Source: https://patents.google.com/patent/US7100839B2/en
Timestamp: 2019-03-26 08:39:54
Document Index: 302249109

Matched Legal Cases: ['Application No. 60', 'art 310', 'art 305', 'arts 305', 'art 305', 'art 305', 'art 310', 'art 310', 'art 305', 'art 310', 'art.\n5']

US7100839B2 - Method of servicing companies associated with a spray device operating under guidelines of a regulatory body - Google Patents
Method of servicing companies associated with a spray device operating under guidelines of a regulatory body Download PDF
US7100839B2
US7100839B2 US10/824,778 US82477804A US7100839B2 US 7100839 B2 US7100839 B2 US 7100839B2 US 82477804 A US82477804 A US 82477804A US 7100839 B2 US7100839 B2 US 7100839B2
US10/824,778
US20050077369A1 (en
Donald C. Swavely
John A. Vennari
Leticia M. Broome
Franklin A. Bales
2003-04-14 Priority to US46286103P priority Critical
2004-04-14 Application filed by Image Therm Engineering Inc filed Critical Image Therm Engineering Inc
2004-04-14 Priority to US10/824,778 priority patent/US7100839B2/en
2005-04-14 Publication of US20050077369A1 publication Critical patent/US20050077369A1/en
2006-07-14 Assigned to IMAGE THERM ENGINEERING, INC. reassignment IMAGE THERM ENGINEERING, INC. AGREEMENT Assignors: BROOME, LETICIA M.
2006-07-14 Assigned to IMAGE THERM ENGINEERING, INC. reassignment IMAGE THERM ENGINEERING, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BALES, FRANKLIN E., FARINA, DINO J., VENNARI, JOHN A., SWAVELY, DONALD
2006-09-05 Publication of US7100839B2 publication Critical patent/US7100839B2/en
A method for servicing companies associated with a spray device operating under guidelines of a regulatory body includes capturing in vitro actuation data associated with operation of the spray device and distributing the data to a company associated with an aspect of the spray device. The company may use the data for testing the spray device to ensure continued compliance with prior approval of the spray device by the regulatory body. The method may also include converting the data to parameters and distributing the parameters. Capturing the in vitro actuation data may include sorting the data based on in vitro age groups. Distributing the data may include providing the data in a format executable by an automated actuation system. The company receiving the data may be a drug development company, spray device manufacturer, or testing service. The regulatory body may be the Food and Drug Administration (FDA).
This application claims the benefit of U.S. Provisional Application No. 60/462,861, filed on Apr. 14, 2003. The entire teachings of the above application are incorporated herein by reference.
A spray pump's performance is characterized in terms of its emitted spray pattern, plume geometry, and/or droplet size distribution. These parameters are known to be affected by the means in which the spray pump is actuated. For example, slow actuation will likely cause poor atomization, producing a stream-like flow. Fast actuation will likely produce too fine a spray, leading to poor absorption in the nasal mucosa and unwanted inhalation and deposition of the droplets in the throat and lungs. These factors and others, such as drug compatibility with the spray device, may result in the drug delivery falling outside the criteria associated with an original clinical trial approval. Testing the delivery or spray devices may be done to verify the spray device actuates the drug within the criteria of the original clinical trial approval, but operator actuation variability may adversely affect test results.
Automated actuation of nasal spray devices subject to in vitro bioequivalence testing may be employed to decrease variability in drug delivery due to operator factors (including removal of potential analyst bias in actuation) and increase the sensitivity for detecting potential differences among drug products. An automated actuation system may include settings for force, velocity, acceleration, length of stroke, and other relevant parameters. Selection of appropriate settings is relevant to proper usage of the product by a trained patient, and, for nasal sprays, may be available from pump suppliers for tests such as droplet size distribution by laser diffraction or spray pattern photographic techniques. In the absence of recommendations from the pump supplier, settings may be documented based on exploratory studies in which the relevant parameters are varied to simulate in vitro performance upon hand actuation. Exploratory studies of hand actuation of the spray pump device are useful to determine appropriate settings for automated actuation.
