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    • 专利摘要:
    Pharmaceutical composition or a nutritional supplement for the prevention and/or treatment of dry eye. The invention relates to a pharmaceutical composition or a nutritional supplement comprising between 20 and 70% by weight of Aristotelia chilensis extract, between 10 and 25% by weight of zinc compound and between 0.01 and 1% by weight of vitamin B2, and one or more pharmaceutically acceptable or edible excipients and/or carriers, and their use for the treatment and/or prevention of a disorder or condition derived from tear deficiency such as xerophthalmia or dry eye syndrome or for the improvement of vision and/or eye comfort. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2685324A1
    申请号:ES201700455
    申请日:2017-03-30
    公开日:2018-10-08
    发明作者:Joaquín TEJERO MARTÍNEZ
    申请人:Phidinut S L；Phidinut SL；
    IPC主号:
    专利说明:

    Pharmaceutical composition or nutritional supplement for the prevention and / or treatment of dry eye.
    The present invention relates to a pharmaceutical composition or nutritional supplement comprising specific amounts of Aristotelia Chilensis extract, a compound of zinc and vitamin 82 for the treatment and / or prevention of disorders or conditions derived from tear deficit, such as dry eye syndrome, and to improve vision and eye comfort.
    State of the art
    Dry eye or xerophthalmia is a painful condition caused by an inadequate tear film or an alteration in the ocular surface. It can be mild and characterized by ocular itching and feeling of having a foreign body on the ocular surface.
    Occasionally, however, it can become a chronic condition that results in severe impairments of vision, the ability to lead a normal life and can trigger serious depressions and a departure from the illusion of living.
    It is a disease of wide social diffusion (it is estimated that 20% of the population suffers from it), but that in its severe manifestations it does not have the social impact it should.
    There are environmental factors that predispose to suffer eye dryness, although there are also other less predictable such as genetic predisposition, age, sex, which lead to suffer. Very dry, very cold environments, excess blue irradiation (coming from electronic devices), many hours setting eyesight, infectious eye diseases, etc. they are factors that can trigger transient ocular dryness crisis, or they can establish it chronically.
    However, even when adequate precautions are taken to mitigate the factors described above, there are patients suffering from chronic dryness.
    The eye drops, drops, ointments and artificial tears that are used to mitigate the problems arising from dry eye have a big problem. What is applied topically, even the novel autologous sera, try to emulate the composition of the endogenous tear, but they never succeed. Beyond this obviousness, an implication that the use of these autologous sera has for the eye is the impossibility of having a clear vision. Any image that crosses the cornea and is reflected in the retina must pass through an aqueous surface such as the endogenous tear. The reflection and refraction system of the eye is adapted to the tear fluid, and no industrialized product can reproduce the individual physicochemical characteristics of the tear. That is why patients report blurred vision after application of topical solutions. That forces them to force more vision to adapt and aggravates their dryness.
    Taking into account the limitations of the previous topical formulations for the treatment of dry eye and associated vision problems, and that this pathology affects an average of 20% of the world population, there is a need to provide new compositions that allow obtaining endogenous tear in eyes affected for various reasons, and that prevent the deterioration of work, social, emotional and family life.
    Explanation of the invention.
    It has been shown in clinical studies that Aristotelia Chilensis extract is effective and safe for the treatment of dry eye. On the other hand, zinc compounds, such as zinc oxide, have the ability to improve vision in a generic way. Finally, it is also known that vitamin 82 (or riboflavin) has improved vision and quality properties on the corneal surface.
    The inventors have found that when combining the extract of Aristotelia Chilensis, a compound of zinc and vitamin B2 in certain proportions, an improved effect is obtained in the reduction and / or prevention of the dry eye that is present with a hypo-secretory component. The incorporation of the vitamin and the zinc compound favors the reactions of the extract of Aristotelia Chilensis in the eye resulting in an effect superior to that which could be expected, due to the fact that a synergistic effect occurs between the mentioned active ingredients. Thus, the composition of the invention, which contains the three active ingredients mentioned above, facilitates the reactivation of the tear glands and achieves an effective, fast, safe and definitive solution for dry eye.
    The composition of the invention can be prepared by a simple and easily industrialized process and also has the advantage that it can be administered orally in various formats, which facilitates acceptance and pOSOlogy for the patient and avoids the problems of topical formulations. of the state of the art.
    Thus, one aspect of the present invention relates to a pharmaceutical composition or nutritional supplement comprising:
    a) Between 20 and 70% by weight of Aristotelia Chilensis extract.
    b) Between 10 and 25% by weight of zinc compound.
    c) Between 0.01 and 1% by weight of vitamin 82.
    and one or more pharmaceutically acceptable or edible excipients and / or carriers; where the percentages are expressed by weight with respect to the total weight of the pharmaceutical composition
    or nutritional supplement.
