The Use of Avasopasem in Diabetes and Diabetes-Related Complications

Abstract

This invention relates to the use of Avasopasem in diabetes and diabetes-related complications, examining its effects on diabetes and diabetes-related complications, its potential to have a positive impact on diabetes and diabetes-related complications, its use in the development or improvement of antioxidant therapies, and its potential for developing a new therapeutic agent or drug, making it valuable in the pharmaceutical and drug industry.

Description

AVASOPASEM IN DIABETES AND DIABETES-RELATED COMPLICATIONS USAGE Technical Area This invention is used to treat diabetes and diabetes-related nephropathy, neuropathy, and organopathy. By examining the effects of Avasopasem in complications such as vasculopathy, diabetes and has the potential to have a positive impact on diabetes-related complications its ability to be used in the development or improvement of antioxidant therapies availability and potential for developing a new therapeutic agent or drug Avasopasem, which is valuable in the pharmaceutical and drug industry because of its properties, is used in diabetes and... It relates to its use in complications associated with diabetes. State of the Art The current technique focuses on keeping blood sugar under control in the primary treatment of Type 1 diabetes. to maintain insulin and to manage insulin needs more precisely Insulin pumps are preferred. Techniques typically involve the use of oral antidiabetic medications in the treatment of Type 2 diabetes. This Medications can help regulate blood sugar and often reduce insulin resistance. It aims to reduce the risk of developing type 2 diabetes, especially as other medications are not sufficiently effective. In cases where this is not the case, some individuals may switch to insulin therapy. Another treatment The method involves hormonal signals that help control blood sugar. GLP-1 Analog works by influencing and often contributes to weight loss. Drugs and DPP-4 inhibitors can be applied. Additionally, cardiovascular benefits are provided and SGLT-2 lowers blood sugar by increasing the excretion of sugar from the kidneys in the urine. Inhibitors are also used. In this technique, the injections and needles used in insulin therapy are problematic for some people. it can cause discomfort and incorrect dosage or sudden changes in food intake These changes can increase the risk of hypoglycemia (low blood sugar). Diabetes 2 Oral antidiabetic drugs used in treatment do not adequately regulate blood sugar. It may not lower the level and may cause side effects. Unlike other treatment methods... GLP-1 analogs and DPP-4 inhibitors are expensive drugs that cause nausea. It can cause side effects such as diarrhea. Another treatment method is... SGLT-2 inhibitors may increase the risk of urinary tract infections and ketosidase. Current treatments generally aim to alleviate oxidative stress associated with diabetes. They may be inadequate in this regard. Oxidative stress, diabetes and its complications. It plays an important role in pathophysiological processes. Therefore, a more effective antioxidant is needed. Treatments may be needed. The molecular-level pathophysiological processes of diabetes and its complications There is a need for treatments that can make more specific interventions. This is cellular. targeting events at that level and as previously mentioned Focusing on GRP78 / PERK / IRE1 / ATF4 / XBP1 and CHOP / Kaspaz 12 pathways. It may include therapeutic agents. Current medications can sometimes cause side effects or require long-term use. Tolerance may develop during this process. It should be better tolerated and have fewer side effects. The need for treatments is significant. Diabetes and its complications usually occur through multiple pathophysiological pathways. It evolves. Therefore, combination therapies targeting different pathways are needed. there are. Based on current technical evaluations, Avasopasem has potential for treating diabetes and diabetes-related conditions. Its use is seen as necessary in cases of complications. Description of the Invention This statement explains that Avasopasem is used in the treatment of diabetes and diabetes-related complications. Its use is aimed at a better understanding of the subject and has no limiting effects. It is explained in a way that will not create a problem. 3 The present invention satisfies the aforementioned requirements and eliminates all disadvantages. Avasopasem eliminates diabetes and provides some additional benefits. It relates to its use in complications associated with diabetes. The primary aim of this invention is to address the existing shortcomings in diabetes treatment in the healthcare field. a general idea that it can provide a solution and overcome technical problems The aim is to provide a framework. Another objective of the invention is to reduce oxidative stress associated with diabetes using Avasopasem. offering a solution to reduce and eliminate free radicals in cells It can increase antioxidant capacity by neutralizing their effects. Another purpose of the invention is to combine GRP78 / PERK / IRE1 / ATF4 / XBP1 and CHOP / caspase 12. By examining the effects on pathways, we can understand diabetes at the molecular level. the potential of an agent that can directly interfere with pathophysiological processes It is to show. Another aim of the invention is to develop Avasopasem with a potentially low side effect profile. having and being a more well-tolerated treatment option with long-term use It is the ability to offer. Another aim of the invention is to treat diabetes and its complications, which often involve multiple factors. Because it develops via a pathophysiological pathway, it affects different mechanisms. the ability to target multiple routes with a single agent is the ability to provide it. The invention relates to diabetes and diabetes-related nephropathy, neuropathy, and organopathy. By examining the effects of Avasopasem in complications such as vasculopathy, diabetes and has the potential to have a positive impact on diabetes-related complications its ability to be used in the development or improvement of antioxidant therapies availability and potential for developing a new therapeutic agent or drug Avasopasem, which is valuable in the pharmaceutical and drug industry because of its properties, is used in diabetes treatment. and its use in complications related to diabetes. 4 The invention, in its preferred form, eliminates the disadvantages of current diabetes treatments. Avasopasem, which will provide an alternative treatment by eliminating the need for other treatments, offers an alternative for diabetes and... Its use is in complications related to diabetes. The invention, in its most preferred form, is Avasopasem's treatment of diabetes and diabetes-related conditions. Its use is in complications. The elements involved in the invention are as follows: a) Preparation of Avasopasem-I (according to protocol-I) b) Preparation of Avasopasem-II (according to protocol-II) c) Application of Avasopasem for local (topical) and systemic effects. The procedural steps involved in the invention are: a) Preparation of Avasopasem-I (according to protocol-I): 10% Dimethyl sulfoxide (DMSO), 40% polyethylene glycol, 5% Tween-80, 45% Saline b) Preparation of Avasopasem-II (according to protocol-II): 10% DMSO (Dimethyl sulfoxide) 90% Sulfobutylether-β-Cyclodextrin (20% saline solution) c) Application of Avasopasem for local (topical) and systemic effects: Dosage range (1-1000 mg / kg) The protocols used in the preparation of Avasopasem are given below. a) Protocol I: When preparing Avasopasem managanez, all of the solvents to be used... They need to be added one by one. These solvents; I 10% Dimethyl sulfoxide II 40% Polyethylene glycol (PEG300) III 5% Tween-80 IV 45% Saline Solubility: ≥ 2.5 mg / mL (5.17 mM) This protocol provides a clear solution with a concentration of ≥ 2.5 mg / mL. Preparation of Saline: 0.9 g of sodium chloride is dissolved in double distilled water (ddH₂O) and To obtain a clear saline solution, it is diluted to 100 mL. Example: Take 1 mL of working solution, add 100 µL of DMSO to 400 µL of PEG300. Stock solution (25.0 mg / mL) is added and mixed; then 50 μL of Tween-80 is added. is added and mixed; then 450 μL of saline is added to adjust the volume to 1 mL. is added. b) Protocol II: When preparing Avasopasem managanez, all of the solvents to be used... They need to be added one by one. These solvents; i. 10% Dimethyl sulfoxide (DMSO) ii. 90% (Sulfobutilether-β-Cyclodextrin (SBE-β-CD) in 20% saline solution) Solubility: ≥ 2.5 mg / mL (5.17 mM) This protocol provides a clear solution with a concentration of ≥ 2.5 mg / mL. Preparation of 20% SBE-β-CD in saline solution (4°C, storage for one week): 2 1 / g SBE-β-CD powder is dissolved in 10 mL of saline solution, and allowed to dissolve completely until it becomes clear. Example: By taking 1 mL of the working solution, add 900 μL of 20% Sulfobutylether-β- to the saline solution. 100 μL of DMSO stock solution (25.0 mg / mL) is added to cyclodextrin (SBE-β-CD) and It is mixed. c) Alternative Applications: Avasopasem is available in different pharmaceutical forms. These pharmaceutical forms are: Avasopasem is selected according to the patient's needs and treatment requirements. Commonly used pharmaceutical forms: i. Tablets: Avasopasem tablets are usually taken orally and are prescribed for a specific period. It represents the dosage. The tablet form is designed for easy use by patients. It is a commonly preferred dosage form. ii. Injectable Solutions: Avasopasem is a solution for intravenous (IV) injection. It is in solution form, and this form is used in emergency situations or intravenously for patients. It is used in situations requiring treatment. iii. Capsules: Avasopasem, in capsule form, is usually swallowed and taken at a specific dosage. It contains. This form can be easily taken, like other oral medications, and provides a specific dosage. 6 Different Carrier Substances or Formulations: Avasopasem's carrier substance or by changing the formulation to provide a more effective delivery of the active ingredient. Alternative compositions that provide release can be developed. Different Dosages and Frequencies of Administration: The dosage of Avasopasem (1-000 mg / kg) and Changes can be made to the frequency of application. Lower or higher. high dosages, different application frequencies, or different application routes conceivable. Combination Therapies: Avasopasem in combination with another drug or therapeutic agent. combined for use in diabetes and diabetes-related complications. A more effective combination therapy can be developed for its treatment. Solution Formulations at Different pH Values: Avasopasem's Solution Different pH values ​​can be considered for the formulation. This will allow the substance to be better... It can solve the problem or improve stability.

