WO2020252545A1 - Composition nutraceutique combinant des probiotiques, des vitamines et de minéraux - Google Patents

Composition nutraceutique combinant des probiotiques, des vitamines et de minéraux Download PDF

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Publication number
WO2020252545A1
WO2020252545A1 PCT/BR2019/050312 BR2019050312W WO2020252545A1 WO 2020252545 A1 WO2020252545 A1 WO 2020252545A1 BR 2019050312 W BR2019050312 W BR 2019050312W WO 2020252545 A1 WO2020252545 A1 WO 2020252545A1
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fact
concentration
acne
probiotic
vitamins
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PCT/BR2019/050312
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English (en)
Portuguese (pt)
Inventor
Fernando Gabriel ITZAINA SANCHEZ
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Farmoquímica S/A
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Publication of WO2020252545A1 publication Critical patent/WO2020252545A1/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents

Definitions

  • the present invention deals with a food supplement in the form of two tablets, one coated with zinc and copper chelated minerals, vitamins A, B3 and B6 and a second simple tablet containing the probiotics Lactobacillus acidophilus and Bifidobacterium lactis.
  • the food supplement in the form of two tablets according to the present invention is useful in the control of dysbiosis and acne.
  • Acne vulgaris is a disease of the pilosebaceous follicle and presents as fundamental characteristics the overproduction of glandular sebum, increased colonization by Propionibacterium acnes, follicular hyperkeratinization and release of inflammation mediators in the follicle and adjacent dermis.
  • the P. acnes bacterium is Gram-positive, anaerobic, of the genus Corynebacterium and is part of the normal resident microbiota of the skin. The proliferation of this bacterium occurs when there is sebum overproduction by the gland, favoring the appearance of acne. In acne patients, P. acnes can reach 120,000 specimens / cm 2 on the skin surface. P. avidum and P.
  • propionicum are also present in large amounts on the skin of acne-prone individuals (COSTA, ALCHORNE, GOLDSCHMIDT, 2008; MONTAGNER, COSTA, 2010).
  • Acne is one of the most common skin problems among young people, and can also extend to other age groups. There is ample evidence that acne persists in adulthood in about 50% of individuals. Acne has a recurrence pattern and a prolonged course; it manifests as an acute rash or may present an insidious onset, promoting psychological and social impact, which may lead to depression and anxiety; therefore, its treatment is extremely important (MONTAGNER, COSTA, 2010; COSTA, BAGATIN, 2013).
  • probiotics can regulate the release of pro-inflammatory cytokines within the skin; for example, the specific reduction in IL-1 levels would certainly have a beneficial potential in the treatment of acne.
  • use of oral probiotics has the potential to alter the local microbiota and still offer beneficial effects in addition to TGI (BOWE, LOGAN, 201 1).
  • Patent application PI0917172 discloses a composition of probiotic bacteria which aims to obtain stable formulations with a long shelf life and a process for producing such compositions.
  • US4,956,295 discloses dry Lactobacilli compositions mixed with a silica gel absorbent.
  • EP148281 1 discloses a process for obtaining a food product comprising the steps of: mixing a preparation of microorganisms and other components, drying the mixture, compacting the mixture, coating the mixture and finalizing as a food product.
  • US2005 / 0266069 discloses a stable probiotic formulation aimed at the intestinal flora, comprising: a plurality of probiotic microspheres comprising each: a nucleus comprising one or more probiotic bacteria, a cellulosic excipient, a disintegrant and one or more additives ; and an enteric coating capable of being resistant to gastric fluids.
  • vitamin A affects human cells in the stages of embryogenesis, reproduction, regulation of the inflammatory process, cell growth and differentiation.
  • Vitamin A was discovered around 1906 and synthesized in mid-1947 and can be found in two main forms, carotenoids and retinols, in foods (CHAPMAN, 2012).
  • Retinoid a form of vitamin A, is necessary to correct keratinization in skin diseases, having a highly effective inhibitory effect on glands and sebum production, which leads to a reduction in the population of Propionibacterium acne, which is one of the etiogenic factors .
