Composition and Production Method of Food Supplements in the Management of Fibromyalgia and Chronic Pain

Abstract

The invention relates to a dietary supplement aimed at reducing muscle and cramp pain seen in fibromyalgia and, with regular use, acting as a symptom regulator in the treatment of chronic pain. This dietary supplement contains combinations of magnesium malate, magnesium citrate, pyrroloquinoline quinone disodium, L-tryptophan, vitamin B6, and vitamin B12.

Description

Dietary Supplement Composition and Management of Fibromyalgia and Chronic Pain Relevant Production Method TECHNICAL FIELD The invention aims to reduce muscle and cramp pain that occurs in fibromyalgia, and to promote regular bowel movements. In use as a symptom modulator in the treatment of chronic pain, magnesium malate, magnesium citrate, pyrroloquinoline quinone disodium, L-tryptophan, B6 It relates to a food supplement containing a combination of vitamin B12 and vitamin C. PREVIOUS TECHNIQUE Food supplements, also known as dietary supplements, contain vitamins, minerals, amino acids, These are products containing plant extracts and enzymes. These products are available in tablet, capsule, and effervescent forms. syrup, drops, spray, sachets, softgel capsules, gummy tablets, and drcaps (cellulose) It is offered in various forms (such as food supplements and capsules). Food supplements are for a healthy life. to maintain and support individual health needs by providing the body with additional nutrients They provide. Fibromyalgia is a common chronic pain disorder and the third most common after lower back pain and osteoarthritis. It is described as the third most common rheumatic disease. This condition affects both the individual and society. It constitutes a significant burden at the level of daily life. Fibromyalgia affects an individual's daily life. This can profoundly affect their activities. Along with medical and pharmaceutical demands, the total annual medical expenses... Costs are significantly higher for individuals diagnosed with fibromyalgia compared to the general population. There are more. Furthermore, high disability rates have been associated with fibromyalgia. Health Due to the costs of services as well as the loss of productivity and work, fibromyalgia is a significant issue. It constitutes a social burden. Magnesium inhibits central nervous system function by blocking N-methyl-D-aspartate (NMDA) receptors. Magnesium is known to play an important role in preventing sensitivity. Magnesium deficiency affects muscles. common symptoms of fibromyalgia such as pain, fatigue, sleep problems, and anxiety It is largely associated with this. 1 Some studies have shown that magnesium deficiency can lead to decreases in muscle ATP levels. It is suggested that it may play a role in the development of fibromyalgia. Other studies have investigated the role of pain perception, as well as pain intensity, in fibromyalgia. Magnesium deficiency with increased levels of substance P, a known neurotransmitter. This indicates a relationship between magnesium deficiency and magnesium deficiency. This raises the question of whether there is a possible link between fibromyalgia and other conditions. Magnesium has muscle-relaxing properties, and thanks to these properties, it helps muscles... It can alleviate headaches caused by tension. It helps regulate muscle function. Magnesium, which plays an important role, helps with muscle pain frequently seen in fibromyalgia patients. And it can help relieve cramps. Additionally, magnesium plays a role in energy production. It has a calming effect on the nervous system. These properties, To alleviate symptoms such as fatigue and insomnia seen in fibromyalgia patients. can contribute. Many chronic pains are related to inflammation, and magnesium has anti-inflammatory effects. This can help reduce these pains. Stress and chronic pain management Reducing anxiety plays an important role. Magnesium soothes the nervous system. It can alleviate symptoms of stress and anxiety and improve communication between nerve cells. It regulates the release of neurotransmitters. Magnesium is essential for ATP metabolism. The mitochondrial intracellular space, It is rich in magnesium because it is derived from ADP (adenosine diphosphate) and inorganic phosphate. It is essential for producing the active form of ATP (adenosine triphosphate) and is energy-rich. It acts as a counterion for the molecule. Magnesium malate is a combination of magnesium and malic acid. Both components, By increasing energy production and relieving muscle pain, it helps with fibromyalgia and chronic fatigue. Magnesium can help alleviate symptoms in conditions such as syndrome. The active mechanism of malate, magnesium and malic acid in cellular energy production, enzymes. Its activation is based on its roles in fundamental biological processes such as muscle and nerve function. This compound is particularly effective in increasing energy levels and relieving muscle soreness. It provides support. 