Analysing substrates with antigen coating


G01N1/28 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (separating components of materials in general B01D, B01J, B03, B07; apparatus fully provided for in a single other subclass, see the relevant subclass, e.g. B01L; measuring or testing processes other than immunoassay, involving enzymes or micro-organisms C12M, C12Q; investigation of foundation soil in situE02D0001000000; monitoring or diagnostic devices for exhaust-gas treatment apparatus F01N0011000000; sensing humidity changes for compensating measurements of other variables or for compensating readings of instruments for variations in humidity, seeG01D; or the relevant subclass for the variable measuredtesting or determining the properties of structures G01M; measuring or investigating electric or magnetic properties of materials G01R; systems in general for determining distance, velocity or presence by use of propagation effects, e.g. Doppler effect, propagation time, of reflected or reradiated radio waves, analogous arrangements using other waves G01S; determining sensitivity, graininess, or density of photographic materials G03C0005020000; testing component parts of nuclear reactors G21C0017000000)

FIELD: medicine.

SUBSTANCE: method for measuring in situ an oral agent applied from a dental care product on a substrate containing: (a) contacting the substrate and the oral agent for applying some oral agent on the substrate with the substrate being coated with saliva, and (b) analysing the substrate with the use of a probe being a part of a toothbrush and applied for infrared spectroscopy (IRS) or ultraviolet spectroscopy (UVS); a wave length used at the stage b) is specific for the above oral agent; a reference signal of the dental care product without the oral agent is deducted from an analysis result to calculate the amount of the oral agent.

EFFECT: method can be applied for the purpose of the monitoring of the patient's dental health or the fast and effective screening or analysis of compositions to be used for applying the oral active substances onto the dental surface.

16 cl, 15 dwg, 2 ex

 

The technical field to which the invention relates.

The present invention relates to methods and devices for measuring the degree of deposition or adsorption agents (e.g., oral active substances) on the substrate (for example, the surface of the hydroxyapatite, imitating the surface of the teeth). The amount or concentration of the agent can be efficiently determined on a substrate (for example, using the agent and the substrate, which is in a solid form) using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region.

The level of technology

The usual methods for the analysis of coating agents, such as oral active substances, which are used in dentistry include incubating the agent with the substrate, the rinsing intubirovannah substrate and its subsequent processing by solvent extraction. Then the extract was analyzed by high performance liquid chromatography (HPLC), providing indirect determination of the amount deposited agent. In a certain type of analysis oral active agents such as Triclosan, in pure solutions or compositions for cleaning teeth, incubated with saliva hydroxyapatite disk that is used for modeling of substrates for bone tissue before extraction disk dissolve elem.

Method solvent extraction/HPLC, however, has limitations. For example, the method is based on an indirect analysis of the extract, rather than by direct surface analysis, which is applied to the agent. As a result of extraction and subsequent stages of the HPLC analysis often requires considerable time. Furthermore, the method is based on the application of the extraction agent, which may not always be compatible with the system agent/substrate (e.g., may cause decomposition or adversely affect the analyzed agent, for example, reacting with it, or otherwise to influence the form of the agent).

Thus, in the prior art there is a need for methods that can provide effective analysis or to characterize the degree or amount of applied agent on the substrate. Ideally, such methods can be performed by direct analysis of the system agent/substrate and provide quick results.

The invention

Technical result achieved when using the claimed group of inventions is to provide an effective analysis of the quality and quantity of the agent applied to the substrate using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region. The invention relates to efficient on the panorama ways, such as methods of screening intended for characterization applied agents (for example, active substances, existing in the oral cavity) on the surface. Such methods can be used for evaluation and comparison of various compositions, including damage to the agent, and various systems for the delivery agent. These methods can also be used to analyze or diagnose patients or other users, and therefore can be applied to systems invivo, for example, when analyzing the application of the active substance, existing in the oral cavity, on the surface of the tooth of the patient. The methods are also suitable for personal use, for example, in the case when the user wants to monitor the effectiveness of a particular mode of care of teeth.

Direct methods described in this application can be used to obtain the result of the analysis in a relatively short time, for example of the order of several minutes (e.g., 5-10 minutes or even seconds (for example, less than 60 seconds or 10-45 seconds). Methods of analysis, according to some versions of the invention, allow to determine the distribution of various agents on the surface, they can be used, for example, to determine whether the agents are distributed uniformly.

Thus, aspects of the invention relate to method measured the I application of oral agent, such as the active connection for the care of the oral cavity on the substrate. The method includes the contact of the substrate with oral agent, with the application of a number of oral agent on the substrate, and the analysis of the substrate using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region.

