Field of application
[0001] The present invention relates to the field of the cosmetic and pharmaceutical industry.
[0002] In particular, the invention relates to a formulation for personal hygiene, provided
with pronounced characteristics of tolerability, and suitable to the use as a co-adjuvant
with soothing properties in case of diseases and inflammatory conditions of external
genital organs.
Background of the art
[0003] The detergent formulations for personal hygiene have to be as delicate as possible,
since they directly contact the mucous membranes of the genital system, which are
very sensitive. Ideally, such formulations should not alter the natural microbial
flora also in case of frequent washing, and they should preferably be free of alcohols
and strong fragrances, in order to reduce the presence of potentially allergenic substances.
[0004] Personal hygiene detergents should not alter the natural acidity of the mucous membranes
and must be formulated with ingredients which are not harsh or irritating. In the
formulations of personal hygiene detergents available on the market, relatively delicate
anionic surfactants are contained, such as sulfosuccinates, acylglutammates, or protein-fatty
acid condensates, such as e.g. those derived from the condensation of coconut fatty
acids and wheat or oat amino acids. The anionic surfactants are sometimes associated
with amphoteric surfactants, such as betaines, or to non-ionic surfactants.
[0005] The known formulations sometimes contain long chain alcohols, oils and functional
substances, such as plant extracts with a specific action. Among these, chamomile,
calendula and lime tree extracts can be mentioned, with a refreshing and soothing
activity, as well as thyme extract and Melaleuca alternifolia oil, with an antiseptic
activity.
[0006] The known formulations for personal hygiene usually have a pH of about 3.5 -4.0,
corresponding to the vaginal pH.
[0007] Despite the measures mentioned above to use surfactants which are as much delicate
as possible, to avoid the presence of irritating substances, and to maintain the vaginal
pH, the formulations for personal hygiene that are currently commercially available
are not completely satisfactory, especially when they are to be used by persons with
more or less severe diseases of the external genital mucous membranes, in particular
the vulva, for example, lichen and vulvites.
[0008] US 2007/269525 A1 discloses O/W gel compositions aimed at providng irritation free formulations, wherein
such compositions include 0.05-5% by weight of a polymeric gel former selected from
acrylic acid, acrylamide and homopolymers of acrylic acid and acrylamide, 0.1-10%
by weight of a wax component, which may be i.a. a C
12-18 fatty alcohol or a partial glyceride, and 0.1-30% of an oil component. These compositions
may contain "biogenic agents" including i.a. tocopherol and tocopherol acetate in
an unspecified amount. The compositions according to
US 2007/269525 A1 can be incorporated into body care formulations, the pH of which is not specified.
Summary of the invention
[0010] The problem underlying the present invention has been to provide a new personal hygiene
formulation which had a higher tolerability than that of the known formulations and
which could be used even by persons with diseases of the external genital mucous membranes,
without causing irritations or other problems, while performing and efficient soothing
and antimicrobial action.
[0011] Such a problem has been solved by providing a formulation for personal hygiene in
the form of O/W emulsion with a pH from 5.5 to 6.5, free of surfactants, except for
comprising an emulsifier consisting of a fatty alcohol with 14 to 22 carbon atoms
or of glyceryl monostearate (INCI name: Glyceryl Stearate) or a mixture thereof, which
formulation further comprises Coco Caprylate and/or Coco Caprylate/Caprate, vitamin
E or an ester thereof in an amount of 2.0 to 15% by weight on the total weight of
the formulation, and Melaleuca alternifolia oil.
[0012] The above-mentioned fatty alcohol is preferably selected from the group consisting
of lauryl alcohol, stearyl alcohol, myristyl alcohol, arachidyl alcohol, behenyl alcohol
and cetylstearyl alcohol, the latter (Cetearyl Alcohol) being particularly preferred.
[0013] Vitamin E can be used as d-α-tocopherol, as a mixture of the two enantiomers d and
1 of α-tocopherol, as a mixture of other tocopherols (β, γ, δ, ε, ζ, η) or as tocotrienols.
