WO2019031976A2

WO2019031976A2 - A multi-ingredient preparation for finger and toe nail regeneration and a method of preparation thereof

Info

Publication number: WO2019031976A2
Application number: PCT/PL2018/000072
Authority: WO
Inventors: Aneta OLESZEK
Original assignee: Podopharm - Sp. Z O. O.
Priority date: 2017-08-10
Filing date: 2018-07-12
Publication date: 2019-02-14
Also published as: EP3615048A2; PL233616B1; WO2019031976A9; PL422524A1

Abstract

The present invention refers to a multi-ingredient preparation for finger and toe nail regeneration and a method of preparation thereof. The multi-ingredient preparation for finger and toe nail regeneration contains 2.00% to 8.00% by weight of an active substance in the form of fat colostrum with 30% to 50% of fat originating from bovine colostrum; favorably, bovine colostrum fat is cow's colostrum milk, 3.0% to 5.00% by weight of an emulsifier in the form of a mixture of olivate cetearyl and olivate sorbitane, 2% to 4.5% by weight of an emollient in the form of olive squalane, 0.30% to 0.70% by weight of an emulsifier in the form of glycerol stearate, 1.70% to 2.20% by weight of an emollient in the form of glycerol tristearate (stearine), 2.50% to 3.50% by weight of an emollient in the form of avocado oil, 0.15% to 0.25% by weight of an emollient in the form of buckthorn oil, 0.60% to 1.00% by weight of a thickener in the form of sodium polyacrylate, 0.05% to 1.50% by weight of an antioxidant in the mixture of polyethylene glycol, vitamin E, ascorbyl palmitate, ascorbic acid, citric acid, 0.50% to 2.00% by weight of vitamin E acetate, 2.00% to 5.00% by weight of a conditioner in the form of pentylene glycol, 3.00% to 6.00% by weight of a conditioner in the form of propanediol, 0.05% to 1.00% by weight of a thickener in the form of xanthan gum polysaccharide, 0.10% to 0.50% by weight of a chelating substance in the form of edetate disodium, 0.50% to 1.50% by weight of a preservative in a mixture of phenoxyethanol and ethylhexylglycerin, 0.10% to 0.40% by weight of a perfume composition with limonene perfume and an addition of linalool, and deionized water to make it up to 100% of weight.

Description

A multi-ingredient preparation for and toe nail regeneration and a method of preparation thereof

The invention refers to a multi-ingredient preparation for finger and toe nail regeneration and a method of preparation thereof.

The main purpose for which the multi-ingredient preparation for finger and toe nail regeneration according to the invention may be used is the treatment and regeneration of finger and toe nails affected by onycholysis of finger and toe nails, as well as the treatment of nails affected by other conditions causing psoriasis .

Frequently occurring severe nail disease is not always a result of severe skin psoriasis, and the type of disease- caused changes in nails is not always related to a specific distribution of skin changes. Clinical symptoms of psoriasis may be referred to the location of the condition in nail epidermal structures. Main psoriasis-related symptoms on nails by frequency are:

1) erosions:

erosions are spot pits, mostly small and shallow, of various size, depth and shape. They form in psoriasis lesions in the back part of the matrix (area where a nail forms) . Most erosions are superficial, however if extensive, they may result in serious color and structure anomalies and may lead to nail brittleness. In the histological sense, erosions are a defect of the nail plate surface but when psoriasis is more advanced, an erosion may enlarge and result in a hole in the nail plate .

) nail discoloration:

a typical symptom is leukonychia (white spots on the nail) if the condition affects nail matrix, or salmon pink discoloration if nail bed is affected. Psoriasis in the nail bed results in oval oily salmon pink spots of various size.

) onycholysis:

is a loss of autonomous integrity between the nail plate on fingers and toes and the nail bed beneath. Onycholysis manifests itself in an irregular border between the pink part of the nail plate and its white edge when it pulls away from the nail bed. This condition occurs mainly when oily spots occur under nail plate, medially or on the side. A nail affected by onycholysis is yellowish as air and scales accumulate under its surface.

) subungual hyperkeratosis:

thickening of tissue under the nail plate. The condition is manifested by the accumulation of scales which results from a change in keratin composition in psoriasis of the nail bed.