Another embodiment according to the principles of the present invention includes a method for servicing companies associated with a spray device operating under guidelines of a regulatory body. The method includes capturing in vitro actuation data associated with operation of the spray device. The method also includes distributing the data to a company associated with an aspect of the spray device. The company may use the data for testing the spray device to ensure continued compliance with prior approval of the spray device by a regulatory body.
The method may also include converting the data to parameters and distributing the data in the form of the parameters. The spray device may include a stationary part and a movable part, and the data may represent a mechanical relationship between the stationary part and the movable part versus time. The method may also include measuring position, velocity, or acceleration relationships between the stationary part and the movable part.
Capturing the in vitro actuation data may include sorting the data based on in vitro age groups. Capturing the in vitro actuation data may also include determining a minimum number of priming strokes by hand actuation. Further, capturing the in vitro actuation data may include determining actuation parameter ranges by hand actuation. Capturing the in vitro actuation data may include determining an initial estimation of delivery performance congruency between hand and automated actuation. The method may also include adjusting automated actuation parameters associated with the automated actuation to achieve a desired shot weight and to determine acceptable ranges.
Distributing the data may include providing the data in a format executable by a machine configured to actuate the spray device in an automated manner. Prior approval may be a clinical trial approval.
The company receiving the data may be a drug development company, spray device manufacturer, or testing service. The regulatory body may be the Food and Drug Administration (FDA).
FIGS. 2A–2B are diagrams of spray devices ejecting an atomized drug produced by actuation of the spray device containing the drug used in the application of FIG. 1;
FIGS. 5A–5B are side views of the assembly embodiments of FIGS. 3 and 4, respectively;
FIG. 13 is a set of waveform diagrams illustrating captured data associated with the spray devices of FIGS. 2A–2B;
FIGS. 14–17 are actual test data associated with in vitro testing and automated testing of the spray device of FIG. 2A;
FIG. 18A is a model of a business environment in which another aspect according to the principles of the present invention related to the application of FIG. 1 may be employed;
FIG. 18B is a block diagram including the businesses of FIG. 18A communicating via a computer network;
FIG. 19 is a process used in the model of FIG. 18A;
FIG. 20 is a subprocess used in the process of FIG. 19; and
FIG. 21 is a subprocess used in the process of FIG. 20.
FIGS. 2A and 2B illustrate spray patterns 200 a and 200 b, respectively, produced by the same or different spray devices 100. In FIG. 2A, the spray pattern 200 a is projected in a relatively conical pattern. In FIG. 2B, the drug is more atomized than in FIG. 2A as evidenced by a broader spray pattern 200 b.
Spray pattern studies characterize a spray either during the spray prior to impaction or following impaction on an appropriate target, such as a thin-layer chromatography (TLC) plate. Spray patterns for certain nasal spray products may be spoked or otherwise irregular in shape.
The mounting assembly 320 a may be connected to the stationary part 310 through use of flexible tie straps 325. Other connection means may also be used, such as Velcro® straps, adhesive, or other suitable attachment means. A rubber or other suitable material may be used to form a solid connection between the adapter assembly 315 a and the movable part 305. Securing of the adapter assembly 315 a or the mounting assembly 320 a to the respective parts 305, 310 of the spray device 100 may be completed through screw means, latching mechanism, or other suitable mechanism.
In operation, a person 105 operates the spray device 100 in a typical manner by placing his fingers on the adapter assembly 315 a and drawing it toward the mounting assembly 320 a to cause the movable part 305 to move. The motion produces a “shot” or dosage to the expelled from the spray device 100. When the spray device 100 is actuated, the linkage 330 causes the transducer 335 to change its state. A change in state of the transducer 335 causes the transducer output to change state in a proportional manner. The data acquisition circuit board (not shown) captures the change in state of the transducer 335 and provides the captured data to a processor for further processing. Prior to testing, the transducer 335 may be calibrated and used during the processing.
FIG. 4 is an illustration of the components applied to a metered-dose inhaler (MDI) 400. The spray bottle 100 and MDI 400 are interchangeably referred to herein as “spray devices”. In the case of the MDI 400, a pressurized canister 405 is the movable part, and a mouthpiece 410 is the stationary part. A person's hand 115 squeezes the pressurized canister 405 toward the mouthpiece 410 to actuate the MDI 400 and cause a “shot” to be expelled from the MDI 400.