[0014] By ester of vitamin E is meant an ester of vitamin E as defined above with a carboxylic
acid of formula R-COOH, wherein R is an alkyl radical having 1 to 19 carbon atoms,
or an alkenyl or alkynyl radical having 2 to 19 carbon atoms.
[0015] Preferably, the above-mentioned ester is vitamin E acetate, n-propionate or linoleate.
[0016] The use of vitamin E acetate, particularly alpha-tocophery acetate, is particularly
preferred.
[0017] The formulation preferably also contain jojoba oil (Simmondsia Chinensis Oil) and/or
shea butter (Butyrospermum Parkii Butter).
[0018] Preferably, the formulation also comprises xanthan gum (Xanthan Gum).
[0019] Preferably, the formulation also comprises an organic acid selected from lactic,
malic, citric and acetic acid. Particularly preferred is lactic acid, which is added
in such an amount as to bring the pH of the formulation to 5.5-6.5, preferably to
a pH of about 6.0.
[0020] Preferably, the formulation also comprises pentylene glycol (Pentylene Glycol).
[0021] Preferably, the formulation according to the present invention contains the following
ingredients, in percentages by weight of the total weight of the formulation:
| Fatty alcohol with 14-22 carbon atoms |
1.5-5.0 |
| Glyceryl Stearate |
2.0-6.0 |
| Coco Caprylate |
15.0-25.0 |
| Vitamin E or ester thereof |
3.0-10.0 |
| Melaleuca Alternifolia Leaf Oil |
1.5-6.0 |
[0022] In an aspect thereof, the formulation may also contain 0.5-2.0% jojoba oil (Simmondsia
Chinensis Oil) and/or 3.0-8.0% shea butter (Butyrospermum Parkii Butter).
[0023] The formulation may further contain 0.2-1.0% xanthan gum (Xanthan Gum).
[0024] The formulation may further contain from 0.05% to 0.25% lactic acid, to adjust the
pH between 5.5 and 6.5, preferably at about 6.0.
[0025] The formulation may further contain from 3.0 to 8.0% pentylene glycol (Pentylene
Glycol).
[0026] A particularly preferred formulation is the one set forth herein below (INCI names):
| Aqua |
51.00 - 58.00 |
| Coco Caprylate |
16.00 - 20.00 |
| Pentylene glycol |
4.00 - 6.00 |
| Glyceryl Stearate |
3.00 - 5.00 |
| Tocopheryl Acetate |
4.00 - 8.00 |
| Butyrospermum Parkii Butter |
4.00 - 7.00 |
| Cetearyl Alcohol |
2.00 - 4.00 |
| Melaleuca Alternifolia Leaf Oil |
2.00 - 5.00 |
| Simmondsia Chinensis Oil |
0.5 - 1.5 |
| Xanthan Gum |
0.3 -0.8 |
| Lactic acid |
0.05-0.15 |
| pH = 5.8-6.2. |
|
[0027] The formulation according to the present invention is provided with a high tolerability,
by virtue of the absence of surfactants. The delicate detergent action of the formulation
according to the present invention is provided by the emulsifiers contained therein,
i.e., fatty alcohol with 14 to 22 carbon atoms and/or Glyceryl Stearate, which components
have all strong affinity for the skin and the mucous membranes. The same affinity
for the skin and mucous membranes is displayed by Coco Caprylate and Coco Caprylate/Caprate,
which are provided with a considerable emollient action.
[0028] The application of the detergent formulation according to the present invention,
by virtue of the absence of surfactants, does not even require the subsequent rinsing
of the cleaned area. In such a case, the formulation may remain in contact with the
skin and the mucous membranes, thus allowing the antimicrobial and soothing active
ingredients contained therein to keep on exerting their action even after cleansing.
[0029] The antimicrobial action of the formulation according to the present invention is
due to the presence therein of the tea tree or Melaleuca alternifolia essential oil.
The latter component is rich in terpene derivatives, mainly oxygenated and non-oxygenated
monoterpenes, sesquiterpenes and triterpene alcohols, which are responsible for the
antimicrobial action.
[0030] In order to prevent any irritant effect related to the essential oils of the tea
tree oil, the formulation according to the present invention provides for the presence
of vitamin E or an ester thereof, in particular, tocopheryl acetate, having a considerable
soothing and emollient action.
