EP4208032A1 - Process for the preparation of colostrum concentrate - Google Patents
Process for the preparation of colostrum concentrateInfo
- Publication number
- EP4208032A1 EP4208032A1 EP21778224.2A EP21778224A EP4208032A1 EP 4208032 A1 EP4208032 A1 EP 4208032A1 EP 21778224 A EP21778224 A EP 21778224A EP 4208032 A1 EP4208032 A1 EP 4208032A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- colostrum
- process according
- fact
- concentrate
- mbar
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 210000003022 colostrum Anatomy 0.000 title claims abstract description 73
- 235000021277 colostrum Nutrition 0.000 title claims abstract description 73
- 238000000034 method Methods 0.000 title claims abstract description 49
- 230000008569 process Effects 0.000 title claims abstract description 44
- 239000012141 concentrate Substances 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 238000000605 extraction Methods 0.000 claims description 5
- 239000008194 pharmaceutical composition Substances 0.000 claims description 5
- 238000001704 evaporation Methods 0.000 claims description 4
- 230000008020 evaporation Effects 0.000 claims description 4
- 230000017423 tissue regeneration Effects 0.000 claims description 4
- ZOEGQXCAXOUFHN-UHFFFAOYSA-N Furosin Natural products OC1C2OC(=O)C(C=3C4C5(O)O)=CC(O)=C(O)C=3OC5(O)C(=O)C=C4C(=O)OC1C(CO)OC2OC(=O)C1=CC(O)=C(O)C(O)=C1 ZOEGQXCAXOUFHN-UHFFFAOYSA-N 0.000 claims description 3
- 201000010099 disease Diseases 0.000 claims description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 3
- 230000005484 gravity Effects 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- CBENFWSGALASAD-UHFFFAOYSA-N Ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 claims description 2
- 208000025865 Ulcer Diseases 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims description 2
- 238000001471 micro-filtration Methods 0.000 claims description 2
- 230000002906 microbiologic effect Effects 0.000 claims description 2
- 230000009854 mucosal lesion Effects 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 238000011069 regeneration method Methods 0.000 claims description 2
- 231100000444 skin lesion Toxicity 0.000 claims description 2
- 206010040882 skin lesion Diseases 0.000 claims description 2
- 230000006641 stabilisation Effects 0.000 claims description 2
- 238000011105 stabilization Methods 0.000 claims description 2
- 230000000699 topical effect Effects 0.000 claims description 2
- 231100000397 ulcer Toxicity 0.000 claims description 2
- CXTMLIMZRPKULL-YXYYPBJFSA-N dnc013643 Chemical compound O([C@@H]1O[C@@H]([C@H]2OC(=O)C=3[C@@H]4C(C(C(=O)C=3)(O)O)(O)OC=3C(O)=C(O)C=C(C4=3)C(=O)O[C@@H]1[C@H]2O)CO)C(=O)C1=CC(O)=C(O)C(O)=C1 CXTMLIMZRPKULL-YXYYPBJFSA-N 0.000 claims 1
- 239000003181 biological factor Substances 0.000 description 5
- 238000004925 denaturation Methods 0.000 description 3
- 230000036425 denaturation Effects 0.000 description 3
- 235000018102 proteins Nutrition 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- YQHPCDPFXQXCMV-VIFPVBQESA-N (2s)-2-amino-6-[[2-(furan-2-yl)-2-oxoethyl]amino]hexanoic acid Chemical compound OC(=O)[C@@H](N)CCCCNCC(=O)C1=CC=CO1 YQHPCDPFXQXCMV-VIFPVBQESA-N 0.000 description 2
- 108060003951 Immunoglobulin Proteins 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000000295 complement effect Effects 0.000 description 2
- 102000018358 immunoglobulin Human genes 0.000 description 2
- 229940072221 immunoglobulins Drugs 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000004445 quantitative analysis Methods 0.000 description 2
- 238000001223 reverse osmosis Methods 0.000 description 2
- 239000011885 synergistic combination Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 241000589876 Campylobacter Species 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 108090000723 Insulin-Like Growth Factor I Proteins 0.000 description 1
- 102000004218 Insulin-Like Growth Factor I Human genes 0.000 description 1
- 108010002350 Interleukin-2 Proteins 0.000 description 1
- 108010063045 Lactoferrin Proteins 0.000 description 1
- 102100032241 Lactotransferrin Human genes 0.000 description 1
