A dietary supplement formulation in spray form

Abstract

The invention relates to a dietary supplement formulation in spray form. The dietary supplement formulation in spray form according to the invention contains both iodine and vitamin A. Iodine and vitamin A have a synergistic effect in the dietary supplement formulation according to the invention. The use of iodine and vitamin A in certain ratios in a dietary supplement formulation in spray form according to the invention helps to balance thyroid hormones, contributes to skin and hair health, supports the health of reproductive organs, is effective for eye health and helps in the treatment of polycystic ovary syndrome (PCOS).

Description

[0001] A DIETARY SUPPLEMENT FORMULATION IN SPRAY FORM

[0002] Related Technical Field

[0003] The invention relates to a dietary supplement formulation in spray form. The dietary supplement formulation in spray form according to the invention contains both iodine and vitamin A. Iodine and vitamin A have a synergistic effect in the dietary supplement formulation according to the invention.

[0004] State of the Art

[0005] Dietary supplements are products for which the daily intake dose is determined in order to supplement the normal diet, provided that they do not replace the normal diet. In addition, dietary supplements may be preferably used in addition to therapeutic pharmaceutical compositions in the treatment of certain diseases. Today, the demand for dietary supplements is increasing day by day due to the inadequate effectiveness of medicines.

[0006] In the state of the art, although the use of dietary supplements in addition to therapeutic pharmaceutical compositions in the treatment of diseases is known, the use of dietary supplements in the present technique for the simultaneous treatment of thyroid and polycystic ovary syndrome (PCOS), and for the support of skin, hair, reproductive organs and eye health has not yet been encountered.

[0007] One of the endocrine glands, the thyroid is the organ responsible for producing and releasing the hormones T3 (triiodothyronine) and T4 (thyroxine) into the bloodstream. If the thyroid gland, which controls and executes all processes related to metabolism, fails to fulfill these functions, many different health problems and related symptoms occur. This condition, which is also defined as thyroid symptoms, can be caused by many different diseases depending on whether the thyroid gland works more or less. Fatigue and asthenia, weight gain or weight loss without a significant change in diet, constant desire to sleep, inability to wake up refreshed, feeling exhausted during the day, inability to fall asleep, depressed mood, lack of concentration, poor memory, brain fog, anxiety, panic attacks, muscle and joint problems, digestive problems [1], in short, many problems from the nervous system to the digestive system are known in the literature as thyroid symptoms. While the present art includes pharmaceutical compositions for use in thyroid treatment that are effective in converting T4 hormone to T3, it is of great importance to include the use of a dietary supplement in treatment routines. In addition, complementary foods containing selenium, zinc, vitamin E and vitamin B6, which are beneficial in converting T4 hormone to T3, are also preferred in the treatment routines of thyroid disease[2].

[0008] Polycystic ovary, which develops as the formation of many small and benign cysts in the ovaries, is a gynecological disease that manifests itself with menstrual irregularities and also causes many complaints such as weight gain, hair growth throughout the body and acne formation. As a result of the disruption of ovulation due to cysts in the ovaries, the inability to conceive a child is frequently observed in women with this disease. Too many cysts in the ovaries disrupt the hormonal structure, causing hair growth and acne formation. This disease, which negatively affects the quality of life and appearance by deteriorating the external look, is a type of disease that brings psychological problems and must be treated. Polycystic ovary syndrome, which is a serious disease, if left untreated for a long period of time, brings many important problems such as fatty liver disease, diabetes, hypertension, metabolic syndrome, infertility, depression and anxiety disorders, hypertension and sleep apnea. For this reason, the treatment process should be started immediately in people with this disease to ensure rapid weight loss and control hormone levels[3]. Although polycystic ovary syndrome is not a disease directly associated with a vitamin deficiency, studies have shown that women with polycystic ovary syndrome have a high prevalence of vitamin D deficiency. Vitamin D deficiency is a trigger for menstrual irregularities. As this can negatively affect different systems in the body, it is generally recommended that women with PCOS take vitamin D supplements. It is important to have enough vitamin D both to protect egg health and to ensure menstrual regularity[6].

