COMPOSITION FOR USE IN THE PREVENTION AND/OR TREATMENT OF OSTEOARTICULAR DISEASES

Abstract

Described herein is a synergistic composition of substances of natural origin, particularly effective in the treatment and prevention of osteoarticular diseases, such as rheumatoid arthritis and osteoarthritis. The composition includes the synergistic combination of aescin, at least one extract of a plant belonging to the genus Boswellia, and an extract of Scutellaria baicalensis. The synergistic composition may be provided in the form of pharmaceutical composition, food supplement, medical device, food for special medical purposes, or a cosmetic.

Claims

1. A composition comprising aescin, at least one extract from a plant belonging to the genus Boswellia, and one extract from Scutellaria baicalensis.

2. The composition according to claim 1, wherein aescin is present in the composition in an amount ranging from 0.5% to 70% by weight on the total weight of the composition.

3. The composition according to claim 1, wherein the at least one extract from the plant belonging to the genus Boswellia is present in the composition in an amount ranging from 1 to 90% by weight on the total weight of the composition.

4. The composition according to claim 1, wherein the Scutellaria baicalensis extract is present in the composition in an amount ranging from 0.5 to 70% by weight on the total weight of the composition.

5. The composition according to claim 1, wherein the plant belonging to the genus Boswellia is Boswellia serrata.

6. The composition according to claim 1, wherein aescin is present in the composition as an extract from Aesculus hippocastanum.

7. The composition according to claim 1, which is a pharmaceutical composition, a dietary supplement, a medical device, a food for special medical purposes, or a cosmetic for oral or topical administration.

8. The composition according to claim 1, for use in the prevention and/or therapeutic treatment of osteoarticular diseases.

9. The composition according to claim 8, wherein the osteoarticular diseases are rheumatoid arthritis and/or osteoarthritis.

10. The composition according to claim 2, wherein aescin is present in the composition in an amount ranging from 2 to 50% by weight on the total weight of the composition.

11. The composition according to claim 3, wherein the at least one extract from the plant belonging to the genus Boswellia is present in the composition in an amount ranging from 5 to 80% by weight on the total weight of the composition.

12. The composition according to claim 4, wherein the Scutellaria baicalensis extract is present in the composition in an amount ranging from 2 to 50% by weight on the total weight of the composition.

Description

EXAMPLES

[0046] The following examples concern any form of pharmaceutical dosage that is acceptable, preferably oral or topical, suitable in the scope of the present invention.

[0047] Some examples of formulations are given, with the quantities of the relative active substances present in each dosage unit.

Example 1

[0048]

TABLE-US-00001 Active ingredient Daily dose Boswellia serrata e.s. 1 g Aescin from Aesculus Hippocastanum 50 mg Scutellaria baicaleusis e.s. 250 mg

Example 2

[0049]

TABLE-US-00002 Active ingredient Daily dose Boswellia serrata e.s. 500 mg Aescin from Aesculus Hippocastanum 100 mg Scutellaria baicaleusis e.s. 50 mg

Example 3

[0050]

TABLE-US-00003 Active ingredient Daily dose Boswellia serrata e.s. 1200 mg Aescin from Aesculus Hippocastanum 40 mg Scutellaria baicaleusis e.s. 50 mg

Example 4

[0051]

TABLE-US-00004 Active ingredient Daily dose Boswellia serrata e.s. 350 mg Aescin from Aesculus Hippocastanum 20 mg Scutellaria baicaleusis e.s. 150 mg

EXPERIMENTAL PART

[0052] The synergistic action of the composition with respect to the individual active ingredients is evaluated using experimental methods in vitro and/or in vivo.

[0053] Various cell studies are able to provide important information about the anti-inflammatory capacity of bioactive compounds able to inhibit cytokine expression. IC50 studies are able to provide information for cellular inhibition. To evaluate in more detail the response (inhibition/activation) of cytokines (TNF-α, IL-1, IL-4, IL-6, IL-8, IL-10, IL-17, INF-γ, COMP) during inflammatory processes induced by LPS, the “Whole Blood Assay (WBA)” or the “peripheral blood mononuclear cell” (PBMC) test or other similar tests are used.

[0054] As an in vivo test, a simple model of general inflammation is the model of carrageenan-induced edema in mice or rats. In this test, the injection of carrageenan into the animal's paw results in an acute inflammatory reaction of the paw with the appearance of classic signs of inflammation; this reaction reaches its maximum within 3 hours after inoculation. This test may be used to assess the ability of the active ingredients of the present invention to reduce the edema of the paw induced by the injection of carrageenan.

[0055] More complex methods that are used for the evaluation of osteoarticular diseases are for example the model of arthritis induced by collagen and arthritis induced by Freund's adjuvant, which allow evaluating the effects of potential agents in the treatment of arthritis for a prolonged period of time.