Excipient Suitable for Preparing Creams

Abstract

An excipient, suitable for the preparation of pharmaceutical and/or cosmetic creams comprises an aqueous phase and organic phase comprising organic components. The components comprise natural or synthetic oil, one or more waxes, one or more organic esters. Each of the general formula R1 COO R2, wherein R1 and R2 are both, independently of one another, is a linear or branched alkyl group having 15 to 30 carbon atoms and sorbitan esters.

Claims

1-28. (canceled)

29. Excipient, suitable for the preparation of pharmaceutical and/or cosmetic creams, which excipient comprises: 10 to 73% by weight of aqueous phase which comprises the following components: 0.01% by weight to 2.25% by weight of preservative; 97.75% by weight to 99.99% by weight of purified water; organic phase comprising the organic components natural and/or synthetic oils and/or fats; 1% by weight to 15% by weight of one or more waxes; 1% by weight to 15% by weight of one or more organic esters, each of the general formula R1-COO—R2, wherein R1 and R2 are both, independently of one another, a linear or branched alkyl group having 11 to 30 carbon atoms; 1% by weight to 8% by weight of sorbitan esters; which percentages by weight of the components of the aqueous phase are expressed as the weight of the component over the total weight of the aqueous phase, the percentages by weight of the components of the organic phase being expressed as the weight of the component over the total weight of the excipient and the percentage by weight of the aqueous phase being expressed as the weight of the aqueous phase over the total weight of the excipient, wherein the excipient is a water-in-oil emulsion.

30. Excipient according to claim 29, wherein the organic phase comprises 20 to 70% by weight of natural or synthetic oil, preferably selected from the group consisting of paraffin oil, vaseline, preferably white vaseline, and combinations of the two.

31. Excipient according to claim 29, wherein the natural or synthetic oil comprises paraffin oil or comprises paraffin oil and vaseline, wherein the weight ratio of paraffin oil to vaseline is greater than 1.

32. Excipient according to claim 29, comprising more than 15% by weight of aqueous phase.

33. Excipient according to claim 29, wherein the natural or synthetic oil is present in a concentration of between 53% by weight and 63% by weight or wherein the natural or synthetic oil has a viscosity of between 110 mPa.Math.s and 230 mPa.Math.s, which viscosity is determined by the method 2.2.9 described in Ph. Eur 7.0.

34. Excipient according to claim 29, wherein wax is present in an amount of from 5.5% to 9.5% by weight or wherein the wax used is cera alba.

35. Excipient according to claim 29, wherein the one or more organic esters are present in the excipient in an amount of from 7% by weight to 14% by weight or wherein the one or more organic esters comprises cetyl palmitate.

36. Excipient according to claim 29, comprising: in the aqueous phase the components 16 to 20% by weight of purified water 0.8 to 2% by weight of propylene glycol, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase 0.07 to 0.09% by weight of methyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase less than 0.03% by weight of propyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase in the organic phase the organic components 53 to 63% by weight of paraffin oil 7 to 9% by weight of cera alba 7 to 12% by weight of cetyl palmitate 2 to 4% by weight of sorbitan sesquioleate the percentages by weight of the components in the organic and aqueous phases are expressed, unless specified otherwise, as the weight of the component over the total weight of the excipient.

37. Excipient according to claim 29, comprising more than 25% by weight of purified water.

38. Excipient according to claim 37, comprising: in the aqueous phase the components 35 to 41% by weight of purified water 0.3 to 2% by weight of propylene glycol, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase 0.02 to 0.04% by weight of methyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase less than 0.01% by weight of propyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase in the organic phase the organic components 35 to 50% by weight of paraffin oil 3 to 8% by weight of cera alba 4 to 9% by weight of cetyl palmitate 3.5 to 6% by weight of sorbitan sesquioleate the percentages by weight of the components in the organic and aqueous phases are expressed as the weight of the component over the total weight of the excipient.

39. Excipient according to claim 37, comprising: in the aqueous phase the components 35 to 41% by weight of purified water 0.3 to 2% by weight of propylene glycol, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase 0.02 to 0.04% by weight of methyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase less than 0.01% by weight of propyl parahydroxybenzoate, which percentage by weight is expressed as the weight of the component over the total weight of the aqueous phase in the organic phase the organic components 35 to 50% by weight of paraffin oil and vaseline wherein the weight ratio of paraffin oil to vaseline varies and is greater than 1; 3 to 8% by weight of cera alba 4 to 9% by weight of cetyl palmitate 3.5 to 6% by weight of sorbitan sesquioleate the percentages by weight of the components in the organic and aqueous phases are expressed as the weight of the component over the total weight of the excipient.

