Pharmaceutical Composition Comprising A Steroid And Vitamins

PHARMACEUTICAL COMPOSITION COMPRISNG A STEROID AND VITAMINS

Technical Field

Background Art

Cortisone Phobia has been established between the peoples since associated with complications and side effects . Regardless kind of ingredients or results of usage, the patients, who have suffered from such complications, are main example and evidence for harm caused by cortisone. Therefore no one desires to complain of such complications.

However, using cortisone ingredients is a must, even in some cases if it leads to complications known to- the physicians , because significance and seriousness of the disease is more dangerous than cortisone complications. In this study, I will stress on complications resulted from using cortisone led to frighten deputation and phobia of using cortisone and answering question like, what is Cortisone? , how and when to cause complications? Does it lead to fibrosis of kidney and hepatocirrhois? Does it cause cancer? These are some daily comments of some patients questioned to the physicians in the clinics and reflecting phobia of cortisone using. Such phobia encourages the patient to refrain using medication meanwhile he is in bad need to. In addition, cortisone has excellent therapeutic effects as well as side effects, which may be, sometimes, dangerous if the patient does not keep with the followed instructions. Such side effects appear when using cortisone excessively by mouth, injection or overdoses for long term which lead to stop normal excretion of cortisone of suprarenal gland . this gland needs weeks or months to resume its work.

As for the potential side effects, it is evident by the studies conducted by many scientists and published in drugs leaflet sold in the pharmacies such

CJ as the following, Raising of eye pressure, cataract which is a layer over person's eyes that prevent him from seeing properly, hyperglycemia, rheumatoid, dysfunction of immunity, circularity of face, increasing of thirsty and urination, pains in the muscles and bones, restrain of sodium in the body which leads to increasing the liquids and establishing edema as well hypertension increasing burden on the heart. Cortisone expels potassium in the urine which leads to heart failure. Cortisone, also, causes disorder in menstruation, reduces immunity delaying of healing formation the wounds, forms microbes, fungal, obesity resulted from gathering of the fats in the fatty areas, osteopsathyrosis, depression, insomnia, moody tempered, feeble resistance for inflammatory diseases, and influencing liver.

If the patients stops suddenly taking cortisone, his flesh will become void from cortisone required for the vital operations because suprarenal gland stops to excrete cortisone normally since it is taken from other source rather than the gland. To return to its normal work , the glands may take weeks, months or even one or two years to restore its previous activity. Consequently, withdrawal symptoms like nausea, vomiting, joints pain, headache, loss of appetite, pypertension, mental changes, fever, or hypoglycemia. In addition, sudden stop may lead to death or recurrent of the disease which was treated before b y cortisone. Withdrawal symptoms are traded through taking high dose of cortisone then to stop taking cortisone gradually.

My experience with my son has largely affected on my research. My son is eighteen years old and complains of ulcerated colitis. He takes cortisones tablets, whenever the dose is reduced; it will lead to recurrence of the disease which leads to retake of the doses. Such matter increase fear of a mother in me and pushed me to look for something reduce side effects

13 which I observe on my son. However, these effects are medium but for me as a mother sees it something unbearable . Frankly I see cortisone tablets as thorns swallowed by my son. I hope to eradicate such thorns to be replaced by healing balsam till its turn comes without causing harm for I love. I love to dedicate such work of art to all the peoples need to touch of recovering to be helpful for the needy.

Disclosure of Invention :

If we discuss the side effects of cortisone and its cause one by one, we will be able to know the main causes of disease resulting from negative effects of cortisone so will be easy prophylaxis, rapid treatment and the body gets ride of its bad effects.

Here I'm discussing some products of cortisone, its side effects and reasons of these effects after studying it and prophylaxis against.

Of these effects cortisone lowers immunity; delays wound healing and enhances bacterial, fungal & viral multiplying.

Resulting;

The immune system fights organisms causing disease is the chief of healing and cure operations and the most well known symptoms of immune system deterioration are:

- Inflammation - allergic reactions - delayed wound healing and - multiplying of some organisms which are normally found in the body as commensals as oral candidacies and systemic candidacies.

The immune system is a system of complicated interactions including different group of organs and substances as - white blood cells ■- bone marrow - lymph vessels and - specialized cells called plasma factors

EJ and in a perfect manner all these components work together to protect the body from infections & diseases.

The thymus gland is considered the main gland of immune system and there are many factors may cause defect in immune system's work.

And use of some cortisone drugs form an overload on the immune system leading to decrease in the ability of wound healing and lowered immunity against infections.

After many studies the searches approved that cortisone destroys some elements in blood which finally lead to decreased human immunity.

And of these elements:

> Vitamin A which is essential for immune functions and against infection.

