Title of Invention

A COMPOSITION CONTAINING A SOLAR FILTER AND DIMETHYL SULPHONE

Abstract ABSTRACT 3129/CHENP/2005 "A composition containing a solar filter and dimethyl sulphone" This invention relates to a composition containing a solar filter and dimctliyl sulphone. wherein the quanlity of dimethyl sulphone is comprised of between 0.5% and 50% by weight and the quantities of solar filters are comprised of between 1% and 20% by weight.
Full Text

The present invention relates to a composition containing a solar filter and dimethyl sulphone.
FIELD OF THE INVENTION
The present invention has as subject a new compoeition for cosmetic or pharmaceutical use intended for ext:ernal use to be applied both to undamaged and damaged skin or onto the mucosa to reduce or inhibit irritation, inflammation and cutaneous erythema induced by events of an exogenous nature (irritations induced by chemical agents, pharmaceuticals, cosmetic ingredients, physical agents - such as, for example, solar radiation, ultraviolet radiation, ionising radiation, X rays, gamma rays, laser light - bacterial agents, viral agents, etc) and to photoprotect the sicin from solar radiation and specifically from damage induced by ultraviolet radiation of types A, B and C. STATE OF THE ART
Erythema is a reddening of the skin caused by the increased delivery of blood to the blood vessels of the superficial dermis. Erythema is defined as active when it conveys the dilation of arterial vessels: showing a vivid red complexion and an increase in localised

temperature can be detected. Passive erythema is due to venal stasis, showing a bluish-red complexion with a reduction in local temperature. Erythema has various dimensions, shapes and localisations; disappearing with vitropressure due to the interruption in blood flow. It can manifest itself for physical (mechanical, thermal, radiant), chemical, infective {mycosis, exanthematous infantile diseases), emotive (sudden reddening, localised to the face and neck, occurring in embarrassing situations) causes, or be provoked by drugs, disvitaminosis, endocrine dysfunction or - even. - appear over the course of an allergic reaction. The inflainination is a defensive response by the body towards tissue lesions by biological agents (micro¬organisms) , chemical agents, physico-mechanical agents (for example trauma, radiation), or as a consequence of diseases. It has the biological function of rendering ineffective or destroying noxious factors of chemical, physical, biological natures, and successively to repair possible damage suffered by the effected tissues. The various vascular phenomena are determined by chemical mediators (mediators of infl animation) such as histamine, leukotrienes, prostaglandins, thromboxanes, interleuJcins.

Photo-protection consists in the putting into action of measures able to reduce the noxious effects of ultraviolet radiation on the skin.
Inflammation and oxidatiye_sp.eclgs
The Reactive Oxygen Species (ROS) are toxic and highly reactive molecules which play an important role in the genesis and the maintenance of inflammatory processes. The superoxide
t
radical (O2 ) is produced by monocytes and macrophages, cells involved in the inflammatory processes, and plays a role in the amplification of the process itself.
The hydroxide radical (OH ) and hydrogen peroxide radical (H2O2) intervene in the
inflammatory processes and are released during the metabolism of prostaglandins and in particular during the enzymatic metabolism of arachidonic acid.
The inflammatory processes are localised at the dermal level
WO 94/05293 (Dl) discloses composition containing methylsuiphonylmethane and at least one of oxypurinol and allopurinol, optionally together with menthol, which is 3 vasodilator substance, and vitamins A and E. Oxypurinol and allopurinol are not solar filters.
WO 94/05293, which is the closest prior art, discloses compositions containing methylsuiphonylmethane in combir^tion with oxypurinol or allopurinol that have synergistic activity in the treatment of skin disorders, such as degenerative, inflammatory, endocrinal, metaboUc, traumatic disorders, and in the protection against skin bums, erythema, itching and scaling following exposure to the sun.
The difference between the subject-matter of the present invention and WO 94/05293 is that the composition of the invention contains dimethylsulphone in combination with a solar

