GB2485834A

GB2485834A - Composition comprising emulsifying ointment and water

Info

Publication number: GB2485834A
Application number: GB1020119.2A
Authority: GB
Inventors: Barry Sonenfeld; Adam Lewandowski
Original assignee: Individual
Current assignee: Individual
Priority date: 2010-11-29
Filing date: 2010-11-29
Publication date: 2012-05-30
Also published as: GB201020119D0

Abstract

A composition comprising emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where the ratio A:B is in the range 60:40 to 30:70 and A+B is in the range 100% to 95% w/w of the total composition. The balance, if any, is one or more substances in a total proportion C% of the total composition, where C% is not more than 5% w/w, in which the emulsifying ointment comprises emulsifying wax made of cetostearyl alcohol and polysorbate 60. The C% may consist solely of preservative, eg phenoxyethanol. The proportion of polysorbate 60 in the emulsifying wax may be in the range 19 to 23%. A method of making the composition comprises heating the emulsifying ointment and water to substantially 60Â°C, stirring and cooling. The composition may be used as a pharmaceutical, or as a non-pharmaceutical composition, for example a soap, emollient and/or moisturiser.

Description

]i.tie: "Pharmaceutical and other Compositions, e.g. for the Skin, comprising Emulsifying Ointment and Water"

FIELD OF THE INVENTION

This invention relates to pharmaceutical and other compositions, e.g. for the skin, comphsing emulsifying ointment and water, including compositions applicable to dermatological conditions and compositions for non-pharmaceutical use, and may include use as a soap substitute (also known as a wash'), as an emollient, or as a moisturiser.

BACKGROUND

Some such compositions were the subject of the earlier published patent GB2456389 of the present applicant, which is referred to for an explanation of how these compositions are thought to work, and for other information as indicated below, including how trials were carried out.

These compositions have been found to have some disadvantages regarding their feel and their action.

The British Pharmacopoeia (BP) lists emulsifying ointment' BP and aqueous cream' BP. Emulsifying ointment BP is made of emulsifying wax 30% ( made of cetostearyl alcohol nine parts and sodium lauryl sulphate one part), white soft paraffin 50%, and liquid paraffin 20%. Aqueous cream BP is made of emulsifying ointment BP 30%, phenoxyethanol 1% as a preservative, and purified water freshly boiled and cooled to 100% (i.e. substantially 70%). All proportions given herein are w/w, and are substantially correct values.

Properties and uses of emulsifying ointment BP and aquecus cream BP were discussed in the earlier patent.

THE INVENTION

According to one aspect of the invention, there is provided a composition as claimed in claim 1. This may have any of the following features: * the proportion of polysorbate 60 in the emulsifying wax is in the range of from 10% w!w to 50% w/w.

* the proportion of polysorbate 60 in the emulsifying wax is in the range of from 15% w!w to 30% w!w.

* the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19% wfw to 23% w/w.

* the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19% w/w to 21% w/w.

* the proportion of polysorbate 60 in the emulsifying wax is in the range of from 21% w/w to 23% w/w.

* A:B is in the range 55:45 to 30:70.

* A:B is in the range 50:45 to 35:65.

* A:B is in the range 45:55 to 35:65.

* A:B is in the range 43:57 to 38:62.

* A:B is substantially 40:60.

* C% is not more than 3%.

* C% is not more than 2%.

* 0% is not more than 1%.

* C%isl%.

* the 0% consists solely of preservative.

* the preservative is phenoxyethanol.

* A + B is 100% of the total composition.

According to another aspect of the invention, there is provided a method of making any such pharmaceutical composition embodying the invention, in which the emulsifying ointment and the water are heated, stirred together (not necessarily in this order), and allowed to cool. This may have the following feature: * the emulsifying ointment and the water are heated to substantially 60°C, stirred together, and allowed to cool.

According to another aspect of the invention, there is provided a method of making a pharmaceutical composition as claimed in claim 22. This may have any of the further features of claims 23 to 31.

According to another aspect of the invention, there is provided a pharmaceutical composition made by any such method.

According to another aspect of the invention, there is provided a method as claimed in claim 34. This may have any of the further features of claims 35 to 37.

is DESCRIPTION REFERRING TO DRAWINGS

Reference is made by way of example to the accompanying drawings, in which: Figure 1 is a graph showing the (subjective) satisfaction factor', on a scale of 1 to 10, averaged over a number of trials for some of the new compositions having (by way of example) 20% of polysorbate 60 in the emulsifying wax and different proportions of emulsifying ointment to water (A%:B%), plotted as A%. This shows a satisfaction peak around A% = 40%.

The reader can visualise a series of such graphs, one behind another (making a three-dimensional graph), for successive percentage values of polysorbate 60; and Figure 2 is a graph showing the satisfaction factor plotted against successive percentage values of proportions of polysorbate 60 in the emulsifying wax (in the third dimension, i.e. the backwards direction, of the sehes of graphs mentioned in relation to Figure 1) for some of the new compositions having (by way of example) A% = 40%.