Other aspects of the invention relate to a method of diagnosing the condition of the oral cavity of the patient. The method comprises measuring the presence of oral agent in the sample obtained from the patient, using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region.

Other aspects of the invention relate to a method of assessing the effectiveness of the system oral delivery. The method comprises applying oral agent on the substrate using a dental tool, and additional analysis of the substrate using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region, to measure the degree of application.

Other aspects of the invention relate to devices or instruments for the implementation of any of the above methods.

Other aspects of the invention relate to one or more tangible machine-readable media (media)on which is stored executable instructions that, when implementing the AI cause the data processing system to perform a method, including the stages of analysis of near-infrared or UV spectrum, obtained in accordance with the methods described above, using a mathematical method selected from the group consisting of the first and second derivative, integration of the peak area, the regression method private least squares (PLS), converting Kubelka-Munch, multiple linear regression and subtraction of spectra (e.g., subtraction of background signals).

The methods and devices described above can be applied in an absolute measurement of the quantities or concentrations of agent deposited on the substrate. In alternative methods can be used to obtain the relative amounts or concentrations of these agents (for example, in the case of the control application). The methods can be used to compare the degree of application of the agent depending on its concentration in the source composition (e.g., means for cleaning the teeth, which is used for incubation of the substrate according to the methods described in this application), depending on the application of different delivery systems (for example, paste in comparison with gel system), or depending on any number of other parameters that will be known to skilled specialists pay attention to the present description.

These and other aspects of the invented what I will be clear from the subsequent detailed description.

Brief description of figures

A more complete understanding of the present invention and its advantages may be achieved by referring to the following description, taking into account the accompanying graphic materials that need to be understood to provide illustrations of various aspects of the invention and/or of the principles included, and where:

Figure 1 is an image of the electromagnetic spectrum that includes wavelengths that are suitable for use in spectroscopy in the near IR region or UV-spectroscopy;

Figure 2 represents the range of near IR region, which shows the "fingerprint" (typical range) oral - active substances : Triclosan;

Figure 3 represents a second derivative spectrum of Triclosan in the near IR region;

Figure 4 shows the relationship between the peak area of Triclosan, as measured by near-IR, and the concentration of Triclosan (in ppm)measured using HPLC;

Figure 5 shows the data obtained during the validation of method of analysis in the near IR region;

Figure 6 shows the phase of the experiment, in which the HAP disks introduced in the near IR and UV spectrometers;

Figure 7 depicts the process by which the methods of analysis in the near IR region correlate with conventional methods of solvent extraction/HPLC;

On Fig shows the use of the methods of data analysis in the correlation analysis in the near IR region with conventional methods of solvent extraction/HPLC;

Figure 9 illustrates the use of data analysis methods, including regression of the private method of least squares, correlation analysis in the near IR region with conventional methods of solvent extraction/HPLC;

Figure 10 illustrates the use of data analysis methods, including regression of the private method of least squares and multiple linear regression, correlation analysis in the near IR region with conventional methods of solvent extraction/HPLC;

Figure 11 shows the UV spectrum for a mixture of two components, obtained using UV-spectroscopy spectrometer, modified fixture diffuse reflectance integrating sphere;

On Fig shows UV spectra for different samples, including samples and placebo substrates, incubated with Triclosan for 5 minutes and 30 minutes;

On Fig illustrates a representative operating environment of a computer system that carries out one or more aspects of the invention;

On Fig shows a representative diagram of the complete care of the oral cavity, which carries out one or more aspects of the invention; and

Fig is a schematic illustration of a tooth brush/nozzle, which carries out one or more aspects of the invention.

Detailed description of the invention

Aspects what s the invention relates to methods and devices for detection agents (e.g., oral agents)that have been delivered and deposited on the substrate (for example, a substrate in the mouth such as tooth or soft tissue). Other substrates include body fluids such as blood and saliva, which can be analyzed according to the methods described in this application, to analyze the accumulation or deposition of agents (e.g., pharmaceutical compounds). The methods provide a quantitative determination of the amount of agent that is adsorbed on the substrate, and therefore, these methods can be applied, for example, when comparing the degree of adsorption and/or the total amount of agent applied in various conditions. The methods can also be used for the study of mechanisms of interaction between the agent and the substrate.

Agents, such as oral agents include drugs used in the care of the oral cavity and/or used as an experimental oral agents. Examples include phosphates, amino acids, potassium salts and compounds of tin (II). Triclosan and sodium lauryl sulfate are typical examples of active substances used in the care of the oral cavity. In the case of oral agents, they can be used in the methods and devices in the form of pure compounds, but are often in the form of a solution in water or an organic solvent. Rest the market usually are physiologically acceptable, in order to best simulate the conditions of actual use. Oral agents can also be in the form of funds for the care of teeth, such as a paste, gel or suspension.