) anomalies of the nail plate area:

include rows of grooved lines running from side to side, in particular on thumbs; similar to Beau's lines. Other frequently occurring anomalies include lateral eruptions on a nail with tubercles resembling drops of melted wax. 6) linear subungual petechiae:

occur on finger nails in 42% of patients with psoriasis suffering from a nail disease, and in 6% on toe nails. Their form reflects the run of capillaries in the nail bed and the growth and brittleness of those capillaries in the course of active psoriasis.

The cause of nail detachment is often unknown. It is known that correctly formed nail bed does not have the granular layer of epidermal cells present as keratinocytes . Each process disturbing the formation of the nail bed, including also psoriasis, may contribute to the formation of the granular layer in nail bed which in consequence leads to onycholysis. Taking into account the cause behind this symptom, we can distinguish between primary onycholysis i.e. idiopathic of unknown cause, and secondary onycholysis .

Primary onycholysis is often observed in people overusing nail treatment such as manicure, moisturizers, or using solvents included in cosmetics. Similarly, primary onycholysis is more often found in people with excessively long nails in whom even a smallest injury may cause the condition .

Secondary onycholysis, on the other hand, is most often caused by: skin conditions - psoriasis, onychomycosis, Reiter's Syndrome (inflammatory arthritis), excessive sweating, pemphigus vulgaris, pellagra, leprosy, syphilis etc.; certain medications: antibiotics cephaloridine, chloramphenicol, doxycycline; chemotherapeutic drugs - adriamycin, bleomycin, fluorouracil (5-FU), mitoxantrone, docetaxel, paclitaxel; other - captopril, retinoids, thiazide diuretics; systemic condition - thyroid gland conditions (including hyperthyroidism or hypothyroidism) , yellow nail syndrome, lung cancer, multiple myeloma, scleroderma, iron-deficiency anemia, diabetes and peripheral vessels conditions.

International patent application WO 98/16251 discloses a composition for treating nail conditions such as bacterial infections, infections caused by unknown substances, psoriasis infections and other nail inflammatory conditions. The composition includes a carrier system for the permeation of active compounds such as for instance fatty acid, its ester or polypropylene glycol, and active compounds such as antimycotics e.g. fluconazole, antibiotics, antiseptics or corticosteroids, and other enhancing additives. Such compositions are prepared in the form of tinctures, emulsions, solutions, ointments, creams or pastes.

European patent EP 0913154 discloses a nail varnish for the treatment of psoriasis of the nails comprising an active substance i.e. corticosteroid being a strong antiinflammatory agent, and salicylic acid and other additives.

European patent EP 1680076 discloses pharmaceutical and cosmetic compositions for treating nails containing compounds of the general formula R-O-Ri, wherein R is a linear or branched alkyl group comprising 5-8 carbon atoms and Ri is a formyl or an acetate group which have an excellent capacity of penetration through the keratinized nail substance and the adjacent skin, but they also have the ability to transport both therapeutic active substances such as antifungals, antibiotics, antiseptics and corticosteroids, as well as substances appropriate for nail care such as nutrients and building blocks. European patent EP 2117565 discloses the use of chitosan, a chitosan derivative or a physiologically acceptable salt thereof, for the preparation of a medication, or a medical device, or a sanitary product, or a cosmetic, in the form of a nail lacquer, useful for the topical treatment of inflammatory diseases of the nails, such as psoriasis, lichen planus and atopic dermatitis .

Prior art does not disclose an efficient agent for topical treatment of nail diseases or topical nail care which contains a carrier transporting an active substance required for a long-term success of the therapy through the nail to the nail bed and nail root (matrix) .

The objective of this invention is to develop a multi- ingredient preparation to be used in a composition which during the described combined topical/systemic treatment of nail psoriasis, including treatment of onycholysis, does not have the defects known from prior art.

Unexpectedly it turned out that natural proteins such as immunoglobulin, lactoferrin, lysozyme or lactoperoxidase present in lyophilized fat colostrum have the capacity to penetrate finger and toe nails, and to successfully treat infections causing nail inflammatory disorders, and in particular to successfully treat onycholysis. An important ingredient of the lyophilized fat colostrum commercially called cream colostrum is fat from bovine colostrum containing over 250 highly-concentrated compounds - not found in any other product of natural origin.