[0031] A further soothing and emollient effect can be obtained by incorporating in the formulation
according to the present invention jojoba oil (Simmondsia Chinensis Oil) and/or shea
butter.
[0032] The possible presence in the formulation according to the present invention, which
is in the form of O/W emulsion, of xanthan gum, serves to stabilize the emulsion and
to confer it a gel texture.
[0033] The possible presence of pentylene glycol also concurs to the stabilization of the
formulation according to the present invention.
[0034] An important aspect of the formulation according to the present invention is its
pH, which, as it has be seen, ranges between 5.5 and 6.5 and is preferably of about
6.0, unlike most of the detergent formulations for personal hygiene in the market,
which have a pH of about 3.5-4.0.
[0035] A pH range centered around 6.0 has been selected because this is the pH value at
the vulvar mucous membrane, which is the portion which is actually cleaned. Instead,
the pH of 3.5-4.0 of most of the personal hygiene detergent formulations in the market
corresponds to the pH of the vaginal mucous membrane, but the latter is not actually
involved in the cleansing. The vaginal mucous membrane is reached only by vaginal
douches, but in such a case, special vaginal formulations are used instead of detergent
formulations.
[0036] On the contrary, a detergent formulation for personal hygiene with a pH of 3.5-4.0
has a risk to be irritant and cause burning sensations in the presence of vulvar lesions
and reddening.
[0037] The pH of the formulation according to the present invention can be adjusted to a
value of about 5.5-6.5 by the addition of a suitable amount of a physiologically compatible
organic acid, and preferably lactic acid.
[0038] The absence of preservatives, colorants and perfumes in the formulation according
to the present invention further concurs to its high tolerability.
Detailed description
[0039] The present invention will be now further described with reference to an example
given by way of illustrative, non-limiting example.
EXAMPLE
[0040]
| a) Aqua |
55.00 |
| b) Coco Caprylate |
17.00 |
| c) Pentylene glycol |
4.00 |
| d) Glyceryl Stearate SE |
3.00 |
| e) Tocopheryl Acetate |
6.50 |
| f) Butyrospermum Parkii Butter |
4.00 |
| g) Cetearyl Alcohol |
4.00 |
| h) Melaleuca Alternifolia Leaf Oil |
5.00 |
| i) Simmondsia Chinensis Oil |
0.50 |
| l) Xanthan Gum |
0.80 |
| m) 50% w/w lactic acid solution |
0.20 |
| pH = 6.0. |
|
[0041] The formulation set forth above was prepared by weighing all the fatty phase (ingredients
b, d, e, f, g, h, i). This phase is then brought to a liquid state by heating to 80
C° +/- 2° C.
[0042] Xanthan gum (l) is added to the solution of water (a) and pentylene glycol (c) heated
to 80° C +/-2° C, under stirring, thus obtaining the aqueous phase. By means of a
vacuum system, the liquid fatty phase is introduced by suction into the turboemulsifier
containing the aqueous phase described above. The turboemulsifier is operated during
about 30 minutes until a homogeneous emulsion is obtained.
[0043] Once the emulsion has been obtained, it is gradually brought back to room temperature;
finally, the amount of lactic acid (m) necessary to obtain a pH = 6 is added.
[0044] The formulation was tested by a group of 35 female subjects, with an age ranging
between 17 and 80 years, with different vulvar diseases, including lichen (both hypertrophic
and hypotrophic, with or without erosions or rhagades), acute forms of vulvitis (fungal
forms, forms due to
Escherichia coli, herpes, outcomes of diathermocoagulation for condylomatosis, outcomes of post-partum
episiorraphy), outcomes of intervention on Bartholin's cyst. These subjects were asked
to use only the formulation at issue for cleansing their private parts during a period
of thirty days.
[0045] All 35 subjects participating in the test declared that they obtained a considerable
improvement by using the formulation of the present example, noting a considerable
reduction of the symptoms (e.g., burning sensation, reddening, itching) and in many
cases the complete disappearance of such symptoms. No adverse reaction has been reported.
1. A formulation for personal hygiene in the form of O/W emulsion with a pH from 5.5
to 6.5, free of surfactants except for comprising an emulsifier consisting of a fatty
alcohol having from 14 to 22 carbon atoms or of Glyceryl Stearate or a mixture thereof,
which formulation further comprises
Coco Caprylate and/or Coco Caprylate/Caprate,
vitamin E or an ester thereof in an amount of 2.0 to 15% by weight on the total weight
of the formulation, and
Melaleuca alternifolia oil.
2. The formulation according to claim 1, wherein said fatty alcohol is selected from
the group consisting of lauryl alcohol, stearyl alcohol, myristyl alcohol, arachidyl
alcohol, behenyl alcohol and cetylstearyl alcohol and is preferably cetylstearyl alcohol
(Cetearyl Alcohol).
3. The formulation according to any one of claims 1 and 2, wherein said ester of vitamin
E is an ester of tocopherol with a carboxylic acid of formula R-COOH, wherein R is
an alkyl radical having 1 to 19 carbon atoms, or a alkenyl or alkynyl radical having
2 to 19 carbon atoms and is preferably alpha-tocopheryl acetate, n-propionate or linoleate.
4. The formulation according to any one of the preceding claims, further comprising jojoba
oil (Simmondsia Chinensis Oil) and/or shea butter (Butyrospermum Parkii Butter).
5. The formulation according to claim 4, further comprising xanthan gum (Xanthan Gum).
6. The formulation according to any one of the preceding claims further comprising an
organic acid selected from lactic, malic, citric and acetic acid, preferably lactic
acid.
7. The formulation according to any one of the preceding claims, also comprising pentylene
glycol (Pentylene Glycol).
8. The formulation according to claim 1, containing the following ingredients, in percentages
by weight on the total weight of the formulation:
| Fatty alcohol with 14-22 carbon atoms |
1.5-5.0 |
| Glyceryl Stearate |
2.0-6.0 |
| Coco Caprylate |
15.0-25.0 |
| Vitamin E or ester thereof |
3.0-10.0 |
| Melaleuca Alternifolia Leaf Oil |
1.5-6.0 |
9. The formulation according to claim 8, further containing 0.5-2.0% of jojoba oil (Simmondsia
Chinensis Oil) and/or 3.0-8.0% of shea butter (Butyrospermum Parkii Butter).
10. The formulation according to claim 9, further containing 0.2-1.0% of xanthan gum (Xanthan
Gum).
11. The formulation according to any one of claims 8 to 10, further containing from 0.05%
to 0.25% of lactic acid, to adjust the pH between 5.5 and 6.5, preferably about 6.0.
12. The formulation according to any one of claims 8 to 11, further containing from 3.0
to 8.0% of pentylene glycol (Pentylene Glycol).
13. The formulation according to any one of the preceding claims, having a pH of 5.8-6.2
and containing, in percentages by weight on the total weight of the formulation (INCI
names):
| Aqua |
51.00 - 58.00 |
| Coco Caprylate |
16.00 - 20.00 |
| Pentylene glycol |
4.00 - 6.00 |
| Glyceryl Stearate |
3.00 - 5.00 |
| Tocopheryl Acetate |
4.00 - 8.00 |
| Butyrospermum Parkii Butter |
4.00 - 7.00 |
| Cetearyl Alcohol |
2.00 - 4.00 |
| Melaleuca Alternifolia Leaf Oil |
2.00 - 5.00 |
| Simmondsia Chinensis Oil |
0.5 - 1.5 |
| Xanthan Gum |
0.3 -0.8 |
| Lactic acid |
0,05-0,15 |
1. Formulierung zur Körperpflege in Form einer O/W-Emulsion mit einem pH-Wert von 5,5
bis 6,5, frei von Tensiden, mit Ausnahme des Umfassens eines Emulgators, der aus einem
Fettalkohol, der von 14 bis 22 Kohlenstoffatome aufweist, oder aus Glycerylstearat
oder einer Mischung davon besteht, wobei die Formulierung ferner umfasst
Coco-Caprylat und/oder Coco-Caprylat/Caprat,
Vitamin E oder einen Ester davon in einer Menge von 2,0 bis 15 Gew.-% des Gesamtgewichts
der Formulierung, und
Melaleuca alternifolia Öl.
2. Formulierung nach Anspruch 1, wobei der Fettalkohol ausgewählt ist aus der Gruppe
bestehend aus Laurylalkohol, Stearylalkohol, Myristylalkohol, Arachidylalkohol, Behenylalkohol
und Cetylstearylalkohol, und der vorzugsweise Cetylstearylalkohol (Cetearylalkohol)
ist.
3. Formulierung nach einem der Ansprüche 1 und 2, wobei der Ester von Vitamin E ein Ester
von Tocopherol mit einer Carbonsäure der Formel R-COOH ist, wobei R ein Alkylradikal
ist, das 1 bis 19 Kohlenstoffatome aufweist, oder ein Alkenyl- oder Alkinylradikal,
das 2 bis 19 Kohlenstoffatome aufweist, und das vorzugsweise Alpha-Tocopherylacetat,
n-Propionat oder Linoleat ist.
4. Formulierung nach einem der vorhergehenden Ansprüche, ferner umfassend Jojobaöl (Simmondsia
Chinensis-Öl) und/oder Sheabutter (Butyrospermum Parkii-Butter).
5. Formulierung nach Anspruch 4, ferner umfassend Xhantangummi (Xhantan Gum).
6. Formulierung nach einem der vorhergehenden Ansprüche, ferner umfassend eine organische
Säure, ausgewählt aus Milch-, Apfel-, Zitronen- und Essigsäure, vorzugsweise Milchsäure.
7. Formulierung nach einem der vorhergehenden Ansprüche, ferner umfassend Pentylenglycol
(Pentylen Glycol).
8. Formulierung nach Anspruch 1, die die folgenden Inhaltsstoffe enthält, nach Gewichtsanteilen
des Gesamtgewichts der Formulierung:
| Fettalkohol mit 14 bis 22 Kohlenstoffatomen |
1,5-5,0 |
| Glycerylstearat |
2,0-6,0 |
| Coco-Caprylat |
15,0-25,0 |
| Vitamin E oder Ester davon |
3,0-10,0 |
| Melaleuca alternifolia Blattöl |
1,5-6,0 |
9. Formulierung nach Anspruch 8, ferner umfassend 0,5 bis 2,0 % Jojobaöl (Simmondsia
Chinensi-Öl) und/oder 3,0 bis 8,0 % Sheabutter (Butyrrospermum Parkii-Butter).
10. Formulierung nach Anspruch 9, ferner umfassend 0,2 bis 1,0 % Xhantangummi (Xhantan
Gum).
11. Formulierung nach einem der Ansprüche 8 bis 10, ferner umfassend von 0,05 % bis 0,25
% Milchsäure, um den pH-Wert zwischen 5,5 und 6,5 anzupassen, vorzugsweise etwa 6,0.
12. Formulierung nach einem der Ansprüche 8 bis 11, ferner umfassend von 3,0 bis 8,0 %
Pentylenglykol (Pentylen Glycol).
13. Formulierung nach einem der vorhergehenden Ansprüche, die einen pH-Wert von 5,8 bis
6,2 aufweist, und nach Gewichtsanteilen vom Gesamtgewicht der Formulierung Folgendes
umfasst (INCI-Bezeichnungen):
| Aqua |
51,00-58,00 |
| Coco Caprylate |
16,00-20,00 |
| Pentylene glycol |
4,00-6,00 |
| Glyceryl Stearate |
3,00-5,00 |
| Tocopheryl Acetate |
4,00-8,00 |
| Butyrospermum Parkii Butter |
4,00-7,00 |
| Cetearyl Alcohol |
2,00-4,00 |
| Melaleuca Alternifolia Leaf Oil |
2,00-5,00 |
| Simmondsia Chinensis Oil |
0,5-1,5 |
| Xanthan Gum |
0,3-0,8 |
| Lactic acid |
0,05-0,15 |
1. Formulation pour hygiène personnelle sous la forme d'une émulsion H/E avec un pH compris
entre 5,5 et 6,5, exempt d'agents tensioactifs à l'exception d'un émulsifiant constitué
d'un alcool gras ayant entre 14 et 22 atomes de carbone ou de Stéarate de glycéryle
ou d'un mélange de ceux-ci, ladite formulation comprenant en outre
du Coco Caprylate et/ou du Coco Caprylate/Caprate,
de la vitamine E ou un ester de celle-ci dans une quantité comprise entre 2,0 et 15
% en poids sur la base du poids total de la formulation, et
de l'huile de Melaleuca alternifolia.