Agents usually result in contact with the substrate, and the resulting agent-containing substrate can be analyzed using the methods described in this application, to determine the accumulation or deposition of the agent on the substrate. In the case of oral agents commonly used substrate is a sample of hydroxyapatite (HAP), such as HAP disk used to model the surface of the tooth. For example, covered with saliva HAP disk (scHAP) can be processed or subjected to contact with the oral agent, under conditions that lead to deposition of at least part of the oral agent on the substrate. "Saliva" can refer to natural saliva or, in the alternative, the saliva, which was purified and/or treated in any other way, or even synthetic saliva, created to mimic the properties of natural saliva for analysis.

According to other variants of implementation, the substrate may be the actual cloth, for example, tissue of the tooth or soft tissue dental patient or user, using the means to care for teeth, who wants to know the extent of application oral agent on Ernest tooth. Information may be relevant to patient care, ongoing care specialist oral cavity or by the patient directly.

In a representative embodiment, the substrate, such as scHAP disk, processed or contact with oral agent such as Triclosan in the form of a solution liquid to take care of teeth or suspension for care of teeth. Then the resulting agent-containing substrate (i.e. the substrate, which caused oral agent) analyzed using spectroscopy in the near IR region or UV spectroscopy, or a combination of these methods. The results of these studies show that the application can be accurately measured on the basis of comparison with conventional methods, including solvent extraction, which are considerably more complex and require time-consuming.

In other embodiments, implementation of the methods described in this application can be used to diagnose the condition of the oral cavity (for example, the oral application of the active substance, the application of biofilms or the whiteness of the teeth, or the Shine of the teeth), including the progress of the treatment regimen of the oral cavity (for example, improvement of the oral cavity, increasing the whiteness of teeth or Shine teeth) patient. In other embodiments, implementation of the method can the be used to define the efficiency of the delivery means to care for the oral cavity. Also describes an apparatus for implementing the above methods, having some difficulties, which vary depending on their intended application. For example, although laboratory device may have the ability to analyze the absorption (or reflection) in a wide wavelength range, a more simple device used by a dentist, may have a more limited ability to measure the absorption only at certain wavelengths or wavelength ranges, which are characteristic for the target system oral agent/substrate (for example, a particular system of oral active substance/tooth).

Even more simple devices can be used for home use by the consumer, for example, to control the current treatment regimen of the oral cavity by determining the relative amounts of the applied agents over time. Such devices may be used separately or in the alternative may be included in toothbrushes or other devices to care for the oral cavity. Users of the device will mainly be able to quickly get the results that provides effective control regimen of the oral cavity. In addition, users can respond to these results, changing the scheme in accordance with them (for example, performing a cleaning brush and/and and flossing more often, or over a longer period).

Thus, the methods described in this application can be used to control the degree or trends over time are desirable agent (for example, useful oral active compounds, such as Triclosan). The methods can also be applied, on the other hand, for the analysis applied, undesirable agents, such as unwanted formation of dental film, which can be counteracted by appropriate response. The methods can be combined with other methods, such as fluorescence, if necessary, the proper characteristics of a particular system agent/substrate.

Analysis of the substrate, which caused the agent to perform using spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region. Typically, the device (instrument) for spectroscopy equipped with a device for solid-phase measurement, which allows direct measurement (amount or concentration) of the agent deposited on the substrate. In the case of devices for spectroscopy in the near IR region or UV spectroscopy, solid-phase measurement can be a quick composition analyzer (RCA) or the integrating sphere, respectively. In the case of an integrating sphere analyzed the sample agent-containing substrate can be placed (for example, in the center using a light beam) reflector disk plate, such as a white ceramic plate, commercially available under the brand name Spectralon®.

Method for sample preparation of the substrate, on which was marked the agent includes drying the sample, for example, to a given concentration of water, to minimize differences from sample to sample results that are not related to the studied parameter. Conventional studied parameters include changes in the number of agent applied in controlled conditions, depending on (i) the concentration of the agent, for example the concentration of the agent, initially prisutsvovavshie in solution or in a composition for caring for teeth, or (ii) the concentration of accelerators delivery agents or moderators delivery agents (e.g., initial concentrations in these solutions or compositions for the care of teeth).