[0009] Ensuring reproductive health starts with ensuring the health of the reproductive organs. If the reproductive organs cannot function normally, conditions such as infertility in women and men, etc. can be encountered, and structures such as cysts, etc. in the reproductive organs bring fatal diseases such as cancer. As a result, ensuring the health of the reproductive organs is of great importance. In the state of the art, complementary dietary supplements are used to maintain the health of the reproductive organs or to treat diseases of the reproductive organs. Vitamin D, for example, is unique in that it is both a vitamin and a hormone, and is very important for male reproductive health. Vitamin D affects a wide range of physiological functions, including male fertility. Another example of such supplements is vitamin B12. Vitamin B12 is a pro-metabolic vitamin involved in many different aspects of cellular energy production. B12 is essential for the sperm production process. Researchers have found that in terms of supporting a healthy sperm count, supplementing with vitamin B12 is as effective as supplementing with antioxidants[4].

[0010] Eye health is of great importance for quality of life. Some eye diseases, if not treated at an early stage, can progress and cause permanent damage leading to loss of vision. In the present art, one of the most important supplements used to support eye health is lutein, which is a type of pigment. Lutein is a type of pigment and is associated with vitamin A and Beta-carotene. Although lutein, known as the eye vitamin, is present in the human eye, it needs to be supplemented externally in some cases[5].

[0011] In the present art, although preferred dietary supplements are supportive in addition to the pharmaceutical components used in the routine treatment of diseases, in the end, the need to purchase a separate dietary supplement ingredient for each disease has negative consequences in terms of both cost and human health. Although vitamins and dietary supplements are generally considered harmless by people because they do not require a prescription, too much of any one food intake can be toxic, and the solution to this problem is to get multiple benefits from a single supplement. However, the state of the art does not include a dietary supplement formulation that is used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS), and to support skin, hair, reproductive organs and eye health.

[0012] Due to reasons such as the limitations and inadequacies of the dietary supplements in the state of the art, the fact that the need to purchase a separate dietary supplement ingredient for diseases in the present art brings both cost and health problems, and the fact that the state of the art does not include a dietary supplement formulation that is used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS) and to support skin, hair, reproductive organs and eye health, it is necessary to present a dietary supplement formulation that addresses all these problems. Summary and Objects of the Invention

[0013] A dietary supplement formulation in spray form is described in the invention. The dietary supplement formulation in spray form according to the invention contains both iodine and vitamin A. Iodine and vitamin A have a synergistic effect in the dietary supplement formulation according to the invention. The use of iodine and vitamin A in certain ratios in a dietary supplement formulation in spray form according to the invention helps to balance thyroid hormones, contributes to skin and hair health, supports the health of reproductive organs, is effective for eye health and helps in the treatment of polycystic ovary syndrome (PCOS).

[0014] The object of the invention is to provide a dietary supplement formulation that is used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS), and to support skin, hair, reproductive organs and eye health. This eliminates the need to use a separate dietary supplement for each treatment and reduces dietary supplement costs. A dietary supplement formulation that is used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS), and to support skin, hair, reproductive organs and eye health is provided by iodine and vitamin A, which are added to the formulation in specific ratios in the invention. A dietary supplement formulation in spray form according to the invention supports thyroid function and helps to restore energy, vitality and general well-being. The specific ratios of iodine contained in the dietary supplement formulation according to the invention are useful in supporting thyroid health. Iodine is primarily involved in the production of thyroid hormones and the vitamin plays a role as a regulator in the conversion of these hormones into their active form. The combined use of iodine and vitamin A helps to maintain thyroid function, which is crucial for metabolism, energy levels and overall health. Vitamin A and iodine both play an important role in supporting the immune system. Vitamin A supports the development and function of immune cells, while iodine supports the production and activity of immune factors. As a result, the dietary supplement formulation according to the invention helps to protect against infections, viruses and other immune-related challenges by strengthening immune defenses. In addition, the combined use of vitamin A and iodine contributes to the vitality of skin and hair health. Vitamin A helps the production of collagen, which supports the elasticity and smoothness of the skin, while iodine supports the optimal functioning of the sebaceous glands, helps protect the scalp and promotes hair growth. Combining these two nutrients, the dietary supplement formulation according to the invention nourishes the skin and hair from the inside. In addition, both vitamin A and iodine are vital for reproductive health in both men and women. Vitamin A supports the development and function of reproductive organs, while iodine is essential for the production of reproductive hormones. The dietary supplement formulation according to the invention plays a role in ensuring optimal reproductive function.

