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    • 专利摘要:
    Method for the administration of active principles. A method of administration of principles without medical supervision is described which comprises the determination of the parameters of the patient before treatment, the administration of an active principle, the determination of the parameters of the patient at the end of treatment where during the treatment time it monitors the geolocation of the patient as a function of time. A kit for the treatment is described. Likewise, a portable device suitable for the administration of photoprotective active principles is described; the device comprises means for the geolocation of the patient, a wireless connection to obtain the meteorological conditions and databases where the patient's position, the dose administered, the patient's parameters and the radiation received by the patient are stored. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2651904A1
    申请号:ES201631054
    申请日:2016-07-29
    公开日:2018-01-30
    发明作者:Nuria CATURLA CERNUDA；Arturo LIZON NORDSTRÖM；Enrique CARTAGENA MARTINEZ
    申请人:Monteloeder Sl；
    IPC主号:
    专利说明:

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    DESCRIPTION
    Method for the administration of active ingredients Technical field of the invention
    The invention describes a method of administration of principles in which the patient is geolocated during treatment. The present invention describes a suitable kit for the administration and monitoring of active ingredients formed by a composition comprising at least one active ingredient and means for the geolocation of the patient. The invention describes a portable device suitable for the administration of photoprotective active ingredients.
    Background of the invention
    The state of the art shows an infinity of active ingredients for the manufacture of medicines, food supplements or cosmetics.
    To evaluate the efficacy and safety of the active ingredients in medicines, food supplements and cosmetics before marketing, clinical tests are carried out on volunteers, but these volunteers are not subjected to the same meteorological conditions nor do they perform the same physical activity.
    On the other hand, it is known that a hypermedication can produce adverse effects and that a hypomedication has no therapeutic or cosmetic effects. For example, an excess of topical photoprotectors to prevent damage from solar radiation can cause vitamin D to not be synthesized by the body; Poor photoprotection can cause sunburn, photo aging and increase the risk of melanoma.
    Ace! The prospects of the photoprotective products indicate that the UV radiation protection factor and estimate some times but the UV radiation varies according to latitude and altitude. The patient does not know what the UV index is. The weather stations calculate daily the maximum value of UVI, which is reached at half a day.
    It has been estimated that the reflection of UV radiation in seawater increases the UV index by 50%; the altitude increases the intensity of the radiation by 5% every 300 meters of altitude and that the snow increases 85% of the intensity of the radiation.
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    There is a need to optimize the regime of administration of drugs, food supplements or cosmetics depending on the environmental conditions and physical activity of the patient.
    In the case of photoprotective products it is necessary to optimize the dose to avoid skin aging (loss of elasticity, melasmas, wrinkles of expression), sunburn and in the worst case the development of melanomas.
    When the active substance comprises vitamin D3 or its derivatives, it is necessary for the patient to receive ultraviolet radiation to assimilate vitamin D3.
    It is known that certain active ingredients, such as those derived from retinoic acid, are photosensitizing so the patient should not receive more than a threshold amount of visible / UV radiation.
    Anti-wrinkle cosmetics protect against environmental conditions (solar radiation, wind, pollution), therefore, its administration regime will be influenced by the dose of radiation received, wind speed and humidity. Excessive exposure to the sun will require a higher frequency of administration. In the same way meteorological conditions with a low relative humidity and wind will need a higher frequency of topical application.
    It is known that one of the risk factors in coronary heart disease is a high cholesterol and sedentary lifestyle. Doctors prescribe drugs to reduce cholesterol, for example statins or phytosterols, and advise moderate exercise, but there are no methods to evaluate what a moderate exercise is for each patient. It is also usual for patients to have incorrect data on their exercise rate.
    On the other hand, GPS devices that geolocate the position with a precision of meters are known. In recent years GPS devices have been implanted in smartphones. Wireless connections that allow obtaining any information from a server are also known.
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    The state of the art describes GPS devices that detect weather conditions (temperature, atmospheric pressure) and store user positions in a database during a journey. These devices are being used for sports purposes both to assess physical activity and to ensure safety in the mountains or high seas. However, the aforementioned devices are not used for the administration of active ingredients, nor do they store the historical data of the meteorological conditions.
    The Australian photoprotection standard indicates the maximum exposure times to the sun without sunscreens before the erythema appears depending on the type photo and the UV index. These values are:
     Phototype  Maximum sun exposure time
     one  67 minutes / UVI
     2  100 minutes / UVI
     3  200 minutes / UVI
     4  300 minutes / UVI
     5  400 minutes / UVI
     6  500 minutes / UVI
    According to the previous table, a person with a phototype III with an ultraviolet index of 10 will begin to burn after 20 minutes of sun exposure without topical or systemic sun protection.
