Compositions: coating or plastic – Coating or plastic compositions – Carbohydrate or derivative containing
Reexamination Certificate
1999-12-06
2001-12-18
Brunsman, David (Department: 1755)
Compositions: coating or plastic
Coating or plastic compositions
Carbohydrate or derivative containing
C106S205200, C106S205300, C106S205310, C106S205500, C106S205700, C106S205710, C106S205720, C242S405000, C242S405000, C264S138000, C264S280000, C264S330000
Reexamination Certificate
active
06331205
ABSTRACT:
BACKGROUND OF THE INVENTION
Field of Invention
The present invention relates to the field of pharmaceutics, cosmetics and dietetics and has for objective to make pure carrageenan films for the manufacturing of hard and soft capsules or gelled capsules as well as a method for making the said film and soft capsules.
Discussion of the Background
Currently, the shell of both gelled capsules and capsules comprises gelatin as a base used either pure (for gelled capsules) or in combination with different substances, glycerine, sorbitol, etc, in the case of soft capsules.
However, due to major problems arising from the origin of gelatin, which comes mainly from bovine bones, the disease called “mad cow disease” or BSE (Bovin Spongiform Encephalitis) makes it crucial to find a substitute for such product.
Quite a number of products having gelifying characteristics or forming pseudo-colloidal solutions have been tested such as starch, cellulose, and hydrocolloids such as alginate, pectin, xanthane gum, etc.
The results obtained have not been conclusive in the case of hard and soft capsules, apart from the cellulosic by-products such as hydroxypropylmethyl cellulose for the manufacturing of gelled capsules.
Quite an amount of work has been carried out and has led to patents. Among these, the Japanese patents No. 09025228, No. 62289530, No. 61010508 and U.S. Pat. Nos. 5,342,626 mention carrageenans as a substitute for gelatin. But, in every case, they are always combined with another gelling agent such as mannans, galactomannans, agar, etc, and in fairly low concentrations in the order of 1 to 2%. The U.S. Pat. No. 5,342,626 and Japanese patent No 60012943 only mention Kappa carrageenans (K-carrageenans) even though it is known that films obtained from this type of carrageenans present an important power of retraction: synerese phenomenon working against the manufacturing of hard and soft capsules. Furthermore, this type of carrageenans does not enable to obtain a highly concentrated fluid solution in hot work as in cold work.
SUMMARY OF THE INVENTION
The aim of the present invention is to make the substitution of film for the hard and soft capsules with a shell based from a product of wholly vegetal origin which is much used in the food industry field, the carrageenans used pure as the one and single gelling agent of the composition of the shell with a concentration higher than 5% in solution in the medium. It is based on the fact that carrageenans heated between 50° C. and 100° C. have, when cooling, the characteristic to gelify and produce more or less breakable films depending on the type of carrageenans used. The Iota (&igr;) type preferally adopted in the present invention does not present the synerese phenomenon and leads to films presenting a certain elasticity necessary to the manufacturing of soft capsules. The addition of a certain number of substances leads to the films obtained presenting similar physical characteristics to those of gelatin on the level of elasticity, thickness of films, time of disintegration, welding of films, as well as their appearance: transparent films, that can be coloured and cut to variable size.
The carrageenans have been known for over 600 years in the medical field and in foods in particular for their original characteristic which consisted in gelifying milk by a simple heating process. These are polysaccharides, polymers of galactose which are more or less sulfated.
The carrageenans that can be used in the present invention are, generally, extracts from different algae:
Chondrus crispus, Gigartina stellata, Gigartina acicularis, Gigartina skottsbergii, Gigartina pistillata, Gigartina chamissoi, Iridea, Eucheuma cottoni, Eucheuma spinosum.
The extracting method implemented leads to different types of carrageenans of which the basic frame is a chain of D-galactoses alternately linked in &agr;—(1-3) and &bgr;—(1-4).
The different qualities are due to the quantity and to the position of the sulfates and the presence or not of a bridge 3, 6 anhydride on the galactose linked in 1 and 4.