By using the bearing 610 and shaft 605 assembly, the pivoting of the movable part 305 of the spray device 100 is dramatically reduced over the embodiment of FIG. 3. Further, the assembly 600 may be constructed of lightweight materials, such as aluminum, to allow a person 105 to operate the spray device 100 in an unimpeded manner to simulate typical use of the spray bottle 100. The shaft 605 may be a hardened precision shaft constructed of ¼″ O.D. stainless steel. The bearing 610 may be lined with various materials to allow the shaft 605 to travel smoothly and freely, thereby facilitating unimpeded in vitro motion.
FIG. 8 is an illustration of an automated actuation system 800 that operates the spray device 100 in an automated manner. The automated actuation system 800 includes a compression plate assembly 805 that travels vertically along a pair of passive, parallel, guide bars 810. In one embodiment, a drive motor assembly (not shown) drives a belt and pulley assembly (not shown) that drives a drive plate assembly 835 along a drive rod 830. The drive plate assembly 835 is connected to the compression plate assembly 805 in this embodiment. In response to upward force by the drive plate assembly 835, the compression plate assembly 805 presses upward on the stationary part 310 of the spray device 100 to actuate the spray device 100. Alternatively, a clamp (not shown) or other attachment means may be used to attach the stationary part 310 of the spray device 100 to the compression plate assembly 805. Embodiments of automated actuation systems 800 are further described in co-pending U.S. patent application Ser. No. 10/176,930 entitled, “Precise Position Controlled Actuating Method and System”, filed on Jun. 21, 2002; the entire teachings of which are incorporated herein by reference in their entirety.
FIGS. 9–17 illustrate a processing system and signals captured or generated thereby. The data processing system 900 captures data produced by the transducer 335. The data processing system 900 is typically distinct from control electronics associated with the automated actuation system 800, but data captured, processed, and/or produced by the data processing system 900 may be transferred to the automated actuation system 800 for use in automated actuation of the spray device 100. Data may be transferred between the data processing system 900 and the automated actuation system 800 via a local area network (LAN), magnetic disk, optical disk, infrared signals, a Wide Area Network (WAN) such as the Internet, or other signal or data transfer means.
FIG. 10 is an alternative embodiment of the data processing system 900 b. The transducer 335 receives an input of +5 VDC 1005 and an output of 0–5 VDC 1010. A data acquisition (DAQ) circuit board 1015 captures the output generated by the transducer 335, which in this case is a position transducer. Therefore, the output from the transducer 335 directly relates to the position of the movable part 305 with respect to the stationary part 310. The DAQ board 1015 may be in communication with a general purpose computer in a daughterboard arrangement. The information captured by the DAQ board 1015 may be displayed on a monitor 1020 and controlled via a Graphical User Interface (GUI) by either a keyboard 1025 or mouse 1030. In this way, a user may provide various parameters and other forms of control to cause the DAQ board 1015 to collect the output 1010 from the transducer 335 in a customized manner.
FIGS. 14–17 are plots that were produced by a method to measure hand actuation parameters for nasal spray pumps that can be used for automated actuation. Actuation parameters were measured for representative commercially available spray pumps filled with water. The average actuation parameters were then checked to confirm that the automation actuation system 800 accurately duplicated the ergonomics of hand actuation. The actuation parameters were optimized within a working range of the hand actuation parameters to obtain shot weight delivery closest to the delivery target (e.g., label claim by the pump manufacturer).
Methods for producing the plots of FIGS. 14–17 include a hand actuation portion, a congruency test portion, and an optimized automated actuation portion.
In the optimized automated actuation portion of the method, three primed units were each actuated ten times in a series of tests that independently varied stroke length, hold time, and Intra Actuation Delay (IAD) within the working ranges previously measured during the hand actuation portion of the method. The stroke length was varied from the average value minus one standard deviation (“−1σ”) to the maximum stroke length that did not damage the bottle. The hold time was varied from the average value −1σ to the point where the shot weight did not increase more than 10% from previous actuations. The IAD was varied from 30, 15, 5, to 1 second(s). The data were analyzed to find the optimum levels for stroke length, hold time, and IAD, where the optimum was defined as the level which obtained shot weight closest to the nominal specified value (i.e., label claim of the manufacturer). Using the optimum values, three primed units were actuated ten times each to confirm shot weight delivery. A stroke length of 5.11 mm, hold time of 45.55 ms, and IAD of 30 sec provided shot weight delivery performance closest to the nominal specified value (i.e., label claim of the manufacturer) as shown in FIG. 17. Three curves 1705, 1710, and 1715 represent shot weights from bottles 1, 2, and 3, respectively, in the plot 1700.