filter. This difference leads to novel compositions having protective activity against damages caused by exposure of the skin to UV radiations.
The objective technical problem addressed by the present invention is to provide an alternative sunscreening composition.
The invention solves the problem by providing a composition containing dimethylsulphone and a solar filter.
Both the solar filter and the dimethylsulphone protect the skin against the degeneration caused by UV radiations. In particular, solar filters are normally used to stop the penetration of UV radiation in the skin and to improve sun tan. Solar filters either absorb or reflect the radiation. In both cases, sun filters alone are not very efficient as they do not completely block the solar radiation, thus allowing a part of it to hit and damage the skin.
The presence of dimethylsulphone enhances the protective activity of the composition as dimethylsulphone alone stops the negative effect of the UV radiation that is not blocked by the solar filter.
Therefore, the combination of solar filter and dimethylsulphone yields a composition that not only blocks the penetration of the radiation into the Skin, but protect the skin against fiirther damages caused by the part of the UV radiation which is not stopped by the sun filter.
A person wishing to have a good sun tan in short time can choose the cream of the invention with a protection factor lower than that that he would normally use, as the dimethylsuphone will protect the skm against damages that can be caused by the UV radiation not stopped by the solar filter.
The result is that the person can obtain a good sun tan in shorter exposure time (by using a cream with lower protection factor) but, at same time, does not suffer from damages of the

skin (thanks to the protective activity of dimethyisulphone). This activity is demonstrated in in vitro texts performed on fibroblasts and keratinocytes herewith enclosed. These texts show that the application of dimethyisulphone on cultured fibroblasts and keratinocytes results in fewer cell mitosis or apoptosis with respect to not-treated cells.
WO 94/05293 does not suggest using a combination of dimethyisulphone and a solar filter in order to obtain a composition having the properties explained above.
WO 94/05293 teaches away because suggests that good results in terms of skin protection can be achieved only with the synergistic effect of dimethyisulphone in combination with oxypurinol or allopurinol. Therefore, the skilled man looking at D would consider to be necessary to combine dimethyisulphone with oxypurino! or atlopurinol in order to achieve a good level of activity. In other words, the skilled practitioner wanted to make a sunscreen containing a solar filter would seriously consider to use the mixture dimethyisulphone and oxypurinol or allopurinol together with a solar filter to obtain a composition having the capacity of both stopping the UV radiation and avoiding that the part of UV radiation, which is not blocked by the sun filter, damages the skin.
The inventor of the present application has found that dimethyisulphone alone has very good sun protective activity on the skin, especially on fibroblasts which are cells that provide a structural framework for many tissues, and play a critical role in wound healing, and on keratinocytes, which are the major cell type of the epidermis. The inventors have also found that mixir^ dimethyisulphone with solar filer yields a sunscreen with the properties explained above.
The composhion according to the invention shows thejjTiergism of inhibiting erythema induced by physical agents.
The problem on which the present invention is based is that of making available a cosmetic and/or pharmaceutical composition for the cure and/or prevention of inflammation.

irritation and cutaneous erythema and to photoprotect the cuteous from solar radiation and in a more specific sense from the damage induced by ultraviolet radiation of types A, B and C.
Such a problem is solved by compositions containing dimethyl sulphone such as these delineated in the attached claims.
BRIEF DESCRIPTION OF THE FIGURES
Fig. I shows the reflectance spectra of the skin obtained prior (curve a) and following (curve b) exposure to UVB radiation;
Fig. 2 shows the variations of the index of erythema (AI.E) as a function of time obtained from the non treated sites (control) and from the sites treated with the formulation SALDMS 5;
Fig. 3 shows the percentage of cutaneous erythema inhibition (P.I.E.) obtained with the formulation SALDMS 5 by the applicant and with the placebo.
DESCRIPTION OF THE INVENTION
The present invention refers to a composition containing a solar filter and dimethyl suphone appropriately vehicularised for topical use, to prevent and/or cure cutaneous irritations induced by chemical, physical, bacterial and viral agents. Within the present invention the dimethyl sulphone is used to inhibit erythema induced by physical agents such as, for non exhaustive indication, ultraviolet radiation (solar radiation), especially when associated with solar filters, ionising radiation, X rays, gamma rays, laser light (of whatever intensity and nature).

