Method for assessing water resistance of antiperspirant product

FIELD: medicine.

SUBSTANCE: invention represents a method for assessing the water resistance of an antiperspirant, involving: a) sampling participants; b) fulfilling the requirement not to use any products or using the products containing no antiperspirant in the axillary region for a specific period of time; c) cleansing the axillary regions of each participant, d) applying a required amount of the antiperspirant product on one axillary region and a placebo product on the other axillary region of each participant; e) performing the stage d) until the required number of applications is completed provided more than one application is preferred; f) the last application is followed by a water test comprising a rotary motion of the participants in the swimming pool and/or swimming for a period of time of the activity in the swimming pool at a depth adequate to wet the axillary regions; g) performing a perspiration test; and h) stating if the antiperspirant shows at least the standard antiperspirant activity.

EFFECT: method improvement.

9 cl

 

REFERENCE TO RELATED APPLICATIONS

This application claims the priority of provisional patent application U.S. number 61/289665, filed on December 23, 2009, which is incorporated into this description by reference.

The LEVEL of TECHNOLOGY

The effectiveness of the antiperspirant products can be measured by the method of U.S. Food and Drug Administration, which is described in 21 CFR 350 and its subsections and Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER ucml06437.pdf). This method describes a technique of applying antiperspirant subject and measuring the level of sweating when the subject is in a hot room. The reduction of sweating is compared with a plot of the test, which was not applied antiperspirant or was caused to control the composition.

When people are going to swim or beach, they may be concerned whether the antiperspirant to show their properties after immersion in water. Up to this time there was no way to evaluate the water resistance of the antiperspirant product.

BRIEF description of the INVENTION

The method of determining the antiperspirant efficacy of the antiperspirant, including:

a) selecting a number of research participants;

b) implementation of requirements of the research participants about the use of any products or the use meantemperature product podmix is cnyh areas within the required period;

c) purification of the underarm areas of each study participant;

d) applying the required quantity of antiperspirant product on one armpit and placebo on the other axillary region of each study participant;

e) implementation stage (d) to achieve the necessary number of applications, if you select more than one drawing;

f) after the last application, conduct a water test, including moving and/or swimming research participants during the time period of activity in the pool of water deep enough so that the axillary region were moistened;

g) evaluating sweat to determine the amount of sweat on each underarm each study participant after water tests; and

h) determining, does antiperspirant product of at least a standard antiperspirant efficacy.

DETAILED description of the INVENTION

All sources listed here are fully incorporated into the present description by reference. In case of conflict, the definitions in the present description and in the indicated references cited in the present description have the advantage.

The method is used to evaluate the water resistance of antiperspirant product, which was used by the study participant. Pic is b can be used for any kind of antiperspirant product, such as sticks, semi-solid, gel, aerosol and roll-on products.

The method requires participation in the research study participants. In some embodiments, implementation of the selected statistically relevant number of study participants. Statistical relevant number can be obtained from already conducted similar studies on the effectiveness of the antiperspirant based on the number of study participants who provided statistically relevant results. In some embodiments, the implementation of the minimum number of study participants is at least 10, 20, 30, 40, 50 or more. In some embodiments, the implementation of the first pick at least 40 participants in the study. This allows to take into account some of the research participants who do not complete the study for any reason. For sprays, usually 50 people selected for statistical values, because the sprays do not include the aluminum-zirconium antiperspirant that you use sticks, gels, creams or roll-products. Sprays contain aluminum salts such as aluminum hydrochloride, which do not show the same antiperspirant efficacy as aluminum-zirconium salt.

Study participants must fulfill the required conditions for a sufficient period of time until the beginning of the research the research to ensure that any previously used antiperspirant was washed away. The time is chosen so that the skin lacked any measurable amount of antiperspirant. In some embodiments, the implementation period of time to perform the required conditions is at least 17 days.

Before executing the first application of the investigated antiperspirant product armpits clean.

