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EP-4736857-A1 - MIXTURES AND NUTRACEUTICAL COMPOSITIONS COMPRISING ARTEMISIA EXTRACT, ERUCA EXTRACT, BOSWELLIA EXTRACT AND VITAMIN D, AND THEIR USE IN THE PREVENTION AND TREATMENT OF OSTEOPOROSIS

EP4736857A1EP 4736857 A1EP4736857 A1EP 4736857A1EP-4736857-A1

Abstract

The present invention relates to a mixture, food, nutraceutical and/or pharmaceutical compositions comprising it and their use in prevention and/or slowdown and/or treatment of osteoporosis.

Inventors

  • UBERTI, Francesca
  • FAÈ, Annalisa

Assignees

  • Nutra Futura S.r.l.

Dates

Publication Date
20260506
Application Date
20251030

Claims (15)

  1. A mixture comprising or, alternatively, consisting of: i) an Artemisia extract; ii) a Boswellia extract; iii) an Eruca extract; and iv) at least one vitamin D.
  2. The mixture according to claim 1, wherein said Artemisia extract is an Artemisia annua extract, and/or said Boswellia extract is a Boswellia serrata extract, and/or said Eruca extract is an Eruca sativa Mill. extract.
  3. The mixture according to claim 1 or 2, where the Artemisia extract comprises artemisinin in a concentration comprised from 80% to 100% by weight; more preferably, comprised from 85% to 99.9% by weight; even more preferably, comprised from 90% to 99.7% by weight, with respect to the total weight of the extract.
  4. The mixture according to any one of the preceding claims, where the Boswellia extract comprises at least one keto-boswellic acid, preferably said at least one keto-boswellic acid is 3-acetyl-11-keto-β-boswellic acid (AKBA).
  5. The mixture according to any one of the preceding claims, wherein said at least one keto-boswellic acid is present in said Boswellia extract in a concentration comprised from 20% to 70% by weight; more preferably, comprised from 25% to 60%; even more preferably, comprised from 30% to 50% by weight, with respect to the total weight of the extract.
  6. The mixture according to any one of the preceding claims, wherein the Eruca extract comprises icariins, preferably in a concentration comprised from 5% to 50% by weight, preferably, comprised from 10% to 40% by weight; more preferably, comprised from 15% to 25% by weight, with respect to the total weight of the extract.
  7. The mixture according to any one of the preceding claims, wherein said at least one vitamin D is chosen from the group comprising, or alternatively consisting of, vitamin D1, vitamin D2, vitamin D3, vitamin D4,and vitamin D5, or mixtures thereof; preferably, said vitamin D is chosen from among vitamin D2 and vitamin D3, or mixtures thereof; more preferably, said vitamin D is vitamin D3.
  8. A composition comprising the mixture according to any one of claims 1 to 7 and, optionally, at least one acceptable pharmaceutical or food grade additive and/or excipient.
  9. The composition according to claim 8, where the Artemisia extract is present in a concentration comprised between 10 and 25% weight/weight of the composition, preferably comprised between 12 and 18% w/w.
  10. The composition according to claim 8 or 9, where the Boswellia extract is present in a concentration comprised between 30 and 65% weight/weight of the composition, preferably comprised between 45 and 55% w/w.
  11. The composition according to any one of claims 8 to 10, where the Eruca extract is present in a concentration comprised between 20 and 45% weight/weight of the composition, preferably comprised between 25 and 40%.
  12. The composition according to any one of claims 8 to 11, where the at least one vitamin D is present in a concentration comprised between 0.005 and 0.007% weight/weight of the composition, preferably comprised between 0.006 and 0.008 % w/w.
  13. The mixture according to any one of claims 1 to 7 or the composition according to any one of claims 8 to 12, for use as a medicament.
  14. The mixture according to any one of claims 1 to 7 or the composition according to any one of claims 8 to 12, for use in the prevention and/or slowdown and/or in treatment of osteoporosis.
  15. A non-medical nutraceutical use of the mixture according to any one of claims 1 to 7 or the composition according to any one of claims 8 to 12 to maintain bone homoeostasis, and/or to maintain bone mineral density and/or to maintain bone microarchitecture and/or for the reduction of the risk of fractures caused by bone fragility in an individual.