Also important for thymus gland which helps in anti-bodies production, protects cells, prevents malignant tumor formation and as well the body cannot utilize and benefit from proteins in absence of vitamin A.

> Cortisone destroys also vitamin B6 which is important as anti-oxidant, increase immunity and activates wound healing.

> Vitamin C is most important vitamin for immune system and it's of the basics for supra-renal gland hormones production, lymph cells production and has a direct effect on bacteria and viruses.

Cortisone also destroys vitamin C which acts as a primary anti-oxidant and a strong eliminator of poisonous free radicals. Also it reacts in coordination with vitamins E & A to prophylactic against cancer, protects against blood clotting and ecchymosis. Vitamin C is also important in collagen formation which protects from skin cracking and helps in production of anti-depression hormones.

Also the body needs zinc accompanied with cortisone treatment where it gets deteriorated with people who are taking cortisone.

> Zinc is important for immune system, supports immune response, and helps in wound healing, prophylactic against acne, so we found people administrating cortisone suffer from acne especially in frontal area of face.

> Zinc increases vitamin A absorption.

^ The body needs vitamin B5 during administration of cortisone.

> Zinc increases vitamin A absorption.

> The body needs vitamin B5 during administration of cortisone.

This vitamin is vital for steroids production in supra - renal gland, plays an important role in anti-biotic formation, helps the use of other vitamins and it's one of the most powerful vitamins against depression and anti-bodies formation.

Over - Weight

Some people who have treated by cortisone suffer from over weight and functional insufficiency in some gland due to long term treatment by cortisone drugs.

Also diabetes, hypoglycemia, psychic tension, all of these disease due to lack of some essential elements to the body to complete its functions.

Blood glucose level disorders due to pancreatic disorders which may result from pancreatic cells destruction or any disorder affects pancreas due to lack of some elements such zinc,vitsC,B6 and A. Vit. B complex helps greatly to maintain pancreatic cells and keeps it healthy

Also vit. B6 helps so much in protein metabolism and absorption efficiently because cortisone wastes vit.Bό and that in decreases protein absorption and improper use of it and conversion to amino-acids essential for functions of pancreas. So even if we take enough amount

Of protein there will be a lack in some essential amino - acids like and Which are important for functions of pancreas.

VIT.B6 is an anti - tension needed by suprarenal gland where insulin secretion is affected by function of supra- renal gland as it secretes adrenaline (epinephrine) which stops insulin secretion, so if there is any disturbance or exhaustion of suprarenal, this may lead to insulin over secretion which leads in turn to hypoglycemia, great desire to eat, especially sweet foods and ends in over weight.

Zinc activates protein formation, anti-oxidant, immunity supportive and protects all body cells from being destroyed by frees radicals. Thyroid gland is affected also but lack of vits.A and c and the decreased gland hormone leads to over weight.

Vit B complex keeps body glands and cells healthy and help in hormones secretion and activation of enzymes.

Irregular menstruation

Regular menstruation results from common work of many systems in the body not only reproductive system. So any disturbance in one of involved systems affects this regularity of menses. We will discuss some of these disturbances in the involved systems of which. Suprarenal gland, thyroid gland and pituitary gland and the latter is considered the leader of all systems mentioned above.

O Hyperthyroidism associating long term treatment by cortisone e leads to decreased rate of menstruation because it affects pituitary gland functions leading to disturbance in its hormonal secretion and of these hormones is thyroxin stimulating hormone (TSH). From its name it's obvious that it stimulates secretion of thyroxin hormone secreted by thyroid gland. Any decrease in secretion of thyroxin leads to great increase in hormone stimulating secretion in blood.

The endocrinologists see that this stimulating hormone level to secrete thyroxin is increased in the first stage of thyroid gland defect. The body can not get use of protein except in presence of vit.A, as proteins are essential for hormones secretion and supplying the body with its needs of all essential amino-acids. If the body can not find its needs of these amino-acid, this will lead to disturbances in all systems, for example amino-acid Tyrosine unites with Iodine to form thyroid hormones, so any lack in vit.A will lead to decreased activity of thyroid gland.

Tyrosine has an effect on supra-renal, thyroid and pituitary functions.

Lack of some amino-acids and some of vitamins may affect gland health and immune system health which can produce anti-bodies to attack thyroid gland leading to disturbance in its hormones.

Also of important amino-acids required for health of glands and immune system are Arginin ,ornithin and thereonin . So proteins are considered very important to keep thyroid gland healthy, this is also helped by presence vit.A.

Then Vit.C comes as a very important factor far activity of above mentioned glands where its normal secretion is important for healthy regular menstruation and it is decreased during treatment by cortisone

O where it keeps supra - renal healthy either its cells or functions because it secretes a sexual hormone like that is secreted by testis in male.