    UVI values between sunrise and sunset can be calculated by interpolation. Also, the UV index varies with altitude (5% every 300 meters); with snow reflection (85%); with water reflection (50%). In this way, the person skilled in the art can determine the value of the Ultraviolet Index for any latitude, longitude, altitude and time.
    The Sun Protection Factor (SPF) indicates the time that sun exposure can be extended before burns appear. A value of SPF = 4 increases the time to sun exposure by 4.
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    Object of the invention
    The problem solved by the invention is to optimize and customize the dosage of active ingredients.
    The solution found by the inventors is a method of administration of active ingredients that is performed without medical supervision. The method comprises:
    - determine the parameters of the patient before treatment,
    - administer an active substance,
    and during the treatment time the geolocation of the patient is monitored as a function of time and the response to the active principle is archived as a function of time and the position of the patient.
    The geolocation of the patient allows you to evaluate the physical exercise performed based on the distance traveled. The doctor after analyzing the response to the initial dose and the distance traveled can optimize the dose of the active substance and modify the physical activity to be performed. The method is suitable to optimize the regimen of administration of statins, phytosterols and other active ingredients in the treatment and prevention of coronary heart disease. Also, the method is suitable for assessing athletic performance by measuring liver enzymes, concentration in lactates, basal pulse, VO2 or oxidative stress.
    In a preferred mode, the administration regime described comprises GPS geolocation and the determination and monitoring of meteorological conditions. When the environmental conditions are monitored, the dosage regimen is suitable for:
    - the administration of photoprotectors avoiding sunburn and the risk of melanoma,
    - the administration of photosenbilizing active ingredients, avoiding adverse reactions due to excessive solar radiation,
    - the administration of derivatives of vitamin D3, to obtain a fixation of calcium in the bones,
    - Cosmetic administration for proper protection of external agents (UV, pollution, dry environments ...)
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    In a preferred mode, the administration regime described is carried out by means of a smart phone that has a GPS, a wireless connection with the meteorological observatories, a memory that monitors the position data and data received and saves the parameters of the patient and the dose managed.
    In a second aspect the invention describes a kit comprising:
    -a formulation comprising at least one active substance,
    -a GPS,
    -a database containing the physiological data of the patient,
    -a database that records the positions of the patient as a function of time and -a database that records the administered dose of the active substance during treatment.
    In a preferred mode the system is integrated with a smart phone with wireless connection to the nearest meteorological station to receive the weather conditions.
    In a third aspect, the invention describes a portable device suitable for the administration of photoprotective active ingredients. The device comprises a GPS that geolocates the patient, a database where the patient's parameters are entered, a database that stores the patient's position data as a function of time, a wireless connection to obtain the meteorological data in place where is the patient The apparatus is characterized in that the meteorological data obtained comprise at least the Ultraviolet Radiation Index, the patient's parameters comprise at least the patient's skin phototype and the database stores the administered dose of a photoprotective principle and the total radiation received by the patient in a time interval.
    Definitions
    Active principle with therapeutic activity: Any substance capable of preventing, alleviating, treating or curing abnormal or pathological situations of living bodies by means such as the destruction of a parasitic organism or the limitation of the effect of the disease or of the abnormal state by modification of the physiology of the foreign body or parasite.
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    Active ingredient with active cosmetics: Any substance capable of deodorizing, protecting, beautifying, modifying the appearance or preserving the skin.
    Meteorological conditions: Includes all environmental parameters, in particular, UV radiation index, solar irradiance, relative humidity, temperature and speed of time, ozone concentration, nitrogen oxide concentration, polenes concentration.
    Skin type: Classify skin type as very dry, dry, normal, oily or very oily skin.
    Patient parameters: Include the biometric, physiological and biochemical parameters of the patients, such as weight, age, sex, height, body mass index, skin type, skin phototype, cholesterol, liver enzymes, HDL, LDL, triglycerides, hematles , medical history, VO2, lactate, basal pulse, GOT, GPT, etc.
    GPS: Acronym for Global Position System. Device for geolocation.
    Geolocation: Determination of latitude, longitude and altitude.
    Monitoring: Detection and storage of any parameter: position, UV index ...
    UVI: UV index.
    SPF: Sun protection factor.
    MED: Minimum erythematous dose.
    Detailed description of the invention
    The method described in the invention is performed without medical intervention during treatment. The described method is suitable for therapeutic purposes, for cosmetic purposes, for photoprotection or for the evaluation of sports performance.
