PHARMACEUTICAL COMPOSITION COMPRISING GLIBENCLAMIDE COENZYME Q10 AND VITAMINS FOR THE TREATMENT OF DIABETES

Technical Field

Background Art

- Treatment of diabetic patients is done by using different rind of drugs that lower blood glucose level without paying attention to many somatic and psychic troubles or to lost elements from the body leading to appearance of some dangerous side effects of diabetes.

- The pancreas, the gland which secretes insuline and glucagone hormones which adjust blood glucose level and help in digestion.

- There two types of diabetes:

- The first type associated with destruction of beta cells in pancreas which secrete insuline and there are new evidences point to a virus as cause in some cases of this type of diabetes. Also auto immune diseases may be a cause. Patients of this type are exposed to attacks of altered blood glucose level, some of which are hyperglycemia and the others may be hypoglycemia and any one of these attacks may lead to a great medical emergency.

- The second type of diabetes may result from one or more than a cause like hepatic disorders, inactive or destroyed insuline receptors in tissues, suprarenal disorders or these causes together. Also accure almost in people having a positive family history of similar cases. In this type pancreas secretes insuline but its effects are not apparent because any of previously mentioned causes.

Some individuals have deterioration in glucose tolerance giving a picture does not carry any of potential symptoms of diabetes.

- Glucose intolerance expression describes those people who have intermediate blood glucose level and response to glucose between healthy people and diabetics.

- Many studies showed that there are many reasons that lead to appearance of diabetes, also there are some symptoms and side effects associate diabetes in diabetic patients.

- Also many studies proved that diabetics are exposed to many health disorders. Which must be given attention by doctors and scientists to be avoided. And they must set up all medical plans to fight these symptom. Which may deteriorate to become dangerous incurable diseases later on like:- diabetic retinopathy, blindness, cataract, kidney failure, thrombosis physical and mental disorders, heart and vascular diseases and many other side effects.

- Fortunately, there are some plans through which we can control these symptoms, prevent functional deterioration of the body and treat these symptoms by adding some elements to drugs which lower blood glucose level to ensure complete protection to diabetic patient, given him chance to live safe without complications.

- After finishing this plan, diabetes will become an ordinary disease not a dangerous, terrifying disease for patients.

-Disclosure of Invention :

Co-enzyme QlO is considered a giant step forward in prophylaxis and treatment of heart and vascular diseases especially for patients having

Diabetes mellitus.

Diabetics are exposed to have weak Cardiac muscle as diabetes causes lack of vit.Bcomplex.

- Also scientists and doctors did not notice importance of an enzyme called Co-enzymeQ10 in keeping diabetic patients free from complications of diabetes.

- This (Co-enzymeQ 10 is produced in the intestin where its production can not be done except in presence of vit.B and this enzyme is known by its ability to enter cardiac tissue, strengthen cardiac muscle and act on saving much energy for the heart through providing mitochondria in cardiac muscle cells with great energy. Also it protects diabetic patients from cardiac attack and this Co-enzymeQ 10 can not be present in the body except through its production in the intestine or by administration of supplements.

- Dr. Yama - mura- in Japan was the 1st to use this compound on cardiac failure patients and record its efficacy in cardiac patients with positive notes which made it considered as a spectacular compound.

- In a study done by (Lewin -A. IVF unit, OB / GYN Department, Hadassah - Hebrew university. Medical school, Jerusalem, Israel) we can find out that this Co-enzymeQ 10 has some principal functions including :-

Decrease free radicals - sharing in growth and regulation of cellular secretion, Regulation of calcium exchange between cells, regulation of PH. Inspite of these function, Co-enzymeQ 10 has a chief role which is moving electrones and protons through mitochondrial membranes So Co-enzymeQ 10 forms Specific linking sites for different hydrogen removers like NADH and succinate where electrons are collected for oxidation process. And pro tones are moved resulting in electrochemical graduation through membran of mitochondria to allow production of ATP.

B vitamins are Decreased in diabetics, so doctors advise diabetics to take vit.bcomplex with anti - diabetes drugs But many, many diabetics refuse or ignor to take vit.B tablets leading to appearence of side effects of diabetes and many other complications.

- So I thought in thougt in adding this vitamin obligatory to antidiabetic drugs for protection, prophylaxis and relieving side effects of diabetes either in patients or in hospitals to relieve financial burden on the government as it spends too much money to treat complication of diabetes like gangrene, heart diseases resulting from side effects of diabetes, kidney disease, eye diseases and other complications mentioned before.