2 Magnesium citrate is a compound formed by the combination of magnesium and citric acid, and It plays a role in the synthesis of neurotransmitters such as serotonin and dopamine. These chemicals, It has an effect on brain functions and emotional balance. Magnesium citrate also... It helps relax muscles and ensures proper transmission of nerve signals. These properties, Contributes to the alleviation of chronic muscle-related pain such as muscle aches, cramps, and spasms. It provides. Combinations of different magnesium salts can affect nerve and muscle function in various ways. By supporting these mechanisms, it can reduce muscle spasms, cramps, and neuropathic pain. Magnesium malate and citrate support muscle health and increase energy production, thus helping to prevent chronic conditions. It can alleviate pain associated with lack of energy, such as in fatigue syndrome and fibromyalgia. Other forms of magnesium also support overall energy levels, relieving pain and discomfort. It can help reduce fatigue. Magnesium taurate and malate are components with anti-inflammatory and antioxidant properties. It includes these properties. By reducing inflammation and oxidative stress, it helps to reduce chronic pain. It can help alleviate the discomfort. Magnesium citrate, on the other hand, has a mild laxative effect on digestion. It can support the health of the system and thus indirectly help with some types of chronic pain. This can create positive effects. Low serotonin levels are common in patients with fibromyalgia. L- Tryptophan can alleviate pain perception by increasing serotonin synthesis. Additionally, tryptophan... to reduce symptoms of depression and anxiety frequently associated with fibromyalgia That can also help. Vitamin B6 supports the nervous system by providing neurotransmitter support and helps with chronic pain. It contributes to the management of symptoms. Vitamin B6 deficiency can cause muscle cramps and It can worsen pain; therefore, adequate intake of this vitamin is very important. It carries P5P (pyridoxal 5'-phosphate), neurotransmitters such as serotonin, dopamine and GABA. It plays a more effective role in synthesis, which results in a faster and stronger effect on the nervous system. It can have effects. In addition, energy metabolism disorders associated with fibromyalgia. In its management, P5P has the potential to provide mitochondrial support. Vitamin B12 supports nerve cells and plays an important role in energy metabolism. It plays a role. Thanks to its positive effects on nerve health, it protects nerve cells. It can alleviate neuropathic pain. In addition, it can reduce fatigue and muscle pain associated with fibromyalgia. 3 It supports red blood cell production to help reduce their pain, and this It helps to alleviate symptoms. Pyrroloquinoline Quinone (PQQ), a powerful antioxidant and inhibitor of mitochondrial biogenesis It is a supporting factor. Fibromyalgia may be associated with mitochondrial dysfunction. When taken in conjunction with other methods, PQQ increases mitochondrial energy production, thereby reducing muscle aches and fatigue. It can help alleviate symptoms. It also reduces oxidative stress. It prevents cell damage, which helps alleviate fibromyalgia symptoms. Thanks to its ability to regulate nerve communication, PQQ also has effects on neuropathic pain. It can have positive effects. Research and development efforts in these areas highlight the negative impacts of their shortcomings on human health. In order to reduce their effects, the relevant substances are combined with other supplements. Whether it will be effective using this method needs to be developed further. In conclusion, all the problems mentioned above necessitate innovation in the relevant field. It has brought it to this state. THE PURPOSE OF THE INVENTION The present invention aims to eliminate the aforementioned problems and provide technical solutions in the relevant field. It is introduced with the aim of creating an innovation. The main purpose of the invention is to investigate the different effects of magnesium salts in the symptomatic treatment of pain. to support nerve and muscle health and neuropathic by taking advantage of their mechanisms The aim is to help reduce pain. Another aim of the invention is to address fatigue and lack of energy caused by pain through cellular means. It aims to alleviate the problem by increasing energy production. DETAILED DESCRIPTION OF THE INVENTION This detailed explanation concerns the invention in the Management of Fibromyalgia and Chronic Pain. The composition of food supplements and the related production methods only provide a better understanding of the subject. To ensure comprehension, it is explained with examples that do not create any limiting effects. The invention aims to reduce muscle and cramp pain associated with fibromyalgia. and with regular use, it can be a symptom regulator in the treatment of chronic pain. 4 magnesium citrate, magnesium malate, pyrroloquinoline quinone disodium, L- A combination of tryptophan, vitamin B6, and vitamin B12 as a food supplement. It is related to its use. Composition components Daily Use Daily Use Minimum Dosage Maximum Dosage Magnesium Citrate 35 mg 115 mg Magnesium Malate 85 mg 260 mg Pyrroloquinoline Quinone Disodium (PQQ) 6 mg 20 mg Vitamin B6 (Pyridoxal 5-Phosphate) 1.4 mg 10 mg L-Tryptophan 30 mg 500 mg Vitamin B12 (Methylcobalamin) 0.0025 mg 0.15 mg Table-1 Daily dosage range formulation for a preferred example of the invention. Table 1 shows the maximum and minimum preferred composition of the invention. The formulations are given. Daily dosage is based on the above components and the maximum dosage used. It includes minimum mg formulations. The final product obtained is a food supplement in the form of tablets, capsules, effervescent tablets, syrups, or drops. any of the following forms: spray, sachet, softgel capsule, gummy and drcaps, for fibromyalgia To meet the needs of relieving muscle and cramp pain that occurs in the disease. It has been prepared in accordance with health standards. In the preferred configuration of the invention, the invention describes muscle problems that occur in fibromyalgia. and to reduce cramp pain and, with regular use, in the treatment of chronic pain. It is a dietary supplement composition designed to provide symptom regulation. according to weight;  Magnesium Citrate in the range of 4.2416 – 48.4409%  Magnesium Malate in the range of 11.6414 – 78.2184%  Pyrroloquinoline Quinone Disodium (PQQ) in the range of 0.6732 – 