FIG. 18A is a model 1800 a of a business environment involving five parties associated with drug and drug delivery development, production, packaging, and distribution. The parties include: (1) the Food and Drug Administration (FDA) 1805, which is a regulatory body, (2) a drug development company 1810, (3) a spray device manufacturer 1815, (4) a device actuation characterization supplier 1820, and (5) a third party test service 1825. This model 1800 a describes approval cycles for developing a drug, packaging the drug for shipping and in vitro use, obtaining approval in multiple cycles, and characterizing the in vitro performance of spray devices 100, 400 used to deliver the drug, optionally for multiple age groups.
The FDA 1805 is charged with the task of ensuring the drugs are safe for human use. A drug development company 1810 develops a drug and obtains clinical trial data 1830 a, which is sent to the FDA 1805 for purposes of gaining clinical trial approval 1835 a. Once the FDA 1805 grants clinical trial approval 1835 a, the drug development company moves into a production phase of the drug. During the production phase, the drug development company 1810 may use the services of a spray device manufacturer 1815, who may also need to undergo clinical trial approvals.
The spray device manufacturer 1815 manufacturers spray devices 100, 400 and may fill the spray devices 100, 400 with the drug and collect clinical trial data 1830 b related to production and/or delivery parameters. The clinical trial data 1830 b may include chemical analysis data and/or metrics, such as spray shot weight, plume geometry, and so forth. The clinical trial data 1830 b is sent to the FDA 1805. The FDA 1805 reviews the clinical trial data 1830 b and grants clinical trial approval 1835 b. Once clinical trial approval 1835 b is granted, the drug development company 1810 and spray device manufacturer 1815 are approved to produce and distribute the drug in the spray device 100, 400 that was granted clinical trial approval 1835 a, 1835 b.
In this cycle of approvals, periodic testing occurs to ensure that what is being manufactured is within the data criteria of the clinical trial approvals 1835 a, 1835 b. In other words, the FDA 1805 wants to ensure that distributed drug products fall within the scope of criteria that was deemed to be safe for human use.
In the past, the drug development company 1810 and spray device manufacturer 1815 would perform the tests by hand. The problem with performing the tests by hand is that there is variability in hand actuation of spray devices. Thus, automated actuation of the spray devices 100, 400 is considered to be useful for continued compliance approval to ensure that the drugs and delivery mechanisms adhere to the criteria associated with the clinical trial approvals 1835 a, 1835 b.
Not only is automated testing useful for production phases of drug manufacturing and spray device manufacturing, but automated testing may also be used in the clinical trial phases of the drugs. In other words, by using a common automated actuation technique for both the clinical trial phase and production phase approval cycles of a drug and spray device, consistency can be applied to the clinical trial and production phases of the drug development and production cycles, thereby offering the FDA 1805 an increased level of testing consistency and the consuming public an increased level of safety.
Continuing to refer to FIG. 18A, the device actuation characterization supplier 1820 receives spray bottles with drugs 1840, optionally from the drug development company 1810 or spray device manufacturer 1815, depending on the production arrangement between the two companies. For example, the drug development company may purchase spray devices from the spray device manufacturer 1815 and fill a bottle or canister with the drugs. Alternatively, the spray device manufacturer 1815 may purchase the drugs from the drug development company 1810 and fill the spray bottle or canister associated with the spray devices 100, 400 with the drug. A third party manufacturer (not shown) may also be involved and purchase both the drugs and spray devices from each of the companies 1810, 1815 and distribute the drug product. In any case, the device actuation characterization supplier 1820 may characterize the spray bottle with drug 1840 in a manner consistent with the methods and assembly(s) disclosed above in reference to FIGS. 1–17.