    At the beginning of the treatment, the parameters of the patient are determined by the methods
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    known to the person skilled in the art, the doctor prescribes an initial dose of the active substance depending on the patient and the pathology to be treated. The patient follows the doctor's guideline and during the treatment the patient's position is monitored during the treatment. At the end of the treatment, the response at the beginning is evaluated based on the initial dose and the monitoring of the patient's geolocation.
    Smart phones known by the person skilled in the art comprise an internal memory where the geolocation of the patient is stored during the treatment. The smart phone comprises a database in which the patient's parameters and the dose of the active substance administered during the treatment are entered, in this way the dose administered and the physical exercise performed by the patient are correlated with the response to the active substance .
    To determine athletic performance, the patient parameters entered in the telephone database can be VO2, lactate, basal pulse, blood pressure, body mass index, age, etc. The active ingredients administered to evaluate sports performance include vitamin C as synthetic ascorbic acid, vitamin C in plant extracts (for example, acerola extracts), vitamin E, group B vitamins, polyphenols, creatine, taurine, acetyl choline, omega fatty acids 3, omega 6 or selenium fatty acid.
    In a preferred mode, the smartphone receives periodically through a wireless connection the meteorological data. The received data is stored in the telephone database.
    When the active substance is a photoprotector, the monitored meteorological conditions comprise at least the ultraviolet radiation received by the patient expressed with the ultraviolet index or irradiance received and the parameters of the patient are the type of phototype.
    The photoprotective active ingredients can be topical application or systematic administration. The photoprotective active ingredients for topical application are known to those skilled in the art and are compounds that absorb or reflect ultraviolet radiation and include for example zinc oxides, titanium oxides, nanoparticles, derivatives of the
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    benzophenone, alkyl cinnamates, ethyl methoxycinnamate, ethylhexyl ferulate, curcumin, ethyl salicylate, plant extracts, mentyl salicylate etc.
    In the same way, photoprotectors for systemic application include antioxidants, derivatives of caffeic acid, curcuminoids, derivatives of ferulic acid, cinnamates, salicylates, qulnic acid, green tea extracts, Polypodium extracts, sklmic acid, citrus extracts, extracts of rosemary, etc.
    In a preferred mode, photoprotectors for systemic application comprise extracts of Citrus Paradise and Rosmarinus officinalis; more preferably, the oral photoprotector comprises mixtures of hydroalcoholic extracts of Citrus Paradise and Rosmarinus officinalis valued in polyphenols expressed as gallic acid. Citrus Paradise and Rosmarinus officinalis hydroalcoholic extracts may be between 25/75 and 75/25 (weight / weight) and have a content greater than 25% in polyphenols expressed as gallic acid.
    When the active substance is a derivative of retinoic acid for the treatment of acne, the meteorological conditions monitored are the Ultraviolet Index.
    In a preferred method, the method is applicable for the administration of photoprotective active ingredients, where the meteorological conditions are monitored in addition to the geolocation of the patient.
    Cosmetic active ingredients are known to those skilled in the art and are those that deodorize protect, beautify, modify or preserve the skin. Cosmetic active ingredients include moisturizing agents, sunscreens, bleaching agents, deodorants, microbial agents, keratolytic agents, anti-free radical agents, etc. These active ingredients are detailed in the inventory of cosmetic ingredients (COSING) published by the European Commission.
    In a preferred mode, the cosmetic active ingredients are:
    - moisturizing agents, such as hyaluronic acid, urea, aloe extracts, arginine, vitamin B3 derivatives; betalna, etc ...
    - free radical scavenging agents such as plant extracts, antioxidants, acetyl
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    cysteine, ascorbyl palmitate, etc.
    Example 1. Method for the administration of an active substance for the treatment of coronary heart disease
    A study was conducted with 20 patients with hypercholesterolemia. Blood values of cholesterol, HDL, were determined. LDL and triglycerides in blood and blood pressure. Patients were prescribed an initial dose of atorvastine of 10 mg / dla and were instructed to walk for 60 minutes a day.
    The patients were provided with a smart phone with a GPS device that stored the route taken, but the patients were not informed that the phone kept the distance traveled. Patients were required to carry the phone with them during treatment. Patients followed the administration regimen prescribed by the method for 1 month. A blood test was performed at the end of the treatment and the distance traveled by each patient during the treatment was evaluated.