Analysis in the near IR or UV region agent-containing sample (sample on which at least part of the agent, initially prisutsvovavshie, for example, in solution or the means to care for your teeth) causes the corresponding spectrum (for example, near-infrared or UV spectrum), which is characterized by the relation between the absorption of the sample and the used wavelength. In the case of UV-a spectrum (e.g., obtained using multi is the dominant sector as equipment for solid-phase measurement), the source spectrum can be characterized by the reflection depending on the wavelength. These values reflect, however, can be converted to the corresponding absorption spectrum by means of conversion operations, such as converting Kubelka-Munch.

In the case of the near IR and UV spectra obtained from analysis according to the methods described in this application, it is often necessary to subtract the background or standard (reference) signal associated with materials, such as known additives that are present in solution with the agent. Thus, the methods of data analysis often require subtraction of the spectrum to improve the resolution of the spectrum of the target agent (for example, when obtaining the individual spectrum by subtracting the standard spectrum, obtained, for example, from one saliva). Additional methods of data processing, which preferably are performed include the identification of the first or second derivative near infrared or UV spectra (which can be converted, in the case of UV, and/or separated as described above) to improve the sharpness of the peaks (for example, highlighting the peaks of the sample from background peaks). After receiving a sufficient definition of the peaks, using the specified (and optional other) methods of data processing, the area under different relevant obtained peaks can be determined is here integrated with the use of space, appropriate concentrations or absolute amounts deposited targeted agents.

In some embodiments, the implementation of other ways data can be used to reduce the level of background peaks, for example, peaks derived from such materials as additives, impurities, or even additional agents, coating or adsorption which is measured using the methods described in this application. In the case of the mixture applied agents, such as multiple linear regression or regression of private of least squares can be used for introduction of amendments to the interaction or overlap of peaks from other agents in the mixture.

Wavelengths used in the methods of the near IR and UV analysis described in this application can be quite wide ranges of wavelengths in the electromagnetic spectrum. These wavelengths can be in the vacuum UV range of wavelengths, the near UV range, the range of visible light, near-infrared range and/or in the IR range. In many cases it is desirable to adjust the wavelengths (or wavelength ranges)used for analysis to such wavelengths that are specific to a particular agent or combination agent/filler (i.e. the wavelength, which is absorbed or reflected under the action of analyzing) the treatment and can thus, be used to obtain a "fingerprint" of the target agent).

The selection of the most appropriate wavelengths (for example, only 3 or 4 of characteristic wavelengths) for this system can be useful to reduce the complexity and/or cost of the spectroscopic device (instrument). The process of selecting wavelengths for use in the analysis can be based, for example, linear regression or analysis by the method of least squares integrated peak area near suitable wavelength, relative to the concentration of the agent, for the measurement in different calibration samples (i.e., containing a known or standard number of agent). The method of selection may also include the determination of absorbed wavelengths that are unique to a particular target agent (e.g., based on the spectrum obtained from a pure solution or pure powder form of the agent), or have minimal overlap with peaks of other materials. Using selection processes, for example, it was determined that the appropriate wavelengths to near-infrared analysis of Triclosan include wavelengths in the ranges 1604-1804 nm and 2190-2300 nm. Suitable wavelengths for near infrared analysis of oral active substance sodium lauryl include wavelengths in the ranges 1192-2198 nm, 1626-1814 nm and 2250-2400 nm. Suitable wavelengths when IP is the use of UV analysis include wavelengths in the range of 200-500 nm.

Near IR and UV/can be used alone or even in combination to obtain the necessary information about shipping agents, such as oral active substance, the key components and additives, such as fillers. According to some variants of implementation, near IR analysis can show the total number of applied agents, and UV analysis can provide a determination of the concentration of individual components in mixtures of agents, or mixtures of one or more agents and one or more additives.

The methods and devices described in this application provide so many advantages in various applications. For example, the methods can be applied when developing methods for the rapid analysis for the direct quantitative determination of the active delivery models of surfaces of the oral cavity. Representative methods provide direct measurement of oral application of active substances to HAP substrates. The methods may additionally be used to study oral active substances in their native state, surrounded by the tools to care for your teeth, and for the evaluation of finished products. In view of the present description, it should be noted that can be achieved other benefits, and can be obtained from other advantageous results. It should also be understood that the methods and services the device, described above, can be applied or performed with conventional methods and devices. Because of the above devices and methods, without deviation from the scope of the present description, may be made different changes, it is assumed that all material contained in this application, should be interpreted only as illustrative.