On one armpit is applied investigated antiperspirant product and placebo product (without the active antiperspirant component) is applied to the other armpit. The damage number is chosen to be the usual amount of antiperspirant product, which is applied by the person. Examples of normal numbers of various products: 0.50 g ± 0.02 g (stick, gel or semi-solid product), 1.08 g ± 0.05 g (for aerosol product) or 0.5 ml of 0.02 ml (for ball product). Accordingly, the scope of application can be chosen to be approximately section 10.2×15.2 cm (4×6 inches) in the armpit.

The number of application of antiperspirant product can be selected. In one embodiment, selects one application. In other embodiments, the implementation of a number may be chosen to simulate the use of renewable product is. Even with daily washing is not all traces of the active antiperspirant component can be removed from the skin when washing. When renewable application of the product may occur the cumulative effect. The number of applications may be selected so as to constitute at least 2, 3, 4, 5, 6, 7 or 8. In some embodiments, the implementation will be at least 4, and in other embodiments, the implementation will be at least 8. The period between the application can be chosen to be once a day, to simulate the daily use of the antiperspirant product.

After the last application perform the water test. Study participants are immersed in a pool of water and perform the actions of moderate activity, such as moving around or swimming. The depth of the pool water must be sufficient for the underarm area of study participants specialise during water testing. In some embodiments, the implementation of the water depth is the depth of the swimming pool 1.2 to 1.5 meters (4-5 feet). Time in the water may be chosen to be any time, which simulates normal activity. In some embodiments, the implementation time in the water is selected to be approximately 20 minutes. After 20 minutes the participants of the IP is to study leave pool. They can use a towel, avoiding the area of application of the antiperspirant product. If required, participants can repeat the dive in the pool any desired number of times. In one embodiment, the number is two. Between visits to the pool should be a waiting period. In one embodiment, the waiting period is approximately 20 minutes. It can be used for modeling normal behavior in water, leaving the water and re-entering the water. Any requirements or conditions in the basin are not available. Typically, the pool is a public pool with a moderate pH (approximately 7) with the usual concentration of chlorine (1-5 ppm) and normal temperature (approximately 30°C).

After water testing research participants referred to the hot room to collect sweat. The period of time between the water test and evaluation sweating can be any length. In one embodiment, the period of time is approximately one hour. Can be used with any methodology for the hot room. In one embodiment, use the following method for the hot room.

After collecting sweat from each study participant after the hot room the resistance of antiperspirant product mo is et to be estimated using standard statistical methods to determine compliance antiperspirant product standard or higher level of efficiency. Examples of statistical methods is given below. If antiperspirant product complies with any of these performance indicators, the antiperspirant product is considered water resistant.

SPECIFIC embodiments of the INVENTIONS

Below are non-limiting examples of various embodiments of the method.

Choose healthy study participants. Factors for selection of study participants without limitation include the following: the research participants must be 18-65 years old, and he should be healthy. In some embodiments, the implementation of age not more than 20% of study participants should not be more than 55. Healthy research participants must have a pulse <100, the temperature of the body <37,3°C (99,2°F) and systolic blood pressure <150 and diastolic <90. The study participant must be allocated 100 mg of sweat in the underarm area after a 20-minute basic collection of sweat. Research participants should be excluded from the study if: (a) the participant's research is evident axillary irritation, (b) the participant has a history of cases of irritation or sensitivity to antiperspirant, deodorant or soap products for underarm areas, c) the participant has a history of recurring infections, boils, abscesses, increase the Oia lymph nodes or removal of lymph nodes in the armpit, d) the study participant observed active psoriasis, eczema, skin cancer or dermatological conditions that may affect the study, (e) research participants used drugs systemic antibiotics or topical antibiotics in the armpit area for two weeks prior to the study, (f) the participant receives any treatment or has a significant disease that can affect the results of the study or to provide the participant unhealthy for participation, (g) the participant has the following condition(I): heart disease, uncontrolled hypertension, kidney disease, significant respiratory disease, epilepsy, intolerance elevated temperatures, h) armpit study participant should be shaved at least 48 hours prior to the start of the study, or (i) the participant is insulin-dependent diabetic.