The dimethyl sulphone is also used to reduce the cutaneous irritation caused by chemical agents such as carboxylic acids, bicarboxylic acids, tricarboxylic acids, monocarboxylic alpha hydroxyacids, bicarboxylic alpha hydroxyacids, tricarboxylic alpha hydroxyacids, monocarboxylic beta hydroxyacids, bicarboxylic beta hydroxyacids, tricarboxylic beta hydroxyacids, resorcine, phenol, retinoic acid, adapalene, azelaic acid, salicylic acid, trichloroacetic acid, bensyl peroxide and other substances which can be used in the cosmetic and/or pharmaceutical field and which are characterised as potential irritants.
The dimethyl sulphone is also used for a specific photoprotective action able to reduce the damage induced by solar radiation, and ultraviolet radiation of types A, E and C, both of natural and artificial origins.
The invention refers in particular to a composition for the aforementioned use which is characterised by comprising dimethyl sulphone, used in a percentage by weight of from 0.5% to 90%, preferably between 5 and 60% w/w, still more preferably between' 8% and 30% by weight. The percentage of dimethyl sulphone used will generally depend on the typology of application and on the fact of whether the intended use is for the

prevention or the cure of the aforecited cutaneous manifestations.
Within the scope of the present invention are comprised both compositions containing dimethyl sulphone as the sole active ingredient, in association, with cosmetic and/or pharmaceutical excipients, and compositions in which the dimethyl sulphone is used in coitibination with agents of various types such as keratolytic agents for carrying out chemical peeling or solar filters or compounds for favouring sun tanning or pharmaceutical substances whose irritation potential should be counteracted.
When dimethyl sulphone represents the sole active ingredient of the composition, said composition being an anti-erythema or anti-irritant, it is included in varying quantities of between 0.5% and 80% by weight, preferably between 1% and 2 0% by weight. When the dimethyl sulphone is in combination with a keratolytic agent, the quantity of dimethyl sulphone is comprised of between 1 % and 60 % by weight and the quantity of keratolytic agent is.comprised of between 5 % and 70 % by weight....
When the dimethyl sulphone is in combination with a solar filter (for example, PAEA, Homosalate, Camphor/ benzalkonium, methosulphate, benzophenone-3.

phenylbenz imidazole sulphoni c acid. Butyl
methoxydibenaoylmethane, terephthalylidene dicamphor
sulphonic acid, benzylidene camphor sulphonic acid,
octocrylene, octyl methoxycinnamate,
polyacrylamidomethyl benzylidene, PEG-25 PAEA, octyl salicylate, Octyl dimethyl PABA, isoamyl p-methoxycinnamate, benzophenones-4, 3-Benzylidene camphor, 4-methylben2ylidene camphor, i sop ropy Ibenzyl salicylate, Octyl-triazonesia), the quantity of dimethyl sulphone is comprised of between 0.5 % and 50 % by weight and the quantities of solar filter are comprised of between 1 % e 20 % and in any case within the limits for use imposed by the various regulations at the international level.
When the dimethyl sulphone is in combination with a pharmaceutically active ingredient endowed with an irritant activity towards the cuteous (for example retinoic acid, salicylic acid, azelaic acid, adapalene, benzoyl peroxide, metronidazole, antibiotics, sulphamidics, including their respective salts and esters, the dextrorotatory and/or levorotatory forms, racemic mixtures and -cis or -trans forms) , the-quantity of dimethyl sulphone is comprised of between 1.0 % and 60.0 % by weight and the quantity of irritant is comprised of between 5.0 % and 70 % by weight.

within the compositione of the invention the weight
balance up to 100% will be obtained through the ■
addition of solvents such as water {in particular
demineralised water), alcohols (such as ethyl alcohol)
' or glycols (for example, ethylene glycol or propylene
glycol) - and/or excipients such as emulsifiers,
antioxidants, lipid based excipients (fluid lipids or
solid lipids), consistency factors, sequestering
substances, preservatives. Such excipients, used in I 1 particular for the preparation of emulsions, gels,
creams, ointments, etc., are widely known to the expert
in the field and will therefore not be described in
further detail.
EXPERIMENTAL SECTION i In corroboration of the present invention, experiments
relating to the evaluation of the photoprotective
action and to the ultraviolet radiation induced
erythema inhibiting effect are reported.
UVB radiation induced cutaneous erythema is considered ) to be a good model for evaluating the damage produced
to the skin by both chronic and acute exposure to solar
radiation. . ., . . ...
In this experiment, using a protocol already reported
in the literature, the capacity of a formulation based i on 5% dimethyl sulphone (SALDMS 5) to inhibit the