- Diabetic patients lack vit.Bό as it's necessary for production of essential amino acid Tryptophan important for production of vitB3. Also the brain uses it to produce Serotonin the neural transmitter important for transmission of neural impulses from cell to another.vit.B6 acts on prophylaxis from atherosclerosis, inhibits with Folic acid and vit.B 12 formation of poisonous substance called Homocystein.

Vit.bl2 protects against nerves damage, keeps fertility, activates growth and normal development through keeping fatty covers on nerve ends to keep them healthy and safe.

- Diabetic patient also suffers from other complications of diabetes like, depression, anxiety, tension due to lack in neural - chemical substances resulting from lack of vit.Bcomplex and especially Folic acid ,B6 and B 12 as these substances from the neurochemical substances called dopamine and Serotonin.

- As vit. B complex decreased in diabetics so they are exposed to have Weak brain functions and weak perceptional activity.

- Vit.B complex improves blood circulation, has an importance in protection from cataract and its treatment as many diabetic may have cataract. And many diabetic may have health and psychic deterioration, and appearance of many disorders due to acute lack in vit.B complex.

- Vit.B complex is added to drugs that lower blood glucose level also Co-enzymeQ10 is added which acts well with vit C.

- New evidences point to that vit.C works with vit.E side to side and they have a great effect when work together more than the effect obtained from each alone.

- Vit.E eliminates free radicals which are very dangerous in cell membranes while vit.C attacks free radicals in vital body fluids and these two vitamins have anti - oxidation effect and each of them strengthens the other and elongats its effect in this field.

- Co-enzymeQ10 which resembles vitamins has effects resemble vit.E effects in the body and may be more stronger as an anti - oxidant - and anti - histaminic. It enters in all body tissues, playes an important role in energy production in every cell in the body.

- Vits. E & C and Co-enzymeQ10 together work on activation and protection of immune system, lowering hyper tension, prevention of atherosclerosis protection from thrombi formation, heart and vascular diseases.

Also work to repair tissues, protection from cataract and from a case called retro lental fibroblast proliferation and protection from cells destruction and nerve damage.

- Zinc is an important element for diabetics as it playes an important role in insulin formation and those having disorders in pancrease lack Zinc because insulin is saved united with Zinc as granules in

cytohyaloplasm of the cell. When there is need for insulin secretion in case of hyperglycemia fine tubules adherent to cell membrane contract to attract these insulin saving granules then these granules unite with another tubules in cell membrane to get insulin out of the cell without any effect on pancreatic cells where insulin can do its physiological functions.

- Also Zinc is a component of insulin hormone and many vital enzymes including an anti - oxidant enzyme called superoxid desmotase which helps, to resist free radicals and prevent its formation. Zinc keeps vit.E concentration in blood in healthy limits. Zinc levels decreased due to some factors of which: - diarrhea, kidney disease, liver cirrhosis and diabetes so it's preferred to Zinc drugs lowering blood glucose for protection. And prophylaxis.

- The body needs Zinc to produce protein which is converted to amino acids absorbed and metabolized by the body. The body also needs vit.Bό and vit.E to activate protein absorption and amino acids which have great ability to protect, and treat many diabetic complications including cardiac disorders, hypertension, eye disorders, protection from Alzhiemer disease, muscle weakness, peripheral neuropathy and many other complication, Also Activation of insulin hormone and establishing of bload glucose level and energy production.

- Here I concenterate on an addition of some essential elements to drugs lowering blood glucose level because they lack Folic Acid especially in diabetic woman who wants to have children as these tablets will secure and protect from decreased Folic Acid which leads to bad side effects in case of pregnancy without good level of Folic Acid is the body.

Because Folic Acid helps in regulation of nerve cells formation in the embryo in both stages early and late of embryo life - which is vital for its normal development.

Also Folic Acidprevents many congenital malformations especially neural malformations like spina bifida and anencephaly and may lead to premature Labour. Also it's important for cell division and proliferation in a healthy manner, enteres in protein metabolism, helps in depression treatment and anxiety where Folic Acid helps in formation of neurochemical substances as Dopamin and Serotonin so it's essential for brain, energy production and support of immune system.

The new invention

^■ In the past scientists did not discover co-enzyme QlO which is considered one of the great discoveries in science of nutrition in the late decades and also returns vitality to the heart.

^■ From this co-enzyme QlO different co-enzymes from 1 to 10 present in fine creatures and animals otherwise in man there is no longer known any of these co- enzymes except co-enzyme QlO as it's formed in the body but it's not known as a traditional vitamin inspite of having same effects of vitamins.