- 241000186779 Listeria monocytogenes Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 102000016943 Muramidase Human genes 0.000 description 1
- 108010014251 Muramidase Proteins 0.000 description 1
- 108010062010 N-Acetylmuramoyl-L-alanine Amidase Proteins 0.000 description 1
- 241000607142 Salmonella Species 0.000 description 1
- -1 TGF01 Proteins 0.000 description 1
- 108700012920 TNF Proteins 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 229940050528 albumin Drugs 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 239000005482 chemotactic factor Substances 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- CSSYQJWUGATIHM-IKGCZBKSSA-N l-phenylalanyl-l-lysyl-l-cysteinyl-l-arginyl-l-arginyl-l-tryptophyl-l-glutaminyl-l-tryptophyl-l-arginyl-l-methionyl-l-lysyl-l-lysyl-l-leucylglycyl-l-alanyl-l-prolyl-l-seryl-l-isoleucyl-l-threonyl-l-cysteinyl-l-valyl-l-arginyl-l-arginyl-l-alanyl-l-phenylal Chemical compound C([C@H](N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CC=CC=C1 CSSYQJWUGATIHM-IKGCZBKSSA-N 0.000 description 1
- 235000021242 lactoferrin Nutrition 0.000 description 1
- 229940078795 lactoferrin Drugs 0.000 description 1
- 235000010335 lysozyme Nutrition 0.000 description 1
- 229960000274 lysozyme Drugs 0.000 description 1
- 239000004325 lysozyme Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 210000002826 placenta Anatomy 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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.
Landscapes
- 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)
Abstract
The process for the preparation of colostrum concentrate, comprising the following steps of: a) supply of colostrum; b) concentration of the colostrum comprising the steps of: b1) subjecting the colostrum to controlled vacuum conditions; b2) applying a temperature lower than 45°C to the colostrum.
Description
PROCESS FOR THE PREPARATION OF COLOSTRUM
CONCENTRATE
Technical Field
The present invention relates to a process for the preparation of colostrums concentrate.
Background Art
The fact is known that 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.
It should be noted that in the context of the present disclosure the term “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 concentration of these factors is at its highest within twenty-four hours of delivery and then decreases dramatically in the following hours.
It is, therefore, of paramount importance that colostrum be processed in the immediate postnatal hours using rapid concentration procedures.
In order to speed up the operational steps necessary to carry out concentration procedures, the latter have process conditions that are often detrimental to the biologically active components of colostrum.
In order to ensure that these components do not lose their effectiveness, it is in fact essential that they retain their relative native structure.
Currently, in order to reduce operating times, these concentration procedures require the colostrum to be subjected to high temperatures or low pH values, which cause, e.g., the denaturation of many of the proteins it contains.
Alternatively, other known concentration procedures involve the use of membranes through which the colostrum is made to pass under high pressure values causing the denaturation of many biologically active components
contained therein.
In view of these characteristics, the need is particularly felt to develop processes for concentrating colostrum containing active biological factors unaltered with respect to native colostrum.
Description of the Invention
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 aforementioned objects are achieved by the present process for the preparation of colostrum concentrate having the characteristics of claim 1.
In a further aspect, the objects mentioned above are achieved by the colostrum concentrate having the characteristics of claim 12.
Furthermore, the objects mentioned above are achieved by the pharmaceutical composition having the characteristics of claim 14.
Embodiments of the Invention
In a first aspect 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.
According to a preferred embodiment of the process according to the invention,
colostrum is supplied whole in the hours following delivery.