    The term "pharmaceutically acceptable carrier" refers to excipients and / or carriers suitable for use in pharmaceutical technology for the preparation of compositions for medical use.
    The term "nutritional supplement" is used here as a synonym for "dietary supplement", "nutritional supplement" or "nutritional supplement" or "nutraceutical" and refers to a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fatty acids or amino acids, which are absent or are found in insufficient amounts in an individual's diet.
    The term "edible" carrier or carrier, as used herein, means that the carrier or carrier is suitable for consumption without being toxic.
    The term "percentage (%)", when not explicitly specified, refers to the percentage of each ingredient of the pharmaceutical composition or nutritional supplement in relation to the total weight.
    The term "Aristotelia Chilensis extract" is used here with its conventional meaning to refer to concentrated preparations obtained using extraction procedures from the Aristotelia Chilensis plant by appropriate means.
    The extract of Aristotelia Chilensis, also known as "maqui", is obtained from the fruit of Chile's own plant and adjacent areas of southern Argentina, especially Patagonia. Suitable means for extracting the active ingredients include, for example, by entrainment with hydroalcoholic solvents.
    Aristotelia Chilensis extract is especially rich in polyphenolic compounds such as flavonols and anthocyanins. Anthocyanins act as potent antioxidants. Preferably, the content of anti-cyanins in the extract used in the invention is about 35% by weight with respect to the weight of the extract, of which at least 25% by weight are delfinidines. Among the anthocyanins present in the extract, the 3-glucoside, 3,5-diglucoside, 3-sambubioside and 3-sambubioside-5-glucosides derivatives of delfinidine and cyanidine, the main anthocyanin delfinidine 3-sambubioside-5-glucoside ( 34% of total anthocyanins).
    In a particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or below, the Arislolelia Chilensis extract is the commercial product MaquiBright®
    In another particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or subsequently, the AristoteJia Chilensis extract comprises anthocyanins. More particularly, anthocyanins are selected from the group consisting of the 3-glucoside, 3,5-diglucoside, 3sambubioside and 3-sambubioside-5-glucoside derivatives of delfinidine or cyanidine and mixtures thereof.
    In another particular embodiment, optionally in combination with one or more features of the various particular or preferred embodiments described above or below, the present invention relates to a composition as previously defined comprising an extract of Aristolelia Chilensis obtainable by a process which includes: a) the extraction of the fruit from the Aristotelia Chilensis plant in Chile and adjacent areas of southern Argentina, by dragging with hydroalcoholic solvents; b) separation of the extract obtained and c) removal of the solvent.
    The term "obtainable" extract is used herein to define the extract by its method of obtaining and refers to the extract that can be obtained by the extraction procedure comprising steps a), b) and c) as defined above. For the purposes of the invention the expressions "obtainable", "obtained" and similar equivalent expressions are used interchangeably and, in any case, the expression "obtainable" encompasses the expression "obtained".
    In a particular embodiment, optionally in combination with one or more features of the various particular or preferred embodiments described above or below, the invention relates to the pharmaceutical composition or nutritional supplement defined above, where each of the three components selected from extract of Aristotelia chilensis, a compound of zinc and vitamin 82 is present in the composition in a safe and effective amount sufficient so that in combination with the two remaining components selected from extract of Aristotelia chilensis, a compound of zinc and vitamin B2 produces a synergistic effect of the combination as a whole.
    For the purposes of the present invention, a "safe and effective amount" refers to the amount of active ingredients that, providing a therapeutic effect after application, is low enough to avoid side effects at a reasonable benefit / risk ratio. In the case of pharmaceutical compositions, the effective amount is the "therapeutically effective amount" and refers to the amount of active ingredients of the pharmaceutical composition or nutritional supplement of the invention which, when administered to a subject, is sufficient to prevent development of, relieve to some extent, or treat one or more of the symptoms of the disorder or condition of interest.
    The particular dose to be administered of the pharmaceutical composition or nutritional supplement of the invention will be determined based on the particular circumstances of each case, including the patient's condition, age, duration of treatment, nature of any concurrent treatment, the specific combination of active ingredients. employees, the specific excipients used and other factors known to the expert.
    In a particular embodiment, optionally in combination with one or more features of the various particular or preferred embodiments described above or below, the pharmaceutical composition or nutritional supplement of the invention defined above comprises: a) between 30 and 68%, more particularly between 35 and 65%, by weight of Aristotelia Chilensis extract; b) between 15 and 25%, more particularly between 20 and 25%, by weight of zinc compound; c) between 0.05 and 0.5%, more particularly between 0.05 and 0.3%, by weight of vitamin 82; where the percentages are expressed in weight with respect to the total weight of the pharmaceutical composition or nutritional supplement.