cutaneous erythema induced, in healthy volunteers, by exposure to UVB radiation has been determined. For a more objective and quantitative evaluation, the erythematogenic course has been monitored using a non invasive technique such as reflectance spectrophotometry. Experimental protocol
For the evaluation of the photoprotective and antierythema capacity of the formulation based on 5% dimethyl sulphone, twelve healthy volunteers, previously informed about the nature of the experiment and of the procedures employed, have been used. The volunteers, from whom written consent has been requested, have been selected from subjects having phototypes II and III.
Cutaneous erythema has been induced using a Mod. UVM-57 (UVP, San Gabriel, CA) ultraviolet lamp, capable of emitting radiation within the interval of 290-320 nm with a peak at 3 02 nm. For each subject, the minimum erythematogenic dose (MED) has been preliminarily determined and therefore, on the central section of each forearm, have been identified and demarcated, six cutaneous sites of 1 cm^, which have been irradiated to provoke erythema, with exposure times equal to twice the MED corresponding to each subject.

Following the UVE irradiation, two sites have been used as controls and therefore not treated and the remaining sites have been treated in double with 100 mg of the formulation under test (SALDMS 5) . The formulation has been applied to the cutaneous sites using appropriate chambers (Hill Top Chambers - Hill Top, Cincinnati, OH) for a period of three hours,
On coirpletion of the period of treatment (three hours) , each site, following removal of the Hill Top Chambers, has been washed with water to eliminate the residues of the formulation and left to rest for 3 0 minutes. For each site the erythema has been monitored over the successive 60 hours with an X-Rite mod.968 reflectance spectrophotometer. The instrument has been calibrated according to a white standard conforming to that envisaged by the National Bureau of Standards using a type C illumination source and an angle of observation of 2". The spectrophotometer was connected to a personal computer which, using software supplied with the instrument {Spectrostart}, was able to elaborate reflectance spectra of the skin in the 400-700 nm region.
In Fig. 1 are reported the reflectance spectra relating to the same cutaneous site before {curve a) and after {curve b) exposure to the UVB radiation. As can be

ascertained from curve b, the reflectance spectrum of the cutaneous site following exposure to the UVB radiation shows two bands of absorbance: a singlet at approx. 400 nm and another doublet between 540 and 580 nra, related to the absorbance of haemoglobin. From the spectral data supplied by the instrument, it has been possible to calculate over time, for each cutaneous site tested and using the following equation:

the value of the erythema index (I.E.) which represents an important parameter proposed by Dawson for quantitatively monitoring cutaneous erythema. In the equation set out above are summed, the values of the logarithms of the reciprocals of the reflectances of these wavelengths (540 nm, 560 nm, 580 nm) at which haemoglobin absorbance peaks are verified, whilst the corresponding values of the wavelengths (510 nm and 610 nm), the absorbance at which is principally due to the presence of melanin, are subtracted.
The E.I. baseline values, determined for each site prior to exposure to UVB radiation have been subtracted from the E.I. values, calculated at the different times for the same site, in such a manner obtaining the typical curves (AE. I. - time, see Fig. 2) from which have been calculated the corresponding areas under the

curves (AUG) . The AtJC values hold particular importance in the evaluation of erythema in as much as they are inversely proportional to intensity and the duration of the erythema itself and therefore to the capacity of the product to inhibit erythema formation. Hence, in order to better compare the efficacy of the individual formulations, the percentage inhibition of erythema (P.I.E.) has been calculated using the formula reported below.
AUC in
The ADC values represent the areas under the AE.I. -
time curves of the treated sites [AUC (T) I or the
control sites [AUC (C) ] . Statistical analyses of the
results have been carried out using the Student t-test
method.
Results
Fig. 2 shows some typical curves, relating to subject
1, obtained by reporting the variations of the erythema
index as a function of time both for. the non treated
sites (control) and for these treated with the SALDMS 5
formulation.