The device actuation characterization supplier 1820 collects and distributes in vitro actuation data 1845 a, 1845 b to the drug development company 1810 and spray device manufacturer 1815, respectively. The device actuation characterization supplier 1820 may also provide services for in vitro actuation testing, data gathering, and correlating of in vitro hand actuation versus automated actuation of the spray devices to provide useful information for continued compliance testing, and, optionally, initial clinical trial testing.
Using the in vitro actuation data 1845 a, 1845 b, the drug development company 1810 and spray device manufacturer 1815 may load and run the data 1845 a, 1845 b in automated actuation systems 1800. Optionally, a third party test service 1825 may be employed to run this testing. In any case, the drug development company 1810, spray device manufacturer 1815, or a third party test service 1825 gathers continued compliance data 1850 a, 1850 b, and 1850 c, respectively, which is sent to the FDA 1805 to receive approval for complying with regulations of continuing to ensure that the drugs that are being produced and packaged for use in spray devices 100, 400 are consistent with the original clinical trial approvals 1835 a, 1835 b. In turn, the FDA 1805 grants continued compliance approval 1855 a, 1855 b, or 1855 c to each of the companies, respectively. If the third party test service 1825 performs the continued compliance approval testing, then the third party test service 1825 sends a notice of approval 1860 to either the drug development company 1810 or spray device manufacturer 1815, depending on which of the companies hires their services.
It should be understood that the third party test service 1825 may be the device actuation characterization supplier 1820 or a subsidiary of one or both of the drug development company 1810 or spray device manufacturer 1815. Because the lines distinguishing the companies sometimes becomes blurred, it should be understood that a variety of models 1800 a of business environments can be constructed without departing from the principles of the present invention.
FIG. 18B is a model 1800 b similar to the model 1800 a just described. The model 1800 b includes a computer network 1865, such as the Internet, that is employed to transfer data in data packets, analog or digital modulated signals, or other signaling means to share the data among the parties 1805, 1810, 1815, 1820, and 1825. For example, the in vitro actuation data or parameters 1845 a may be transmitted from the device actuation characterization supplier 1820 to any of the other parties 1805, 1810, 1815, or 1825 via the network 1865 or through use of a data disk 1870, which may be an optical disk, magnetic disk, or other computer readable media.
FIG. 19 is a flow diagram or a process 1900 that embodies the approval cycles described above. A process 1900 begins with the drug development company developing a new drug (Step 1905). A determination is made whether the drug is over-the-counter (OTC) or a prescription drug (1910). If the drug is an OTC drug, then the FDA 1805 grants approval based on safety, effectiveness, and so forth in different age groups (Step 1915).
The FDA 1805, in the case of an OTC drug, does not have to grant approval based on the delivery mechanism (i.e., spray device 100, 400). If, however, the drug is a prescription drug (Step 1910), initial FDA approval (Step 1920) must be gained in Phases I–III clinical trials, which test for safety, effectiveness of the drug, drug delivery means, and so forth. An automated actuation system 800 may be useful for the initial FDA approval, described as the clinical trial approvals 1835 a, 1835 b in FIGS. 18A and 18B. After gaining initial FDA approval (Step 1920), the drug development company 1810 and spray device manufacturer 1815 begin the manufacturing phase to produce what was approved in the clinical trials (Step 1925). Optionally, the FDA 1805 and/or drug development company 1810 may require further testing, including stability testing (Step 1930), such as product stability over time, temperature, humidity, and so forth.
During the manufacturing cycle, one of the companies 1810, 1815, or 1825 may seek continued FDA approval (Step 1935) to gain continued compliance approval 1855 as described above in reference to FIG. 18A. If the company receives continued compliance approval (Step 1940), the manufacturing of the drug and spray device 100, 400, may be allowed to continue under FDA 1805 auspices; otherwise, an investigation (Step 1945) of the drug and delivery means begins to determine why the data does not show the drug or delivery means meets the criteria associated with the initial clinical trial approval 1835. Therefore, stability testing (Step 1930) or manufacturing (Step 1925) may fall into the investigation cycle. The manufacturing processes (Steps 1925–1945) continue for the lifetime of the drug.