    In another particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or below, the pharmaceutical composition or nutritional supplement of the invention as defined above comprises approximately 55% by weight of extract. of Aristotelia chilensis, approximately 22% by weight of zinc compound and approximately 0.1% by weight of vitamin 82, where the percentages are expressed by weight with respect to the total weight of the pharmaceutical composition or nutritional supplement.
    The composition of the invention comprises a zinc compound. In a particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or subsequently, the zinc compound is zinc oxide. In another embodiment, the zinc compound is zinc enriched yeast.
    In another particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or below, the pharmaceutical composition or nutritional supplement of the invention as defined above further comprises hyaluronic acid. More particularly, the content of hyaluronic acid in the pharmaceutical composition or nutritional supplement is between 1 and 5% by weight, with respect to the total weight of the pharmaceutical composition or nutritional supplement.
    In a particular embodiment, optionally in combination with one or more features of the various particular or preferred embodiments described above or below, the pharmaceutical composition or nutritional supplement of the invention is administered orally. More particularly, the pharmaceutical composition or nutritional supplement is in the form of tablets, capsules or powders.
    The pharmaceutical compositions and nutritional supplements of the invention can be prepared according to methods well known in the state of the art. One skilled in the art will know how to easily determine the appropriate excipients and / or carriers, and their amounts, according to the type of formulation to be prepared. The specific combination of excipients and / or carriers in the final composition will be determined largely by their chemical compatibility. In particular, said selection will take into account that the rest of the components do not interfere with the effect of the combination of Aristotelia chilensis, a compound of zinc and vitamin 82.
    The pharmaceutical compositions and nutritional supplements of the invention may comprise excipients and / or carriers such as diluents, disintegrants, lubricants and dyes, among others. Thus, in a particular embodiment, optionally in combination with one or more characteristics of the various particular or preferred embodiments described above or subsequently, pharmaceutically acceptable or edible excipients and / or carriers are selected from diluents, disintegrants, lubricants, colorants and combinations of the same.
    Examples of suitable disintegrants include, but are not limited to, croscarmellose sodium, starch and crospovidone. The amount of disintegrant in the pharmaceutical compositions or nutritional supplements of the invention is comprised between 0.51.5% by weight / weight.
    Examples of suitable diluents include, but are not limited to, microcrystalline cellulose and tricalcium phosphate. The amount of diluent in the pharmaceutical compositions
    or the nutritional supplements of the invention are comprised between 5-20% by weight / weight.
    Examples of suitable lubricants include, but are not limited to, colloidal silica and magnesium stearate. Preferably, the lubricating agent is magnesium stearate. The amount of lubricant in the pharmaceutical compositions or nutritional supplements of the invention is comprised between 0.5-2% by weight / weight.
    Additionally, pharmaceutical compositions, preferably oral, or nutritional supplements of the invention may further comprise other ingredients, such as dyes, such as red iron oxide (E-172), titanium dioxide (E-171) and carmoisin red (E-122); sweeteners and other components commonly used in oral formulations.
    As previously indicated, the combination of the extract of Aristotelia Chilensis, a compound of zinc and vitamin 82 in certain proportions provides an improved effect in the reduction and / or prevention of dry eye, promoting good functionality of the lacrimal glands and thus avoiding corneal injuries caused by the lack of lubrication.
    Thus, the present invention also relates to the use of an extract of Aristotelia Chilensis, a compound of zinc and vitamin 82, for the preparation of a pharmaceutical composition or nutritional supplement comprising:
    a) Between 20 and 70% by weight of Aristotelia Chilensis extract.
    b) Between 10 and 25% by weight of zinc compound.
    c) Between 0.01 and 1% by weight of vitamin 82.
    and one or more pharmaceutically acceptable or edible excipients and / or carriers; where the percentages are expressed in weight with respect to the total weight of the composition, for the treatment and / or prevention of a disorder or condition derived from the tear deficit.
    This aspect of the invention can also be defined as a pharmaceutical composition or nutritional supplement comprising
    a) Between 20 and 70% by weight of Aristotelia Chilensis extract.
    b) Between 10 and 25% by weight of zinc compound.
    c) Between 0.01 and 1% by weight of vitamin 82.
    And one or more pharmaceutically acceptable or edible excipients and / or carriers; where the percentages are expressed in weight with respect to the total weight of the composition, for use in the treatment and / or prevention of a disorder or condition derived from the tear deficit.