Vit.C is essential for supra-renal hormones formation and for pituitary gland to keep normal functions of thyroid in turn.

Vit.B5 plays an important role in supra - renal gland hormones production and helps in use of vitamins and its metabolism. Also considered anti-tension because tension increase elimination of some vitamins and minerals needed by the body to do its function in healthy and right manner.

Vit.Bό essential for absorption of essential amino-acids required for healthy suprarenal, thyroid and pituitary glands as all these glands as we mentioned before affect regular menstruation. Also vit.Bό shares in keeping immune system health to do its functions and production of anti-bodies.

Zinc is decreased much during treatment by cortisone.

Zinc is needed by the body for protein production which is needed by glands to do its functions in a healthy manner as we mentioned before, also helps to keep cells healthy away from free radicals and supports immune system.

Dizziness

Use of cortisone leads to some dizziness due to loosing some elements which lead to some troubles in central nervous system accompanied by nausea. And this may be due to lack of vitamin B6 which is essential for:

Normal functions of the brain & central nervous system & its lack leads to depression, dizziness & over - irritation.

And treatment with cortisone also leads to lack of calcium which is important for preserving regular nervous impulse helping to prevent dizziness.

Vitamin C improves blood circulation & brain efficiency.

Adding Folic acid is essential for producing red blood cells which carry oxygen.

As well hyper-tension, hypotension & hypoglycemia resulting from supra-renal function deterioration in some people who are being treated with cortisone may lead to feeling of dizziness & nausea.

O Headache

Headache occurs in people who are taking cortisone due to lack of chemical substance in brain which is called serotonin which is decreased due to lack of folic acid & vitamin B6 because serotonin consists of these elements which when decreased leads to chemical imbalance in the brain.

Serotonin is a chemical substance in the brain which is decreased during headache and this leads to generation of electrical impulses in Trigeminal nerve affecting blood vessels in meningeal membranes which cover brain from outside leading to inflammation & edema of these vessels causing headache.

Lack of vitamin B6 leads to headache, migraine and eliminates extra - water from tissues.

■ Calcium regulates muscle contraction & neural impulses transmission through the body from the brain.

■ Lack of vitamin B5 pantothonic acid leads to headache & depression.

■ And potassium causes balance between sodium & potassium required get ride of excess water which may increase pressure on the brain with no reason.

Skin disorders

o Delicate fragile skin o Blue colored skin o Minute bleedings beneath the skin.

The most important factor in skin disorders is lack of essential elements required for skin health which leads to release of free radicals which may destroy skin cells.

Vit. A is needed in the body and it is decreed during treatment by cortisone with and that lads to skin disorders

Vit.A strengthens and protects skin tissues and important for healing and new skin tissue formation.

Treatment by cortisone leads to fragile skin and different skin disorders mentioned in leaflet of cortisone drug package, also as shown in the attached photos of my son who is treated by cortisone.

Vit. C decreased so much due to treatment by cortisone as it's essential for collagen formation which is a protein gives the skin its normal elasticity and important for glands functions like thyroid gland where its disorders lead to skin disorders. Also fights free radicals, reinforces blood capillaries supplying the skin and activates wound and burns healing.

Vit. C is important also for glands functions like suprarenal gland and lack of vit.C where it causes fragility and minute bleeding beneath the skin (as shown in photos) also lack of vit.C leads to blue discoloration of the skin because these individuals have weaker blood vessels. The body needs zinc during treatment by cortisone because it helps in production and formation of protein and collagen, important for regular functions of oil secreting skin glands, protects tissues and repairs it.

Decreased calcium resulted to treatment by cortisone leads to delicate fragile skin as it protects the skin.

Vit. D helps in thyroid gland function where thyroid gland disorders lead to skin disorders and change in thickness of the skin also lack of vit.D leads to aging of the skin.

Lack of vit. ) also cause skin fissures.

Digestive System

o Gastro-intestinal disorders o Gastric ulcer o Gastric ulcer perforation and bleeding.

Cortisone may lead especially with long term use to hyper secretion of gastric acid (HcI) leading to inflammations and stomach ulcers. Also Cortisone affects absorption of vitamin B essential for secretion of enough amount of mucus which protects the stomach wall and in this case inner layer of gastric wall isn't protected against increased gastric acid.

Also tension and stress resulting from destroying cortisone lead to loss of important vitamins like calcium and vit.Bwhich resist tension and stress,and are essential for normal alimentary tract function and may expose the body to increased gastric acidity and this explains relation between ulcer and tension levels, so vit.A is essential for healing, protects mucous membranes of stomach and intestine and helps in colonic lining healing. Vit.C activates healing, protects against infection repairs tissues and helps in production of anti-tension hormones.