From the variation in the eryt hematogenic course, reported in Fig. 2, the inhibitory effect exercised, at different degrees, by the formulations tested in comparison to the erythema induced by UV B irradiation, is quite evident.
In table 1 are reported the mean AUC values obtained from the AE.I. - time curves for the dimethyl sulphone based formulations and for the individual subjects. From the results obtained it is evident that the SALDMS 5 formulation has notable efficacy in the inhibition of cutaneous erythema induced by UVB radiation. To qiiantify the erythema inhibition capacity for the evaluated products, the values of the percentage inhibition of erythema (P.I.E.) have been calculated which are reported in figure- 3 .
In conclusion, from the results obtained in this experiment, the SALDMS 5 formulation has an interesting photoprotective effect, useful in the protection of the skin from the degenerative effects provoked by the actions of ultraviolet radiation.
The high antierythema and photoprotective capacity of the SALDMS 5 "formulation allows for the efficacious use -of this active ingredient in the cosmetic and pharmaceutical fields and in particular in the

prevention and protection from the damage induced by ultraviolet radiation.
Tab. 1 - AUC values obtained for the control sites (non treated) and for the sites treated with the 5% dimethyl sulphone based formulation.

Subject Control SALDMS S
A 1580.2 828.4
B 1468.5 726.3
C 1698.3 864.1
D 1152.4 952.7
E 1338-2 764.5
F 1637.5 686.7
G 1212.5 921.54
H 1692.3 623.7
I 1547.8 721.6
L 1463.0 864.9
M 1865.5 786.3
N 1545.3 505.1
Mean 1516.8 770.5
S.D. 206.3 128.2
P.I.E 49.2
* Percentage ; inhibi tion of erythema
p EXAMPLES OF FORMULATIONS
Preparation 1 - lot ion/solution

N** Description % w/w
a
1 Dimethyl isosorbide 40.00
2 Pyruvic acid 50.00
3 Dimethyl sulphone 10.00
Method of preparation: dissolve 03 in 01, to the solution obtained, mix in 02 Preparation 2 - lotion/solution
N° Description % w/w
a
1 Dimethyl isosorbide 40.00
2 Trichloroacetic acid 50.00
3 Dimethyl sulphone 10.00
Method of preparation: dissolve 03 in 01, to the solution obtained, mix in 02 Preparat_ion 3 - lotion/solution
N* Description % w/w
a
1 Dimethyl isosorbide 20.00
2 Glycolic acid 50.00
3 Dimethyl sulphone 20.00
04 ■ Water 10.00
Method of preparation; dissolve 03 + 02 in 01; mix the solution obtained with 04

Preparation 4 - oil in water emulsion
N* Description % w/w
a PHASE A
1 Sreareth 2 3.00
2 Steareth 21 2.00
3 Ppg 15 stearyl ether 10.00
4 Tocopheryl acetate 1.00
5 Jojoba oil 2.00
6 Bht 0.01
7 Ascorbyl palmitate 0.10 OS Octyl 5.00
methoxycinnamate
09 4-methylbenzylidene 2.00
camphor
PHASE B
10 Propylene glycol 2.00
11 Retinoic acid 0.025
12 Demineralised water 10.00
PHASE C
13 Dimethyl sulphone 10.00
14 Propylene glycol 2.00
15 Disodium EDTA 0.07
16 Glycerol 5.00
17 Phenoxyethanol l. 0 0

18 Methyl paraben O.lO
19 Ethyl paraben 0.10 2 0 Propyl paraben 0.10 21 Demineralised water 100
qba Method of preparation: heat PHASE A) to 75°C; heat PHASE C) to +7500; combine PHASE A) with PHASE Owith stirring to make a homogeneous solution; cool to +45°C; then add PHASE B) still with continual stirring and cool to 25°C. Preparation 5 - oil in water emulsion
N'= Description % w/w
a PHASE A
1 Sreareth 2 3.00
2 Steareth 21 2.00
3 Ppg 15 stearyl ether 10.00
4 Tocopheryl acetate 1.00
5 Jojoba oil 2.00
6 Bht 0.01
7 Ascorbyl palmitate 0.10
8 Ethyl lactate 5.00
PHASE B
09 Propylene glycol 2.00