A multi-ingredient preparation for finger and toe nail regeneration according to the invention contains: 2.00% to 8.00% by weight of active substance in the form of lyophilized fat colostrum containing 30% to 50% of fat from bovine colostrum; preferably the fat from bovine colostrum is cow colostrum milk. Commercial name of fat colostrum is Cream Colostrum; and as emulsifiers, emollients, antioxidants, conditioners, thickeners and other necessary substances such as:

3.00% to 5.00% by weight of an emulsifier in the form of a mixture containing 50% to 70% by weight of cetearyl olivate and 30% to 50% by weight of sorbitan olivate. Commercial name of this emulsifier is Olivem 1000;

2.00% to 4.50% by weight of an emulsifier in the form of olive squalane;

0.30% to 0.70% by weight of an emulsifier in the form of glyceryl stearate. Commercial name of this emulsifier is Cutina GMS V;

1.70% to 2.20% by weight of an emulsifier in the form of glyceryl tristearate (stearin). Commercial name of this emulsifier is Crodamol GTIS;

2.50% to 3.50% by weight of an emulsifier in the form of avocado oil;

0.15% to 0.25 by weight of an emulsifier in the form of

buckthorn oil;

0.60% to 1.00% by weight of a thickener in the form of

sodium polyacrylate. Commercial name of this thickener is Cosmedia SP; 0.05% to 1.50% by weight of an antioxidant being a mixture of 69% by weight of polyethylene glycol with 24% by weight of vitamin E, with 5% by weight of ascorbyl palmitate, with 1% by weight of ascorbic acid with 1% by weight of citric acid. Commercial name of the antioxidant is Oxynex K liquid;

0.50% to 2.00% by weight of antioxidant being vitamin E

acetate ;

2.00% to 5.00% by weight of a conditioner being pentylene glycol. Commercial name of this conditioner is Hydrolite 5;

3.00% to 6.00% by weight of a conditioner being

propanediol. Commercial name of this conditioner is Zemea;

0.05% to 1.00% by weight of a thickener in the form of

xanthan gum polysaccharide;

0.10% to 0.50% by weight of a chelating substance being

edetate disodium;

0.50% to 1.50% by weight of a preservative being a mixture of 90% by weight of phenoxyethanol with 10% by weight of ethylhexylglycerin . Commercial name of this preservative is Euxyl PE 9010;

0.10% to 0.40% by weight of a perfume composition

containing parfum with limonene with an addition of linalool. Commercial name of the perfume composition is Babynours Natflor RS27147/03;

to make it up to 100% by weight, a multi-ingredient preparation for the regeneration of finger and toe nails contains a solvent in the form of deionized water. The formula of a multi-ingredient preparation for finger and toe nail regeneration is based on liquid crystal emulsions, thanks to which penetration of active ingredients is effective due to their lamellar structure. A multi-ingredient preparation for finger and toe nail regeneration contains olive squalane and valuable oils such as buckthorn oil and avocado oil, which are known for their regenerating properties.

Lyophilized fat colostrum contains at least 30% to 50% of fat from bovine colostrum obtained no later than two hours from the termination of delivery. Lyophilized fat colostrum is a basic component of a multi-ingredient preparation for finger and toe nail regeneration, in particular for nails affected by onycholysis. The biggest advantage of the colostrum lies in proteins it contains such as immunoglobulin, lactoferrin, lysozyme or lactoperoxidase . These substances show strong antibacterial, antiviral and antifungal properties. Bovine colostrum also contains fats, carbohydrates, growth factors and derivatives of nucleic acids and easily digestible calcium. Fat colostrum is also characterized by high content of vitamins from group B and A, D and E.

Preferably, a multi-ingredient preparation for finger and toe nail regeneration according to the invention contains :

5.00% by weight of an active substance in the form of

lyophilized colostrum containing 30% to 50% fat from bovine colostrum. Preferably the content of fat from bovine colostrum is 40% and preferably the bovine colostrum is the cow milk colostrum. Commercial name of fat colostrum is Cream Colostrum;

% by weight of an emulsifier in the form of a mixture of 50% to 70% by weight of cetearyl olivate with 30% to 50% by weight of sorbitan olivate. Commercial name of this emulsifier is Olivem 1000;

% by weight of an emollient in the form of olive

squalane;

% by weight of an emulsifier in the form of glycerol stearate. Commercial name of this emulsifier is Cutina GMS V;