Basic amounts of sweat can be defined by the participants in the study, excluding those sweating which amounted to less than 100 milligrams of sweat/20 minutes/axillary area. Each study participant must refrain from the use of antiperspirants. Basic volumes can be used for comparing the difference between the highest and lowest readings potootdelenie what I have researched participants. In some embodiments, the implementation of the difference between the largest and smallest values of sweating in the entire study group of participants should not exceed 600 milligrams or to the right or to the left axillary region, with two 20-minute fees sweat. In one embodiment, the survey participants distribute in order from the most intense to the lowest sweating, such as from the right armpit. The study participants assign distribution of number processing. Study participant 1 participant research with high perspiration, study participant 2 will be followed by research participants with high perspiration, and so forth.

Prior to the research study participant must be in such conditions, to ensure that the results of the study based on antiperspirant used in the study. Each study participant chooses to use any appropriate conditions deodorant product (not containing antiperspirant or nothing uses in the armpit during a period of time sufficient to ensure that any previously used antiperspirant composition was washed away. This should lead to absent any measurable residues is of antiperspirant in the armpit. In the General case, the specified period is at least 17 days. Each study participant can ad libitum to use only satisfying the conditions of deodorant in a specified period and shall refrain from the use of antiperspirants in the armpit during a specified period of time. In some embodiments, require shaving the underarm area of study participants 48 hours prior to the start of the study. This provides the possibility of applying antiperspirant product directly on the skin.

Controlled washing is carried out before each application of the investigated product. The study participants are given instructions on how to wash in accordance with the following method: 1) wash the right axillary area within 10 seconds disposable towel with 2%aqueous solution of soap Camay, 2) to moisten a fresh disposable towel with tap water and rinse the armpit to remove soap, 3) gently blot until dry armpit is dry disposable towel, and 4) repeat for the left armpit.

For this study one armpit put the investigational product, and the other underarm area will be caused to the product-placebo. The order of application of the investigated product to the underarm area can be randomizers the n subjects. At the time of the survey should not be used antiperspirant product for underarm any study participant during the study. The effect of processing on sweating in the armpit area is estimated on charges of sweat made at intervals subsequent specific application. Each study participant will receive 4-8 processing of applications on the armpit, after 1 day each. Investigational products put in the amount of 0.50 g ± 0.02 g (for a product in the form of a stick), 1.08 g ± 0.05 g (for aerosol product) or 0.5 ml of 0.02 ml (for ball product) with a uniform coating of approximately of 10.2×15.2 cm (4×6 inch) square armpit. For the monotony of all the application can be performed by a technician. Study participants can be in a location to research for about 20 minutes after each application of the investigated product for drying and absorption of the products examined.

The evaluation is made at the initial time and after approximately 3 hours after the last processing application (approximately 1 hour after water tests).

Study in a hot room

Sweating of study participants is induced when the study participants in the room with the set temperature and otnositelnoi humidity. Temperatures can range from to 36.8°C (98°F) to 55°C (131°F). Relative humidity can range from 25 to 75%. In some embodiments, the implementation of the temperature can be from 37 to 40°C. In some embodiments, the implementation of the relative humidity ranges from 25 to 45. In one embodiment, the temperature is approximately 37.8°C±1°C (100°F±2°F)and relative humidity is 35%±5%.

During the first 40 minutes of the period to stimulate sweating study participants hold unweighted non-woven cotton fabric cosmetic wipes (Webril™ cosmetic wipes from Kendall) in the armpit. This pre-warming step is two successive 20-minute collection period, during which study participants holding balanced woven cotton cosmetic wipes (Webril™ cosmetic wipes) in the armpit. These cosmetic wipes weighed in strongly occluded polystyrene test tubes before and after application. The tubes are labeled by the participants in the study, the designation of the armpit and collection. The first collection made on a weighted cosmetic wipes, defined as the Collection B, and the second as the Collection C. while collecting on a weighted cosmetic pads study participants are required to sit in an upright position with both the tops of the feet on the floor and put his hands on his hips symmetrically on either side of itself. The number of collected sweat in grams determined by subtracting the initial weight of napkins from the mass with sweat.