Computer processing environment data

Various aspects of the present invention may be implemented within data structures, program modules, programs, and computer instructions executed in a computer environment. Thus, it is appropriate to briefly discuss universal computing environment. Thus, one or more aspects of the invention may be implemented in one or more computer systems, such as the system shown in Fig. On Fig the computer 100 includes a Central processor 110, system memory 112, and a system bus 114, which couples various system components including the system memory 112, the CPU 110. The system bus 114 may be any type of several types of bus structures including a memory bus or memory controller, a peripheral bus and a local bus using any of a variety of bus architectures. The structure of the system memory 112-known work, istam, skilled in the art, and may include basic input/output system (BIOS)stored in permanent memory (ROM), and one or more program modules such as operating systems, application programs and program data stored in the storage device, random access (RAM).

The computer 100 may also include various interface modules and drives for reading and writing data. Specifically, the computer 100 includes a hard disk interface 116 and a removable memory interface 120, respectively connecting the hard disk drive 118 and the drive for removable media 122 with the system bus 114. Examples of drives for removable media include hard drives, magnetic disks and optical drive. The drives and their associated computer-readable media, such as a flexible disk 124, provide nonvolatile storage of computer-readable instructions, data structures, program modules and other data for the computer 100. One hard disk 118 and one drive for removable media 122 is shown solely for purposes of illustration, it should be understood that the computer 100 may include several such drives. In addition, the computer 100 may include drives for connection with other types of computer-readable media.

Users who ü can interact with the computer 100 via various input devices. On Fig shows the interface 126 serial port that connects the keyboard 128 and a pointing device 130 with the system bus 114. The pointing device may be equipped with a mouse, a trackball, a stylus or similar device. Of course, the computer 100 may be associated with one or more other input devices (not shown), such as a joystick, game controller, satellite antenna, scanner, touch screen, etc.

The computer 100 may include additional interfaces for connecting devices to the system bus 114. On Fig shows the interface 132 universal serial bus (USB), which connects a video or digital camera 134 with the system bus 114. To connect additional devices to the computer 100 can be used with the IEEE 1394 interface 136. In addition, the interface 136 may be designed to work with specialized interfaces such as FireWire, developed by Apple Computer, and i.Link, developed by Sony. Input devices can also be connected to system bus 114 through a parallel port, game port, a PCI card, or any other interface used to connect input devices to the computer.

The computer 100 also includes a video adapter 140, the connecting device 142 display with the system bus 114. The device 142 display may include electron-lucemburska (CRT), liquid crystal display (LCD), display, field emission (FED), plasma display or any other device that reproduces the image seen by the user. Computer 100 can be connected to an additional output devices such as printers (not shown).

Sound can be recorded and reproduced using a microphone 144 and dynamics 146. Sound card 148 can be used to connect a microphone 144 and dynamics 146 with the system bus 114. Specialist, skilled in the art will be able to understand that the connection device shown in Fig used exclusively for purposes of illustration, and that some of the peripheral devices can be connected to system bus 114 through alternative interfaces. For example, the camera 134 may be associated with the interface IEEF 1394 136, and a pointing device 130 can be connected with USB interface 132.

The computer 100 may operate in a networked environment using logical connections to one or more remote computers or other devices, such as a server, a router, a network PC, a peer device or other common network node, and a cordless phone or wireless pocket personal computer. The computer 100 includes a network interface 150, which connects the system bus 114 is a local area network (LAN) 152. The network environment is typically available in offices, computer networks and systems home computers.

The computer 100 may also have access to a wide area network (WAN) 154, such as the Internet. On Fig shows the modem unit 156 connected to the serial port interface 126 and WAN 154. The modem unit 156 in the computer 100 may be integrated or external, and may be any type of conventional modem, such as cable modem or satellite modem. LAN 152 can also be used to connect to WAN 154. On Fig shows the router 158, which can connect LAN 152 WAN 154 in the usual way.

It should be understood that the illustrated network connections are presented as examples, there can be used other ways of communicating between computers. The existence of any of various well-known protocols such as TCP/IP, Frame Relay, Ethernet, FTP, HTTP, and so on, it is assumed, and the computer 100 can be controlled in the configuration client-server to allow the user to retrieve web pages from a server accessible over the network. In addition, to display and manipulate data on a web page can use any of the standard web browsers.

The computer 100 can be controlled using various software modules. Examples of the program modules include routines, programs, about jetty, components, data structures, libraries, etc. that perform specific tasks or provide specific abstract data types. The present invention also may be practiced with other configurations of the computer system, including hand-held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computer, handheld personal computers, mobile phones, etc. in Addition, the invention can also be practiced in distributed computing environments where tasks perform remote processing devices that are linked through a wireless or wired communication network. In a distributed computing environment, program modules may be located in both the local and remote storage devices.