An embodiment of a drug manufacturing process (Step 1925) is shown in further detail in FIG. 20. Referring to FIG. 20, the process 1925 begins with the manufacturing of the prescription drug (Step 2005). The drug is bottled in a metered dose spray bottle or canister, or more generically, a spray device 100, 400 (Step 2010). The manufacturer of the drug (e.g., drug development company 1810 or spray device manufacturer 1815) may order the in vitro actuation data associated with operation of the spray device (Step 2015) from the device actuation characterization supplier 1820. The company performing the compliance testing receives the data from the device actuation characterization supplier 1820 and installs the data into an automated actuation system 800 (FIG. 8) (Step 2020). The manufacturing company collects data for continued compliance approval (Step 2025), such as through use of a spray measurement system. The process 1925 returns to the process 1900, Step 1925 of FIG. 19 (Step 2030).
Continuing to refer to FIG. 20, the steps associated with ordering in vitro actuation data (Step 2015) and receiving the in vitro actuation data (Step 2020) is further described in FIG. 21.
Referring to FIG. 21, a process 2100 begins with the receipt of the order for the in vitro actuation data from FIG. 20, Step 2015 (Step 2105). The process 2100 continues in which the device actuation characterization supplier 1820 determines a minimum number of priming strokes by hand actuation (Step 2110). The process 2100 continues with a determination of the actuation parameter ranges by hand actuation (Step 2115). A determination of an initial estimation of delivery performance congruency between hand and automated actuation is performed next (Step 2120). The process continues in which an adjustment of the automated actuation parameters to achieve desired shot weight is made, and a determination of acceptable ranges is made (Step 2125). The process 2100 ends (to FIG. 20, Step 2020) with the delivery of the in vitro actuation data, optionally in a format for use in an automated actuation system (Step 2130).
Each of the steps 2110, 2115, 2120, and 2125 is provided in further detail below in steps 1, 2, 3, and 4, respectively.
1.6. Repeat steps 1.2–1.5 for the remaining units.
1.7. Analyze the shot weight data from each unit and determine the minimum number of actuations required to obtain stable shot weight performance (e.g., the shot weight being within 95–105% of label claim.)
2.4. Calculate the minimum, maximum, average, relative standard deviation (“RSD”), and standard deviation (σ) values for each of the automated actuation system parameters plus shot weight, based on the individual actuation recordings. Additionally, compare the calculated shot weight values to the manufacturer's specifications, if available.
3.8. The definition for delivery performance congruence will be that the measured shot weight values will be within ±1σ of the values specified by the pump manufacturer.
4.6. Adjust a single actuation parameter (starting with stroke length) in continuous increments of 10% of the average value and repeat Steps 4.4–4.5 until a plateau is reached (10 shot average does not change by more than ±10% of the previous 10 shot average) or until the adjusted actuation parameter is equal to its average value+2σ.
Minimum Minimum value to produce shot weight levels within ±1σ of the average from Step 2.
Maximum Maximum value to produce shot weight levels within ±1σ of the average from Step 2, up to the average +2σ.
The transducer 335 may have a draw wire with a stroke length/displacement range of 0–1.5 inches. The electrical output circuitry for the transducer 335 may form a simple voltage divider with the output voltage signal scaling linearly with the absolute position of the draw wire. In addition, the DAQ board 1015 may have a 5 volt DC output that can be used as the input voltage for the transducer 335, and this sets the output range of the sensor to be 0–5 volts DC, corresponding to 0–1.5 inches of displacement, respectively. In addition, this output range is preferably compatible with the input measurement range of the DAQ board 1015. This DAQ board 1015 may be able to read and record the analog voltage signal 902 from the transducer 335 up 10 kHz or more. In addition, the DAQ board 1015 may be designed to operate in a standard personal computer.
The curves of FIGS. 14–17 are indicated for three users. However, it should be understood that many more users of the spray device 100, 400 may be involved in the testing to make more accurate measurements and determine accurate parameters. Further, persons of multiple age groups, sizes, hand sizes, health, hand impairments (e.g., carpal tunnel syndrome), and other criteria may be used in the testing and actuation characterization process.
It should also be understood that the FDA 1805 is an example of a regulatory body. Alternatively, depending on the application, the regulatory body may be a different department of the U.S. or foreign government, such as the Department of Defense (DOD), National Institute of Health (NIH), or a non-governmental body, such as a regulatory body that defines paint colors, for example. Moreover, the regulatory body may not necessarily “regulate” an industry, but, instead, “suggest” or recommend certain industry-wide parameters. For purposes of this application, the regulatory body definition covers government and non-government regulatory bodies as well as non-regulatory bodies per se.