  • isotretinoin is a retinoid found in organisms of animal and plant origin such as carotenoid, is found in dark green vegetables and orange vegetables and its main mechanism of action occurs in the sebaceous gland, reducing its size, activity and the amount of sebum produced by up to 75%, after four weeks of treatment.
  • Vitamin A acts to inhibit the induction of IL-17 by Propionibacterium acnes, reducing the number of Th17 cells since these are IL-17 producing in the pathogenesis of acne (AGAK, 2014).
  • nicotinamide on acne vulgaris seems to mainly involve the inhibition of 3 ' -5 ' -AMPphosphodiesterase and the transformation of the induced antigen lymphocyte, which inhibits the epithelial proliferation of the pilo-sebaceous unit, primary factor in the development of lesions acne, being an alternative to antibiotics in topical treatments for inflammatory acne.
  • Vitamin B6 is used to prevent and treat the states of your deficiency, in the treatment of certain metabolic disorders, in depression and other symptoms associated with PMS and the use of contraceptives, in the prophylaxis of isoniazid-induced peripheral neuritis and for treatment of acute ioniazide intoxication. Vitamin deficiency due to inadequate nutrition or malabsorption syndrome. Deficiency of a single vitamin B is rare, as deficiency is usually multiple. Pyridoxine deficiency can cause xanthurenic aciduria, sideroblastic anemia, neurological problems, seborrheic dermatitis and achilles.
  • Some newborns have a hereditary pyridoxine dependence syndrome and need to take it in the first week of life, to avoid anemia and mental retardation; the signs are hypersensitivity and epileptiform attacks. It is also used in formulations for topical use, for its anti-seborrheic action, in hair treatments for dandruff, seborrheic alopecia and acne. Associated with zinc, it potentiates its action on 5 alpha reductase.
  • people with insulin resistance usually develop acne, as insulin influences the concentration of IGF-1 and its binding protein, IGFBP-3, which directly regulates keratinocyte proliferation and apoptosis.
  • IGFBP-3 IGFBP-3
  • Hyperinsulinemia leads to an increase in IGF-1 and a decrease in IGFBP-3. This free IGF-1 directly stimulates the proliferation of keratinocytes and its binding protein inhibits this proliferation (BODEN and SHULMAN, 2002).
  • Both insulin and IGF-1 stimulate the synthesis of androgens in the ovary and testicles, but inhibit hepatic synthesis of sex hormone-binding globulin (SHBG) and increases the bioavailability of circulating androgens.
  • SHBG sex hormone-binding globulin
  • sebum itself is stimulated by insulin and IGF-1 (BARBIERE, SMITH and RYAN, 1998). It is also believed that the endocrine cascade induced by eating with carbohydrates with a high glycemic index leads to hyperinsulinemia, causing all the changes already mentioned (WOLEVER, MEHLING, 2003).
  • Copper is an essential mineral for our body.
  • the human body cannot produce copper, which needs to be ingested through food or absorbed by the skin in dermocosmetics. It helps in the formation of some blood cells, hormones and antioxidant enzymes (which are responsible for keeping the skin younger and healthier). It stimulates the production of an enzyme (lysyl oxidase) responsible for the cross-linking of collagen and elastin, which are essential for the formation of strong and flexible connective tissue, it also has an antioxidant action responsible for cell renewal and skin elasticity. It also helps in reducing skin oiliness, excellent for fighting acne
  • compositions containing bacterial cells having an improved stability and a greater supply of viable bacterial cells.
  • the present inventors have surprisingly determined that a tablet containing cells from a Bifidobacterium and Lactobacillus strain, may have superior stability. Superior stability is directly related to the process for obtaining the tablet.
  • composition of Bifidobacterium and Lactobacillus is especially advantageous in combination with a tablet containing a formulation of vitamin A, vitamin B6, zinc, copper and niacin.
  • the present invention relates to a process to stabilize a composition comprising cells from a Bifidobacterium and Lactobacillus strain and to the use of a combination of Bifidobacterium and Lactobacillus tablets with tablets of a formulation of vitamin A, vitamin B6, zinc, copper and niacin as an adjunct in the treatment of acne in all its stages.
  • the present invention relates to a process for preparing a bacterial composition, which comprises the following steps: a) weighing the inputs; b) mixing and c) direct compression.
  • the purpose of the mixing step is to put the bacterial cells in contact and, therefore, the mixing sequence is not important.