This means that colostrum is collected in the hours immediately after delivery, i.e., within 36 hours of delivery.
Preferably, colostrum is collected within 24 hours of delivery.
This means that colostrum does not undergo any treatment aimed at modifying its native properties.
Advantageously, colostrum is of bovine, equine or caprine origin.
Alternatively, the supply phase involves freezing the colostrum.
In this case, the colostrum supplied frozen undergoes melting at a temperature of between 4°C and 15°C.
In a further embodiment of the process according to the invention, the supply phase involves supplying colostrum in a freeze-dried or dehydrated state. In the latter case, colostrum is solubilized in water.
In detail, the solubilization ratio between colostrum and water is between 30:70 and 60:40.
In order to promote water removal, controlled vacuum conditions comprise pressure values lower than the atmospheric pressure.
Preferably, such pressure values are lower than 300 mbar.
Advantageously, such pressure values are lower than 150 mbar.
According to a preferred embodiment of the process according to the present invention, the pressure values are comprised between 40 mbar and 80 mbar.
In association with the step of subjecting colostrum to controlled vacuum conditions, the process comprises the step of applying temperature values comprised between 20°C and 40°C.
According to a preferred embodiment, the process comprises the step of applying temperature values comprised between 25°C and 35°C.
Alternatively, such temperature values are lower than 30°C.
Next, the concentration phase comprises an evaporation step of the water contained in the colostrum.
In detail, 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.
It should be underlined that the synergistic combination of controlled vacuum conditions, i.e. the application of pressure values lower than 300 mbar and temperature values lower than 45 °C, makes it possible to achieve the boiling of the colostrum and, therefore, the evaporation of the water contained therein under conditions that are not harmful to the biological active components in the native colostrum.
Advantageously, 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.
If residual water remains in colostrum concentrate, the process comprises an extraction phase of the latter.
Preferably, 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.
Alternatively, the aforementioned extraction phase is carried out by reverse osmosis.
As is well known, 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.
Next, 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.
In a further aspect, 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.
In addition, 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.
MATERIAL AND METHODS A qualitative-quantitative analysis of colostrum obtained by the process according to the present invention is shown in table 1.
RESULTS
Table 1
The analysis in Table 1 shows a furosine content of less than 0.1 mg/lOOg colostrum.
Further confirmation of the efficacy of the process according to the present invention shows the total absence of Salmonella spp, Listeria monocytogenes and Campylobacter spp.
In particular, 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.
It should be pointed out that the synergistic combination of IgG, IgA and IgM with albumin, lactoferrin and lysozyme makes it possible to obtain a surprising healing effect in the process of tissue reconstruction following wounds.
In particular, 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.
This is of fundamental importance, since in order to perform their functions within the body, the active biological factors must not lose their native structure, since loss of structure corresponds to loss of efficacy.
In this regard, in a further aspect, the present invention relates to a pharmaceutical composition comprising colostrum obtained from the previously described process together with other pharmacologically acceptable excipients and/or adjuvants.
Moreover, the aforementioned composition is suitable for topical application or oral administration.
Furthermore, this 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.
It has in practice been ascertained that the described invention achieves the intended objects.
In particular, the fact is emphasized that the special measure of allowing the colostrum to boil at temperatures lower than 45°C in combination with the application of controlled vacuum makes it possible to obtain colostrum concentrate having the biologically active components in their native state, i.e. unaltered from the time of collection in the hours immediately following delivery.
Claims
8
1) Process for the preparation of colostrum concentrate, comprising the following steps of: a) supply of colostrum; b) concentration of said colostrum comprising the steps of: bi) subjecting said colostrum to controlled vacuum conditions; bz) applying a temperature lower than 45°C to said colostrum.
2) Process according to claim 1, characterized by the fact that said controlled vacuum conditions comprise pressure values lower than the atmospheric pressure.
3) Process according to one or more of the preceding claims, characterized by the fact that said pressure values are lower than 300 mbar.