% by weight of an emollient in the form of glycerol tristearate stearin) . Commercial name of this emollient is Crodamol GTIS;

% by weight of an emollient in the form of avocado oil;% by weight of an emollient in the form of buckthorn oil ;

% by weight of a thickener in the form of sodium

polyacrylate . Commercial name of this thickener is Cosmedia SP;

% by weight of an antioxidant being a mixture of 69% by weight of polyethylene glycol with 24% by weight of vitamin E with 5% by weight of ascorbyl palmitate, with 1% by weight of ascorbic acid with 1% by weight of citric acid. Commercial name of the antioxidant is Oxynex K liquid;

% by weight of an antioxidant in the form of vitamin E acetate;

% by weight of a conditioner in the form of pentylene glycol. Commercial name of this conditioner is Hydrolite 5;

% by weight of a conditioner in the form of propanediol. Commercial name of this conditioner is Zernea;

0.05% by weight of a thickener in the form of xanthan gum polysaccharide;

0.10% by weight of a chelating substance in the form of

edetate disodium;

1.00% by weight of a preservative being a mixture of 90% by weight of phenoxyethanol with 10% by weight of ethylhexylglycerin . Commercial name of this preservative is Euxyl PE 9010;

0.20% by weight of a perfume composition containing perfume with limonene with an addition of linalool.

Commercial name of the perfume composition is

Babynours Natflor RS27147/03; and up to 100% by weight of a complementary solvent being deionized water.

A method of preparation of a multi-ingredient preparation for finger and toe nail regeneration according to the invention consists in the preparation of a hot oil phase of the preparation in a container with a stirrer. Components constituting the oil phase in the formula of the preparation are pre-weighed according to the invention in % by weight. Stirring and heating up of the components of the oil phase up to the temperature of 80 °C is performed in a container with a stirrer. Pre-weighed components of the oil phase in the following amounts are added to the container with the stirrer in the following proportins: 2.00% to 5.00% of a mixture of cetearyl olivate with sorbitan olivate;

2.00% to 4.50% of olive squalane;

2.50% to 3.50% of avocado oil;

1.70% to 2.20% of an emulsifier in the form of glycerol

stearate, and then the stirrer and the container heating system are activated.

During the heating, the oil phase is continously stirred. When a temperature of the stirred oil phase reaches approx. 70°C-78°C, the following components are added in weighed % by weight:

0.15% to 0.25% of buckthorn oil;

0.50% to 2.00% of vitamin E acetate;

0.60% to 1.00% of sodium polyacrylate;

0.05% to 1.50% of an antioxidant being a mixture of

polyethylene glycol, vitamin E, ascorbyl palmitate, ascorbic acid and citric acid.

At the same time deionized water pre-heated to 75°C - 80 °C in the amount of 95% of the total volume of deionized water resulting from the volume of components is added to the mixer preheated to 75°C. Then the following components weighed in % by weight are added to the mixer with heated deionized water:

0.10% to 0.50% of a chelating substance in the form of

edetate disodium; and 3.00% to 6.00% of a conditioner in the form of propanediol.

Following the addition of these components, the stirrer of the mixer is activated, its speed is set preferably at 30 revolutions per minute, and at the same time the mixer heating system is activated. The mixture in the mixer is heated up to 80°C. At the end of the heating process, when temperature reaches approx. 75°C, another conditioner in the form of pentylene glycol in the amount of 2.00% to 5.00% by weight is added to the continuously stirred and heated mixture. Then the container with the stirrer containing the oil phase with a thickener and an emollient heated up to 80°C is connected with a tight pipe to a mixer containing a mixture of deionized water with conditioner and the chelating substance heated up to 80°C. Then a vacuum pump connected to the mixer is activated and a negative pressure of 0.02 MPa to 0.06 MPa is obtained inside the mixer. Preferably, the value of negative pressure inside the mixer remains at the level of 0.04 MPa. Negative pressure value ranging from -0.02 MPa to -0.06 MPa makes it possible to suction the entire oil phase from the container with the stirrer to the mixer with the deionized water and added components. Once the mixture containing deionized water, conditioners and chelating substance is blended with oil phase mixture suctioned from the mixer, the mixtures are stirred together for two more minutes. Then homogenizer is activated for 5 minutes, preferably revolving with a speed of 2000 revolutions per minute. Following the homogenization process, the mixture obtained together with the stirrer is cooled to a temperature of approx. 60°C. 1.70% to 2.20% by weight of an emollient in the form of glycerol trxstearate is poured into a separate vessel to which 0.05% to 1.00% by weight of a thickener in the form of xanthan gum powder is added and the components undergo stirring. The process of stirring xanthan gum with glycerol tristearate results in dispersion being a suspension of xanthan gum in a liquid emollient.