Claims

1. The invention relates to the use of the active substance avasopasem in the treatment of diabetes and diabetes-related complications. Use in complications such as nephropathy, neuropathy, organopathy, and vasculopathy. and it is prepared using two different protocols; its characteristic feature is its antioxidant capacity. Its ability to increase [the effect of] interfering with molecular pathways, and its lack of side effects. It is the combination of effects.

2. It complies with Request 1, and its characteristic feature is that it uses the protocols to be used in its preparation. One contains 10% dimethyl sulfoxide (DMSO), 40% polyethylene glycol, and 5% tween-80. It contains 45% saline.

3. Compliant with Claim 1 and Claim 2, its characteristic is that the saline is prepared in 0.9 g. Sodium chloride is dissolved in double distilled water (ddH₂O) and added to 100 mL. dilution to provide a clear solution of ≥2.5 mg / mL (5.17 mM) The solution is obtained in this way.

4. Complies with Claim 1, and its characteristic is; in the other preparation protocol, it contains 10% dimethyl. sulfoxide (DMSO) and 90% Sulfobutylether-β-Cyclodextrin (SBE-β-CD)) It includes.

5. Complies with Claim 1 and Claim 4, and consists of: 2 g Sulfobutylether-β-Cyclodextrin (SBE-β-CD) powder is dissolved in 10 mL of saline solution and left at 4 °C for one week. Providing a clear solution of ≥2.5 mg / mL (5.17 mM) after standing This involves obtaining a solution.

6. Complies with Claim 1, characterized by an application dose in the range of 1-1000 mg / kg. and different pharmaceutical forms such as tablets, injectable solutions, and capsules It is the use of these methods.