As described above, various methods of the invention can be implemented as machine readable instructions stored on a machine-readable medium/media, such as floppy disks, CD-ROM, removable storage device, hard disk, system memory, built-in memory or another storage device. Machine-readable medium stores executable computer components or software modules. An alternative can be used more or less software is odula. Each component may be performed by a program, library binding data, configuration file, database, graphic image file of binary data, text data file, object file, a source code, etc. When one or more computer processors execute one or more software modules, software modules interact, causing one or more computer systems to act according to the description of the present invention.

Medium tooth brush/tip

As shown in Fig and 15, the user holds the toothbrush/probe (tip) 300, and can brush your teeth 401. Sometimes the user may also brush your tongue 402. When working tooth brush/tip 300 may collect various samples using diagnostic sensor system 305 and, in combination with the processor 110, to provide at home application is the user control, for example, the current pattern of the oral cavity, determining the relative amount deposited agents over time. Such devices toothbrush/tips can be applied separately or alternatively can be included in toothbrushes or other devices to care for the oral cavity. Users of the device will preferably be able to get quick results that will ensure effective the passive control of the flow of the oral cavity. In addition, users can respond to such results, respectively regulating mode (for example, by performing a clean tooth brush and/or floss more often or for a longer period).

Addressing pig and 15, toothbrush/tip 300 has a head 301 and the handle 302. Head 301 may include the area of care for the mouth including one or more items, cleaning the teeth 303, such as bristles. Head 301 and the handle 302 may be made of a desired material, such as hard plastic, resin, rubber, etc., for example, from polypropylene.

Used in this application, the term "cleaning teeth elements" or "cleaning elements" include any type of structure, which is commonly used or is suitable for use in order to ensure the healthiness of the oral cavity (e.g., tooth cleaning, teeth cleaning, teeth whitening, massaging, stimulating, and so on), through contact with parts of the teeth and gums. These items, cleaning the teeth, include, inter alia, the tufts of bristles, which can have many different shapes and sizes, and an elastomeric cleaning elements, which can have many different shapes and sizes, or a combination of bundles of bristles and an elastomeric cleaning elements.

Toothbrush/tip 300 may include a lighting device 307 such as a light is oslocale diode (LED), or any other desired form of visual output that provides electromagnetic frequency for spectral analysis. For example, the lighting device 307 may be an organic LED, which can be configured to provide desired characteristics, such as color, temperature, intensity of the electromagnetic wavelength, etc. of the OLED Technology can be embedded in a molded toothbrush or may be deposited on the surface of the main part of the toothbrush. Specialist, skilled in the art it will be clear that the present invention is not limited to any particular type of light devices used in the analysis.

Toothbrush/tip 100 may also include a diagnostic sensor system or biosensor system 305. Diagnostic sensor system 305 may include one or more separate sensors or sets of sensors, which are designed to detect various parameters according to the described methods, including the flow of light for spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region. For example, the diagnostic sensor system 305 may include a sensor that determines the presence of certain chemical or active compounds in the sample, or any on the other required parameters, as described in this application.

Sensor system 305, as described above, may be electrically or communication is connected, for example, by the CPU 110 or processor. The processor 110 typically processes the information received by the sensory system 305, and reports data on the analysis of the received information to the user, notifying the user about the status of his/her mouth. For example, the processor 110 toothbrush/tip 300 may report that he has determined the level of Triclosan in the upper left part of the teeth of the user.

The following examples are given as typical examples of the present invention. These examples should not be construed as limiting the scope of the invention, as are other equivalent ways to implement will be apparent in view of the present description.

Example 1

The study was performed to evaluate and develop methods for rapid analysis for the direct determination of the number of active delivery models of surfaces of the oral cavity, to verify the application of spectroscopy in the near IR region for analysis delivery of Triclosan coated saliva hydroxyapatite disks and to compare the results obtained with the conventional method based on solvent extraction. Spectroscopy in the near IR region measures the vibrations of molecules. The signal g is PP-CH, =NH, -O and-SH are strong. The overtones in the near IR spectroscopy provides a unique combination of bands for analysis. The equipment allows to perform measurements on the surface of a large area.

Human saliva was collected and measured. Stimulated by parafilm whole saliva was collected from healthy adults in sterile centrifuge tubes. Whole saliva was osvetleni by centrifugation for 10 minutes at 10,000 rpm (Sorvall rotor SS-34). The supernatant saliva were sterilized under UV light for at least 45 minutes. After that clarified sterilized saliva was ready to use for the formation of a film. The formation of a film on HAP included the incubation of HAP disks (diameter of 0.5" and a thickness of 0.05", Clarkson Chromatography, Inc.) with 1 ml of clarified sterilized saliva in a sterile round-bottom test tube with a volume of 14 ml for 20 hours at 37°C in shake a water bath. The saliva was removed by aspiration. Covered with saliva HAP disks were incubated with 1 ml of solution for containing Triclosan, within 5 minutes (in triplicate). The treated discs 3 times washed with deionized water, dried for 1 hour in a thermostat at 37°C. the Treated disks were measured directly using near infrared using 3 disk solution for processing. Each side was measured three times. Subsequently, the disks also is measured by extraction with a solvent (using ethanol) and HPLC.