The computer network 1865 of FIG. 18B may be other forms of computer networks based on different arrangements of the companies 1810, 1815, 1820, or 1825, depending on organization of these companies, such as if the companies are subsidiaries, sister companies, and so forth.
The processes of FIGS. 19–21 may be different for the drug and drug delivery industries based on changing rules, regulations, and guidelines defined by the regulatory body (e.g., FDA 1805) governing the industry. However, it should be understood that if a different regulatory body is involved with this or other processes associated with the clinical trial and continued approval process cycles described herein, the process or steps may vary without departing from the principles of the present invention. Moreover, in different industries, the processes may be industry dependent and vary accordingly.
1. A method of servicing companies associated with a spray device operating under guidelines of a regulatory body, the method comprising:
capturing in vitro actuation data associated with operation of a spray device; and
distributing the data to a company associated with an aspect of the spray device for testing the spray device to ensure continued compliance with prior approval of the spray device by a regulatory body.
2. The method according to claim 1 further including converting the data to parameters and distributing the data in the form of the parameters.
3. The method according to claim 1 wherein the spray device includes a stationary part and a movable part, and wherein the data includes a mechanical relationship between the stationary part and the movable part versus time.
4. The method according to claim 3 further including measuring position, velocity, or acceleration relationships between the stationary part and the movable part.
5. The method according to claim 1 wherein capturing the in vitro actuation data includes sorting the data based on in vitro age groups.
6. The method according to claim 1 wherein capturing the in vitro actuation data includes determining a minimum number of priming strokes by hand actuation.
7. The method according to claim 1 wherein capturing the in vitro actuation data includes determining actuation parameter ranges by hand actuation.
8. The method according to claim 1 wherein capturing the in vitro actuation data includes determining an initial estimation of delivery performance congruency between hand and automated actuation.
9. The method according to claim 8 further including adjusting automated actuation parameters associated with the automated actuation to achieve a desired shot weight and to determine acceptable ranges.
10. The method according to claim 1 wherein distributing the data includes providing the data in a format executable by a machine configured to actuate the spray device in an automated manner.
11. The method according to claim 1 wherein the prior approval is a clinical trial approval.
12. The method according to claim 1 wherein the company is a drug development company.
13. The method according to claim 1 wherein the company is a spray device manufacturer.
14. The method according to claim 1 wherein the company is a testing service provider.
15. The method according to claim 1 wherein the regulatory body is the Food and Drug Administration (FDA).
US10/824,778 2003-04-14 2004-04-14 Method of servicing companies associated with a spray device operating under guidelines of a regulatory body Active 2024-07-22 US7100839B2 (en)
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US10/824,778 US7100839B2 (en) 2003-04-14 2004-04-14 Method of servicing companies associated with a spray device operating under guidelines of a regulatory body
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US7100839B2 true US7100839B2 (en) 2006-09-05
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US10/825,082 Active 2028-06-18 US7658122B2 (en) 2003-04-14 2004-04-14 Method and apparatus for measuring manual actuation of spray devices
US10/824,778 Active 2024-07-22 US7100839B2 (en) 2003-04-14 2004-04-14 Method of servicing companies associated with a spray device operating under guidelines of a regulatory body
US12/686,705 Abandoned US20100116070A1 (en) 2003-04-14 2010-01-13 Method and Apparatus for Measuring Manual Device Actuation
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DE102012210143A1 (en) 2012-06-15 2013-12-19 Aptar Radolfzell Gmbh Tester for a liquid dispenser
JPH0342605B2 (en) 1983-11-10 1991-06-27
US6618127B2 (en) 2001-11-26 2003-09-09 Patheon Inc. Spray plume characterization system
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2004-04-14 WO PCT/US2004/011599 patent/WO2004091806A1/en active Search and Examination
2004-04-14 AT AT04759550T patent/AT400367T/en not_active IP Right Cessation
2010-01-13 US US12/686,705 patent/US20100116070A1/en not_active Abandoned
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