GB2456389A

GB2456389A - Pharmaceutical composition comprising emulsifying ointment and water

Info

Publication number: GB2456389A
Application number: GB0800659A
Authority: GB
Inventors: Barry Sonenfeld
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-01-15
Filing date: 2008-01-15
Publication date: 2009-07-22
Anticipated expiration: 2028-01-15
Also published as: GB0800659D0; GB2456389B

Abstract

A pharmaceutical composition comprising emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where A + B is substantially 100% of the total composition and the ratio A:B is in the range 60:40 to 40:60 w/w. The composition may also include one or more substances in a proportion C% of the total composition, where C% is not more than 5% w/w. The C% may consist solely of preservative, e.g. phenoxyethanol. In a method of making the pharmaceutical composition, the emulsifying ointment and the water are heated, e.g. to substantially 60{C, stored together, and allowed to cool. The pharmaceutical composition may be applied to the skin, or used as a soap substitute.

Description

2456389

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Tjtje: 'Pharmaceutical Compositions"

FIELD OF THE INVENTION

This invention relates to pharmaceutical compositions, and more particularly those applicable to dermatological conditions.

5 BACKGROUND

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% and purified water 70%, together with phenoxyethanol 1% as a preservative. All proportions given herein are w/w, and are substantially 10 correct values.

Emulsifying ointment BP is used as an emollient to make the skin, particularly very dry skin, more soft and supple, but has the feel of thick, viscous grease, and is difficult to dean off in lighter skin condtions such as eczema or dermatitis when the condtion is neilher severe nor flaking, and is messy, and therefore it is not ideal as an emollient (in the vast majority of cases) and often disliked; it is not 'user-friendly'. Aqueous cream BP comprises a small proportion of 15 emulsifying ointment BP and a large pnoportion of water (i.e. 30:70) and is used to have the effect of a 'moisturiser1; this effect is believed by some authorities to be because the water acts as a vehicle for the ointment which which acts as a crude barrier to prevent some of the water content of the skin from escaping thereby preventing evaporation and therefore preventing dehydration which in turn makes the skin supple, others believe the water serves to add moisture to the skin and the ointment to keep it there; however, regardless, this composition is so thin, with so little ointment 20 content that it is fairly inefficient as a moisturiser aid the efficacy of the ointment (in the aqueous cream BP concentration) as an effective bamer to prevent escape of water from the skin is questionable; it has a thin, and not very satisfactory, feel; if rinsed off, which can be done fairly readly, it leaves behind very little of the emollient ointment An attempt to improve on these compositions is known to the inventor, in which emulsifying ointment BP was mixed 50:50 with aqueous cream BP (i.e. the total of emulsifying ointment to water was 13070 = 65:35), which gave a slight 25 improvement but not enough to make this promise to be worth using.

THE INVENTION

According to one aspect of the invention, there is provided a pharmaceutical composition comprising emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where A + B is substantia^ 100% of the total composition and A:B is in the range 60:40 to 40:60 w/w. This may have any of the

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t 30 foSowingfeatures:

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A: B is in the range 55:45 to 40:60. A: B is in the range 55:45 to 45:55. A: B is in the range 56:44 to 42:58.

• A: B is in the range 52:48 to 47:53.

• A: B is in the range 52:48 to 48:52.

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• A:B is in the range 50:50 to 45:55.

• A B is substantially 50:50.

• including other than emulsifying ointment and water only one or more substances in a proportion C% of the total composition, where C% is not more than 5% w/w.

• C% is not more than 3%.

• % is not more than 2%.

• C% is not more than 1%.

• C% is substantially 1 %.

• the C% consists solely of preservative.

• the preservative is phenoxyethand.

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, end allowed to cool.

According to another aspect of the invention, there is provided 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 A + B is substantially 100% of the total composition and A:B is in the range 60:40 to 40:60 w/w, in which the emulsifying ointment and the water are heated (not necessarily in this order), stirred together, and allowed to cool. This may have any of the following features:

• A.B is in the range 55:45 to 45:55.

• A.B is in the range 52:48 to 48 52

• A: B is substantially 50:50.

• the emulsifying ointment and the water are heated to substantially 60°C, stirred together, and allowed to cool.