Vit.B6 is essential for production of hydrochloric acid, enzymes and helps wound healing.

Hypersensitivity

Lack of elements and long term treatment by cortisone leads to loss from the body which are needed to resist allergy.

Vit.B6 helps in treatment of allergy and it is lost during treatment by cortisone.

Vit.C protects from allergens, decreases inflammatory response, activates anti-vital protein (interferon) in the body and its anti-oxidant and reinforces immunity system, and this vitamin is decreased in the body due to treatment by cortisone.

The body needs vit.A for healthy immune functions and this vitamin is decreased during treatment by cortisone.

During treatment by cortisone the body needs amino-acid Methonin which is one of the essential amino-acid preferred to be obtained through supplement to replace decrease during and from other side to treat side effects resulting from cortisone of which: allergy for chemical substance and lowers histamine in the body. Also it's powerful antioxidant good source for sulfur which resists free radicals, important for elimination of poisoning effects of harmful elements and protect the body from destructive effects of poisonous compounds. Cataract

This disease has many causes of them: aging, diabetes, poisoning with . heavy metals, exposure to irradiation or use of medications like cortisone and mostly due to harm resulting from free radicals which attacks proteins enzymes and cellular membrane of lenses.

Vitamin C which is lost with cortisone treatment is essential to destroy free radicals and for lowering elevated intra-ocular pressure resulting from cataract, also zinc protects from damage due to exposure to light.

Cortisone also effects the suprarenal cortex like dixamethasone, Decadrone,hydrocortisone , bredensalone and Bredensone may lead to some eye troubles or cause harm for optic nerve, retina or other vital parts of the eye.

Zinc which decreased much during cortisone therapy helps in dietetic assimilation in vascular layer of the eye.

■ Hypertension leads to gradual increase in thickness of blood vessels in the eye leading to decreased visual acuity or even blindness.

■ Vitamin A is important in all eye troubles and the body needs it especially during cortisone therapy.

Also it helps in preventing cataract, in eye disorder called retro-lental fibrocytes proliferation, also prevents cells destruction.

Osteoporosis - Muscle weakness

Treatment by cortisone leads to lack of potassium essential for good assimilation of calcium and magnesium and vitamin D3 these elements are important and essential for muscles and bones.

Potassium is essential for edema relief and sodium, and they keep water balance in the body which is important for chemical reactions, keeping constant blood pressure, electrochemical impulses transmission through the body and its lack leads to acne, weak nervous reflexes, body edema, glucose intolerance, easy fatigue, and muscle weakness, headache in a cyclic manner and sodium retention in tissues. All these symptoms appear in people treated with steroids.

The body needs potassium for hormones production and tension hormones (like adrenaline) secretion leads to decrease in rate of potassium and sodium inside and outside the cells, so tension increases body needs of potassium.

Also calcium is essential for strong bone formation, keeping regular heart rate, nervous impulses transmission, essential for muscle growth and contraction, prevents loss of osteagenic substance which leads to osteoporosis.

Also shares in protein integration in nucleic acids DNA and RNA, enters in activation of many enzymes like lipase which analyses fat.

calcium lack leads to joint pain, hypertension, nervous spasm, nervous mood, rheumatic arthritis, deterioration in sensual abilities, depression, convulsions, and psychic and nervous irritability.

Vitamin D and calcium protects from muscle weakness and osteoporosis, cortisone prevents absorption of vitamin D. When body is treated by cortisone it needs vitamin B5 which is needed by the body during treatment with cortisone and vitamin B5 relives symptoms related to Rheumatoid.

Vitamin B6 which is decreased by cortisone helps in keeping the sodium and potassium balance and its lack leads to arthritis.

Vitamin B6 increase fat and carbohydrates assimilation in muscles and acts as a light diuretic.

Vitamin C which is decreased by cortisone and it is essential for muscle, bone and tissue repair. And it is important for calcium absorption and reduces pain and swelling.

Vitamin A helps in proteins use which are essential in muscle building and tissues repair.

Cortisone decreases levels of vitamin A, in the body which has many functions in the body as:

Bone, connective tissue and muscle repair.

Using of proteins and making use of them.

Relieves pain and edema.

Vitamin A is important in muscle and bone formation because the body cannot use and benefit from protein in absence of vitamin A and it's known that vitamin A is decreased during treatment by cortisone.

Many peoples think that lack of only calcium causes osteoporosis so it can be treatment by using calcium supplements and this is not true.

In spite of being useful in osteoporosis treatment, there are other considerations like vitamin C, vitamin D and zinc which are destroyed by treatment with cortisone and they playa vital role with proteins in resistance against osteoporosis.