    Also part of the invention is a method for the treatment and / or prevention of a disorder or condition derived from the tear deficit, which comprises administering to a subject, preferably a human being, between 20 and 70% by weight of extract of Aristotelia chilensis, between 10 and 25% by weight of zinc compound, between 0.01 and 1% by weight of vitamin 82, and one or more pharmaceutically acceptable or edible excipients and / or carriers.
    In a particular embodiment, optionally in combination with one or more features of the various particular or preferred embodiments described above or subsequently, the disorder or condition derived from the tear deficit is xerophthalmia or dry eye syndrome.
    Also part of the invention is the use of an extract of Aristotelia Chilensis, a compound of zinc and vitamin 82, for the preparation of a pharmaceutical composition or nutritional supplement comprising:
    a) Between 20 and 70% by weight of AristoteUa Chilensis extract.
    b) Between 10 and 25% by weight of zinc compound.
    c) Between 0.01 and 1% by weight of vitamin 82.
    And one or more pharmaceutically acceptable or edible excipients and / or carriers; where the percentages are expressed in weight with respect to the total weight of the composition, for the improvement of vision and / or eye comfort.
    This aspect of the invention can also be defined as a pharmaceutical composition or nutritional supplement comprising:
    a) Between 20 and 70% by weight of Aristotelia Chilensis extract.
    b) Between 10 and 25% by weight of zinc compound.
    c) Between 0.01 and 1% by weight of vitamin 82.
    and one or more pharmaceutically acceptable or edible excipients and / or carriers; where the percentages are expressed in weight with respect to the total weight of the composition, for use in improving vision and / or eye comfort.
    Also part of the invention is a method for improving vision and / or ocular comfort, which comprises administering to a subject, preferably a human being, between 20 and 70% by weight of AristoteNa ChiJensis extract, between a 10 And 25% by weight of zinc compound, between 0.01 and 1% by weight of vitamin 82, and one or more pharmaceutically acceptable or edible excipients and / or carriers.
    Throughout the description and the claims the word "comprises" and its variants are not intended to exclude other technical characteristics, additives, components or steps. In addition, the word "comprises" includes the case "consists of". For those skilled in the art, other objects, advantages and features of the invention will be derived partly from the description and partly from the practice of the invention. The following examples are provided by way of illustration, and are not intended to be limiting of the present invention. In addition, the present invention covers all possible combinations of particular and preferred embodiments indicated herein.
    Examples
    Preparation of a composition according to the invention
    The following powder composition was prepared containing the following components:
    • 55% by weight of Aristotelia Chilensis extract (Maqui8right®).
    • 22% by weight zinc oxide.
    • 0.1% by weight of vitamin 82.
    • 10% by weight of diluent (5% microcrystalline cellulose and 5% tricalcium phosphate).
    • 5.9% by weight of titanium dioxide.
    • 7% by weight magnesium stearate. The procedure for preparing this composition was as follows:
    one. Vitamin 82 and a similar weight of zinc oxide were incorporated in a mixing vessel and mixed for 5 minutes.
    2. 25% of the weight of zinc oxide was incorporated into the above mixture and mixed for 5 minutes.
    3. To the mixture of step 2, another 25% of the weight of the zinc oxide was incorporated and mixed for 5 minutes.
    Four. To the above mixture, the rest of the weight of the zinc oxide was incorporated and mixed for 10 minutes.
    5. The mixture obtained from the mixer was changed and passed through the final mixer.
    6. The tricalcium phosphate was added to the previous mixture already in the final container and mixed for 10 minutes.
    7. The extract of Arislolelia Chilensis, previously sieved by a 0.5 mm mesh light sieve, was incorporated into the previous mixture and mixed for 15 minutes.
    8. The microcrystalline cellulose and titanium dioxide were incorporated on the previous mixture and mixed for 15 minutes.
    9. On the above mixture, magnesium stearate was incorporated and mixed for 5 minutes.
    This mixture can be used in different final pharmaceutical forms as appropriate. If it were decided to present in envelopes, it should be conveniently diluted.
    10 Brief description of an observational study
    A study was carried out on 20 patients, with different etiologies of dry eye. For this purpose, a composition according to the invention was orally administered (in the form of 30 mg tablets, 3 tablets per day for a subgroup of patients, with Sj6egren's syndrome and 1 15 tablets per day in the rest of patients) for 3 days in treatment concomitant with the usual treatments of the patient and from the third day only with the composition of the invention. The results of this study revealed that 95% of the patients included reported significant improvement in dry eye sensation (stinging, irritation, foreign body sensation ...) from the first days. 95% of patients said they did not need it
    20 the usual treatment at the dose they saw using. 90% of this 95% left the previous treatment definitively.