Dispersion or a disperse system of xanthan gum with glycerol tristearate is a suspension of two phases of which one phase is a finely divided xanthan gum which is dispersed in the second phase i.e. glycerol tristearate, referred to as continuous phase.

Thus prepared dispersion is added to the mixture cooled to the temperature of approx. 60 °C and then the mixture undergoes another homogenization process for 2 minutes, with the stirrer speed preferably at 2000 revolutions per minute. Once the homogenization process is over, the mixture is stirred for 10 minutes with stirrer speed preferably at 60 revolutions per minute. The mixture and the stirrer are then cooled to approx. 40°C.

Fat colostrum is dissolved in a separate vessel in the remaining amount of deionized water making up for 5% by weight of total amount of deionized water resulting from the quantitative composition of components and is added to the mixture cooled to approx. 40°C, and the mixture undergoes stirring for 10 minutes with stirrer speed preferably at 40 revolutions per minute. The mixture and the stirrer are then cooled to approx. 30°C. 0.50% to 1.50% by weight of a preservative being a mixture of phenoxyethanol with ethylhexylglycerin and 0.10% to 0.40% by weight of a perfume composition containing perfume with limonene with an addition of linalool is added to the mixture cooled to approx. 30°C, and the mixture again undergoes stirring with mixer speed preferably at 40 revolutions per minute. During the stirring process and further cooling of the mixture to ambient temperature of approx. 20°C, pH value of the mixture is measured. The pH value of the mixture being a multi-ingredient preparation for finger and toe nail regeneration is 6.0 to 6.5. If the pH value after the measurement is lower than 6.0, the mixture in the mixer undergoes neutralization by adding 20% solution of sodium hydroxide in the amount making it possible to achieve pH value of 6.0 to 6.5. Once the neutralizer is added, the mixture in the mixer again undergoes homogenization by activating the homogenizer set preferably at 1500 revolutions per minute for approx. 30 seconds and then the value of pH is checked again.

A ready multi-ingredient preparation for finger and toe nail regeneration is poured into a temporary vessel and is then is portioned and packaged for sale.

The advantage of the multi-ingredient preparation for finger and toe nail regeneration is permanent regeneration of nail bed, and in consequence disappearance of onycholysis, bigger elasticity of the plate, proper nourishment of nail tissue, stimulated nail plate growth and restoration of proper color to nails treated with multi-ingredient preparation for nail regeneration.

A multi-ingredient preparation for the regeneration of finger and toe nails and the method of the production thereof was disclosed in an embodiment. Example kg set of the following components was prepared:

5.00 kg of a lyophilized active substance powder in the form of fat colostrum, known under commercial name of Cream Colostrum, containing 40% of fat from bovine colostrum;

4.00 kg of a mixture of olivate cetearyl with olivate sorbitan;

3.00 kg of olive squalane;

0.50 kg of glycerol stearate;

2.00 kg of glycerol tristearate (stearin);

3.00 kg of avocado oil;

0.20 kg of buckthorn oil;

0.80 kg sodium polyacrylate;

0,.5 kg of an ani-oxidant in the form of a mixture of polyethylene glycol, vitamin E, ascorbyl palmitate, ascorbic acid and citric acid;

1.00 kg of vitamin E acetate;

5.00 kg of pentyl glycol;

6.00 kg of propanediol;

0.05 kg of xanthan gum polysaccharide;

0.10 kg of edetate disodium;

1.00 kg of a preservative in the form of a mixture of phenoxyethanol and ethylhexylglycerin; 0.20 kg of perfume composition in the form of a

mixture of limonene and linalool.