40. Cosmetic or medicinal cream comprising 75% by weight to 100% by weight of excipient according to claim 29.

41. Cosmetic or medicinal cream according to claim 40, which cream comprises 75% by weight to 99.9% by weight of excipient, and 0.1% by weight to 25% by weight of one or more active components, the percentages by weight of the components in the cosmetic or medicinal cream being expressed as the weight of the component over the total weight of the cosmetic or medicinal cream.

42. Cosmetic or medicinal cream according to claim 40, wherein the one or more active components comprise one or more components selected from the group consisting of calcium pantothenate, rosemary essential oil, lavender spike essential oil, lemon essential oil and peppermint essential oil and/or wherein the one or more active components comprise calcium pantothenate and/or wherein the one or more active components comprise lavender essential oil or wherein the one or more active components comprise lavender essential oil and rosemary essential oil.

43. Cosmetic or medicinal cream according to claim 40, wherein the one or more active components comprise lavender essential oil, rosemary essential oil and lemon essential oil.

44. Cosmetic or medicinal cream according to claim 40, wherein the one or more active components comprise lavender essential oil, rosemary essential oil, lemon essential oil and peppermint essential oil.

45. Cosmetic or medicinal cream according to claim 40, wherein the one or more active components comprise lavender spike essential oil and/or wherein the one or more active components comprise essential oil of Rosmarinus officinalis var cineole.

46. Cosmetic or medicinal cream according to claim 40, wherein the one or more active components comprise one or more zinc-containing compounds.

47. Cosmetic or medicinal cream according to claim 46, wherein one or more zinc-containing compounds are zinc-containing compounds selected from the group consisting of zinc oxide, zinc citrate and zinc sulphate.

48. Cosmetic or medicinal cream according to claim 46, wherein the one or more active zinc-containing compounds form 0.1% by weight to 10% by weight of the cosmetic or medicinal cream, which percentage by weight is expressed as the total weight of the zinc-containing compounds with respect to the weight of the cosmetic or medicinal cream.

Description

DESCRIPTION OF EXAMPLES OF EMBODIMENTS

[0213] The present invention is described below making use of specific embodiments.

[0214] It should be noted that the term “comprising” as used for example in the claims is not to be interpreted in any limiting sense implying any restriction to the following elements, features and/or steps. The term “comprising” does not exclude the presence of other elements, features or steps. Thus, the scope of an expression “an object comprising the elements A and B” is not limited to an object which includes only the elements A and B. The scope of an expression “a method comprising steps A and B” is not limited to a method which includes only steps A and B.

[0215] In the context of the present invention, these expressions mean only that the relevant elements or steps constitute the elements or steps A and B for the purposes of the invention.

[0216] In the specification which follows, reference is made to “an embodiment” or “the embodiment”. Such reference means that a specific element or feature, described on the basis of this embodiment, is included in at least this one embodiment. The occurrence of the term “in an embodiment” or “in one embodiment” at various places in this description, however, does not necessarily refer to the same embodiment, although it may refer to the same embodiment.

[0217] Furthermore, the properties or the features may be combined in any suitable way in one or more embodiments, as will be clear to a person skilled in the art.

[0218] An embodiment of an excipient according to the invention has a composition as follows:

TABLE-US-00001 Liquid paraffin/paraffinum liquidum 60.51 g White beeswax/cera alba 7.68 g Cetyl palmitate 9.60 g Sorbitan sesquioleate/arlacel 83 3.00 g Aqua conservans 19.21 g Total weight 100 g

[0219] Cetyl palmitate is an organic ester having the general formula R1-COO—R2, wherein R1 is a linear alkyl group having 15 carbon atoms and R2 is a linear alkyl group having 16 carbon atoms.

[0220] The components liquid paraffin, white beeswax, cetyl palmitate and sorbitan sesquioleate together form the organic phase, which forms 80.79% by weight of the excipient. The aqueous phase, referred to above as aqua conservans, forms the remaining 19.21% by weight. This aqueous phase or aqua conservans consists of:

TABLE-US-00002 Purified water 99.00 g  Propylene glycol 0.90 g Methyl parahydroxybenzoate 0.08 g Propyl parahydroxybenzoate 0.02 g Total 100.00 g 

[0221] The excipient is formed by combining the ingredients in a suitable container, provided with a mixer, preferably a Stephan mixer and suitable for evacuation.