[0015] With the invention, there is provided an easy-to-use dietary supplement formulation to be used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS), and to support skin, hair, reproductive organs and eye health. Since the formulation according to the invention is in the form of a spray, it can be easily taken into the body orally by spray without the need for a supporter such as water, etc. in daily use. Compared to the pill-shaped supplements in the state of the art, the necessary supplements are provided without the need to swallow a pill. In addition, the dietary supplement formulation in spray form according to the invention is rapidly absorbed into the body. Since the dietary supplement formulation according to the invention is in the form of a spray, its absorption is faster than other products such as capsules, etc., and again, since it is in the form of a spray, it is very easy to use. Since the supplements in the state of the art are in drop form, dose controls are not easily achieved. Due to the spray form of the dietary supplement formulation according to the invention, the dose control can be carried out in a more reliable way and thus, problems such as overdose etc. are prevented.

[0016] Detailed Description of the Invention

[0017] The invention relates to a dietary supplement formulation in spray form. The dietary supplement formulation in spray form according to the invention contains both iodine and vitamin A. Iodine and vitamin A have a synergistic effect in the dietary supplement formulation according to the invention. The use of iodine and vitamin A in certain ratios in a dietary supplement formulation in spray form according to the invention helps to balance thyroid hormones, contributes to skin and hair health, supports the health of reproductive organs, is effective for eye health and helps in the treatment of polycystic ovary syndrome (PCOS).

[0018] The dietary supplement formulation according to the invention comprises: • deionized water as solvent,

[0019] • menthol as a flavoring agent,

[0020] • vitamin A and iodine as active ingredients,

[0021] • aspartame (E951 ) as a sweetener,

[0022] • glycerol (E422) as a thickener,

[0023] • potassium sorbate (E202) as a preservative. The aforementioned iodine is sodium iodide and the menthol is chosen from L-lysine, ascorbic acid or limonene. In addition, the aforementioned vitamin A is retinol.

[0024] In one embodiment of the invention, the dietary supplement formulation according to the invention comprises, in its composition of 0.142 mL (1 spray dose):

[0025] • 142.039 mg deionized water (99.40%) as solvent,

[0026] • 0.29 mg menthol (0.20%) as a flavoring agent,

[0027] • 0.450 mg vitamin A (0.31%) and 0.075 mg iodine (0.05%) as active ingredients,

[0028] • 0.036 mg aspartame (E951 ) (0.03%) as a sweetener,

[0029] • 0.009 mg glycerol (E422) (0.006%) as a thickener,

[0030] • 0.001 mg potassium sorbate (E202) (0.0007%) as a preservative. The aforementioned iodine is sodium iodide and the menthol is chosen from L- lysine, ascorbic acid or limonene. In addition, the aforementioned vitamin A is retinol.

[0031] 1 spray dose of the dietary supplement formulation according to the invention is 142.9 mg (0.142 mL), 7 spray doses are 1000 mg (1 mL).

[0032] The commercial presentation form of the dietary supplement formulation according to the invention will be in 10-20-30 mL vial packages.

[0033] Weight of 1 container with 10 g spray dose is 10 mL x 7 spray doses = 70 mL.

[0034] Weight of 1 container with 20 g spray dose is 20 mL x 7 spray doses = 140 mL.

[0035] Weight of 1 container with 30 g spray dose is 30 mL x 7 spray doses = 210 mL. The dietary supplement formulation according to the invention is used twice a day and 450 pg of vitamin A and 100 pg of Iodine are taken into the body in a single use. When used twice a day, a total of 900 pg vitamin A and 200 pg Iodine are taken into the body. The daily usage dose of 2 sprays of the dietary supplement formulation according to the invention is 285.8 mg in total (142.9 mg x 2).

[0036] All raw materials used in the dietary supplement formulation according to the invention are stored at 5-30°C and 75% humidity prior to preparation. In addition, taste, odor and pH controls are carried out while mixing the aforementioned raw materials in the liquid product mixing tank. A product is obtained with a pH in the range of 9-7.