68.10 kg of deionized water to make it up to

100 kg. This volume of deionized water was divided in two parts:

64.70 kg making up 95% by weight of its weighed volume

and

3.40 kg making up 5% by weight of its

weighed volume

An amount of 10 kg of pre-weighed components of the oil phase was poured into a 100 1 melter, said oil phase composed of a mixture of cetearyl olivate with sorbitan olivate from olive squalane and from avocado oil. A stirrer was started up with a speed of 30 rotations per minute. The melter was heated with an oil phase inside for a time of 40 minutes until a temperature of 80 °C was reached. At the end of oil phase stirring and heating, when its temperature was 75 °C 2.05 kg of pre-weighed further components were added, such as buckthorn oil, vitamin E acetate, sodium polyacrylate and an antioxidant in the form of a mixture of polyethylene glycol and vitamin E, with ascorbyl pamitate, ascorbic acid and citric acid. Everything was mixed together for 2 minutes with a stirrer preset to 10 revolutions per minute.

Afterwards a water heater was turned on to heat 64.7 kg od deionized water up to 78 °C and a system of mixer preheating was activated and heated up to 75°C.

64.70 kg of deionized water preheated up to 78°C was poured into a preheated mixer, type A6 HM 65-005 manufacture by VAKUMIX, with a capacity of 150 liters, and 6.10 kg of pre-weighed edetate disodium and propanediol was added. After addition of deionized water and 6.10 kg of the next components, temperature of a mixture inside the mixer dropped to 73^CC. Furthermore, a stirrer preset to 30 revolutions per minute was activated, and a system of mixer preheating was turned on, with a mixer being heated up to 80 °C. When, while heating, a temperature of deionized water mixed with component additions reached 75 °C, a conditioner in the form of pentylene glycol was added to the mixture in the amount of 5.00 kg, and afterwards deionized water with component additions was further stirred and preheated.

After the mixture reached 80 °C while it was continuously stirred in mixer, the mixer and the melter were connected with an additional tight pipe enabling utilities flow. Furthermore, a vacuum pump was started up to create a negative pressure of -0.4 MPa .

The negative pressure achieved in the melter thanks to the use of said tight pipe suctioned the preheated oil phase and other components from the melter to the mixer. After the preheated oil phase blended with preheated deionized water, the mixture was stirred for 2 minutes and the stirrer was turned off. Then, for 5 minutes, a homogenizer preset to 2000 revolutions per minute was activated in the mixer. After homogenization process was completed, the mixer with the mixture inside was cooled to 60 °C. Cooling time was 10 minutes.

In a separate 3-liter vessel, dispersion was prepared of 0.05 kg of xanthan gum mixed in 2.00 kg of glycerol tristearate .

This dispersion was added to a mixture cooled to 60 °C, which was inside the mixer, and the mixture and the dispersion were homogenized again for approx. 2 minutes in a homogenizer preset to 2000 revolutions per minute.

After secondary homogenization was completed, a mixture in the mixer was stirred with a stirrer preset to 60 revolutions per minute for 10 minutes. Afterwards, the well mixed mixture and the mixer were again cooled to 40°C.

The remaining amount of 3.40 kg of deionized water was poured into a separate 5 liter vessel, where 5.00 kg of fat colostrum in the form of lyophilized powder with 40% of fat from bovine colostrum was solved. A glass rod was used to mix deionized water in the vessel until fat colostrum solved completely in it.

Fat colostrum solved in deionized water, with 40% of fat from bovine colostrum was added to the mixture cooled to 40°C. Afterwards, the mixture in the mixer underwent stirring process with a stirrer preset to 40 revolutions per minute.

Afterwards, the mixture after stirring and the mixer were cooled to 30°C. Cooling time was 10 minutes.

1.20 kg of a mixture of phenoxyethanol and ethylhexylglcerin and perfume compositions was added to the mixture in the mixer cooled to 30°C. The stirrer was preset to 40 revolutions per minute. At the end of the stirring process, pH was measured.

A multi-ingredient preparation for finger and toe nail regeneration was obtained, the basic parameters of which were assessed as shown in table 1.

Table 1

Physical and chemical requirements for resultant multi-ingredient preparation for regeneration of finger and toe nails suffering from onychliosis

# Feature Requirements Examination method

Homogenous, smooth

1. emulsion without

Appearance

mechanical

contamination

From light-yellow to

2. Organoleptic

Color orange / according to

the accepted model

Pleasant, specific for

3. Scent a perfume composition

used

4. Directly in pH at 20°C ±1°C 6.3

the mass

5. Density at 20°C

0.995 Pycnometric ±1°C [g/cm³]

Stability at Centrifuge :

6. +40°C±5°C for Complete stability 5000 24h revolutions per minute,

7. Stability at time of 10

Complete stability

4°C±5°C for 24h minutes

8. Microbiological According to Polish standard PN EN requirements IS017516 The resultant multi-ingredient preparation for finger and toe nail regeneration was then poured into a disinfected container, from which it was portioned and packed into commercial packaging.