The study found that spectroscopy in the near infrared region can be used for direct measurement of the application of Triclosan on the substrates scHAP. In addition, the developed method can be used for a quick evaluation of the application, regarding various delivery systems for active substances.

Example 2

Direct methods for the analysis of active substances using spectroscopy in the near IR region and the UV/visible region

1) Methods of analysis (sample preparation and data collection)

Control samples were prepared for all measurements to ensure that the difference between placebo samples from the treated samples.

2) Selection of wavelength (performed in several ways)

Pure materials was measured in the form of powders or in the form of solutions, and measure indicated by the minus control sample. The spectral fingerprint of the component of interest were considered and the field, and wavelength were identified, which seems to be free from intervening components. In some cases, was used by pre-treatment with the first or second derivative to enhance the separation of components present in a mixture.

Other ways of identifying wavelengths selection included 1) the use of 2-D correlation spectroscopy using other methods, such as IR, that pic is bestoweth definition of wavelengths, required both in the NIR and UV. When using 2-D correlation of the data sets, which consisted of samples prepared in the range of active concentrations, areas that vary depending on the concentration, can be correlated, so that you can make an exact assignment of the bands in the near IR and UV regions, using middle infrared region, in order to hold data interpretation. 2) Another way to select the wavelength was in the use of simple methods of linear regression to find the individual strips, which were highly correlated with concentration. After you have identified the exact wavelengths, it was possible to apply the methods of quantitative analysis, including, among others, the method of the peak areas, multiple linear regression and regression-private method of least squares. 3) the Last method of choice wavelength was using "Genetic algorithms". This method allowed us to find the right combination of wavelengths to maximize the correlation of statistical data and to minimize the regression error using the regression analysis method private least squares and multiple linear regression analysis.

3) Equipment used in the experiment

FOSS™ Dispersive Near IR Model XDS rapid composition analyzer (RCA).

Spectrophotometer Perki Elmer Lambda 650 UV-Vis software UV WinLabS Enhanced Security. Console (device) for sampling consisted of integrating sphere L650 60 mm

4) data Collection

In the case of the analysis in the near IR region, the samples were placed in the upper part of the window measurement RCA. The sample was measured using a 32 sequential scanning from 400 nm to 2500 nm. The average measurement is maintained. To analyze disk HAP each treatment was performed on 3 separate disks HAP. Measurement BIC was performed 3 times on each side, running a total of 6 measurements for each disk 18 for each treatment. To determine the concentration of the applied active substances or filler (for example, LSN), for each spectrum was obtained 2-th derivative. The peak area was integrated using the program for integration of the peaks, manufactured by Thermo Galactic. Used wavelengths depended on isolated areas identified above. Triclosan includes 1604-1804 nm and/or 2190-2300 nm. For LSN near infrared region included 1192-1298, 1626-1814 and 2250-2400 nm. In the UV-range area used for the analysis of active substances, included the area from 200-500 nm. The average results for each disk were evaluated to ensure reproducibility between the disks when the same processing.

In the case of UV-analysis, the samples were mounted in the center of the disc Spectralon 99% reflection, using double-sided adhesive tape. The sample was measured from 200 to 400 is m with an interval of 1 nm. UV detection was recorded as % reflectance depending on the wavelength. The percentage of reflection were converted into units of absorption Kubelka-Munch, which correlated with concentration. Then the average number n of replicas are subtracted from the average of the n disks placebo. To calculate the 2nd derivative using a smoothing function on 10 points. At this stage, or received area target maximum or used PLS regression 262 to 324 nm.

General approaches for the above examples, therefore, evaluated the methods of analysis using Triclosan as a standard oral active substances. Studies were performed using NIR and UV spectroscopy. Used different methods of data processing, including determination of the peak area, multiple linear regression (MLR), private method of least squares (PLS) (geometria). In these experiments, a new analytical method was compared with conventional solvent extraction.