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

Accordng to another aspect of the invention, there is provided a method of using any such pharmaceutical composition embodying the invention, in which the composition is applied to the skin.

Accordng to another aspect of the invention, there is provided a method of using any such pharmaceutical composition embodying the invention, in which the composition is used as a soap substitute.

The sole Figure in the accompanying drawing is a graph showing the (subjective) 'satisfaction factor*, on a scale of 1 to 10, averaged over a number of trials for the compositions of dfferent proportions.

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

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The present inventor, on the basis of his experience and expertise, felt that there should be a better composition obtainable from the two ingredients emulsifying ointment BP and water than plain emulsifying ointment or aqueous cream or even the 50-50 combination of these mentioned above. He tned 50:50 w/w of emulsifying ointment BP and water, and found that the feel was vastly siperior to any of the prior products mentioned above, to a completely 5 unexpected degree. He also carried out trials to ascertain the range and degree of improvement he asked a number of people to try a range of cffferent 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.

There was a noticeable improvement in feel throughout the range 60:40 (emulsifying ointment to water) to 40:60, skewed towards a better feel when there was more water than emulsifying ointment in the outer parts of the range, but 10 a substantially better feel in the range 55:45 to 45:55; but at substantially 50:50 the feel was vastly superior.

These 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.

The present compositions appear to be more effective as a moisturiser than aqueous cream, apparently because the 15 greater proportion of ointment base poses a greater barrier to the loss erf moisture from the skin, they have a better feet', a thick creamy feel, compared with the aqueous cream and are not so greasy as the emiisrfying ointment The feel and 'satisfaction factor* are much greater than with either of the latter.

As a bonus, it was found that the present compositions (when, after application to the skin, are rinsed with water) have a better soapy feel than aqueous cream, partly because they are not so thin, and in fact make an excellent wash, such 20 that sufferers from eczema and dermatitis who cannot use soap find these 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 the compositions, the preservative phenoxyethanol (a liquid at room temperature) 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.

25 It is possible to vary the composition of the emulsifying ointment as will be apparent to those skilled in the art It is also 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 ait

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

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• 30 formed. Where a preference or particularisation is stated, there is implied the possibility of its negative, i.e. a case in

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» « • •••

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• • I

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which that preference or particularisation is absent

Many variations of the invention and embodiments hereinbefore described will be apparent to people skilled in the art and all such variations are to be considered as falling within the scope of the invention.

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Claims

I. A pharmaceutical composition comprising emulsifying ointment and water substantially in the proportions A% aid B% respectively of the total composition, where A + B is substantially 100% of the total composition and A:B is in the range 60:40 to 40:60 w/w.
2 A composition as claimed in claim 1, in which A: B is in the range 55:45 to 40:60
3. A composition as claimed in claim 2, in which A.B is in the range 56:44 to 42:58.
4. A composition as claimed in claim 2, in which A: B is in the range 50:50 to 45:55.
5. A composition as claimed in claim 2, in which A:B is in the range 52:48 to 47:53.
6. A composition as clamed in daim 2, in which A: B is substantially 50:50.
7 A composition as claimed in any one of daims 1 to 6, including other than emulsifying ointment and water only one or more substances in a proportion C% of the total composition, where C% is not more than 5% w/w.
8. A composition as daimed in daim 7, in which C% is not more than 3%.
9. A composition as darned in dam 7, in which C% is not more than 2%.
10. A composition as daimed in dam 7, in which C% is not more than 1 %.
II. A composition as daimed in dam 7, in which C% is substantially 1 %.
12. A composition as darned in any one of claims 7 to 11, in which the C% consists solely of preservative.
13. A composition as daimed in daim 12, in which the preservative is phenoxyethanol.
14. A pharmaceutical composition as darned in daim 1, and substantially according to any example hereinbefore described.
15. A method of making a pharmaceutical composition as claimed in any one of claims 1 to 14, in which the emulsifying ointment and the water are heated, stirred together, and allowed to cool.
16. A method as daimed in daim 15, in which the emulsifying ointment and the water are heated to substantially 60*C, stirred together, and allowed to cool.
17. 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 A + B is substantially 100% of the total composition and A.B is in the range 60:40 to 40:60 w/w, in which the emulsifying ointment and the water are heated, stirred together, and allowed to cool.
18. A method as darned in claim 17, in which A.B is in the range 55.45 to 45.55.
19. A method as daimed in daim 17, in which A:B is substantially 50:50.
20. A method as daimed in any one of daims 17 to 19, in which the emulsifying ointment and the water are heated to substantially 60*C, stirred together, and allowed to cool.