4) Process according to one or more of the preceding claims, characterized by the fact that said pressure values are lower than 150 mbar.
5) Process according to one or more of the preceding claims, characterized by the fact that said pressure values are comprised between 40 mbar and 80 mbar.
6) Process according to one or more of the preceding claims, characterized by the fact that said temperature is comprised between 20°C and 40°C.
7) Process according to one or more of the preceding claims, characterized by the fact that said temperature is comprised between 25°C and 35°C.
8) Process according to one or more of the preceding claims, characterized by the fact that said temperature is lower than 30°C.
9) Process according to one or more of the preceding claims, characterized by the fact that said concentration phase comprises an evaporation step of the water contained in said colostrum.
10) Process according to one or more of the preceding claims, characterized by the fact that it comprises an extraction phase of the residual water contained in said colostrums concentrate.
11) Process according to one or more of the preceding claims, characterized by the fact that said extraction phase is carried out through separation by gravity.
12) Process according to one or more of the preceding claims, characterized by
9 the fact that it comprises a microbiological stabilization phase of said colostrum concentrate carried out through one of: UV rays, microfiltration, ozone flow and high pressure treatment.
13) Process according to one or more of the preceding claims, characterized by the fact that said concentration phase is carried out until a density value of said colostrum comprised between 1,100 mg/kg and 1,250 mg/kg is reached.
14) Colostrum concentrate obtainable through the process according to one or more of the preceding claims having a content of furosin lower than 0.1 mg/lOOg of said colostrum concentrate. 15) Colostrum according to claim 14 having a density lower than 5 kg/1, preferably lower than 2 kg/1.
16) Pharmaceutical composition comprising colostrum concentrate according to claims 14 or 15 together with other pharmacologically acceptable excipients and/or adjuvants. 17) Pharmaceutical composition according to claim 16 suitable for topical application or oral administration.
18) Pharmaceutical composition according to claims 16 or 17 for use in the treatment of diseases requiring tissue repair or regeneration, said diseases being selected from the list comprising: ulcers, skin lesions and mucosal lesions.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102020000020971A IT202000020971A1 (en) | 2020-09-03 | 2020-09-03 | PROCEDURE FOR THE PREPARATION OF CONCENTRATED COLOSTRUM |
| PCT/IB2021/058056 WO2022049531A1 (en) | 2020-09-03 | 2021-09-03 | Process for the preparation of colostrum concentrate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4208032A1 true EP4208032A1 (en) | 2023-07-12 |
Family
ID=73139295
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21778224.2A Pending EP4208032A1 (en) | 2020-09-03 | 2021-09-03 | Process for the preparation of colostrum concentrate |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4208032A1 (en) |
| IT (1) | IT202000020971A1 (en) |
| WO (1) | WO2022049531A1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ239466A (en) * | 1990-08-17 | 1993-12-23 | Us Agriculture | Desalted colostrum: spray dried product from retentate of |
| CZ279422B6 (en) * | 1992-04-28 | 1995-04-12 | Biofeed S.R.O. | Process for preparing loose , biologically valuable feeding mixtures suitable for storage |
| AU6847894A (en) * | 1993-06-23 | 1995-01-17 | Viable Bioproducts Ltd. | Method for the improvement of wound healing and compositions therefor |
| IT1291340B1 (en) * | 1997-05-09 | 1999-01-07 | Vander Way Limited | PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF ORAL CAVITY DISEASES |
| CN1059128C (en) * | 1997-08-28 | 2000-12-06 | 王文荣 | Milk powder containing specific immunity globulin and its prodn. method |
-
2020
- 2020-09-03 IT IT102020000020971A patent/IT202000020971A1/en unknown
-
2021
- 2021-09-03 WO PCT/IB2021/058056 patent/WO2022049531A1/en unknown
- 2021-09-03 EP EP21778224.2A patent/EP4208032A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IT202000020971A1 (en) | 2022-03-03 |
| WO2022049531A1 (en) | 2022-03-10 |
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