[0037] Analyses regarding the dietary supplement formulation according to the invention were carried out on 03.12.2020 by Bereket Kimya Tip Teknik San. Ve Tic. Ltd. §ti.

[0038] Table 1. Analyses related to the dietary supplement formulation according to the invention

[0039] The urine iodine test results of a patient who used the dietary supplement formulation according to the invention for 1 month are given in Table 2, the results are from 1 month before and after.

[0040] Table 2. Results of the urine iodine test.

[0041] • High > =300

[0042] • Iodine deficiency 0-19

[0043] • Moderate iodine deficiency 20-49

[0044] • Mild iodine deficiency 50-99

[0045] • Sufficient levels of iodine 100-199

[0046] • Ideal iodine value 200-299

[0047] As a result of thyroid hormonal disorder, even if enough sleep is ensured, there is a constant state of fatigue, energy levels decrease, and even simple tasks during the day become very difficult to perform. Furthermore, a brain fog develops and patients have difficulty remembering things and concentrating. In addition to all this, digestive system problems come up, which in turn cause a feeling of uneasiness. Moreover, there is an unpredictable weight gain or the weight loss process fails, even if high efforts are made. In addition, there are sudden drops in mood, and anxiety and restlessness may appear. Along with all the negative effects, the hair becomes brittle and thinner, and the skin loses its healthy glow. A dietary supplement formulation in spray form according to the invention supports thyroid function and helps to restore energy, vitality and general well-being. The specific ratios of iodine contained in the dietary supplement formulation according to the invention are useful in supporting thyroid health. Iodine is primarily involved in the production of thyroid hormones and the vitamin plays a role as a regulator in the conversion of these hormones into their active form. The combined use of iodine and vitamin A helps to maintain thyroid function, which is crucial for metabolism, energy levels and overall health. Vitamin A and iodine both play an important role in supporting the immune system. Vitamin A supports the development and function of immune cells, while iodine supports the production and activity of immune factors. As a result, the dietary supplement formulation according to the invention helps to protect against infections, viruses and other immune-related challenges by strengthening immune defenses. In addition, the combined use of vitamin A and iodine contributes to the vitality of skin and hair health. Vitamin A helps the production of collagen, which supports the elasticity and smoothness of the skin, while iodine supports the optimal functioning of the sebaceous glands, helps protect the scalp and promotes hair growth. Combining these two nutrients, the dietary supplement formulation according to the invention nourishes the skin and hair from the inside. In addition, both vitamin A and iodine are vital for reproductive health in both men and women. Vitamin A supports the development and function of reproductive organs, while iodine is essential for the production of reproductive hormones. The dietary supplement formulation according to the invention plays a role in ensuring optimal reproductive function.

[0048] With the invention, there is provided an easy-to-use dietary supplement formulation to be used simultaneously for the treatment of thyroid and polycystic ovary syndrome (PCOS), and to support skin, hair, reproductive organs and eye health. Since the formulation according to the invention is in the form of a spray, it can be easily taken into the body orally by spray without the need for a supporter such as water, etc. in daily use. Since the dietary supplement formulation according to the invention is in the form of a spray, its absorption is faster than other products such as capsules, etc., and again, since it is in the form of a spray, it is very easy to use. Since the supplements in the state of the art are in drop form, dose controls are not easily achieved. Due to the spray form of the dietary supplement formulation according to the invention, the dose control can be carried out in a more reliable way and thus, problems such as overdose etc. are prevented. References

[0049] [1] Tiroid Nedir? tiroid belirtileri Nelerdir?. Medical Park. (n.d.). https: / / www.medicalpark.com.tr / tiroid / hg-2285

[0050] [2] Tiroid hastaliklannda vitamin kullanimi. Functional Endocrinology - Prof. Dr. Metin Ozata - Endocrinologist - Istanbul, (n.d.). http: / / fonksiyonelendokrinoloji.com / tr / faydali- bilgiler / tiroid-hastaliklari / tiroid-hastaliklarinda-vitamin- kullanimi / #:~:text=T4%20hormonunun%20T3’e%20%C3%A7evrilmesinde,ve%20selen yumdan%20zengin%20g%C4%B1dalarla%20beslenmelidir.