Peoples treated by cortisone may have some muscle weakness and decreases muscle bulk.

Evidences point to a problem in immune system which occurs due to lack of some elements due to long-term use of cortisone and some doctors say that depression is involved in patient suffering from such like case.

Treatment with cortisone leads to depression due to lack of some essential element for nerves and nervous system. Depression in turn leads to lack in essential elements for keeping bones, muscles and tendons healthy.

There is Taurine which is one of unessential amino-acids found in high concentrations in skeletal muscles and central nervous system and it vital for perfect benefits from sodium, potassium, calcium and magnesium. It also plays a special role in limiting loss of potassium from heart muscle.

Taurine is formed in presence of enough amount of vitamin B6 in blood, so patients treated by cortisone have decreased vitamin B6, so it's proffered to be added with cortisone drugs to replace this decrease in to allow it to play its vital functions in the body.

During treatment by cortisone the body needs zinc which is essential for protein production and collagen formation.

Also it activates immune system, supports it, activates wound healing and vital for bone building.

Level of zinc decreased during administration of cortisone. * Vascular edema of the eye * Increased intra-ocular pressure

* Eyes disorders.

These troubles pointed to in the title accompany long term treatment by cortisone. And in a study for Dr. Eliot person master of ophthalmology faculty of medicine, Harvard university declared that doses of vit A and delay loss of vision power or the rest of it by 20% in every year.

Vit.A which is decreased during treatment with cortisone is considered important in eye disorders, essential in all eye disease, fluid balance in the eye and it's a powerful anti-oxidant.

Vit.A ,vit.C and Zinc help in immunity reinforcement which is very important in protection of the eyes from diseases and enhances cure.

Vit.C is an important anti-oxidant, essential for removal of free radicals, protects eyes from damage, lowers elevated blood pressure improves blood circulation, helps in wound healing and antiviral.

Zinc lack is linked with eye diseases and essential for immunity

Diabetes may lead to complications in retina in the form of blood and fluid leak from capillaries supplying retina leading to harm of rods and cones, then new capillaries start to form in affected parts causing difficult vision.

As we know that long term therapy by cortisone may cause pancreatic cells destruction leading to pancreatic disorders and develop of diabetes which affects eyes health.

Because treatment by cortisone leads to loss of most of important elements for cells and eyes health. Glaucoma

It's a dangerous disease characterized by increase in fluid pressure inside the eye ball.

Vit.A is important for visual purple formation required for night vision, also it's a strong anti-oxidant and so important in all eye diseases.

Vit.B5 is anti-nervous hypertension and important component for coenzyme A which is important for many of biological assimilation and dietary assimilation inside eye cells.

All kinds of cortisone drugs cause eye troubles and may lead to harm in optic nerve, retina or other vital organs of the body.

Many clinical studies showed that Vit.C lowers intra-ocular pressure, anti-oxidant and protects eye cells, and tissues, and vit.C is lost from the body during treatment by cortisone.

Zinc which is lost from the body during treatment by cortisone is important for activation of vit.A from liver and useful in treatment of glaucoma.

It's known that lack of Zinc may lead to night blindness, increased exposure for infection, exposure to have diabetic disease, delayed wound healing and many other symptoms.

Cortisone drugs may lead to glaucoma through destruction of collagen formations in the eye , so essential elements must be added which is vital for prophylaxis and protection of the eye against glaucoma. The negative balance of Nitrogen

As it's known to many doctors that treatment by cortisone leads to negative balance of nitrogen in the body which is considered a bad and dangerous side effect on the body especially for liver.

Cortisone therapy leads to a great lack of some essential elements in the body like vits.C,B6,B5 anc[ zinc,causes negative balance of nitrogen in the body.

When an amino-acid is analysed, nitrogen, is released, this free nitrogen may be converted to ammonia which is poisonous for the body especially the brain.

The body needs vit.B6 and Vit.C to activate amino-acids absorption and to create some other amino-acids. The body needs also vit.A which helps in use and benefit from proteins converted to amino-acids helping in nitrogen balance in the body like Argenin,Asparthic Acid ,Glutamin,Sitrolin,cystin and Falin.

Also Zinc is considered essential for protein production in the body an protection of liver from damage. Also it increases absorption of vit.a and helps in addition to vit. and vit.C to resist free radicals and prevents its formation.

The lack of these elements due to treatment by cortisone and bad absorption, due to lack of vitamins B which are important for secretion of gastric enzymes, good digestion, HcI production and protein absorption affects prevalence of essential amino-acids.