    权利要求:
    Claims (16)
    [1]
    1. A pharmaceutical composition comprising:a) between 20 and 70% by weight of Aristofelia chilensis extract,
    5 b) between 10 and 25% by weight of zinc compound,c) between 0.01 and 1% by weight of vitamin 82,and one or more pharmaceutically acceptable excipients and / or carriers; where thepercentages are expressed in weight with respect to total weight of the compositionPharmaceutical
    [2]
    2. The pharmaceutical composition according to claim 1, comprising 55% by weight of Aristatelía chilensis extract, 22% by weight of zinc compound and 0.1% by weight of vitamin 82.
    3. The pharmaceutical composition according to any of claims 1-2, wherein the zinc compound is zinc oxide.
    [4]
    4. The pharmaceutical composition according to any of claims 1-3, further comprising hyaluronic acid.
    [5]
    5. The pharmaceutical composition according to any of claims 1-4, which is administered orally.
    [6]
    6. The pharmaceutical composition according to claim 5, which is in the form of tablets, capsules or powders.
    [7]
    7. The pharmaceutical composition according to any of claims 1-6, wherein the pharmaceutically acceptable excipients and / or carriers are selected from diluents, disintegrants, lubricants, colorants and combinations thereof.
    [8]
    8. Use of an extract of Aristotelia Chilensis, a compound of zinc and vitamin 82, for the preparation of a pharmaceutical composition as defined in any of claims 1-7, for the treatment and / or prevention of a disorder or condition derived from tear deficit
    [9]
    9. Use according to claim 8, wherein the disorder or condition derived from the tear deficit is xerophthalmia or dry eye syndrome.
    [10]
    10. Use of an extract of Aristotelía chilensis, a compound of zinc and vitamin 82,

    5 for the preparation of a pharmaceutical composition as defined in anyof claims 1-7, for the improvement of vision and / or eye comfort.
    [11]
    11. A nutritional supplement that includes:a) between 20 and 70% by weight of Aristotelia chiJensis extract,
    10 b) between 10 and 25% by weight of zinc compound, c) between 0.01 and 1% by weight of vitamin 82, and one or more excipients and / or edible carriers; where the percentages are expressed in weight with respect to the total weight of the nutritional supplement.
    12. The nutritional supplement according to claim 11, comprising 55% by weight of Aristotelia chiJensis extract, 22% by weight of zinc compound and 0.1% by weight of vitamin 82.
    [13]
    13. The nutritional supplement according to any of claims 11-12, wherein the zinc compound is zinc oxide.
    [14]
    14. The nutritional supplement according to any of claims 11-13, further comprising hyaluronic acid.
    15. The nutritional supplement according to any of claims 11-14, which is administered orally.
    [16]
    16. The nutritional supplement according to claim 15, which is in the form of tablets, capsules or powders.
    [17]
    17. The nutritional supplement according to any of claims 11-1 6, wherein the excipients and / or carriers or edibles are selected from diluents, disintegrants, lubricants, colorants and combinations thereof.
    35 18. Use of an extract of Aristotelía Chilensis, a compound of zinc and vitamin 82, for the preparation of a nutritional supplement as defined in any of

    claims 11-17, for the treatment and / or prevention of a disorder or condition derived from the tear deficit.
    [19]
    19. Use according to claim 18, wherein the disorder or condition derived from the tear deficit is xerophthalmia or dry eye syndrome.
    [20]
    twenty. Use of an extract of Aristotelia chilensis, a compound of zinc and vitamin 82, for the preparation of a nutritional supplement as defined in any of claims 11-17, for the improvement of vision and / or eye comfort.
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    同族专利:
    公开号 | 公开日
    ES2685324B1|2019-07-22|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    EP0930072A1|1998-01-13|1999-07-21|Kartar Dr. Lalvani|Vitamin and mineral containing compositions for the treatment of dry eye|
    JP2011042632A|2009-08-24|2011-03-03|Q P Corp|Oral dry eye ameliorant and food composition and pharmaceutical composition each containing the oral dry eye ameliorant|
    JP2017012144A|2015-10-09|2017-01-19|株式会社東洋新薬|Bloodstream improvement composition|
    法律状态:
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    ES201700455A|ES2685324B1|2017-03-30|2017-03-30|Pharmaceutical composition or nutritional supplement for the prevention and / or treatment of dry eye|ES201700455A| ES2685324B1|2017-03-30|2017-03-30|Pharmaceutical composition or nutritional supplement for the prevention and / or treatment of dry eye|
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