All study participants involved in water testing after approximately 1 hour after the last processing application. Participants should arrive at the pool after the application of the investigated product and the 20-minute waiting period. Study participants can be investigated separately in the swimming pool or study participants can participate as a group in the pool. Study participants are in the water for about 20 minutes. During your stay in water research participants should move/swim at a moderate pace. Study participants leave the pool after 20 minutes and wipe, avoiding underarm areas. All study participants must re-enter the water after a 20 minute break. Study participants remain in the water for about 20 minutes, performing motion at a moderate pace. Approximately 20 minutes later, the study participants again wipe (avoiding axillary regions) and returned to the laboratory for testing in a hot room after approximately 1 hour.

The antiperspirant activity can be calculated by determining the changes of indicators sweating from processed armpit and raw p is myshechnoi area for each study participant. Calculate the estimated percentage reduction and 95% confidence intervals. Data can be analyzed according to the ranking criteria Wilcoxon signed. The source data for this analysis are processed to obtain corrective control coefficients for the ratio of sweating in the left and right armpit areas. These ratios are calculated using average charges after processing and for each individual in each time period. Adjusted processed before the benchmarks for this analysis can be calculated as follows: Z=(PC×T)/(PT×C), where Z is a correction factor, PC represents the measured moisture before processing control underarm (placebo), PT represents the dimension before processing the analyzed armpit, T is a measurement after processing the analyzed armpit, and C is an appropriate number for the control of axillary region (placebo).

Standard efficiency antiperspirant can be shown as follows. Analysis of the results is done by comparing the correction factor from 0.80 coefficient, which corresponds to a 20% reduction of moisture in the processing result. The hypothesis that the decreased sweating prevyshaet percent, investigated statistically by subtracting 0,80 from Z for all study participants, and the resulting number is compared with the ranking criterion of Wilcoxon signed. The hypothesis evaluated by the ranking criteria below:

H0: Median Z>0,80

Hand: Median Z<0,80

Test of hypothesis is performed when the value of α=0,05. Rejection of the null hypothesis makes a fair conclusion that at least 50 percent of the studied will be decreased sweating for at least 20 percent.

The higher efficacy of the antiperspirant can be shown as follows. Analysis of the results is done by comparing the correction factor with 0.70 coefficient, which corresponds to a 30% reduction of moisture in the processing result. The hypothesis that decreased sweating exceeds 30 percent, is investigated statistically by subtracting 0,70 from Z for all study participants, and the resulting number is compared with the ranking criterion of Wilcoxon signed. The hypothesis evaluated by the ranking criteria below:

H0: Median Z>0,70

Hand:The median Z<0,70

Test of hypothesis is performed when the value of α=0,05. Rejection of the null hypothesis makes a fair conclusion that at least 50 percent of the studied will be decreased sweating for at least 30 percent.

If after the water and the tests of the antiperspirant product shows typical efficiency of antiperspirant or more high performance antiperspirant, antiperspirant product is water-resistant.

1. The method for determining the water resistance of antiperspirant, including:
a) selection of research participants;
b) implementation of requirements of the research participants about the use of any products or using products that do not contain an antiperspirant, in axillary regions within the required period;
c) cleaning the armpit areas of each study participant
d) applying the necessary amount of antiperspirant product on one armpit and placebo on the other axillary region of each study participant;
e) implementation stage (d) to achieve the necessary number of applications, if you select more than one application;
f) after the last application of conduct water testing, including the circular motion of the study participants in the pool with a depth of water sufficient to wet underarm areas during the execution of a transaction within the time period of activity and/or swimming during the time period of activity in the pool with a depth of water sufficient to wet underarm areas during the voyage;
g) assessment of sweating; and
h) determining, does antiperspirant product of at least a standard antiperspirant efficacy.

2. The way pop, where the number of study participants is at least 30.

3. The method according to claim 1, where the time period for fulfillment of the conditions is at least 17 days.

4. The method according to claim 1, where the number of applications is at least 4.

5. The method according to claim 1, where the period of activity time is approximately 20 minutes

6. The method according to claim 1, where between the end of the water tests and conduct the final evaluation of sweating happens at about 1 o'clock

7. The method according to claim 1, where the water test further includes the timeout period, the study participants ' expectations, and then re-moving or swimming research participants in the pool during the time period of activity.