■ If the body is not supplied by enough amount of essential amino-acids the lack will appear in the picture of somatic disorders including negative balance of nitrogen in the body. Also Folic Acid is involved in protein assimilation, support of immune system acts as Co-enzyme in process of DNA and RNA production and it's important for cells division and multiplication in a healthy manner.

Amino-acid Methonin is considered a strong anti-oxidant, good source for sulpher which resists free radicals, also important for proteins and amino-acid production in every cell in the body, elimination of poisonous effects of any harmful elements in the body.

Also amino-acids cyctecin and Tourin production depends on prevalence of Methonin.

Pancreatic Disorders

As it's known: treatment by cortisone affects a large group of elements like vit.B complex,Calcium,Zinc and vit.C which are important and essential for pancreatic cells.

Of these pancreatic cells α-cells which secrete the hormone which transforms glucose stored in liver and muscles to glucose ready for use when glucose level in blood is lowered, also convert glycogen to glucose.

■ Another type of pancreatic cells is β-cells which secrete insulin hormone responsible for glucose utilization by the body and without this insulin, glucose will accumulate in blood leading to appearance of different pathologic symptoms.

Also insulin regulates glucose level in blood and its storage in liver.

Zinc playes an important role in insulin formation and patient with pancreatic troubles suffer from lack of Zinc because insulin saved inside the cell cytohyaloplasm in the form scattered small granules in union with Zinc.

When there is a need for insulin due to hyperglycemia, fine tubules adherent to cell membrane contract to attract insulin saving granules to fuse with other granules in cell membrane aiming to let insulin get out from cells to the blood without harming pancreatic cells, so insulin can do its physiological functions and we must mention that presence of calcium elements is necessary for these tubules also energy producers of phosphorous peptides in order to have their ability of attraction of insulin saving granules.

So Zinc & calcium are considered essential and important to protect from pancreatic troubles, as the body's need to calcium and Zinc is increased during the treatment by cortisone, researches also proved that lack of potassium during treatment by cortisone leads to glucose intolerance because long term use of cortisone affects badly supra-renal functions.

Also production of insulin is affected by suprarenal as it secretes adrenaline which stops insulin secretion, so if there is any problems in supra-renal leading to its deterioration, this will lead to increased insulin level in the blood leading to decreased blood glucose below normal level.

It's known to many doctors that Potassium leads to glucose intolerance and Potassium is essential for nervous system health, work with Sodium on regulation of body's water balance, important for cellular chemical reactions, regulates food elements passage through cell membrane and lack of Potassium leads to nervous mood, depression, deterioration of mental abilities, thirst, growth retardation, poor neural reflexes, fatigue, muscle weakness and many other symptoms.

• Because lack of Potassium increases tension, so suprarenal also increases its hormones responsible for most of symptoms associating tension which lead to decreased nutritional elements.

Also long-term tension is considered dangerous as it damages vit.B complex which is important for health and safety of pancreas.

Also continuous tension increase free radicals formation which can be oxidized and destroy body tissues especially cell membranes including pancreatic cells.

So vit.C protects from free radicals and cell destruction also it's essential for supra-renal insufficiency common in patients with hypoglycemia.

It's known that Glycosylation of blood proteins, nerve cells and eye lenses may be responsible for many of long-term effects of diabetes and researches in Syris University for Biological science and academic unit for diabetic and glands science Wetington Hospital in United Kingdom (London) showed that vit.C may discourage this reaction.

Also vit.B5 is essential for suprarenal functions, conversion of glucose to energy .Vit.B5 in addition of being anti-tension and essential for thymus gland,it playes also an important role in suprarenal hormones production, anti-bodies formation. And this vit. is a basic element in coenzyme A composition.

Vit.A is required for eye health in diabetic patients, in addition it's antioxidant, helps to protect cells and essential for growth of new cells. Unessential amino-acids includes an important group for diabetic patients like Tourin as diabetes increases body needs of Tourin which lowers body needs of insulin and help its secretion.

■ Also it represents the building unit in all amino-acids, useful in hypoglycemia and plays a special role in limiting Potassium loss of heart muscle.

■ Tourin shares with Zinc in keeping eye functions good.

So lack of these two elements may cause harm to eyes and that's why it's important for eye health in diabetic patients.

This amino-acid formation in the body is essential, so it's preferred to administrate vit.Bό to help formation of this amino-acid in the body.

Cardiac Disorders

■ During treatment by cortisone some essential element for cardiac health are decreased leading to different cardiac disorders.

Vit.Bό which is decreased during use of cortisone helps in protection from heart disease, atherosclerosis, lowers a poisonous chemical substance called hoecyctin which attacks heart muscle causing accumulation of cholesterol in heart muscle. Also vit.Bό helps excretion of excess body fluids.