    The results obtained showed a correlation between the reduction of cholesterol with the distance walked. The atorvastine dose of 10 mg / dla was maintained for patients who walked more than 5 kilometers per day and reduced the cholesterol rate. For patients who walked more than 5km per day and the cholesterol rate was reduced, the dose of atorvastine was increased to 80 mg / dla. It was observed that certain patients did not comply with the doctor's instructions to walk for 60 minutes, since the distance traveled was less than 1 km.
    Example 2. Monitoring of atmospheric conditions
    A smartphone equipped with GPS stores user positions and time in its memory with a sample rate of 5 minutes. Concomitantly, the telephone established a wireless connection with the server of the State Meteorological Agency (AEMET) and extracted from the xml files the meteorological conditions and the values of temperature, atmospheric pressure, wind, relative humidity and UV index were determined for each position and time. The generated data was stored in the smartphone's memory.
    Example 3 Oral photoprotective activity of rosemary and citrus extracts
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    A 35-year-old male with phototype III was on the beach without protection for 20 minutes.
    The UV index was 10. At 20 minutes he began to show an erythema. He began an oral treatment of the photoprotective composition described in example 6 which was administered once a day with breakfast. At 15 days of treatment the erythema was shown at 23 minutes of exposure to the sun with an UV index of 10. At 90 days of treatment the erythema was shown at 32 minutes of exposure to the sun with an UV index of 10.
    Example 4. Oral photoprotective activity of rosemary and citrus extracts in combination with a topical photoprotector
    The male of example 3 was treated with the rosemary and citrus extract described in example 6, which was administered once a day with breakfast and a photoprotective cream with SPF 10 was applied. After 15 days of treatment the erythema appeared at 230 minutes After 30 days of treatment the erythema appeared at 240 minutes. At 60 days of treatment the erythema appeared at 260 minutes. At 90 days of treatment the erythema appeared at 312 minutes.
    Example 5 Method for administration of photoprotective active ingredients
    The smartphone described in example 2 was used by a person with a phototype III. The phone monitored the patient's geolocation and the Ultraviolet radiation Index. The average ultraviolet radiation index was 9. The user entered their phototype value and age on the phone. The user was exposed to the sun and at 22 minutes the phone issued an alert signal that indicated that the maximum radiation had been reached to prevent the appearance of erythema. The previous user was treated with rosemary and citrus extracts for more than 90 days. according to the composition detailed in example 6 with a capsule per day.
    The administered dose and the treatment time were introduced in the smartphone.
    The user walked on a sunny day with an ultraviolet index of 10. At 32 minutes the smartphone issued an alert signal.
    Example 6. Quantitative composition of the photoprotective formulation of extracts of
    citrus and rosemary
    Gelatin capsules were manufactured with:
    Citrus paradise and Rosmarinus officinalis hydroalcoholic extract 250 mg 5 Excipients cps 450 mg
    The polyphenol content expressed as gallic acid of the extract was 34% (w / w) determined by the Folin-Ciocalteu method.
    The extract contains a concentration of Citrus paradise alcohol extract of 25% 10 (weight / weight) and a concentration of the hydroalcoholic extract of Rosmarinus officinalis of 75% (weight / weight).
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    权利要求:
    Claims (4)
    [1]
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    1. Portable geolocator device, suitable for determining the coordinates of a patient, comprising memories for:
    - store the patient's location,
    - store the physiological parameters of the patient,
    - store the administered dose of an active substance, characterized in that it also contains:
    - means to determine the radiation received,
    - means for storing the received radiation and
    - an alarm that is activated when the received radiation reaches a threshold value.
    [2]
    2. Kit consisting of:
    - a portable geolocation device, suitable for determining the coordinates of a patient, comprising memories for:
    - store the patient's location,
    - store the physiological parameters of the patient
    - store the administered dose of an active substance,
    Y
    - a composition with an active principle selected from:
    - active photoprotective ingredients,
    - vitamins and
    - active ingredients for the treatment of coronary heart disease.
    [3]
    3. Kit according to claim 2 characterized in that the photoprotective active ingredients are administered orally and are hydroalcoholic extracts of Citrus paradise and Rosmarinus officinalis.
    [4]
    4. Kit according to claim 2, suitable for evaluating sports performance, characterized in that a composition comprising vitamin C, vitamin E, vitamin B12, vitamin B1, vitamin B6 or creatine.
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    同族专利:
    公开号 | 公开日
    WO2018020074A1|2018-02-01|
    ES2651904B1|2019-07-16|
    引用文献:
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    US20110247718A1|2008-10-23|2011-10-13|L'oreal|Cosmetic or dermatological system with automatic adjustment of the properties of a preparation as a function of data transmitted by a transmitter external to the system|
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