Claims

Claims l.A multi-ingredient preparation for finger and toe nail regeneration, containing emulsifiers, emollients, antioxidants, conditioners, thickeners and perfume compositions and deionized water, characterized in that it comprises: 2.00% to 8.00% by weight of an active substance in the form of lyophilized fat colostrum containing 30% to 40% of fat from bovine colostrum milk; 3.00% to 5.00% by weight of an emulsifier in the form of a mixture of cetearyl olivate with sorbitan olivate; 2.00% to 4.50% by weight of an emollientu in the form of olive squalane; 0.30% to 0.70% by weight of an emulsifier in the form of glycerol stearate;

1.70% to 2.20% by weight of an emollient in the form of glycerol tristearate (stearin);

2.50% to 3.50% by weight of an emollient in the form of avocado oil;

0.15% to 0.25% by weight of an emollient in the form of buckthorn oil;

0.60% to 1.00% by weight of a thickener in the form of sodium polyacrylate;

0.05% to 1.50% by weight of an antioxidant being a

mixture of 69% by weight of polyethylene glycol with 24% by weight of vitamin E, with 5% by weight of ascorbyl palmitate, with 1% by weight of ascorbic acid and with 1% by weight of citric acid,

2.00% to 5.00% by weight of a conditioner in the form of pentylene glycol,

3.00% to 6.00% by weight of a conditioner in the form of propanediol ;

0.05% to 1.00% by weight of a thickener in the form of xanthan gum polysaccharide;

0.10% to 0.50% by weight of a chelating agent in the form of edetate disodium;

0.50% to 1.50% by weight of a preservative in a mixture comprising 90% by weight of phenoxyethanol and 10% by weight of ethylhexylglycerin , 0.10% to 040% by weight of a perfume composition with

limonene perfume and an addition of linalool ; and deionized water to make it up to 100% of weight.

2. A preparation as claimed in claim 1 characterized in that bovine colostrum is cow colostrum milk.

3. A preparation as claimed in claim 1, characterized in that: by weight of an active substance in the form of lyophilized fat colostrum with 30% to 50% of fat from bovine colostrum;

by weight of an emulsifier in the form of a mixture of cetearyl olivate and sorbitan olivate;

by weight of an emollient in the form of olive squalane ;

by weight of an emulsifier in the form of glycerol stearate;

by weight of an emollient in the form of glycerol tristearate;

by weight of an emollient in the form of avocado oil ;

by weight of an emollient in the form of buckthorn oil;

by weight of a thickener in the form of sodium polyacrylate ;

by weight of an antioxidant in a mixture of

polyethylene glycol with vitamin E, with ascorbyl palmitate, with ascorbic acid and with citric acid; by weight of an antioxidant in the form of vitamin

E acetate;

by weight of a conditioner in the form of pentylene glycol ;

by weight of a preservative in the form of

propanediol ;

by weight of a thickener in the form of xanthan gum polysaccharide;

by weight of a chelating agent in the form of edetate disodium;

by weight of a preservative in the form of a mixture of phenoxyethanol and ethylhexylglycerin; 0.20% by weight of a perfume composition with limonene perfume and an addition of Linalool; and deionized water to make it up to 100% of weight;

4. A preparation as claimed in claim 1 or 3, characterized in that fat colostrum contains 40% of fat from bovine colostrum.