10

lv„„T ^A „ _«-; ^

11 Demineralised water 10.00
PHASE C
12 Dimethyl sulphone 10.00
13 Propylene glycol 2.00
14 Disodium EDTA 0.07
15 Glycerol 5.00
16 Phenoxyethanol 1.00
17 Methyl parahen 0.10
18 Ethyl paraben 0.10
19 Propyl paraben 0.10
20 Demineralised water 100
qba
Method of preparation: heat .PHASE A) to 75oC; heat PHASE C) to +75°C; combine PHASE A) with PHASE C) with constant stirring homogenising the solution; cool to +45°C; then combine with PHASE B) still with constant stirring and cooling to 25^C. Preparation 6 - oil in water emulsion
NO Description % w/w
a PHASE A
1 Sreareth 2 3.00
2 steareth 21 2.00
3 Ppg 15 stearyl ether 10.00
4 Tocopheryl acetate 1.00

5 Jojoba oil 2.00
6 Bht 0.01
7 Ascorbyl palmitate 0.10 0 8 Ethyl pyruvate 5.00
PHASE B
9 Propylene glycol 2.00
10 Benzoyl peroxide 5.00
11 Demineralised water 10.00
PHASE C
12 Dimethyl sulphone 10.00
13 Propylene glycol 2.00
14 Disodiuitl EDTA 0.07
15 Glycerol 5.00
16 Phenoxyethanol i.00
17 Methyl paraben 0.10
18 Ethyl paraben 0.10
19 Propyl paraben O.lO
20 Demineralised water 100
qba
Method of preparation: heat PHASE A) to IS'^C; heat
PHASE C} to +75°C; combine PHASE A) with PHASE C) with
constant stirring homogenising the solution; cool to
+45°C; then combine with PHASE B) still with constant
stirring and cooling to 25*>C.
Preparation 7 - oil in water emulsion

HO
01 02 03 04 05 06 07 08
09 10 11
12
13
14
15
16
17
IS
19
20 Demineralised water 100

Description % w/w
a
PHASE A

Sreareth 2 3.00
Steareth 21 2.00
Ppg 15 stearyl ether 10.00
Tocopheryl acetate 1.00
Jojoba oil 2.00
Bht 0.01
Ascorbyl palmitate 0.10
Retinoic acid 0.02
PHASE B
Propylene glycol 2.00
Lactic acid 10.00
Demineralised water 10.00
PHASE C
Dimethyl sulphone 10.00
Propylene glycol 2.00
DisodiuiCi EDTA 0.07
Glycerol 5.00
Phenoxyethanol 1,00
Methyl paraben 0,10
Ethyl paraben 0.10
Propyl paraben 0.10

qba Method of preparation; heat PHASE A] to 75"C; heat PHASE C) to +75^C; combine PHASE A) with PHASE'C) with constant stirring homogenising the solution; cool to +45°C; then combine with PHASE B) still with constant stirring and cooling to 25 N" Description V w/w
a PHASE A
1 Sreareth 2 3.00
2 Steareth 21 2.00
3 Ppg 15 stearyl ether 10.00
4 Tocopheryl acetate 1.00
5 Jojoba oil 2.00
6 Bht 0.01
7 Ascorbyl palmitate 0.10
8 Ethyl pyruvate 5.00
PHASE B
9 Propylene glycol 2,00
10 Adapalene 0,20
11 Demineralised water 10.00
PHASE C
12 Dimethyl sulphone 10.00
13 Propylene glycol 2.00

14 Disodium EDTA 0.07
15 Glycerol 5.00
16 Phenoxyethanol 1.00
17 Methyl paraben 0.10
18 Ethyl paraben 0.10
19 Propyl paraben 0.10
20 Demineralised water 100
qba
Method of preparation: heat PHASE A) to IB^C; heat PHASE C) to +75»C; combine PHASE A) with PHASE C) with constant stirring homogenising the solution; cool to +45°C; the combine with PHASE B) still with constant stirring and cooling to 25°C. Preparation 9 - oil in water emulsion
N" Description % w/w
a PHASE A
1 Sreareth 2 3.00
2 Steareth 21 2.00
3 Ppg 15 atearyl ether 10.00
4 Tocopheryl acetate 1.00
5 Jojoba oil 2.00
6 Bht 0.01
7 Ascorbyl palmitate 0,10
8 Ethyl pyruvate 5.00

PHASE B
9 Propylene glycol 2.00
10 Lactic acid 10.00 ,11 Deinineralised water 10.00
PHASE C
12 Dimethyl sulphone 10.00
13 Propylene glycol 2.00
14 Disodium EDTA 0.07
15 Glycerol 5.0 0
16 Phenoxyethanol 1.00
17 Methyl paraben 0.10
18 Ethyl paraben 0.10
19 Propyl paraben 0.10
20 Demineralised water 100
qba
Method of preparation: heat PHASE A) to 75°C; heat PHASE C) to +75°C; combine PHASE A) with PHASE C) with constant stirring homogenising the solution; cool- to +45'C; then combine with PHASE B) still with constant stirring and cooling to 25"'C.