^■ The ability of the body to form co-enzyme QlO decreased with aging due to taking low nutritional values foods and many negative environmental effects. Laboratory searches results in Japan and U. S. A proved that the great effect of co-enzyme QlO in case of very difficult heart diseases as there is no negative effect in case of continuous administration of the nutritional supplement, so it's advised to take coenzyme QlO in heart diseases treatment.

^■ Of the important discoveries that vit.B complex shares in formation of hundreds of enzymes including co-enzyme QlO. Because diabetes affects in damage of vit. B in blood especially and this makes doctors advise their diabetic patients to take vit.B complex to keep health of tissues, systems and organs in the human body but many patients of diabetics did not pay attention to this matter.

^■ Vitamins are of the most fast vitamins to be damaged, so it is preferred as a new developed discovery addition of most important B vitamins as folic acid -vit-B6-B12 to drugs lowering blood glucose level.

^■ Vit.B complex has many roles in the human body from which:

1. Share in formation of enzymes including co-enzyme QlO which protects cardiac muscle, so the diabetic patient is not exposed to cardiac attacks and cardiac muscle weakness, as the biggest amount of co-enzyme QlO is present in cardiac muscle and its lack leads to its weakness. Also co-enzyme QlO helps in supplying cardiac muscle and tissue by oxygen and improves blood circulation.

■ Also B vitamins as folic acid,B6 and B 12 protect diabetic patient form acute nervous tension, keep nervous system and nerves healthy and the body needs enough amount of vit.Bό important for production of Trypophan which is an essential amino acid needed by the body to produce vit.B3-Niacine), also Tryptophan is used in the brain for production of serotonin which is a neurotransmitter important for nerve impulses transmission from one cell to another and responsible on normal sleep, fighting depression, anxiety, insomnia and establishment of psychic mood, relieving to tension. Also, it activates growth hormone secretion, helps in decreasing

over-weight, useful in treatment of migraine. Tryptophan Lack due to lack in diabetics may lead to spasm of coronary arteries.

^■ Of the dangerous complication of diabetes is dry gangrene caused by stopped blood flow or diminished which result in deprivation of tissues from oxygen. This event happens a lot in the foot and its toes, and many doctors see that this case occurs due to decreased of some important elements in the body due to diabetes mellitus which leads to poor blood circulation or blockage of blood vessels.

^■ Of the essential elements which secure against gangrene is addition of to drugs lowering blood glucose level as it improves blood circulation, supplies cells and tissues with oxygen and effect vit.E&C enhance co-enzyme QlO effect we, activate it and improve, its absorption vit.E, helps in oxygen consumption, improves blood circulation, inhibits free radicals formation which destroy tissues and cells, also vit.E keeps co-enzyme QlO safe from damage.

^■ Vit.C Which improves circulations, helps in wound healing, fights infection helps to prevent thrombosis in legs, heart and lungs protects from free radicals, activates immune system and enhances effects of co-enzyme QlO.

^■ Folic acid helps in production of red blood cells which carry oxygen to the tissues.

^■ Diabetic retinopathy is considered associated with diabetes mellitus where some elements are decreased due to diabetes leading to fluid leak or blood leak from fine capillaries supplying retina resulting in rods and cones damage then new capillaries start to form in diseased areas and obscure vision. Also vit.B complex is linked to eye health

where its lack lead to eye congestion, also improves cellular metabolism in the eyes.

^■ Also eye disease and retinal detachment is linked somewhat with zinc lack and its presence protects from damage caused by exposure to light. Also zinc reinforces wound healing, supports immune response and helps in protein production as protein is considered vital for healthy eye functions zinc , also helps vit.Bό -B12&folic acid in protein digestion, absorption and metabolism in the body to supply the body with its needs for its vital functions.

^■ Vit.C Decreases pressure inside the eye, relieves inflammation and a powerful eliminator for free radicals which causes damage to retina and fine capillaries supplying it. Also reduces incidence of occurrence of cataract which almost occurs due to diabetes, improves blood circulation in the eye, protects fine capillaries in the eye, helps in healing process and fighting infections.

^■ Vit.E Destroys free radicals and in some cases delays and stops cataract formation, prevents scars formation and damage to tissues and important for healing and immunity.