11.6684%  Vitamin B6 (Pyridoxal 5-Phosphate) in the range of 0.1561 – 6.0240%  L-tryptophan in the range of 6.8941 – 79.6936%  Vitamin B12 (methylcobalamin) in the range of 0.0002 – 0.0952% It includes. Composition components by weight Daily weight Daily Minimum Usage Maximum Usage Percent Magnesium Citrate 4.2416% 48.4409% Magnesium Malate 11.6414% 78.2184% Pyrroloquinoline Quinone Disodium (PQQ) 0.6732% 11.6684% Vitamin B6 (P5P) 0.1561% 6.0240% L-Tryptophan 6.8941% 79.6937% Vitamin B12 (Methylcobalamin) 0.0002% 0.0952% Table-2 Preferred formulation of the invention Table 2 shows the maximum and minimum weight values ​​of the preferred composition of the invention. Their structures are given. In alternative formulations of the invention, tablets or capsules containing the appropriate composition, effervescent tablets, syrups, drops, sprays, sachets, softgel capsules, gummies (chewable tablets), and Dr. Caps It is a dietary supplement in any of the following forms: (cellulose-based capsules). In alternative formulations of the invention, the dietary supplement in capsule form consists of 1 capsule. The dosage for this includes the following components;  Magnesium Citrate 35 mg  Magnesium Malate 85 mg  Pyrroloquinoline Quinone Disodium (PQQ) 6 mg  Vitamin B6 (Pyridoxal 5-Phosphate) 3.33 mg  L-tryptophan 30 mg  Vitamin B12 (Methylcobalamin) 0.05 mg The invention aims to reduce muscle and cramp pain that occurs in fibromyalgia and to promote regular exercise. In use, it aims to provide symptom regulation in the treatment of chronic pain. It is a method related to the production of food supplements. Accordingly, the invention, a. Magnesium malate, magnesium citrate, vitamin B6, PQQ, L-tryptophan, and B12 Vitamin active ingredients should be stored at a temperature range of 15-25°C and a humidity level of 30-60% RH. weighing and sifting within the specified range, 6 The raw material mixture obtained in the first step of the process is transferred to the manufacturing boiler. and the manufacturing boiler at a temperature range of 15-25°C and a humidity range of 30-60% RH. and stirring for 1-5 minutes, c. Weighing and sieving of magnesium stearate to prevent clumping and manufacturing. added to the boiler and the mixture inside the manufacturing boiler is heated to 15-25°C. within a range of 30-60% RH humidity and for 2-5 minutes. mixing, The mixture obtained in the dc method step is stored at a temperature range of 15-25°C, with a concentration of 30-60%. Filling is done by transferring the capsules to the capsule filling machine within the RH humidity range. to be done, e. Making adjustments to the punch and capsule settings on the capsule filling machine and filling the capsules. The mixture is filled and stored at a temperature range of 15-25°C and a humidity range of 30-60% RH. Encapsulation within the specified range, f. Transferring the filled capsules to primary packaging. The method includes the steps. a. The weighing and sieving processes mentioned in method step a are used in pharmaceutical production and many other applications. It is involved in the initial stages of the formulation process. The purpose of these steps is to ensure the product... The goal is to ensure its quality and consistency. The weighing process ensures that the raw materials used in the formulation are measured in accurate quantities. This step directly affects the effectiveness and safety of the product, because each The ratio of a component determines the overall performance and stability of the formula. Weighing The process is carried out using precision balances. These balances are used for very small quantities. It measures even the smallest particles with precision. The screening process removes clumps from powdered raw materials and... This is done to obtain a homogeneous mixture. Sieving involves passing the powders through a fine mesh. This is achieved by passing the powders through a filter. This process results in the powders becoming finer and more uniform. This ensures the right consistency, allowing them to mix more evenly in the production tank. Filtering also involves removing foreign substances and unwanted particles. It also helps to remove it from the formulation, which improves product quality. In the preferred configuration of the invention, magnesium malate is used in step a. of the methodology. magnesium citrate, vitamin B6, PQQ, L-tryptophan and vitamin B12 active ingredients 7 Weighing and sieving at a temperature range of 15-25°C and a humidity range of 30-60% RH. The process is being carried out. "RH" stands for "Relative Humidity". Humidity is the amount of water vapor in the air, the maximum amount of water the air can hold at that temperature. It expresses the ratio of the amount of steam to the total amount as a percentage. Because these processes are carried out at the beginning of the formulation, they affect all subsequent production stages. This is crucial for its success. Any mistakes or deviations in these early stages... If this occurs, it will negatively affect the quality of the entire batch of product, so these processes... It is being carried out in accordance with the procedure. In step b, the raw material mixture obtained in step a is used for manufacturing. and the material is placed in the boiler and manufactured in a boiler temperature range of 15-25°C and 30-60% RH humidity. The mixing process is carried out within a specific ratio and for a duration of 1-5 minutes. A suitable boiler is selected for manufacturing, and the necessary cleaning and sterilization processes are carried out. Mixing is a process that generally involves homogeneously mixing solid particles within a liquid. To ensure even distribution, to ensure that the solutes in a liquid are distributed homogeneously. to ensure