The methods described and developed in this application can be used in the investigation of new agents, such as oral active substances. The methods can be applied to the development of improved methods of delivery and retention of the active substances on surfaces in the oral cavity. The methods can be applied in those cases when it is necessary or Celes is figuratively to perform a quantitative determination of the number of agent deposited (adsorbed) on the surface. In the experimental examples described above, in the methods used hydroxyapatite (HAP) disks as a substrate, modeling of solid tissue. The developed methods allow to overcome various limitations of the conventional method solvent extraction/HPLC, including indirect nature of the analysis, time-consuming stage and the lack of information about potential interactions of the agent and the substrate.

The technique of NIR analysis is based on measuring the vibration of molecules, has the advantage of providing direct and rapid analysis of solid and liquid substrates, and finished products, as well as a good identification agents, such as oral active substances in the mixture. Thus, it is possible multicomponent analysis (e.g., mixture such as a mixture of triclosan and sodium lauryl).

The technique of UV-analysis based on electronic transitions between energy levels, also provides a direct and rapid analysis of solid and liquid substrates. Various advantages and benefits associated with direct analytical methods described in this application, including the ability to analyze such agents as oral active substances in their native state, surrounded by the tools to care for your teeth, increases productivity and simplifies provedennoego screening method and analytical testing.

In the foregoing detailed description was given of various embodiments of the devices and/or methods through the use of bar charts, block diagrams, examples. Because these bar charts, block diagrams and examples contain one or more functions and/or operations professionals in this field will be obvious that each function and/or operation within such graphs, flowcharts, or examples can be implemented separately and/or together with a wide range of technical equipment, software, firmware or any combination of these. In one embodiment, aspects may be implemented through specific integrated circuits (ASICs). However, specialists, skilled in this field, it is obvious that embodiments of which are disclosed in the present application, in whole or in part, may be equivalent implemented in standard integrated circuits, in the form of a computer program running on your computer, in the form of a program executed in the processor, as firmware, or as virtually any combination of the above, and that the design and/or writing the code for the software or firmware within the competence of the medium with which ecialist in this area in light of the present description.

1. The way of measuring in situ coating of the oral agent of the funds for the care of teeth on the substrate containing:
(a) contact of the substrate with the oral agent for applying a certain amount of oral agent on the substrate, and the substrate coated with saliva, and
(b) analysis of the substrate using contained in the toothbrush of the probe used for spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region, and the wavelength used in stage b)is a characteristic referred to an oral agent, while the reference signal means for care of the teeth without oral agent is subtracted from the result of the analysis to determine the number of oral agent.

2. The method according to claim 1, in which oral agent is an active ingredient for the care of the oral cavity.

3. The method according to claim 1, wherein the substrate comprises hydroxyapatite (NAR).

4. The method according to claim 1, additionally containing after step (a) and before step (b) drying obtained in step (a) substrate containing oral agent.

5. The method according to claim 4, in which obtained in step (a) a substrate containing oral agent, is subjected to a first washing in deionized water, and then drying in a thermostat to remove the remaining water from its surface.

6. The method according to claim 1, in which oral agent is in races of the thief.

7. The method according to claim 6, in which the solution includes oral agent and an agent that improves the delivery.

8. The method according to claim 1, in which the probe NIR-spectroscopy and UV spectroscopy is a device for solid-phase measurement.

9. The method according to claim 8, in which the substrate is analyzed using the probe NIR-spectroscopy and device for solid phase measurement is a fast composition analyzer (RCA).

10. The method according to claim 8, in which the substrate is analyzed using the probe for UV-spectroscopy and device for solid phase measurement is a device integrating sphere.

11. The method according to claim 10, further containing after step (a) and before step (b) location obtained in step (a) substrate containing oral agent, reflecting the disk plate in the fixture with the integrating sphere.

12. The method according to claim 1, additionally containing after step (b) application of a mathematical method to obtain quantitative information from the NIR spectrum or UV spectrum, obtained in step (b).

13. The method according to item 12, in which mathematical method selected from the group consisting of the first and second derivative, integration of the peak area, the regression method private least squares (PLS), converting Kubelka-Munch and subtraction of spectra.

14. Device for measuring in situ coating of the oral and the enta of funds for care of teeth on the substrate, includes:
toothbrush made with possibility of contact of the substrate with the oral agent for applying a certain amount of oral agent on the substrate, and the substrate coated with saliva, and
the probe, is used to perform spectroscopy in the near infrared (NIR) region or spectroscopy in the ultraviolet (UV) region contained in a toothbrush and used for analysis of the substrate, and the wavelength used for the analysis is a characteristic referred to an oral agent, while the reference signal means for care of the teeth without oral agent is subtracted from the result of the analysis to determine the number of oral agent.



 

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Portal // 2484449

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1 ex

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