5. A method of preparation of a multi-ingredient preparation for finger and toe nail regeneration, comprising mixing and heating of an oil phase, homogenizing, heating and cooling of a resultant mixture being an oil phase, deionized water and additives in the form of emulsifiers, emollients, antioxidants, conditioners, thickeners and perfume compositions, characterized in that it comprises mixing and heating up to 80°C in a vessel with a stirrer of pre-weighed oil phase components defined by % of weight in the form of a mixture of cetearyl olivate with sorbitan olivate in the amount of 2.00% to 5.00%, olive sgualane in the amount of 2.00% to 4.50%, avocado oil in the amount of 2.50% to 3.50% and an emulsifier in the form of stearate glycerol in the amount of 1.70% and 2.20%, where oil phase is continuously stirred while heating, and after oil phases reaches around 70°C-78°C while heating, the following components are added to an oil phase: buckthorn oil in the amount of 0.15% to 0.25% by weight, vitamin E acetate in the amount of 0.50% to 2.00% by weight, sodium polyacrylate in the amount of

0.60% to 1.00% by weight and an antioxidant being a mixture of polyethylene glycol, vitamin E, ascorbyl palmitate, ascorbic acid and citric acid in the amount of 0.05% to 1.50% by weight, and entire mixture is still heated and stirred, and at the same time deionized water preheated to 75°C-80°C in the amount of 95% of total amount of deionized water as foreseen according to the quantity of components is poured into a mixer preheated to around 75°C, then a chelating agent, i.e. edetate disodium is added to preheated deionized water in the amount of 0.10% to 0.50% by weight and 3.00% to 6.00% by weight of a conditioner in the form of propanediol, wherein a stirrer of a mixer is turned on with its speed preset favorably to 30 revolutions per minute and at the same time a system for heating up a mixer with deionized water and added components is turned on to reach 80^eC, and close to the heating end, when the mixture is around 75^eC, another conditioner is added to the continuously stirred and stirred mixture, i.e. pentylene glycol in the amount of 2.00% to 5.00% by weight, after which a vessel with a stirred containing a preheated oil phase with a thickener and an emollient is connected by a tight pipe to a mixer containing a mixture of preheated deionized water and conditioners and a chelating agent, after which a vacuum pump connected to a mixer is turned on, and a negative pressure inside the mixer, of a value of -0.02 MPa to -0,06 MPa suctions entire oil phase through a tight pipe to a mixer with a stirrer, after which the mixtures merged together are stirred together for further 2 minutes, and afterwards, a homogenizer is activated for 5 minutes, rotating favorably at 2000 revolutions per minute, after which homogenized mixture and a stirrer are cooled to around 60²C, and thickener dispersion is prepared in a separate vessel in the form of xanthan gum in the amount of 0.05% to 1.00% by weight mixed with an emollient in the form of 1.70% to 2.20% by weight of glycerol tristearate, and this dispersion is added to a mixture cooled to around 60^QC, after which the mixture is further homogenized for 2 minutes and with stirrer speed favorably at 2000 revolutions per minute, and after homogenization process is completed, the mixture is stirred for 10 minutes with stirrer speed favorably at 60 revolutions per minute, after which the mixture and the stirrer are cooled to around 40²C, and in a separate vessel, fat colostrum is solved in the remainder deionized water in the amount of 5% by weight of total deionized water amount as foresees according to the quantities of components, wherein fat colostrum solved is added to the mixture cooled to around 40^SC and then the mixture is again stirred for 10 minutes with stirrer speed at favorably 40 revolutions per minute, after which the mixture and the stirrer are cooled to around 30^SC, and 0.50% to 1.50% by weight of a preservative in the form of phenoxyethanol and ethylhexylglycerin and around 0.10% to 0.40% by weight of perfume compositions with limonene perfume and addition of linalool are added to the mixture cooled to 30^SC and the entire mixture is again stirred with stirrer speed at favorably 40 revolutions per minute, and it is again cooled to ambient temperature of around 20^QC, and a ready multi-ingredient preparation for finger and toe nail regeneration is poured into a disinfected temporary vessel and portioned and packaged for sale.

6. A method as claimed in claim 5 characterized in that the value of negative pressure inside a mixer is kept at the level of -0.04 MPa .

7. A method as claimed in claim 5 characterized in that while stirring at stirrer speed of 40 revolutions per minute and while cooling the mixture down to ambient temperature, pH of the mixture is measured, and pH is from 6.0 to 6.5.

8. A method as claimed in claim 5 or claim 7 characterized in that to adjust pH of a mixture to 6.0 to 6.5, the mixture in a mixer is neutralized by adding 20% sodium hydroxide solution in the amount making it possible to obtain pH of 6.0 to 6.5, after which the mixture in the mixer is further homogenized in a homogenizer preset to 1500 revolutions per minute for around 30 seconds.