DETAILED DESCRIPTION OF THE INVENTION
The different types of carrageenans that can be used in the present invention are
Iota (&igr;) carrageenans;
Lambda (&lgr;) carrageenans;
Mu (&mgr;) carrageenans;
Nu (&ngr;) carrageenans;
the last two being in lower quantity in the wild.
The proportions of the different combinations vary according to the algae species.
The different carrageenans differ from one another by the proportion of sulfate groups present on the basic frame of the molecule.
The Lambda (&lgr;) shapes present several sulfate groups in comparison with the Kappa (&kgr;) shapes. The Iota (&igr;) shapes are intermediary.
The Mu (&mgr;) and Nu (&ngr;) shapes are in lower quantity and are considered as impureties lowering the gelling effect of the Iota (&igr;) and Kappa (&kgr;) shapes.
The Lambda (&lgr;) shape presents thickening characteristics but not gelling ones.
The Iota (&igr;) carrageenans are, in the concept of the present invention, used on their own without the addition of another gelling agent, contrary to carrageenans used in the prior art of manufacturing films for hard or soft capsules. The concentration in carrageenans will preferably be higher than 5% of the medium with a maximum limit set to 80%. Advantageously, the volume of dissolution of the carrageenans can be water as well as a polyhydric alcohol blend of which the proportion in alcohol will vary between 0 and 60%.
The medium must be buffered so as to avoid a deterioration of the carrageenans in time under the effect of heat. In effect, in buffer medium and during a twenty-four hour period, a diminution of the viscosity of the medium through progressive hydrolysis of the carrageenans freeing acid radicals in the medium can be seen. This reaction is blocked when the medium is buffered. The pH value can vary between 5 and 12. Different buffering systems can be used
citrates buffer: citric acid/citrates,
phosphates buffer: sodium phosphate or potassium phosphate,
phthalate buffer: potassium diphthalate/hydrochloric acid,
borate buffer: boric acid/ sodium borate,
carbonate buffer: bicarbonate/carbonate.
The agents favorising the dissolution of carrageenans belong to the alkaline class and the alkaline earth: sodium, calcium, potassium, etc, and are introduced in the medium in the shape of:
salts of hydrochloric, sulfuric, nitric, phosphoric, and citric acids and derived acids;
hydroxides.
The proportion of alkaline ions and alkaline earths that can be introduced in the medium varies between 0 and 50% in relation to the final volume of solution.
The elasticity of the films is obtained by the use of plasticizers which belong to the polyoxyls class: glycerol, sorbitol, maltodextrins, dextrose, mannitol, xylitol, polyoxyethylene glycol 400 to 6000, natural glycerides and hemisynthetics and their derivatives, etc.
The quantity of these substances introduced in the solution of carrageenans is such that the coefficient of elasticity of the film can vary from 1 to 5 (1 to 5 times the initial length). The proportion of these substances that can be introduced in the medium varies between 0 and 30% in relation to the final volume of the solution.
The obtaining of a gradual disintegration time defined from the film is controlled by the introduction of tensio-actives in the medium, combined or not to substances presenting a power of disintegration. The tensio-actives used in the present invention can be
non ionics. These are:
sorbitane esters: polysorbates, spans, tweens, etc.
fatty acids polyethoxyls: stearate of PEG 8 to stearate of PEG 100;
fatty polyethoxyled alcohols: blend of ethyl of monolaurate of PEG having from 4 to 23 oxyethylen groups on the polyoxyethylenic chain, etc.
glycol esters: stearate of methylglycol;
glycerol esters: monostearate of glycerol; etc.
esters of PEG;
saccharose esters;
ethyls of fatty alcohol and of PEG: Brij;
ethyls of alkyl phenol and of PEG;
tensio-actives presenting an amide function such as:
monoethanolamide of fatty acids of coprah, of lauric acid, etc.
diethanolamide o
Paris Laurence
Viaud Fabrice
Brunsman David
Paris Laurence
Paul & Paul
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