Description

The present invention relates to a mixture and a composition comprising an Artemisia extract, a Boswellia extract, an Eruca extract and at least one vitamin D, and their use in prevention and/or slowdown and/or treatment of osteoporosis. The invention also relates to a non-medical use of the mixture or the composition to maintain bone homoeostasis in an individual. STATE OF THE ART Osteoporosis is a systemic disease of the skeletal system, characterised by a low mineral density and by the deterioration of the microarchitecture of the bone tissue, which becomes more fragile and more exposed to a risk of spontaneous fractures or fractures caused by minor traumas. Osteoporosis is divided into two forms: primary, which includes the postmenopausal and senile varieties, and secondary, which is due to different pathologies and to the taking of certain drugs over the medium/long-term. In more detail, in the case of osteoporosis, the physiological process of remodelling, in which the old and damaged skeletal tissue is removed by osteoclasts and new bone is reformed by osteoblasts, is altered. In fact, with age, the activity of the osteoclasts tends to be greater than the activity of the osteoblasts, with a consequent loss in bone mass. As for most diseases, osteoporosis can be prevented by adopting a healthy lifestyle, with regular exposure to the sun, physical exercise, following a diet that provides for a sufficient intake of foods with a high calcium content, and avoiding abuse of alcohol and smoking of cigarettes. However, these precautions are often not sufficient to prevent the onset of the disease. In fact, genetics and heredity play a leading role in the development of osteoporosis and in susceptibility to fractures. In this regard, in fact, the results of a genome-wide meta-analysis study published in Nature Genetics discovered that variants of 56 genome regions influence the bone density (BMD, Bone mineral density) of an individual and 14 of these variants are associated with an increase in the risk of fracture (Estrada K., Styrkarsdottir U., Evangelou E. et al. Genome-wide meta-analysis identifies 56 bone mineral density loci and reveals 14 loci associated with risk of fracture. Nat Genet 44, 491-501 (2012). Therefore, in these cases, it is necessary to act on slowing down the onset of osteoporosis. It is therefore necessary to provide a product (mixture and/or composition) capable of preventing and/or slowing down the onset of osteoporosis. It is also useful to provide a food, nutraceutical and/or pharmaceutical composition for use in the treatment of osteoporosis, which contains natural ingredients and therefore does not result in the known side effects of the drugs commonly used for the treatment of osteoporosis. Anti-osteoporosis drugs act on skeletal remodelling by restoring the balance between bone resorption and new bone formation. Most of the drugs used as the first line (bisphosphonates, denosumab, selective estrogen receptor modulators - SERM) act by inhibiting the function of the osteoclasts and therefore bone resorption. However, there are known main adverse effects common to most of the active ingredients in the class of bisphosphonates (nausea, abdominal pain, diarrhoea, and esophagitis), denosumab (hypercholesterolemia, bladder infections, hypocalcemia, serious infections, including skin infections, dermatitis, eczema and skin rashes, osteonecrosis of the jaw/lower jaw) and SERM (hot flushes, muscle spasms, increase in hematic levels of triglycerides and/or hepatic enzymes and sleepiness, among the most common). Considering the strong side effects caused by the drugs commonly used for the treatment of osteoporosis, there is therefore a need to provide products (mixtures and/or compositions) that do not result in heavy adverse effects in individuals who are often elderly and who, in any case, already have, in certain cases, one or more fractures. The technical problem that the present invention addresses and solves is thus to provide a product (mixture and/or composition) that does not cause side effects and that is capable of preventing and/or slowing down and/or treating osteoporosis. Furthermore, it is necessary to provide a mixture and/or a composition which are useful for that purpose, easy to prepare and free of side effects, and which do not require the use of costly machinery and processes. SUMMARY OF THE INVENTION A first aspect of the present invention relates to a mixture comprising or, alternatively, consisting of: i) an Artemisia extract;ii) a Boswellia extract;iii) an Eruca extract; andiv) at least one vitamin D. Preferably, said Artemisia extract comprises artemisinin. In one embodiment, the Artemisia extract is an Artemisia annua extract, and/or said Boswellia extract is a Boswellia serrata extract, and/or said Eruca extract is an Eruca sativa Mill. extract. Preferably, the Artemisia extract has an artemisinin titre comprised from 80% to 100% by weight; more preferably, compr