Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1991-04-16
1995-12-19
Wityshyn, Michael G.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 54, 514885, 536 111, 536 41, 5361231, 536124, 536127, A01N 4304, A61K 31715, C07H 100, C07G 1700
Patent
active
054768446
DESCRIPTION:
BRIEF SUMMARY
This invention relates to compositions including inulin in the gamma polymorphic form, which may be used as immunoactive agents.
The properties and uses of the novel gamma polymorphic form of inulin have been described in International Patent Specification No. PCT/AU86/00311. In that specification, it is disclosed that this form of inulin may be used as an activator of the alternative pathway of complement and may be appropriate as an antitumourigenic agent. It is also disclosed in that specification that the gamma polymorphic form of inulin possesses adjuvant activity.
It has now been found that the activity of the gamma polymorphic form of inulin as an immunoactive agent such as an adjuvant may be enhanced if it is associated with an antigen-binding carrier material, and that this association provides synergistic effects.
In accordance with the present invention there is provided a composition comprising particles containing inulin or an inulin derivative in the gamma polymorphic form and an antigen-binding carrier material.
The gamma polymorphic form of inulin or an inulin derivative (hereinafter referred to as "gamma inulin") and the antigen-binding carrier material may be associated in the particles by way of electrostatic or hydrophobic interactions, covalent bonding, co-precipitation, crystallization of one component onto the other component, or by a combination thereof. Preferably, the particles are prepared by co-crystallizaton of the gamma inulin and the antigen-binding carrier material so that both of these components are contained in the same particles.
The antigen-binding carrier material may comprise any material of low solubility capable of binding proteinaceous, lipid, carbohydrate and/or other antigens. For example, the antigen-binding carrier material may be selected from metal-containing precipitates such as magnesium, calcium or aluminium phosphates, sulphates, hydroxides or hydrates thereof, organic bases such as chitin (poly N-acetylglucosamine) or deacetylated derivatives thereof or basic cellulose derivatives, or organic acids including sulphated or phosphorylated polysaccharides such as heparin, dextran or cellulose derivatives.
The antigen-binding carrier material may comprise poorly soluble particles of such materials as aluminium hydroxide (alum) gel or a hydrated salt complex thereof. Conveniently, particles of the antigen-binding carrier material are smaller than 5 .mu.m and more preferably smaller than 1-5 .mu.m. Most preferably, the particles are 50-2000 nanometers in diameter. It is particularly favoured to have an antigen-binding carrier material which is endotoxin- and pyrogen-free, and which is pharmaceutically acceptable. Advantageously, the antigen-binding carrier material does not tend to aggregate or is treated to avoid aggregation.
In accordance with another aspect of the invention there is provided a process for the production of a composition of the invention as broadly described above, the process comprising the steps:
of providing a suspension of an antigen-binding carrier material; and thereafter converting the inulin or inulin derivative to the gamma polymorphic form; or gamma polymorphic form;
to effect association of the inulin or inulin derivative in the gamma polymorphic form with said antigen-binding carrier material.
Preferably, a suspension of fine particles of the antigen-binding carrier material is added to a solution of inulin or inulin derivative to give-a controlled ratio of gamma inulin to antigen-binding carrier material of, for instance 200:1 to 1:1 and more suitably 50:1 to 5:1 (w/w). The inulin concentration is conveniently kept above 5% w/v. An initial 6-7% w/v solution of inulin is convenient.
The resulting suspension may be rapidly cooled to a temperature such as 5.degree. C. and stirred at such a temperature for several days to crystallize the inulin, prior to several days at 37.degree. C. to encourage transformation of the inulin to the gamma configuration, and subsequent washing and removal of large particles.
Alternatively, it may be de
REFERENCES:
Leslie et al., Chemical Abstracts 114(5):35579v (1990).
Snyderman et al., Infect Immun (Abstract), 11(2) pp. 273-279, (1975 Feb. ).
Cooper et al.; Molecular Immunology (vol. 23, No. 8); Anti-Complementary Action of Polymorphic "Solubility Forms" of Particulate Inulin; 1986.
Mino et al.; "Separation of Acetylated Inulin by Reversed-Phase High Performance Liq Chromatography"; (vol. 33, No. 8); Chemical Pharmaceutical Bulletin, 1985.
Cooper et al.; "The Anti-Melanoma Activity of Inulin In Mice"; Molecular Immuno; (vol. 23, No. 8); 1986.
Leary Louise N.
The Australian National University
Wityshyn Michael G.
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