■ Zinc helps in protein production which is very essential for healthy eye functions and protein is metaboslised to form amino acids essential for many of vital functions like healthy kidney. Also helps in keeping of healthy eye functions through formation of amino acid tourine where its lack may causes harm to vision and it's found that its lack is associated with lack of zinc in the body. Also vits.B6&C help in formation of amino acid methionine involved in amino acid tourine formation important for healthy kidney and liver functions as it playes a special role in limiting potassium loss from cardiac

muscle, helps in preventing serious troubles in heart rate because it's present in high concentrations inside cardiac muscle, nervouse system and muscles. Diabetes increases body need of amino acid and tourine in case of prevalence of this amino acid in the body the diabetic patient will not need the ordinary dose of insuline and it's also useful in ascites, hypertension, heart diseases and poor brain functions.

^■ Vit C&E with zinc Protect from glomerulonephritis which is an inflammation affecting filtration units in kidnies, also protect from pyelonephritis and hydronephrosis. All these diseases of kidney mentioned occurs due to infection of glomeruli which are small units formed of fine blood capillaries in the kidney where its inflammation occure as a result of chronic disease like diabetes or systemic lupus erthymatosis.

^■ Vit C &E Destroy free radicals, support immunity, protect kidnies from functional deteriotion and improve renal blood flow zinc is important for repaire of damaged tissues and improves immune response.

^■ Vit B6 Helps in decreasing fluid accumulation in the body, so it's preferred to added these elements to drugs used in diabetes as they are decreased in diabetic patients.

^■ Of the complications of diabetes is neuritis which is an inflammation or deterioration occur in a nerve or group of nerves leading to weakness and muscles a trophy, loss of sensation, loss of sensation ,loss neural reflexes, and muscles supplied by affected nerves become painful if pressure is applied on it.

^■ Many researches proved that lack of B complex is one of cause s of neuritis, unbalanced metabolism due to lack of B complex as folic acid ,B6-B12 _an d sharing in digestion because vit.Bό important for HcI production of and shares folic acid and B12 in digestion, fat, carbohydrates and proteins absorption, also in its formation and metabolism according to body needs.

^■ Lack of vit.Bό leads to numbness and tingling sensation and associated with carpal tunnel syndrome. On the other hand vit.B 12 resists nerve damage through keeping health of fatty covers which covers and protects nerves endings and vit,B12 works as best as possible with folic acid and vit,C .

^■ These elements mentioned before are decreased in diabetes and this problem if ignored may lead to a major problems in diabetics like deterioration of many vital functions, so it's preferred that these elements folic acid B6 -B12-zink to be added to drugs used in diabetes.

^■ Of benefits of vit,C in diabetics that it's anti-inflammatory, essential for transmission of nerve impulses. Also zinc considered essential for nerve repaire, immune response, good for absorption and production of proteins, shares with vit B6 and vit,C in amino acid methionine formation in the body which is a powerful anti-oxidant, fights free radicals, essential for creation of nucleic acid, collagen and proteins present in every cell in the body. As long as amino acid and are present this help in prevalence of Carnitine which is not an in nature but it has a chemical composition resembling that of amino acids so it's mentioned among amino acid. This carnitine is considered an important source of energy in muscles, decreases

dangers resulting from weak fat metabolism associated with diabetes and decreases incidence of cardiac disorders.

^■ Studies showed that cardiac damage due to cardiac surgeries can be decreased if treated by carnitine as it activates efficacy of vit,E - vit,C as anti-oxidants.

^■ Also of diabetes complications is thrombi formations which is a dangerous problem if the diabetic reaches it because it threatens his life and the problem ends by taking thrombi solvents and anticoagulants without paying attention for handling with the main problem from doctors which is lack of B complex and some other elements due to diabetes as vit,C protects from thrombi formation, improves blood circulation, keeps liver healthy because the liver is the site of formation of blood proteins like fibrinogen,prothrombin and heparin other factors entering in blood clotting mechanism.

^■ Vit,B complex which decreased in diabetic patients are considered very important for healthy digestion and absorption of protein and for protein production inside the body as many of enzymes formed in the body are proteins in nature and catalyzer of biological processes in the body, so vit,B are considered important for liver functions and reformation of liver cells as vit,B lack especially vit,B6-B12 &folic acid with zinc exposes liver to some troubles due to protein not metablolised to amino acid used by the body enabling it to do its functions efficiently because even in presence of vitamins and minerals it cannot be effective except in presence of amino acid so lack of some elements considered as cause in liver disorders and insufficiency of its enzymes which enter in production of

fibrinogen-prothrombin and hebarin and other factors related to blood clotting process.