[0051] [3] Polikistik over Sendromu Nedir? polikistik over Sendromu Belirtileri ve Tedavi Ybntemleri Nelerdir?. Medical Park. (n.d. -a), https: / / www.medicalpark.com.tr / polikistik- over-sendromu-nedir / hg- 1955#:~:text=Yumurtal%C4%B1 klarda%20k%C3%BC%C3%A7%C3%BCk%20ve%20i yi%20huylu,neden%20olan%20bir%20kad%C4%B1 n%20hastal%C4%B1%C4%9F%C 4%B1d%C4%B1 r.

[0052] [4] Sperm Kalitesi Artirmak igin vitamin VE Bitkisel takviyeler - prof. Doctor Omer Faruk Karatag. Prof. Dr. Omer Faruk Karata§ - Urology & Andrology & Male Infertility. https: / / omerfarukkaratas.com / vitaminler-bitkisel-takviyeler-ve-sperm- kalitesi / #:~:text=B12%20Vitamini%20ve%20D%20Vitamini,- B12%20vitamini%2C%20h%C37oBCcresel&text=Bunun%20yan%C4%B1%20s%C4% B1 ra%20D%20vitamini,bir%20fizyolojik%20i%C5%9Flev%20yelpazesini%20etkiler

[0053] [5] Magazasi, T. V. (n.d.). Lutein Gbz Vitamini Markalan ve fiyatlan: Vitaminler.

[0054] Vitaminler.com. https: / / www.vitaminler.com / c / goz-vitamini-lutein-

[0055] 152#:~:text=%C3%9Cr%C3%BCn%C3%BC%20%C4%B0ncele- ,G%C3%B6z%20Vitamini%20(Lutein),vitamini%2C%207oC3%A7inko%2C%20demir% 20vb.

[0056] [6] Op. Dr. Mucteba GUNDUZ General Surgery at Istanbul University Istanbul Faculty of Medicine. (2023, August 21 ). Polikistik over Sendromunda Nasil Beslenilmeli?. Op. Dr Mucteba Gunduz. https: / / www.muctebagunduz.com / blog-tr / polikistik-over- sendromunda-nasil-beslenilmeli / #:~:text=asitlerinden%20zengin%20bal%C4%B1 klar- ,Polikistik%200ver%20Hangi%20Vitamin%20Eksikli%C4%9Finden%200lur%3F,olma %20oran%C4%B1 n%C4%B1 n%20y%C3%BCksek%20oldu%C4%9Funu%20g%C3% B6sterir.

Claims

CLAIMS1. A dietary supplement formulation for use in the treatment of thyroid and polycystic ovary syndrome (PCOS), and supporting skin, hair, reproductive organs and eye health, comprising:• deionized water as solvent,• menthol as a flavoring agent,• vitamin A and iodine as active ingredients,• aspartame (E951) as a sweetener,• glycerol (E422) as a thickener,• potassium sorbate (E202) as a preservative.

2. A dietary supplement formulation according to claim 1 , comprising, in 1 spray dose (in its composition of 0.142 mL):• 142.039 mg deionized water (99.40%) as solvent,• 0.29 mg menthol (0.20%) as a flavoring agent,• 0.450 mg vitamin A (0.31%) and 0.075 mg iodine (0.05%) as active ingredients,• 0.036 mg aspartame (E951) (0.03%) as a sweetener,• 0.009 mg glycerol (E422) (0.006%) as a thickener,• 0.001 mg potassium sorbate (E202) (0.0007%) as a preservative.

3. A dietary supplement formulation according to any one of claims 1 or 2, wherein said iodine is sodium iodide.

4. A dietary supplement formulation according to any one of claims 1 or 2, wherein said vitamin A is retinol.

5. A dietary supplement formulation according to any one of claims 1 or 2, wherein said menthol is L-lysine, ascorbic acid or limonene.

6. A dietary supplement formulation according to any one of claims 1 -5, wherein it is administered orally in spray form.

7. A dietary supplement formulation according to claim 6, wherein the daily usage dose of 2 sprays is 285.8 mg in total.

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