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BR-102024017721-A2 - PRODUCTION PROCESS, PHARMACEUTICAL COMPOSITION CONTAINING MILK KEFIR AND USE OF THE PHARMACEUTICAL COMPOSITION

BR102024017721A2BR 102024017721 A2BR102024017721 A2BR 102024017721A2BR-102024017721-A2

Abstract

This innovation involves a new method of auxiliary treatment for periodontitis, through the production of a powder-type pharmaceutical formulation containing dried fermented milk kefir. This formulation can be extended to include mouthwash, capsules, lozenges, dragees, tablets, drops, syrup, suspension, scaffold, gel, and oral solutions. These pharmaceutical compositions, obtained through the powder formulation, aim to treat periodontitis, an inflammatory bone disease characterized by the destruction of the soft and hard tissues that support the teeth. It affects 35% to 60% of the adult population, and its most severe form affects 5% to 10% of the world's population. However, it can also be used in other diseases characterized by bone loss. The use of fermented milk kefir in different pharmaceutical formulations is relevant because it maintains therapeutic properties, facilitates storage and administration, and does not compromise organoleptic properties such as taste, odor, and pH. The method for obtaining the powder form consists of steps involving the fermentation of milk kefir and the excipients necessary for the stability of the powder. The composition of other pharmaceutical formulations consists of the addition of preservatives, colorings, sweeteners, flavorings, thickeners, stabilizers, emulsifiers, and antioxidants; however, it is not limited to these. Therefore, the pharmaceutical formulation of dried milk kefir with different fermentation times provides products that can serve as an auxiliary resource for the treatment of periodontal disease and other bone diseases.

Inventors

  • MARIA ELENIR NOBRE PINHO RIBEIRO
  • LORENA VASCONCELOS VIEIRA
  • EVERTON CAVALCANTE DA SILVA
  • ANA BEATRIZ NOGUEIRA LIMA
  • DELANE VIANA GONDIM

Assignees

  • UNIVERSIDADE FEDERAL DO CEARÁ

Dates

Publication Date
20260310
Application Date
20240828

Claims (9)

  1. 1. Production process for a pharmaceutical composition containing milk kefir, characterized by comprising the following steps: a) Packing milk kefir grains in a 5% w/v ratio in commercial whole milk, keeping them in a semi-open glass container (01); b) Fermenting at 20 to 24°C for a period of 6 to 8 days with daily checks using a plastic spatula/spoon (02); c) Separating the fermented milk using a sieve and a plastic spatula/spoon (03); d) Storing in plastic containers and under refrigeration between 4 and 8°C (04); e) Drying (05); f) Adding 0.01 to 0.1% of dried fermented milk kefir; adding the anti-caking agent: silicon dioxide 0.1 to 10.0%; adding the sweetener: sodium saccharin 0.1 to 0.5%; adding the flavoring 0.5 to 1.0% (06);
  2. 2. Process, according to claim 1, characterized by further comprising the following step: g) Adding excipients in order to obtain another desired presentation form.
  3. 3. Process according to claim 2, characterized in that the excipients can be selected from the group comprising: preservatives, colorings, sweeteners, flavorings, thickeners, stabilizers, emulsifiers, antioxidants.
  4. 4. Process according to claim 1, characterized in that the fermentation step (02) is at a temperature of 21 to 23°C for 7 days.
  5. 5. Process, according to claim 1, characterized in that the drying step (05) is carried out by lyophilization, fluidized bed, tray dryer (low temperatures) and tunnel dryer.
  6. 6. Process, according to claim 1, characterized in that the step of adding dry fermented milk kefir (06) to the pharmaceutical composition is at a concentration of 0.02 to 0.07%.
  7. 7. Pharmaceutical composition containing milk kefir characterized by comprising a formulation as described in claims 1 to 6.
  8. 8. Composition according to claim 7, characterized in that it can be presented in the form of: powder, mouthwash, capsules, lozenges, coated tablets, tablets, drops, syrup, suspension, scaffold, gels and oral solutions.
  9. 9. Use of the pharmaceutical composition, as described in claims 7 to 8, characterized by being for the preparation of a medicine or oral hygiene product to prevent and treat periodontal diseases and other bone diseases.