  • bacterial strains can be mixed with the vehicle one before the other or in a concerted manner. It is preferred that all the constituents are mixed at the same time.
  • the purpose of the compression step allows a bacterial composition to be obtained in a solid pharmaceutical form such as a tablet.
  • a first goal to achieve is to have an adequate number of UFCs (colony-forming unit) per day. If the concentration of probiotics in the product does not exceed a certain limit value, the beneficial effect is not provided. Thus, based on the observation that an effective dose is in the range of 10 9 UFC per person per day and, assuming that the consumer has to take it within his daily intake, the goal is to provide this amount of UFCs within one to three servings.
  • the bacterial strains of the present invention are strains producing lactic acid and / or probiotics, and are of the species Lactobacillus acidophilus and Bifidobacterium lactis and are in the 10 9 UFC range.
  • the manufacture of tablets containing probiotics consists of steps for weighing the inputs, mixing and direct compression. All of these steps are carried out in a controlled environment, that is, with temperature and humidity strictly monitored.
  • the temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% U.R.
  • a dilution is made in one and / or up to three stages: in each stage 25 to 100% of excipient and active content (probiotic strains) are added and mixed at intervals of five to twenty minutes, totaling , at the end of the process, one to three mixtures with 100% of the content in 20 minutes.
  • This type of manipulation is necessary to guarantee the homogeneity of the mixture and, thus, the uniformity of the desired dose of probiotic strains in the tablets.
  • Compression of probiotics is a process that requires special care.
  • the force required to generate tablets must be finely controlled so that it does not cause significant impacts on the viability of the strains present in the formulation.
  • the greater the force applied to obtain the tablets the greater the loss of probiotics during the manufacturing process and over the product's shelf life.
  • Probiotics are live microorganisms that, despite being lyophilized, that is, in a latent state, are sensitive to the impact of compression.
  • the product development in the matrix presented was based on the study “Compression of Probiotics and Enzymes with JRS Technology”.
  • the technological excipient silicified microcrystalline cellulose (Prosolv® SMCC 90) was used as a matrix for a Lactobacillus strain. This formulation was compared with another similar formulation, with the exception of Prosolv® SMCC 90, which was replaced by conventional microcrystalline cellulose.
  • probiotic survival rate (viability) was 40% lower for the last formulation when compared to the first, using a compression force of 8 kN and approximately 70% less when using a compression force of 10 kN.
  • Prosolv® SMCC 90 better absorbs the impact of punches on compression when compared to conventional cellulose, in addition to better accommodating strains within the matrix. Therefore, the matrix selected for the development of the product in question was based on the results of the aforementioned study, ensuring greater effectiveness and quality to the product during its validity period.
  • the excipient matrix of the probiotic formulation is composed of a grease agent, an anti-humectant and a lubricant.
  • a dough agent are: corn starch, lactose, microcrystalline cellulose, among others.
  • microcrystalline cellulose was used in the formulation.
  • concentration used of this excipient in the formulation varied between 50 to 90 percent of the total content of the finished product, with the preferred concentration being the arithmetic mean between the lowest and highest concentration.
  • antiumectant are: pharmaceutical talc, sodium carbonate, silicon dioxide, among others.
  • silicon dioxide was used in the formulation.
  • the concentration used of this excipient in the formulation varied between 1 to 3 percent of the total content of the finished product, with the preferred concentration being the arithmetic mean between the lowest and the highest concentration.
  • lubricants are: sodium stearyl fumarate, stearic acid, magnesium stearate, among others.
  • magnesium stearate was used in the formulation.
  • concentration used of this excipient in the formulation varied between 0.5 to 2 percent of the total finished product content, with the preferred concentration being the arithmetic mean between the lowest and the highest concentration.
  • Another aspect of extreme relevance is the delivery of probiotic strains of the product to the human body.