[0222] After the air has been evacuated from the container to a vacuum of around 0.25 bara, the ingredients are gently stirred using the Stephan® mixer while the temperature is increased to 80° Celsius. This is followed by high-shear mixing of the mixture for 3 minutes using the Stephan mixer, mixing at 3000 rpm. Thereafter, the emulsion is actively cooled to below 40° Celsius, if appropriate to room temperature. The vacuum is removed.

[0223] The excipient obtained in this way is then left to stand for a few hours, at least 2 but preferably 6 hours, and preferably approximately 24 hours.

[0224] Then, if appropriate the active components are added, and the excipient (together with any active components) again undergoes high-shear mixing in the Stephan mixer, mixing at 3000 rpm for a few minutes. This mixing may if appropriate takes place after the air has been evacuated from the container to a vacuum of around 0.25 bara.

[0225] This produces the excipient according to the invention.

[0226] The excipient is also mixed again if no further active components are added in order to obtain a cosmetic or medicinal cream. This is in order to obtain a homogeneous and stable cream or excipient with few or no lumps.

[0227] This excipient can be used, inter alia, for the production of an itch-reducing and/or burn/wound-repairing cream. The following different active components are added to the excipient in order to obtain a cream, i.e. a w/o emulsion, having the following composition:

TABLE-US-00003 Calcium pantothenate 1.00 g Rosemary essential oil 0.50 g Lavender spike essential oil 0.09 g Lemon essential oil (peel) 0.37 g Peppermint essential oil 0.37 g Liquid paraffin/paraffinum liquidum 58.58 g White beeswax/cera alba 7.61 g Cetyl palmitate 9.51 g Sorbitan sesquioleate/arlacel 83 2.97 g Aqua conservans 19.01 g Total weight 100 g

[0228] The active components as listed above are added and mixed with the excipient.

[0229] Calcium pantothenate and rosemary essential oil are added for their tissue-restoring effect. It is preferable to use essential oil of Rosmarinus officinalis var. cineole, although var. camphor and/or verbenone or combinations of these variations are possible.

[0230] The rosemary essential oil also has an anti-infectious action. Lavender spike (Lavendula spica) essential oil provides a wound-healing effect, while lemon essential oil (produced from the peel) and peppermint essential oil both further increase the refreshing effect of the excipient.

[0231] Another embodiment of an excipient according to the invention has a composition as follows:

TABLE-US-00004 Liquid paraffin/paraffinum liquidum 44.32 g White beeswax/cera alba 5.46 g Cetyl palmitate 6.82 g Sorbitan sesquioleate/arlacel 83 4.96 g Aqua conservans 38.45 g Total weight 100 g

[0232] The components liquid paraffin, white beeswax, cetyl palmitate and sorbitan sesquioleate together form the organic phase, forming 61.55% by weight of the excipient. The aqueous phase, referred to above as aqua conservans, forms the remaining 38.45% by weight. This aqueous phase or aqua conservans is the same as that used in the first embodiment.

[0233] The excipient is formed using the same procedure as described above in connection with the first embodiment.

[0234] In a third embodiment, some of the liquid paraffin is replaced by vaseline, preferably white vaseline, in the same quantities by weight (i.e. 1 g of paraffin is replaced by 1 gram of vaseline). For example, half or a quarter of the paraffin can be replaced by vaseline. An excipient containing vaseline can be obtained by a similar or even identical preparation method to that explained in connection with the first and second embodiments.

[0235] These excipients can be used for, inter alia, the production of an itching-reducing and/or burn/wound-repairing cream. The following different active components are added to the excipient in order to obtain a cream, i.e. a w/o emulsion, having the following composition:

[0236] The same quantity of essential oils are added, either after the excipient has been made or before the thorough mixing of the excipient, or added as an additional ingredient to the aqueous and organic components before the heating and emulsifying of these components.

[0237] It will be clear that, although the embodiments and/or the materials have been discussed for the purpose of providing embodiments in accordance with the present invention, various alterations or changes may be made without deviating from the scope and/or the spirit of the present invention.