Also lack of calcium during treatment by cortisone helps in keeping regular heart rate, lowers blood cholesterol, helps in protection from heart and vascular diseases and it's important for blood clotting, prevents malignancy and lowers elevated blood pressure.

Potassium is essential for regular heart rate and treatment by cortisone deprives the body from Potassium. Potassium is essential for cellular chemical reactions, keeping constant blood pressure, transmission of electrochemical impulses through the body and regulates transport of dietetic elements through cell membranes.

The body needs Potassium for hormones secretion and tension hormone secretion as adrenaline leads to lack of Potassium and Sodium ratio inside and outside the cells.

As a result of this, tension and use of cortisone increases body needs of Potassium. Also Potassium is essential for electrolyte balance especially during administration of cortisone or hypertensive drugs.

Vit.B6 helps in formation of amino-acid Tourin which is found in high concentrations in heart muscle and useful for patients of atherosclerosis, ascites, heart disease or hypertension. Also plays an important role in limiting Potassium loss from heart muscle and helps to prevent serious troubles in heart rate.

Also vit.B6 activates both nervous and immune systems.

Growth inhibition in children

General growth is related to many factors some of them accelerate it and the others inhibit it, here we try to show some of these inhibitory factors especially in childhood.

For example long-term treatment by cortisone leads to lack of Zinc which is related to growth problems because Zinc is needed in the body for protein production and formation of most of bio-enzymes.

Protein is converted to amino-acid which is used in many processes, for example amino-acid Arginin needed by pituitary to release growth hormone, also amino-acid Ornitin activates growth hormone secretion in addition to amino-acid Lycin needed by the body for growth and the correct bone formation in children and Leocin which helps in production of growth hormone.

■ Vit.Bό and vit.C help in activation, absorption and creation of these amino-acids. Vit.Bό and vit.C are decreased during treatment by cortisone which affects many of body biological functions including normal growth.

Also vit.A which is decreased in the body due to cortisone therapy is required for normal growth of bones and tissues, and body cannot benefits from proteins in absence of vit.A.

Vit.A shares vit.C in protection of glands cells including pituitary gland which secretes growth hormone, also keep it safe from destruction by free radicals.

Zinc strengthen immune system and prevents free radical formation, also Zinc increases the absorption of vit.A.

Depression

Depression is one of side effects of the treatment by cortisone drugs.

It's a disease affects nervous system, mood thoughts and behavior it affects the way of patients sleep, food even his self-feeling and surroundings.

After wide researches it's found that Zinc is lacking in patients who are treated by cortisone which affects in turn on depression occurrence and serotonin rates decreased in the brain during administration of cortisone drugs due to lack of vit.Bό

As well vit.B5 enters in production of chemical substances which transmit nervous impulses. So it's useful in depression treatment. The rate of brain chemicals known as neuro-transmitters regulating our behavior is strongly related to our mood and of this mood related neurotransmitters: Dopamine, serotonin and Nor-epinephrine.

When serotonin is produced by brain, nervous tension is decreased and when Dopamine or Epinephrine produced we are more likely to think and work faster, and be more alert in general.

The neuro-transmitter; serotonin is formed of the amino-acid Tryptophan with help of Folic Acid and vit.Bό

As well vit .B6 is anti-depression vitamin, also vit .B5 is the most powerful anti-depression hormone, helps in perfect use of other vitamins and supports suprarenal and thyroid glands functions.

Folic Acid found to be lacking in depression patients.

Calcium has a sedative effect, important for nervous system work, transmission of nervous motive and its lack which occurs due to administration of cortisone drugs leads to a nervous mood.

Vit.C is important for suprarenal gland as tension depletes suprarenal hormones and anti-depression hormones.

Administration of cortisone drugs destroys vit.C which is needed by the body during administration of cortisone drugs

Potassium is administered to replace the loss of this element during nervous tension and its lack leads to a nervous mood, nervous tension and also has real effects on body.

■ The body responds to tension by a chain of physiological reactions including increased adrenaline secretion.

> All body organs reacts with tension as: The pituitary gland increase ACTH (Adreno - Cortico - Trophic - Hormone) production which stimulates Cortisol release. This increase in suprarenal hormones leads to lack of some elements especially if tension takes long time or becomes continuous and in this situation the body loses many of elements and becomes uncapable enough to replace it.

Also most of these troubles resulting from tension and due to lack of some element especially vit.B6,vit.B5 and Folic Acid which are considered basics for nervous system.

Also tension increase removal of some minerals which are depleted during body respone to tension.

Tension also increase free radicals formation which can be oxidised & destroy body tissues especially cell membranes.

Tension also affects body parts related to nervous system especially digestive system and if tension isn't handled in a right manner serious problems may occurs as long term nervousness especially is considered dangerous due to its effects on immune system and possibility of being diseased.