Some preferred ranges of A:B are shown by the respective horizontal dashed lines in Figure 1, as labelled on the hght of Figure 1.

Some preferred ranges of percentage of polysorbate 60 are shown by the respective horizontal dashed lines in Figure 2, as labelled on the hght of Figure 2.

It was felt that there could be improvement on the compositions of the earlier patent. Based on his experience and expertise, the present applicant felt that the ingredient sodium lauryl sulphate (SLS) could be improved upon. Various substitutions were tried and many investigations carded out on each one, with a large number of tdals, and it was found possible to obtain compositions with improved feel and usefulness and other advantages compared with the compositions of the earlier patent by the use of polysorbate 60 instead of SLS. It was further found that the proportion of polysorbate 60 could be varied considerably while still giving useful improvements. While the new compositions showed clear improvements over those disclosed in the earlier patent for the general purposes described therein, it was also found quite surprisingly that, within the range of such vahation, there were particularly advantageous and differing properties to the new compositions having quite narrow sub-ranges of vahation of the proportion of polysorbate 60; and within two very narrow ranges of composition there was an unexpected and substantial improvement for use (a) as a cream in one of these two narrow ranges and (b) as a soap substitute in the other of these two narrow ranges.

More particularly, building on the results and observations of the trials with the compositions of the earlier patent, the same range of trials was carried out as described in the earlier patent for each one of a number of the new compositions diffehng from each other only in the proportion of polysorbate 60 in an emulsifying wax. Initially, some trials were made of compositions with every 5% w/w, from 5% to 95%, proportion of polysorbate 60 in emulsifying wax, and it was found that those within the range 10% to 50% showed a clear and noticeable improvement, while those within the range 15% to 30% showed a substantial improvement, and those at 20% and 25% showed a much more marked improvement. Therefore there was made the full range of trials as described in the earlier patent at every 1% from 15% to 30% proportion of polysorbate 60 in emulsifying wax. Quite unexpectedly, it was found that at around substantially 20% the composition was particularly suitable as a cream and at around substantially 22% the composition was particularly suitable as a soap substitute (a wash'). For each percentage proportion of the polysorbate 60, the range of trials echoed the results of the earlier patent, giving a response curve (Figure 1) of "satisfaction" plotted against "% emulsifying ointment" in a similar manner to that given in the earlier patent. Since there was a very large number of trials, there have for simplicity been abstracted those results relating to trials with 40% emulsifying ointment to water (being approximately the peak point for best-feel' for the present (new) compositions, corresponding to the 50% for the compositions of the earlier patent) and differing percentage proportions of polysorbate 60 in the emulsifying wax and there has been plotted a new curve of "satisfaction" against "% polysorbate 60' (Figure 2). It was noticeable that, responsive to a question as to general satisfaction on a scale 1 to 10, the curve plotted from the answers was somewhat flat-topped around the range 20% to 25% (from 19% to 26%), but in response to a further pair of questions as to the satisfaction with the composition (a) as a cream or (b) as a soap substitute, fairly narrow peaks of the satisfaction curve were observed around 20% (from 19% to 21%) when considered as a cream and around 22% (from 21% to 23%) when considered as a soap substitute (the range of best satisfaction being around 1% on either side of these peaks and worse as we moved further away). As with the trials for the earlier patent, a number of people were asked to try a range of different proportions of the composition, and to mark them on a satisfaction scale' of 1 to 10, and also to comment generally on the new compositions. The actual running of each test was to ask the subject to rub onto the hands a measured quantity of the composition and appraise its feel generally, then specifically as a cream, then to wash off the composition and appraise it as a soap substitute. It was also found, when using polysorbate 60 compared with SLS, that the proportions and ranges (and the peak values obtained) could be varied somewhat from those disclosed in the earlier patent and still provide a useful and improved degree of satisfaction. In particular, useful and improved compositions were found having ratios of emulsifying ointment to water extending over somewhat wider ranges than disclosed in the eahier patent. The improvement in feel was skewed towards 40% emulsifying ointment to water.

As with the compositions of the earlier patent, the figures are approximate, since for example there is included 1% of preservative, and indeed figures of up to 2%, 3% and 5% of various other substances than emulsifying ointment and water were tried and found not to reduce the good feel of the compositions.

Compared with the compositions of the earlier patent, the present compositions also appear to have long-term beneficial effects on the skin, which make some of them even more suitable for use by sufferers from eczema and dermatitis who find them for example very effective as a soap substitute, e.g. using 5gm on the hands and wrists, rubbing it in well, then rinsing it off.

To make those compositions that include the preservative phenoxyethanol (a liquid at room temperature), this is dissolved in the purified water at about 60°C and added to the emulsifying ointment at the same temperature, then the mixture is stirred gently and allowed to cool.