2. Formulation selon la revendication 1, caractérisée en ce que ledit alcool gras est choisi dans le groupe constitué de l'alcool laurique, de l'alcool
stéarique, de l'alcool myristique, de l'alcool arachidylique, de l'alcool béhénylique
et de l'alcool cétostéarylique et est de préférence de l'alcool cétostéarylique (Cetearyl
Alcohol).
3. Formulation selon une quelconque des revendications 1 et 2, caractérisée en ce que ledit ester de vitamine E est un ester de tocophérol présentant un acide carboxylique
de formule R-COOH, dans laquelle R est un radical alkyle ayant entre 1 et 19 atomes
de carbone, ou un radical alcène ou alcyne ayant entre 2 et 19 atomes de carbone et
est de préférence un acétate, un n-propionate ou un linoléate d'alpha-tocophérol.
4. Formulation selon une quelconque des revendications précédentes, comprenant en outre
de l'huile de jojoba (huile de Simmondsia Chinensis) et/ou du beurre de karité (beurre de Butyrospermum Parkii).
5. Formulation selon la revendication 4, comprenant en outre une gomme de xanthane (gomme
de xanthane).
6. Formulation selon une quelconque des revendications précédentes, comprenant en outre
un acide organique choisi parmi les acides lactique, malique, citrique et acétique,
de préférence l'acide lactique.
7. Formulation selon une quelconque des revendications précédentes, comprenant également
du Pentylène glycol (Pentylène Glycol).
8. Formulation selon la revendication 1, comprenant les ingrédients suivants, en pourcentages
en poids du poids total de la formulation :
| Alcool gras avec 14 à 22 atomes de carbone |
1,5 à 5,0 |
| Stéarate de glycéryle |
2,0 à 6,0 |
| Coco Caprylate |
15,0 à 25,0 |
| Vitamine E ou un ester de celle-ci |
3,0 à 10,0 |
| Huile des feuilles de Melaleuca Alternifolia |
1,5 à 6,0 |
9. Formulation selon la revendication 8, comprenant en outre 0,5 à 2,0 % d'huile de jojoba
(huile de Simmondsia Chinensis) et/ou 3,0 à 8,0 % de beurre de karité (beurre de Butyrospermum Parkii).
10. Formulation selon la revendication 9, comprenant en outre 0,2 à 1,0 % de gomme de
xanthane (gomme de xanthane).
11. Formulation selon une quelconque des revendications 8 à 10, comprenant en outre de
0,05 % à 0,25 % d'acide lactique, afin d'ajuster le pH entre 5,5 et 6,5, de préférence
à environ 6,0.
12. Formulation selon une quelconque des revendications 8 à 11, comprenant en outre de
3,0 à 8,0 % de Pentylène glycol (Pentylène glycol).
13. Formulation selon une quelconque des revendications précédentes, ayant un pH de 5,8
à 6,2 et comprenant, en pourcentages en poids sur la base du poids total de la formulation
(noms INCI) :
| Aqua |
51,00 à 58,00 |
| Coco Caprylate |
16,00 à 20,00 |
| Pentylene glycol |
4,00 à 6,00 |
| Glyceryl Stearate |
3,00 à 5,00 |
| Tocopheryl Acetate |
4,00 à 8,00 |
| Butyrospermum Parkii Butter |
4,00 à 7,00 |
| Cetearyl Alcohol |
2,00 à 4,00 |
| Melaleuca Alternifolia Leaf Oil |
2,00 à 5,00 |
| Simmondsia Chinensis Oil |
0,5 à 1,5 |
| Xanthan Gum |
0,3 à 0,8 |
| Acide lactique |
0,05 à 0,15 |