  • the product in the form of a tablet disintegrates completely in approximately 1 minute and laboratory analyzes of viability assessment of the strains for 24 months (product shelf life), demonstrated that there was recovery of probiotic microorganisms at a concentration of 10 8 CFU / portion.
  • the formulation was able to withstand gastrointestinal stress evidenced by the gastric resistance test performed with the product. The loss of viable cells was approximately 1 log, demonstrating that the strains resist the passage of digestive enzymes and bile and are able to reach the intestinal colon region in full condition to act in this location.
  • the manufacturing process for vitamin and mineral tablets consists of the weighing, mixing, compression and coating steps.
  • the component mixing step is a geometric dilution.
  • the entire content is divided and mixed in up to two stages, so that vitamins and minerals of lower concentration are added and mixed first. Then the components of greatest concentration are added and mixed last, ensuring better homogeneity and uniformity of the formulation content.
  • the compression process is carried out by direct compression of the powder.
  • the suspension uses a suspension that offers moisture barrier, being very important for the preservation of vitamins and minerals in addition to masking the metallic flavor of the components of the formulation.
  • the final composition of probiotics is a composition free of gluten, lactose and sugars.
  • the compositions comprise: Lactobacillus acidophilus NCFM®, 10 9 CFU whose concentration in the formulation can vary between 5 to 25 percent of the total content, with the preferred concentration being the range of 10 to 20 percent of this ingredient in the formulation; Bifidobacterium lactis HN019, 10 9 UFC whose concentration in the formulation can vary between 2.5 to 25 percent of the total content, with the preferred concentration being the range of 5 to 15 percent of this ingredient in the formulation; vitamin A, 600 pg RE (100% IDR); niacin, 16 mg (100% IDR); vitamin B6, 1.3 mg (100% IDR); chelated zinc, 7 mg (100% IDR) and copper, 900 pg (100 IDR).
  • lactis in turn, is a bacterium commonly used as a probiotic, found mainly in yogurts and other dairy products.
  • Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements.
  • Micronutrients are elements or compounds that are present in food in small amounts, or traces, and include vitamins, minerals or other elements, and compounds found in foods for which a recommended daily intake (RDI) has not yet been determined.
  • RDI recommended daily intake
  • Some elements such as calcium, sodium, potassium, chloride and phosphorus are consumed in relatively large amounts, while many, such as iron, iodine and zinc, are consumed in small amounts.
  • Vitamins like B12 and folic acid and the minerals copper, selenium and chromium are consumed in very small amounts or trace amounts.
  • composition of probiotics is especially effective when administered together with vitamins and minerals.
  • the preferred formulation of vitamins and minerals comprises vitamin A, vitamin B6, niacin, copper and zinc.
  • the present invention relates to the use of a combination of the compositions of the present invention as a food, food additive, a nutraceutical product, a dietary supplement or a probiotic.
  • tablette refers to a compressed powder.
  • the term includes all physical forms and all sizes, such as a pill, a pellet, a tablet, etc.
  • bacterial composition should be understood as a composition comprising bacterial cells, or a cell culture.
  • the cells are preferably alive or dormant, and it is still preferred that the composition contains at least 10 9 colony-forming units per portion of the product.
  • the bacterial cells may belong to a single strain, or be a mixture of cells belonging to different strains .
  • Two mixtures are prepared, one containing the inputs of the probiotic tablet and the other containing the inputs of the vitamin and mineral tablet.
  • the probiotic product is mixed in one step: 100% excipient and active content (probiotic strains) are added and mixed in twenty minutes. This type of manipulation is sufficient to guarantee the homogeneity of the mixture and, thus, the uniformity of the desired dose of probiotic strains in the tablets.
  • This procedure is performed in a controlled environment, that is, with temperature and humidity strictly monitored. The temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% RH
  • the product mixture containing vitamins and minerals is carried out as follows: the entire content of vitamins and minerals and excipients is added and mixed in a once.