8. The method according to claim 7, where the timeout period is approximately 20 minutes

9. The method according to claim 1, where
a) the number of study participants at least 30;
b) time period for compliance is at least 17 days;
c) the number of applications is at least 4, and between the application passes one day;
d) water testing includes:
i) moving or swimming of the participants in the study for approximately 20 min;
ii) the output of the research participants from the pool and finding out the pool for about 20 minutes; and
iii) repeated movement or floating of the exhibitors who research in the pool for about 20 minutes; and
e) final evaluation sweating is carried out after approximately 1 h after water tests.



 

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6 cl, 13 dwg, 2 tbl, 6 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to cosmetic industry and represents a cosmetic preparation containing water-dispersible polyurethane with linear main chains generally consisting of alternating hydrophilic and hydrophobic sections; herewith: a) both terminal sections (T) are hydrophibic and at least one of both sections (T) are a branched alkyl residue, b) a hydrophilic section (S) is attached to each section immediately (T), c) at least one hydrophobic section (D) is attached to at least one end of each section (S) immediately, and d) the main chain contains at least one hydrophilic section (P), if there are more than one sections (P) are provided, two sections (P) are divided by at least one hydrophobic section (D).

EFFECT: invention provides creating the cosmetic preparations having the improved viscosity maintained for longer periods of time.

9 cl, 13 ex, 4 tbl

Anti-wrinkle agents // 2503443

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to chemical-pharmaceutical industry and represents wrinkle-reducing agents containing compounds presented by general formula (1), stereoisomers or pharmacologically acceptable salts thereof, wherein R1 represents a hydrogen atom or a linear or branched alkyl group with 1-8 carbon atoms; R2 represents -SH, -SO3H, -S-X2, -SO-X3, -S02-X4, X2-X4 represents carbon atoms or aliphatic hydrocarbon groups with 1-8 carbon atoms independently, R3 represents a hydrogen atom or an acyl group with a linear or branched alkyl chain with 1-8 carbon atoms, R4 represents a phenyl, tolyl, ethyl phenyl, propyl phenyl, butyl phenyl, pentyl phenyl, hexyl phenyl, methoxyphenyl, ethoxyphenyl, propyl oxyphenyl, butyl oxyphenyl, pentyl oxyphenyl, hexyl oxyphenyl or biphenyl group, m is equal to 0, n is equal to the integer 1 or 2.

EFFECT: invention provides preparing the compounds and cosmetic products possessing the anti-wrinkle effectiveness.

10 cl, 11 ex, 2 tbl, 7 dwg

FIELD: medicine.

SUBSTANCE: invention refers to methods of treating early enamel loss. The presented method of treating or reducing early enamel caries involves the dental application of an effective amount of a dental composition wherein the dental composition has a main formulation containing dicalcium phosphate, wherein the dental composition additionally contains arginine in the free or salt form, and an effective amount of fluoride, wherein arginine is found in the amount of 2 to 10 wt % of total weight of the dental composition.

EFFECT: composition used in the method possess an ability to increase enamel demineralisation that enables treating or reducing early enamel caries.

3 cl, 1 tbl, 4 ex

FIELD: cosmetic industry, in particular deodorant and/or antiperspirant composition.

SUBSTANCE: stable deodorant and/or antiperspirant composition represents suspension essentially free from residue. Said composition is obtained by incorporation of a) cross-linked polymer, cyclomethycone (and) dimethycone from polysiloxane, containing group and α,ω-diene of formula CH2=CH(CH2)хCH=CH2, wherein cross-linked polymer has viscosity from 5000 to 3000000 cPs, and cyclomethycone contains preferably 8-18 % of non-volatile substances; b) polyethylene beads with density of 0.91-0.98 g/cm3 and particle size of 5-40 mum; c) volatile silicone; d) softening agent (or mixture of two or more softening agents) which may include non-volatile silicone and additional amount of volatile silicone; and e) effective substance with antiperspirant activity in amount sufficient to provide deodorant and/or antiperspirant composition activity. Composition of present invention reduces body perspiration by at least 40 %, essentially free from white residue.

EFFECT: deodorant and/or antiperspirant composition of improved efficiency and stability.

10 cl, 5 tbl, 24 ex

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