dispersion or homogeneous mixing of different solid components It is a process carried out to ensure mixing. This process ensures the homogeneity of the mixture. This is done with the aim of increasing and ensuring an equal distribution among the components. The mixing process is carried out for a specific period of time and at a specific speed. In the preferred design of the invention, in method step b, obtained in method step a. The raw material mixture is transferred to the manufacturing boiler and the manufacturing boiler is heated to 15-25°C. within a temperature range, a humidity range of 30-60% RH, and a time interval of 1-5 minutes. The mixing process is carried out. This step involves mixing the raw material components together. It ensures thorough integration and the formation of a homogeneous mixture. In the next method step, step c, we will prevent clumping. Weighing and sifting magnesium stearate, adding it to the manufacturing tank, and manufacturing... The mixture inside the boiler should be at a temperature range of 15-25°C and a humidity level of 30-60% RH. The mixing process takes place within a range of 2-5 minutes. The process aims to ensure the homogeneity of the mixture and the integration of the components. This means that it is carried out for a specified period of time and at a specific pace in order to provide support. 8 Magnesium stearate is used as an anti-caking agent in powdered products. It is used to increase the fluidity of the products, thus ensuring a homogeneous mixture. It also prevents the dispersion of powdered products entering the mold and the powder It ensures that the products come out of the mold smoothly and evenly. In the next method step, step d, the results obtained in method step c are used. The mixture is filled into capsules at a temperature range of 15-25°C and a humidity range of 30-60% RH. The process involves transferring the contents to the machine and then filling them. During this process... the mixture is fed into the filling machine homogeneously and in specified quantities. Capsule filling machines are available as semi-automatic or fully automatic. It is positioned. Staple size is selected according to capsule size, and filling parameters are adjusted. Entry is made and the relevant filling is ensured. In the preferred configuration of the invention, d. In step c of the method, the mixture obtained in step c is at a temperature range of 15-25°C. Filling is done by transferring the capsules to the capsule filling machine within a humidity range of 30-60% RH. The process is being carried out. In the next method step, method step e, the punch and in the capsule filling machine... Capsule adjustments are made and the mixture is filled into the capsules at 15-25°C. Encapsulation process within a temperature range and humidity range of 30-60% RH. is being carried out. The adjustments on the filling machine are made according to the type of capsule used. Capsule Adjustments are made according to their dimensions, shapes, and filling quantities. This ensures that the product is filled in the correct dosage and quality. Filling The staples in the machine ensure that the capsules are properly sealed during the filling process. and ensures sealing. Correct positioning and adjustment of the staples, ensuring the capsules are filled securely and protected from external factors. This is ensured by staple and capsule adjustments, which increase the efficiency of the filling process. It ensures a faster and more orderly progress in the production process. The preferred invention In its structure, in step e of the process, the punch and capsule in the capsule filling machine. Adjustments are made and the mixture is filled into the capsules at a temperature of 15-25°C. Encapsulation process within the range of 30-60% RH humidity. is being carried out. Capsules are usually filled using specially designed filling machines. To ensure the mixture is filled into the capsules in the correct amount, the filling machine must be pre-filled. 9 It has defined dosage settings. This ensures the product is at the labeled dosage and quality. This process ensures that the product is in the correct quantities, of the correct quality, and in accordance with the procedure. By ensuring that the filling is done under these conditions, it improves product quality and reliability. In the next step of the method, step f, the information filled in step e is used. The capsules are transferred to primary packaging. The filled capsules are then placed in the packaging. The process step of transferring capsules to primary packaging is the final preparation of the product for end use. This is an important step in making it suitable. Depending on the type and characteristics of the product, the appropriate one will be chosen. Primary packaging materials are selected. These packages are airtight, protecting the product from the outside. It is designed to protect against harmful elements and to allow the product to be stored for a long time. It has the durability and protection to provide. These steps are the building blocks of the production process and have a direct impact on the quality of the final product. They are effective. Each step must be planned and implemented in accordance with the procedure. This ensures that the product is manufactured in accordance with the desired specifications and standards. The scope of protection of the invention is specified in the claims attached hereto, and these details are strictly adhered to. The explanation cannot be limited to those given for illustrative purposes. Because a technically skilled person... the person, without deviating from the main theme of the invention, in light of what has been described above, similar It is clear that these structures can emerge.