  • This type of manipulation is sufficient to guarantee the homogeneity and uniformity of the formulation content.
  • This procedure is performed in a controlled environment, that is, with temperature and humidity strictly monitored.
  • the temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% RH
  • Two mixtures are prepared, one containing the inputs of the probiotic tablet and the other containing the inputs of the vitamin and mineral tablet.
  • the probiotic product is mixed in two stages: in each stage 50% of the excipient and active content (probiotic strains) are added and mixed in ten minute intervals, totaling, at the end of the process, two mixtures with 100% of the content in 20 minutes.
  • This type of manipulation is sufficient to guarantee the homogeneity of the mixture and, thus, the uniformity of the desired dose of probiotic strains in the tablets.
  • This procedure is performed in a controlled environment, that is, with temperature and humidity strictly monitored.
  • the temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% RH
  • the product mixture containing vitamins and minerals is performed by geometric dilution. The entire content is divided and mixed in two stages, so that vitamins and minerals of lower concentration are added and mixed first. Then, the highest concentration components are added and mixed last, ensuring better homogeneity and uniformity of the formulation content. This procedure is performed in a controlled environment, that is, with the temperature Q humidity closely monitored.
  • the temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% RH
  • Two mixtures are prepared, one containing the inputs of the probiotic tablet and the other containing the inputs of the vitamin and mineral tablet.
  • the probiotic product is mixed in four stages: in each stage 25% excipient and active content (probiotic strains) are added and mixed at 5 minute intervals, totaling, at the end of the process, four mixtures with 100% of the content in 20 minutes.
  • This type of manipulation is sufficient to guarantee the homogeneity of the mixture and, thus, the uniformity of the desired dose of probiotic strains in the tablets.
  • This procedure is performed in a controlled environment, that is, with temperature and humidity strictly monitored. The temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% U.R.
  • the product mixture containing vitamins and minerals is performed by geometric dilution.
  • the entire content is divided and mixed in two stages, so that vitamins and minerals of lower concentration are added and mixed first.
  • the highest concentration components are added and mixed last, ensuring better homogeneity and uniformity of the formulation content.
  • This procedure is performed in a controlled environment, that is, with temperature and humidity strictly monitored.
  • the temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% U.R.
  • BECKENBACH L. et al. Retinoid treatment of skin diseases. Journal of the European Academy of.
  • CHAPMAN M.S. Vitamin A: History, Current Uses, and
  • BARBIERI R.L .; SMITH, S .; RYAN, K.J.The role of hyperinsulinemia in the pathogenesis of ovarian hyperandrogenism. Fertile Steril, vol. 50, pg. 197-212, 1998;

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Abstract

La présente invention concerne un complément alimentaire sous forme de deux comprimés, soit un comprimé enrobé à base de minéraux chélates de zinc et de cuivre, de vitamines A, B3 et B6, et un autre comprimé simple contenant les probiotiques Lactobacillus acidophilus et Bifidobacterium lactis. La présente invention concerne également un procédé de préparation desdits comprimés ainsi que leur utilisation dans le traitement de la dysbiose et de l'acné.
PCT/BR2019/050312 2019-06-18 2019-08-01 Composition nutraceutique combinant des probiotiques, des vitamines et de minéraux WO2020252545A1 (fr)

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BRBR1020190126370 2019-06-18
BR102019012637-0A BR102019012637A2 (pt) 2019-06-18 2019-06-18 composição nutracêutica combinando probióticos, vitaminas e minerais

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WO2023198814A1 (fr) * 2022-04-13 2023-10-19 Bluestone Pharma Gmbh Produit comprimé comprenant des probiotiques et son procédé de production

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Publication number Priority date Publication date Assignee Title
WO2023198814A1 (fr) * 2022-04-13 2023-10-19 Bluestone Pharma Gmbh Produit comprimé comprenant des probiotiques et son procédé de production

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