Description

Field of invention [001] The present invention relates to the composition and uses of pharmaceutical formulations containing dried fermented milk kefir and their use in the treatment of periodontal disease and other bone diseases. The unique composition of the dried fermented milk kefir obtained in this invention in the different pharmaceutical formulations demonstrates anti-inflammatory, anti-resorptive and periodontal health-promoting properties, making it an effective alternative to conventional treatments for periodontal disease and other bone diseases. This patent falls within the fields of pharmacy, dentistry and medicine. Fundamentals of the invention [002] Periodontitis is characterized by a chronic inflammatory process that leads to the destruction of the soft and hard tissues that support the dental units. This condition affects 35% to 60% of the adult population, and its most severe form affects 5% to 10% of the world's population. The therapeutic modalities used in the treatment of periodontal disease, however, still present limitations and adverse effects, making it necessary to search for new therapeutic targets. In this context, probiotics have assumed a prominent role due to their numerous beneficial effects already used for other pathological conditions. [003] In this scenario, there is kefir, composed of a complex microbiological diversity, which has already shown an anti-inflammatory and anti-resorptive effect in experimental periodontitis in rats, without presenting considerable adverse effects, when administered in the form of milk kefir drink with 4 days of fermentation (Vieira et al. Biomed Pharmacother, 139:111677, 2021). However, it is worth highlighting that milk kefir drink with 1 day of fermentation showed positive results in controlling bone density loss in rats with osteoporosis when associated with resistance exercise (Vasconcelos et al. Experimental Gerontology, 167:111921, 2022). [004] With emphasis on periodontitis, it is important to highlight that the oral microbiota plays a crucial role in the development and progression of periodontal disease, with the proliferation of pathogenic bacteria associated with gingival inflammation and destruction of periodontal tissue. Conventional treatments include mechanical removal of bacterial biofilm, use of antimicrobial agents, and surgical procedures. However, these approaches may have limitations, such as bacterial resistance and adverse side effects. [005] Currently, the gold standard in the treatment of periodontal disease is scaling and root planing, a mechanical therapy. However, this treatment is not entirely effective in more severe cases of the disease, as well as when the patient, due to some physical limitation or lack of adherence to the treatment itself, does not maintain mechanical therapy at home, making it necessary to use systemic or local antimicrobials as adjuvant therapy, which can contribute to the emergence of opportunistic infections and increased bacterial resistance. Therefore, new therapeutic targets are being researched in order to act as adjuvants in this treatment. [006] In this context, probiotics emerged, live microorganisms that, when ingested in sufficient quantities, are capable of causing beneficial effects to organisms. The use of probiotics in the treatment of periodontal disease corroborates the current definition of the disease, which addresses the concept of dysbiosis, that is, an imbalance in the oral and intestinal microbiota. It also aligns with the current understanding of the etiopathogenesis of this condition, since it considers local aspects of the oral cavity, but also systemic aspects in the determining and modifying factors of periodontal disease. [007] Other probiotics, such as Bifidobacterium, have already been used as adjuvants in the treatment of periodontal disease, with systemic administration, based on the assumption of the bacterial shift they cause in the intestinal microbiota, with effects on the oral microbiota. [008] In a preliminary study by our group (unpublished data), we worked with milk kefir beverage fermented for seven days, showing satisfactory effects on inflammatory parameters and alveolar bone loss characteristic of periodontal disease. However, this product has limitations for human consumption due to the sensitivity of its organoleptic properties. It is known that several factors impact patient adherence to treatment, and when these factors are related to organoleptic properties, they become more significant in treatment abandonment. [009] To highlight the novelty of what is presented in this report, we emphasize that the patents already filed that denote some activity related to kefir generally only concern the production process aimed at the food industry (BR 10 2016 023940 0; BR 10 2022 003219 0) and pharmaceutical industry (BR 10 2020 022544 8; BR 10 2022 017628 0), but no correlation with periodontal disease. Patent BR 10 2016 023940 0, for example, adds