Classifications

• • 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
  • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
  • A61K35/20—Milk; Whey; Colostrum
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
  • A23C9/00—Milk preparations; Milk powder or milk powder preparations
  • A23C9/20—Dietetic milk products not covered by groups A23C9/12 - A23C9/18
  • A23C9/206—Colostrum; Human milk
• • 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
  • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

• the present invention relates to a process for the preparation of colostrums concentrate.
• serum, placenta and colostrum contain numerous biologically active factors, e.g. vital protein factors such as cytokines, growth factors, chemotactic factors, complement factors and other active components.
• vital protein factors such as cytokines, growth factors, chemotactic factors, complement factors and other active components.
• biologically active factors or “active biological factors” relates to components that have a certain biological activity, including all substances that have a therapeutic or beneficial effect on the body.
• Colostrum is particularly rich in these factors, which are in particular INFy, TNFa, TGF01, IGF-1, immunoglobulins such as IgG, IgM and IgA, IL-2 and complement factors C3A and C4A.
• the main aim of the present invention is to provide a process for the preparation of colostrum concentrate which makes it possible to keep the biologically active components of native colostrum unaltered.
• One object of the present invention is to provide a process for the preparation of colostrum concentrate which has low operating times, compared to known processes, allowing the biological effectiveness of the components contained therein to be maintained.
• Another object of the present invention is to devise a process for the preparation of colostrum concentrate which enables the aforementioned drawbacks of the prior art to be overcome within the framework of a simple, rational, easy and effective to use as well as affordable solution.
• the objects mentioned above are achieved by the colostrum concentrate having the characteristics of claim 12.
• the present invention relates to a process for the preparation of colostrum concentrate.
• the process comprises the following phases of: a) supply of colostrum; b) concentration of colostrum comprising the steps of: bi) subjecting colostrum to controlled vacuum conditions; bi) applying a temperature lower than 45°C to colostrum.
• colostrum is supplied whole in the hours following delivery.
• colostrum is collected in the hours immediately after delivery, i.e., within 36 hours of delivery.
• colostrum is collected within 24 hours of delivery.
• colostrum is of bovine, equine or caprine origin.
• the supply phase involves freezing the colostrum.
• the colostrum supplied frozen undergoes melting at a temperature of between 4°C and 15°C.
• the supply phase involves supplying colostrum in a freeze-dried or dehydrated state.
• colostrum is solubilized in water.
• solubilization ratio between colostrum and water is between 30:70 and 60:40.
• controlled vacuum conditions comprise pressure values lower than the atmospheric pressure.
• such pressure values are lower than 300 mbar.
• such pressure values are lower than 150 mbar.
• the pressure values are comprised between 40 mbar and 80 mbar.
• the process comprises the step of applying temperature values comprised between 20°C and 40°C.
• the process comprises the step of applying temperature values comprised between 25°C and 35°C.
• such temperature values are lower than 30°C.
• the concentration phase comprises an evaporation step of the water contained in the colostrum.
• the evaporation step allows removing the water from the colostrum allowing it to be concentrated at a concentration ratio of 5:1 with respect to the native colostrum. This means that 1 kg of colostrum concentrate is obtained for 5 kg of native colostrum by carrying out the process according to the present invention.
• the concentration phase is carried out until a density value of colostrum comprised between 1,100 mg/kg and 1,250 mg/kg is reached.
• the process comprises an extraction phase of the latter.
• the aforementioned extraction phase is carried out through separation by gravity.
• This separation by gravity is achieved by means of centrifugation at 10,000 RPM for an operating time of substantially 120 seconds.
• the aforementioned extraction phase is carried out by reverse osmosis.
• reverse osmosis also known as hyperfiltration, is the process whereby solvent molecules, in the present case residual water, are forced from the more concentrated solution, in the present case colostrum concentrate, to the less concentrated solution obtained by applying a pressure greater than the osmotic pressure to the colostrum concentrate.
• the process comprises a microbiological stabilization phase of the colostrum concentrate carried out through one of: UV rays, microfiltration, ozone flow and high pressure treatment.
• the present invention relates to colostrum concentrate obtainable from the process described above and having a furosine content of less than 0.1 mg/lOOg of colostrum concentrate.
• the aforementioned colostrum has a density lower than 5 kg/1, preferably lower than 2 kg/1.
• Example 1 Qualitative-quantitative analysis of colostrum concentrate obtained by the process according to the invention.
• Table 1 shows a furosine content of less than 0.1 mg/lOOg colostrum.
• the process described in the present invention offers the advantage of obtaining colostrum concentrate characterized by the presence of active biological factors comprising immunoglobulins specific to the animal species from which it is derived and which may be used for therapeutic purposes.
• the process according to the present invention offers the advantage of obtaining the aforementioned active biological factors in a biologically active form, thanks to the non-use of any treatment which could cause denaturation of the proteins and modification of their tertiary structure, such as high temperatures or low pH values.
• the present invention relates to a pharmaceutical composition
• a pharmaceutical composition comprising colostrum obtained from the previously described process together with other pharmacologically acceptable excipients and/or adjuvants.
• composition is suitable for topical application or oral administration.
• composition is suitable for use in the treatment of diseases requiring tissue repair or regeneration, the latter being selected from the list comprising: ulcers, skin lesions and mucosal lesions.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Medicinal Chemistry (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Dermatology (AREA)
• Polymers & Plastics (AREA)
• Food Science & Technology (AREA)
• Nutrition Science (AREA)
• General Chemical & Material Sciences (AREA)
• Biotechnology (AREA)
• Cell Biology (AREA)
• Developmental Biology & Embryology (AREA)
• Immunology (AREA)
• Virology (AREA)
• Zoology (AREA)
• Epidemiology (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)

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Citations (5)

• 2020
  • 2020-09-03 IT IT102020000020971A patent/IT202000020971A1/it unknown
• 2021
  • 2021-09-03 EP EP21778224.2A patent/EP4208032A1/en active Pending
  • 2021-09-03 WO PCT/IB2021/058056 patent/WO2022049531A1/en unknown

Patent Citations (5)

Non-Patent Citations (1)

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