Preparation 10 - oil in water emulsion

01 02 03 04 05 06 07 08
09 10 11
12 13 14 15 16 17 IS 19


Description.
PHASS A a
Steareth 2 3.00
Steareth 21 2.00
Ppg 15 stearyl ether 10.00
Tocopheryl acetate 1.00
Jojoba oil 2.00
Bht 0.01
Ascorbyl palTnitate 0.10
Ethyl pyruvate 5.00
PHASE B
Propylene glycol 2.00
Lactic acid 10.00
Deraineralised water 10.00
PHASE C
Dimethyl sulphone 10.00
Metronidazole 2.00
Disodium EDTA 0.07
Glycerol 5.00
Phenoxye thano1 1.00
Methyl paraben 0.10
Ethyl paraben 0.10
Propyl paraben 0.10

20 Demineralised water 100
qba Method of preparation: heat PHASE A) to 75*C; heat PHASE C) to +75°C; combine PHASE A) with PHASE C) with constant stirring homogenising the solution; cool to +45°C; then combine with PHASE B) still with constant ^ stirring and cooling to 25°C.


WE CLAIM:
1- A composition containing a solar filter and dimeth\i suiphonc. wherein the quantity of dimethyl sulphone is comprised of between 0.5% and 50% by weight and the quantities of solar filters are comprised of between 1% and 20% by weight.
2. The composition as claimed in claim 1. wherein said solar filter is selected
from PABA, Homosalale. Camphor, benzalkonium, metho sulphate,
benzofcnone-3, Phenylbenzimidazole sulphonic acid. Butyl
mcthoxydibcnzoyimethane, Tcrephthalylidene dicamphor sulphonic acid. Benzyiidene camphor sulphonic acid. Octocn,'lene, Octy! methoxycinnamale. Polyacf) lamidomelhyl benzyiidene. PEG-25 PABA. Oclyl salicylate, Octyl dimethyl PABA, Isoamyl p-melhoxycinnamatc. Benzophenonc-4. 3-lienzylidcnc camphor. 4-mcthylbenzylidcne camphor, isopropylbenzyl salicylate. Octyl-triazonesia.


Documents:

3129-chenp-2005 abstract duplicate.pdf

3129-chenp-2005 abstract.pdf

3129-chenp-2005 claims duplicate.pdf

3129-chenp-2005 claims.pdf

3129-chenp-2005 correspondence-others.pdf

3129-chenp-2005 correspondence-po.pdf

3129-chenp-2005 description (complete) duplicate.pdf

3129-chenp-2005 description (complete).pdf

3129-chenp-2005 drawings duplicate.pdf

3129-chenp-2005 drawings.pdf

3129-chenp-2005 form-1.pdf

3129-chenp-2005 form-18.pdf

3129-chenp-2005 form-26.pdf

3129-chenp-2005 form-3.pdf

3129-chenp-2005 form-5.pdf

3129-chenp-2005 pct.pdf

3129-chenp-2005 petition.pdf


Patent Number 228826
Indian Patent Application Number 3129/CHENP/2005
PG Journal Number 12/2009
Publication Date 20-Mar-2009
Grant Date 11-Feb-2009
Date of Filing 23-Nov-2005
Name of Patentee DE PAOLI AMBROSI, Gianfranco
Applicant Address c/o General Topics S.r.l., Località Santigaro, 32, I-25010 San Felice Sul Benaco,
Inventors:
# Inventor's Name Inventor's Address
1 DE PAOLI AMBROSI, Gianfranco c/o General Topics S.r.l., Località Santigaro, 32, I-25010 San Felice Del Benaco,
PCT International Classification Number A61K31/10
PCT International Application Number PCT/IT03/00340
PCT International Filing date 2003-05-30
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA