecting an angle of orientation for the flow channel such that at least a portion of the flow channel angularly extends in a non-vertical, non-horizontal orientation in the axial direction;

providing a quantity of a target dry powder;

outputting a vibration excitation signal having a first carrier frequency from a signal generator to the piezoelectric material;

flowing the dry powder out of the flow channel;

outputting a vibration excitation signal having a second carrier frequency from the signal generator to the piezoelectric material; and

determining a dispensing vibration excitation signal for the target dry powder that generates a repeatable or a uniform or a repeatable and uniform fluid-like substantially non-agglomerated flow output based on flow data from the first and second vibration excitation signals,

wherein the determined vibration excitation signal comprises a carrier frequency modulated by a plurality of modulating frequencies.

22. A method for selecting and/or determining excitation signals suitable for fluidly dispensing dry powders, comprising the steps of:

providing an elongate flow channel;

providing a quantity of a target dry powder in the flow channel;

vibrating the target dry powder in the flow channel with a first vibration excitation signal having a first carrier frequency and a first modulating frequency;

flowing the dry powder out of the flow channel using the first vibration excitation signal;

vibrating the target dry powder in the flow channel with a second vibration excitation signal different from the first vibration excitation signal, the second vibration excitation signal having a second carrier frequency and a second modulating frequency;

flowing the target dry powder out of the flow channel using the second vibration excitation signal; and

determining a dispensing vibration signal for the target dry powder that comprises a carrier frequency and at least one selected modulating frequency that generates at least one of a repeatable or uniform fluid-like substantially non-agglomerated flow output using flow data of the target dry powder derived from the first and second vibration excitation signals.

23. A method according to claim 22, wherein the at least one modulating frequency of the dispensing vibration signal is a plurality of low frequency modulating frequencies.

24. A method according to claim 22, wherein the plurality of modulating frequencies of the dispensing vibration signal are superimposed.

25. A method according to claim 22, wherein the dispensing vibration signal is configured to dispense unit meted amounts of dry powder with about 5% or less dose to dose variation.

26. A method according to claim 25, wherein the dispensing vibration signal is configured to dispense unit meted amounts of dry powder with about 2% or less dose to dose variation.

27. A method according to claim 22, further comprising orienting the flow channel to angle downwardly in the direction of flow.

28. A method according to claim 22, wherein the flow channel comprises a piezoelectric member, and wherein the first and second vibrating steps comprise transmitting the respective first and second vibration excitation signals to the piezoelectric member which vibrates the target dry powder during the flowing steps.