It is possible to vary the temperature of manufacture of the compositions embodying the invention, e.g. up to ±10°C, as will be apparent to those skilled in the art.

It will be apparent to one skilled in the art, that features of the different embodiments disclosed herein may be omitted, selected, combined or exchanged and the invention is considered to extend to any new and inventive combination thus formed that is within the scope of the appended claims. Where a preference or particularisation is stated, there is implied the possibility of its negative, i.e. a case in which that preference or particularisation is absent, provided it is within the scope of the appended claims.

Many variations of the invention and embodiments hereinbefore described will be apparent to people skilled in the art and all such vahations are to be considered as falling within the scope of the invention, provided they are within the scope of the appended claims. -5-

Claims

CLAIMS1. A composition comprising emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where the ratio A:B is in the range 60:40 to 30:70 w/w and A + B is in the range 100% to 95% w!w of the total composition, the balance, if any, being one or more substances in a total proportion C% of the total composition, where C% is not more than 5% w/w, in which the emulsifying ointment comprises emulsifying wax made of cetostearyl alcohol and polysorbate 60.
2. A composition as claimed in claim 1, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 10% w!w to 50% w/w.
3. A composition as claimed in claim 1, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 15%w!wto30%wlw.
4. A composition as claimed in claim 1 in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19% w/w to 23% wlw.
5. A composition as claimed in claim 1 in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19%w/wto2l%w/w.
6. A composition as claimed in claim 1 in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 21% w/w to 23% w/w.
7. A composition as claimed in any preceding claim, in which A:B is in the range 55:45 to 30:70.
8. A composition as claimed in any preceding claim, in which A:B is in the range 50:45 to 35:65.
9. A composition as claimed in any preceding claim, in which A:B is in the range 45:55 to 35:65.
10. A composition as claimed in any preceding claim, in which A:B is in the range 43:57 to 38:62.
11. A composition as claimed any preceding claim, in which A:B is 40:60.
12. A composion as claimed in any preceding claim, in which C% is not more than 3%.
13. A composition as claimed in any preceding claim, in which C% is not more than 2%.
14. A composition as claimed in any preceding claim, in which C% is not more than 1%.
15. A composition as claimed in any preceding claim, in which C% is 1%.
16. A composition as claimed in any preceding claim, in which the C% consists solely of preservative.
17. A composition as claimed in claim 16, in which the preservative is phenoxyethanol.
18. A composition as claimed in any one of claims 1 to 11, in which A + B is 100% of the total composition.
19. A composition as claimed in claim 1, and substantially according to any embodiment hereinbefore described.
20. A method of making a composition as claimed in any preceding claim, in which the emulsifying ointment and the water are heated, stirred together, and allowed to cool.
21. A method as claimed in claim 20, in which the emulsifying ointment and the water are heated to substantially 60°C, stirred together, and allowed to cool.
22. A method of making a pharmaceutical composition consisting substantially of emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where the ratio A:B is in the range 60:40 to 30:70 w!w and A + B is in the range 100% to 95% w/w of the total composition, the balance, if any, being one or more substances in a total proportion C% of the total composition, where C% is not more than 5% w/w, the emulsifying ointment comprising emulsifying wax made of cetostearyl alcohol and polysorbate 60, in which method the emulsifying ointment and the water are heated, stirred together, and allowed to cool.
23. A method as claimed in claim 22, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 15%w/wto30%w!w.
24. A method as claimed in claim 22, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19% w/w to 23% wlw.
25. A method as claimed in claim 22, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 19%w/wto2l%w/w.
26. A method as claimed in claim 22, in which the proportion of polysorbate 60 in the emulsifying wax is in the range of from 21% w/w to 23% w/w.
27. A method as claimed in claim 22, in which A:B is in the range 55:45 to 35:65.
28. A method as claimed in claim 22, in which A:B is in the range 45:55 to 35:65.
29. A method as claimed in claim 22, in which A:B is in the range 43:57 to 38:62.
30. A method as claimed in claim 22, in which A:B is substantially 40:60.
31. A method as claimed in any one of claims 22 to 30, in which the emulsifying ointment and the water are heated to substantially 60°C, stirred together, and allowed to cool.
32. A method of making a composition, substantially according to any embodiment hereinbefore described.
33. A composition made by a method as claimed in any one of claims 20 to 32.
34. A method of using a composition as claimed in any one of claims I to 19 or 33, in which method the composition is used as a ron-pharmaceutical preparation.
35. A method as claimed in claim 34, in which the composition is used as a soap substitute.
36. A method as claimed in claim 34, in which the composition is used as an emollient.
37. A method as claimed in claim 34, in which the composition is used as a moisturiser.
38. A method of using a composition as claimed in claim 34, and substantially according to any embodiment hereinbefore described.