Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1998-09-17
2001-02-20
Jordan, Kimberly (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S440000, C424S441000, C424S442000
Reexamination Certificate
active
06190686
ABSTRACT:
FIELD OF INVENTION
The present invention provides ready-to-use water dispersible compositions containing natural hydrophobic pigments, which compositions are in paste or liquid form and are useful for the colouring of edible products and pharmaceutical products.
TECHNICAL BACKGROUND AND PRIOR ART
Colouring agents are commonly used as additives in the manufacturing of food products and pharmaceuticals. A wide range of such colouring agents are commercially available making it possible when a particular colour tone is desired to select a single agent having the desired colour or a mixture of colours which in an appropriate combination impart the desired colour to the product.
The commercial colouring agents can be synthetic substances which are also normally referred to as dyes or azodyes, or the agents can be pigments of natural origin, e.g. in the form of plant material containing the pigment or as more or less purified pigments extracted from plants, animals or microorganisms.
Occasionally, food grade or pharmaceutically acceptable colouring agents are provided in the form of synthetic or artificial substances having the same chemical composition as naturally occurring pigments. This type of colouring agents are also referred to in the art as “nature identical” colours. However, in the present context the term “natural pigment” is used exclusively to designate pigments which are derived from a natural source.
Food grade or pharmaceutically acceptable natural pigments can be water soluble or they can be essentially water-insoluble or sparingly soluble in water, including hydrophobic pigments. A water soluble natural pigment as such can therefore only be used for colouring a product having an aqueous phase during and/or after manufacturing. Similarly, the use of a hydrophobic natural pigment as such requires that the product to be coloured has a lipid phase in which the pigment is soluble. Certain hydrophobic natural pigments such as curcumin are insoluble in water at neutral pH or below but soluble in alkaline aqueous media.
However, it may be desirable to obtain the colour tone of a particular water-insoluble and/or hydrophobic natural pigment or a mixture of such pigments in a food product or a pharmaceutical product which does not comprise a phase in which the pigment is readily soluble. There is therefore an industrial need for colouring agents containing water-insoluble and/or hydrophobic natural pigments in the form of water-miscible compositions.
In EP-B1-0 498 824 is disclosed a process for preparing a hydrophobic/aerophilic solid, including a natural colourant, in the form of a water dispersible microencapsulated powder resulting from spray drying a suspension of the solid.
Commercial water dispersible preparations of hydrophobic and/or water insoluble natural pigments such as turmeric are e.g. available from Overseal Foods Ltd, Derbyshire, England under the trade name miChroma™. These products are provided as suspensions in propylene glycol and glucose syrup and the manufacturer states in data sheets that the products will stain clothing and skin. This manufacturer also provides hydrophobic, water dispersible colouring agents containing lutein, natural carotene or paprika in the form of oil in water emulsions which are rendered water dispersible by addition of emulsifiers (Em-Seal™ products).
In the pharmaceutical industry and the food industry colouring agents are used widely for the colouring of sugar coatings of e.g. sugar confectioneries, dragees, tablets, pills, gums and granulates. Presently, most colouring agents available for this purpose are based on synthetic dyes, e.g. in the form of food grade lakes which are pigments formed by precipitation and absorption of a dye on an insoluble base or substrate, such as alumina hydrate. A wide range of coating compositions comprising such lakes are available. Propylene glycol-based dispersions are presently commonly used to incorporate such dyes into solutions used for film-coating of pharmaceutical tablets. It is recognized in the art that propylene glycol has a negative effect on both the processing time and physical properties of the film.
In DE 2 820 981 is disclosed an edible, water-insoluble powder for coating pharmaceutical tablets, consisting of cellulose or starch or derivatives hereof which is coloured with a natural pigment such as curcumin, annatto or grape skin extract.
WO 92/11002 discloses a film-forming composition for use in coating tablets and capsules, consisting of powdered pigment particles, a film-forming, water soluble or water dispersible, edible polymer and about 1-30% by weight of water. This composition is described as a wet powder blend and it is manufactured by blending the dry ingredient followed by the addition of water by spraying it onto the blend.
A well-known problem associated with the use of water soluble or dispersible compositions of colouring agents is the tendency of such agents to migrate from one compartment of a food product or a pharmaceutical product to another where the colouring is undesired. This phenomenon is also referred to as “bleeding”.
It is therefore particularly desirable to have water soluble or dispersible natural pigment preparations which do not migrate during manufacturing or within the finished product during storage and handling, or come off when handled.
Other problems or shortages associated with known water-miscible natural colouring agents are low stability against light, heat, catalyst and oxygen generated changes of the colour hue and an unsatisfactory covering ability when used for coating purposes.
Thus, it is apparent that non-powdered, water dispersible colouring compositions containing water-insoluble and/or hydrophobic natural pigments, which are based on aqueous dispersions of the pigment without potentially undesirable additives including surface active substances or propylene glycol, which are more stable to degradation than known products, which are suitable for manufacturing of food products as well as pharmaceutical products, which do not migrate and which are not associated with the above problems have hitherto not been available to the industry.
The advantages obtained with the colouring agents of the present invention include:
their use give no dusting problems as it is the case with powdered products,
their manufacturing does not include a drying step which implies that the production costs are lower and that the pigments are not damaged by heat and oxygen,
they can be provided with a water content and a consistency which is adapted to the particular field of use, e.g. ranging from concentrated pastes to low viscosity products,
they do not give rise to migration problems,
they do not contain undesirable additives,
they possess increased dosage performance,
they possess increased chemical stability
they confer desirable cloudiness or reflection to otherwise clear media.
SUMMARY OF THE INVENTION
Accordingly, the invention pertains in one aspect to a ready-to-use water dispersible pigment composition comprising a dispersion of a water-insoluble and/or hydrophobic natural pigment in the form of bodies of an average size which is at the most 10 &mgr;m, said bodies being dispersed in the absence of a surface active substance in an aqueous phase comprising a hydrocolloid in an amount of at least 1% by weight of the pigment, the composition containing at least 5% by weight of water.
In further aspects the invention relates to the use of such a composition in the manufacturing of an edible product whereby the composition is dispersed in the aqueous phase of said food product, including its use in the manufacturing of an edible product comprising multiple, separated compartments whereby the composition is dispersed in one or more selected compartments, the composition in one compartment essentially not migrating to other compartment.
In a still further aspect, the invention relates to the use of the above composition in the manufacturing of a pharmaceutical product.
Still further objectives of the invention are to provide an edible product or
Isager Per Pihlmann
Winning Marianne
Chr. Hansen A/S
Foley & Lardner
Jordan Kimberly
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