Claims

1. The invention aims to reduce muscle and cramp pain associated with fibromyalgia and With regular use, it acts as a symptom regulator in the treatment of chronic pain. It is a method related to the production of food supplements to provide the following, and its characteristics are as follows: A. Magnesium malate, magnesium citrate, vitamin B6, PQQ, L-tryptophan, and B12 Vitamin active ingredients should be stored at a temperature range of 15-25°C and at a RH level of 30-60%. weighing and sieving within the moisture content range, In the BA process step, the raw material mixture obtained is transferred to the manufacturing boiler. and manufacturing process in a boiler with a temperature range of 15-25°C and humidity of 30-60% RH. Mixing within the specified ratio range and for a duration of 1-5 minutes. C. To prevent clumping, magnesium stearate should be weighed and sieved. adding it to the manufacturing boiler and the mixture inside the manufacturing boiler being heated to 15-25°C within a temperature range, a humidity range of 30-60% RH, and for 2-5 minutes. mixing within the range, The mixture obtained in the DC method step is kept in the temperature range of 15-25°C. By transferring the capsules to the capsule filling machine within a humidity range of 30-60% RH. filling process E. Making adjustments to the punch and capsule settings on the capsule filling machine. The mixture is filled into capsules and stored at a temperature range of 15-25°C. Encapsulation should be carried out within a humidity range of 30-60% RH. F. Transferring filled capsules to primary packaging. It is characterized by including methodological steps.

2. The invention aims to reduce muscle and cramp pain that occurs in fibromyalgia and With regular use, it acts as a symptom regulator in the treatment of chronic pain. It is a food supplement composition designed to provide; its characteristic feature is; by weight  Magnesium Citrate in the range of 4.2416 – 48.4409%  Magnesium Malate in the range of 11.6414 – 78.2184%  Pyrroloquinoline Quinone Disodium (PQQ) in the range of 0.6732 – 11.6684%  Vitamin B6 (Pyridoxal 5-Phosphate) in the range of 0.1561 – 6.0240%  L-tryptophan in the range of 6.8941 – 79.6936%  Vitamin B12 (methylcobalamin) in the range of 0.0002 – 0.0952% It is characterized by containing 35. 11 3. The food supplement composition conforms to Claim 2, and its characteristic feature is that the daily dosage is... It includes the following components: Magnesium citrate 35-115 mg Magnesium Malate 85-260 mg o Pyrroloquinoline Quinone Disodium (PQQ) 6-20 mg o Vitamin B6 (Pyridoxal 5-Phosphate) 1.4-10 mg L-tryptophan 30-500 mg o Vitamin B12 (Methylcobalamin) 0.0025- 0.15 mg 4. Tablets or capsules containing the composition conforming to any of the requirements 2-3. effervescent, syrup, drops, spray, sachet, softgel capsule, gummy and drcaps (cellulose) It is a dietary supplement that comes in any of the following forms: capsule-based.

5. Complies with claim 4, and its characteristic is; a dietary supplement in capsule form, 1 capsule The dosage should include the following components:  Magnesium Citrate 35 mg  Magnesium Malate 85 mg  Pyrroloquinoline Quinone Disodium (PQQ) 6 mg  Vitamin B6 (Pyridoxal 5-Phosphate) 3.33 mg  L-tryptophan 30 mg  Vitamin B12 (Methylcobalamin) 0.05 mg 12