Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2001-01-22
2003-04-08
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S725000, C424S405000, C424S434000, C514S886000, C514S937000
Reexamination Certificate
active
06544530
ABSTRACT:
CROSS REFERENCES TO RELATED APPLICATIONS
This application is a §371 national stage filing of PCT/IL00/00142 filed Mar. 9, 2000, and claims the benefit of priority from Israel patent application IL 129102, filed Mar. 22, 1999, the full disclosures of which are incorporated herein by reference.
TECHNICAL FIELD
The present invention relates to a stable oil-in-glycerin emulsion.
BACKGROUND ART
Oil-in-water emulsions and water-in-oil emulsions are well-known in the art.
Emulsions are thermodynamically non-stable dispersions systems containing two immiscible liquids. A large amount of energy is required to rupture an internal phase of a liquid into small droplets producing very large surface and interfacial free energy. This free energy is the driving force for reuniting the droplets, a phenomenon leading to phase separation and the breakdown of the emulsion. Instability in emulsions is characterized as coalescence, creaming and finally phase separation. Coalescence is the unification of suspended droplets where larger droplets are produced from smaller ones. Creaming is the migration of particles (usually in an upward direction), due to differences of specific weight between internal and external phases. Creaming brings many droplets closer together, thereby increasing coalescence. Coalescence, in turn, increases creaming since larger droplets migrate at a quicker rate. Coalescence is irreversible while creaming may be reversible. Phase separation is the final stage of emulsion break.
Stable emulsions coalescence and cream at a very low rate. The low rate allows for an adequate shelf life of an emulsion. Emulsions are considered stable if no phase separation is detected for a defined period of time and conditions and if creaming occurs, it is practically reversible.
Many emulsion classifications are described in the literature. Basic emulsions are classified by the type of liquid constituting the internal or external phases. The classical types are oil-in-water or water-in-oil emulsions. Cosmetic emulsions, for example, are named according to their use: cold cream, absorbing creams, night creams, vanishing cream, moisturizing creams, lotions, etc.
Known emulsions are routinely used as a delivery vehicle of active substances. However, said vehicle is not optimal for the proper delivery of all types of active substances.
Known emulsions are not optimal, for example, in the delivery of essential oils.
Essential oils are potent bioactive herbal extracts which are regularly utilized in the practice of phytomedicine, aromatherapy and homeopathy. Essential oils are also used as food additives and in spices. Essential oils are hydrophobic and practically insoluble in water or glycerin. Said oils are, however, soluble in alcohols such as ethyl alcohol and isopropanol and in oils such as tryglycerides and organic solvents such as acetone. In light of the above, essential oils are regularly and traditionally dispensed in vegetable tryglyceride oils or alcohol. Dispersion of essential oils in water is possible through the utilization of ample amounts of surfactant solubilizers or emulsifiers, however these solutions tend to be unstable.
The delivery of essential oils within pure oils such as vegetable tryglyceride oils is possible, but is not always optimal. For example, the use of oils within the oral cavity or on the scalp is not pleasant and undesirable due to the oily remnant and the need for removal of said remnant with soap.
A further drawback of known delivery vehicles is the presence of alcohol therein.
Recent scientific data suggests that alcohol may play a role in toxic and genotoxic biological effects. Consumers are therefore refraining from using products containing alcohol, especially for sensitive body organs such as for the oral cavity and babies' skin. Alcohol is an irritant to the skin, scalp, mucous membrane and gastrointestine. In the oral cavity alcohol has a foul taste which is especially unpleasant for young and elderly people. Alcohol bums tissues in a way that delays tissue healing after skin traumas. Alcohol dehydrates the skin, mucous membrane and tissues, which dehydration causes discomfort and pain. Therefore medical research is investing in finding alcohol free medicaments.
DISCLOSURE OF THE INVENTION
In light of the above, the present invention provides a stable oil-in-glycerin emulsion that can perform as an adequate storage and delivery vehicle for bioactive, water insoluble active ingredients, including essential oils.
According to the present invention there is provided a composition of matter comprising a stable oil-in-glycerin emulsion containing at least one oil, at least one emulsifier and glycerin.
In a preferred embodiment there is provided a composition of matter wherein the emulsion further comprises at least one bioactive component, wherein said bioactive component is selected from the group consisting of a plant extract, an essential oil, and an oleoresin.
The present invention also provides a composition of matter wherein said emulsion is substantially alcohol free.
In a preferred embodiment of the present invention said oil is selected from the group consisting of at least one mineral oil, at least one vegetable oil, at least one water insoluble botanical extract and mixtures thereof wherein said vegetable oil is a vegetable tryglyceride, wherein said vegetable tryglyceride is a medium chain tryglyceride, wherein said medium chain tryglyceride is a capric-caprylic tryglyceride and wherein said capric-caprylic tryglyceride is fractionated coconut oil.
In a most preferred embodiment said oil is selected from the group consisting of a plant extract, an essential oil, and an oleoresin and functions also as an active ingredient.
In another preferred embodiment said mineral oil is a paraffin oil.
In preferred embodiments of the present invention the following quantities are preferable:
a) said vegetable tryglyceride is present in an amount ranging from about 1-40 wt/wt %, or from 2-20 wt/wt %;
b) said emulsifier is present in an amount ranging from about 0.1-20 wt/wt %, or from about 0.1-5 wt/wt %; and
c) said bioactive component is present in an amount ranging from about 0.1-20 wt/wt %.
In a most preferred embodiment said emulsifier biodegradable (i.e., degradable in the human body and the environment) and/or is substantially free of polyoxyethylene.
In a most preferred embodiment of the present invention said bioactive component is water insoluble.
In an even further preferred embodiment of the present invention said glycerin constitutes a continuous phase of said emulsion and a minor portion of water is included in said glycerin phase.
It is important to note that the botanical extract of the present invention may have has anti-inflammatory, anti-bacterial, anti-parasitic, anti-viral, immunity modulation and/or stress relaxant properties.
It also should be noted that the emulsifier of the present invention may be one of the following:
a) a fatty acid conjugated to a natural hydrophilic molecule;
b) a fatty alcohol conjugated to a natural hydrophilic molecule;
c) an ester of fatty acid/s and carbohydrates or poly-carbohydrate saccharides; and
d) an ether of fatty alcohol/s and carbohydrates or poly-carbohydrate saccharides.
In a preferred aspect of the invention, the combination of an oil-in-glycerin emulsion and a plant extract enables the dispersion of a water insoluble bioactive component in a biocompatible, safe and convenient dosage form, while avoiding the disadvantages associated with classical vehicles.
The oil-in-glycerin emulsions are pleasant for use on the skin and on mucous membranes such as the oral cavity, ears and scalp. Additionally, the emulsions of the present invention are well accepted organoleptically and physiologically, hence, offering good patient compliance. The oil-in-glycerin emulsions are easy to apply, as well as being easy to remove after the substantial absorption thereof. Stable oil-in-glycerin emulsions containing essential oils are advantageous for obtaining physical and chemical stability of essential oil compo
J.P.M.E.D. Ltd.
Tate Christopher R.
Townsend & Townsend & Crew LLP
Winston Randall
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