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21. A method of making a pharmaceutical composition, substantially according to any example hereinbefore described
22. A pharmaceutical composition made by a method as daimed in any one of claims 15 to 21.
23. A method of using a pharmaceutical composition as claimed in any one of claims 1 to 14 or 22, in which the composition is applied to the skin.
24. A method of using a pharmaceutical composition as claimed in any one of claims 1 to 14 or 22, in which the composition is used as a soap si&stitute.
25. A method of using a pharmaceutical composfflon as daimed in daim 23 a 24, and substantiafy according to any example hereinbefore described.

25. A method of using a pharmaceutical composition as claimed in daim 23 or 24, and substantially according to any example hereinbefore described.

Amendments to the claims have been filed as follows

1. A pharmaceutical composition comprising emiisifylng ointment and water substantially in the proportions A% and B% respectively of the total composition, where the ratio AB is in Hie range 30:40 to 40:60 wAw and A + Bis 100% to 95% w/W of toe total composition, the balance, if any, being one or more substances In a total proportion C%ofthe total composition, where C% is not more than 5% w/w.

2. A composition as claimed in daim 1, In which A:B is in the range 55:45 to 40:60.

3. A compositon as claimed In ddm 1, in which AB is in the range 56:44 to 4258.

4. A composition as claimed in daim 1, in which AB is in the range 5050 to 45:55.

5. A composition as daimed in daim 1, in which ABisintherange 52:46 to 47:53.

6. A composition as daimed in daim 1, in which AB to 50:50.

7. A composition as claimed In any one of daims 1 to 6, In which C% is not more than 3%.

8. A composition as daimed in any one of daims 1 to 6, In which C% is not more than 2%.

9. A composition as claimed in amy one of daims 1 to 6, in whlchC% is not more than 1%.

10. A composition as daimed in anyone of daims 1 to 6, in which C%b 1%.

11. A composition as daimed in any preceding daim, In which the C% consists solely of preservafra.

12 A composition as daimed in daim 11 Jn which the preservative is phenoxyetharnl.

13. A composition as daimed in any one of daims 1 to 6, in which A+ B is 100% of the total composition.

14. A pharmaceutical composition as claimed In daim 1, and substantially accordng to any example hereinbefore described

15. A method of making a pharmaceutical competition as daimad in any one of daims 1 to 14, in which the emulsifying ointment arid the water are heated, stfred together, and allowed to cool.

16. A method as daimed in daim 15, In which tie emulsifying ointment and the water are heated b st4)stanlMly 6CC, stirred together, and slowed to cod.

17. A method of maMng a pharmaceutic^ composition consisting substantially of emulsifying ointment and water substantially in the proportions A% and B% respectively of the total composition, where the ratio AB is in the range 60:40 to 40:60 w/W and A + B is 100% to 95% ulw of the total composition, the balance, if any, being one or more substances In a totat proportion C% of the total composition, where C% is not more than 5% w/w, in which metiod the emulsifying ointment and the water are heated, stirred together, and allowed to cod.

18. A method as claimed in daim 17, in which AB is in the range 55:45 to 45:55

19 A method as claimed in daim 17, in which A B is 50.50.

20. A method as daimed in any one of claims 17 to 19, in which the emulsifying ointment and the water are heated to substantially 60°C, stirred together, and allowed to cod

n

21. A method of making a phamnacsufcd composition, eubstantlalty accordng to any example hereinbefore described

22 A pharmai^ticaJ composition made by a method as claimed in any one of claims 15 to 21.

23. A method of using a pharmaceutic^ composition as claimed in any one of daims 1 to 14 or 22, in which the composition is applied to trie skin.

24. A method or using a pharmaceutical composition a9 claimed in any one of daims 1 to 14 or 22, in which the composition Is used as a soap substitute.