Acne

The cause of acne is unknown definitely but it's proved that long term treatment by cortisone is one of the factors sharing in this disease. The skin is considered the largest organ in the body and one of its function is elimination of waste products from the body, also removal of results of metabolism through sweat. So if poisons formed in the body are in amount more than the amount can be handled by liver and kidney, the skin starts to finish this work and this makes some doctors call the skin by the third kidney.

And when these poisons get out through the skin, this leads to a harmful effect on its health and this is the secret, behind most of skin disorders like acne.

The poisons present in the body may have many reasons, of these reasons increased tension-hormones secretion, free radicals prevalence due to use of some drugs, pollution and others.

Prevalence of free radicals leads to destruction of protective cellular membranes and causes many destructive changes in the body including immune system.

Vit.C eliminates poisons of many harmful substances, playes an important role in immunity and increases, inter-ferone formation which is a naturally an anti-viral substance stimulates activity of some cells.

One of side effects of treatment by cortisone is acne appearance and this is may be due to lack of Zinc due to treatment by cortisone,as Zinc is important for oily glands of the skin.

Potassium which is greatly decreased during treatment by cortisone is associated by acne formation.

Vit.Bβ enters in cellular proliferation and it is also decreased during treatment by cortisone.

Lack of vit.B6 is associated by acne appearance.

Vit.A is important to support protective coating tissues and acts as an intermediate anti-inflammatory. Vit.C activates immune system, relieves inflammation and supports blood capillaries.

Vit.B5 is anti-tension, helps in keeping skin healthy, playes a role in anti-baiotics formation and helps in using other vitamins.

* Fluid retention

* Fluid and Mineral disturbance

Deterioration of functional abilities mostly results from long term treatment by cortisone drugs for some other diseases.

Cortisone therapy leads to much destruction of vits.A ,C and B complex which are essential for suprarenal and pituitary glands health, which fed on these elements and are essential for amino-acids created in the body from these elements ,and any decrease in these lements due to adminstrtion of cortisone drugs may lead to disturbance in these glands which are important for the body. For example the amino acid called Tourin is considered one of unessential amino acids and produced by the body when needed. As long as enough amount of vit.Bό found, this amino-acid can be produced in the body with help of amino-acid cysteine which needs also presence of B6 for its formation in the body.

Tourin is important for right use of sodium, potassium, calcium and magnesium playes an important and special role in limiting loss of potassium from heart muscle, useful in hypertension and ascites and during lack of vit.Bό from the body during treatment by cortisone.

Vit.Bό is needed in the body for formation of some amino-acids which is turn enable vitamins and minerals to do its functions.

Vit.Bό decreases fluid accumulation. The body needs Zinc for production of proteins important for suprarenal gland safety, also increase activity of vit.A important for safety, health and activity of suprarenal cortex which keeps water and electrolyte balance in the body.

During exposure to pressure and tension a chain of events and biochemical reaction occur resulting in release of ACTH from pituitary gland to stimulate suprarenal cortex which activates some substances leading to elevation of blood pressure, also this hormone leads to sodium retention in the body and excretion of potassium, as a result of this action the body keeps fluid inside leading to elevation of blood pressure, but in presence of vit.B5 Pantathinic Acid which plays an important role in suprarenal&thymos glands hormones production,and it is vital to produce estroids in suprarenalgland.

Also cortisone drugs and destroy potassium leading to lack in its level resulting in salt retention in the body. Also body needs potassium for hormones secretion.

Secretion of tension hormones like adrenaline leads to decrease in Potassium and Sodium ratio inside and outside cells, as a result for this tension increases body needs of Potasium.

And Potassium is important for chemical reactions in cells, helps in maintaining blood pressure and electrochemical impulses transmission.

Lack of potassium also leads to salt and water retention, thirst which cannot be satisfied easily, nervous mood, depression and many other diseases. Blood Clotting

Blood clotting is considered life saving in some situations but in presence of some disorder it may become lethal. During our dealing with blood clotting we must point to liver and its role in this process by product of clotting factors, also to proteins which consist these factors and effect of some drugs and substances on these factors and the process itself.

As an example long-term treatment by cortisone leads to sever lack in essential elements and this may result in dangerous complications one of them is clot formation, inside blood vessels.

Vit.C keeps blood like liquid, protects from clotting, improves blood circulation, keeps liver healthy because the liver is like a factory inside which blood protein and clotting factor like Fibrinogen, prothrombin, and heparin, which are concerning blood clotting.

Vit.B complex which decreased during treatment by cortisone is considered very important for digestion and good absorption of proteins and for proteins composition in the body because all hormones and enzymes stimulating and regulating biological processes in the body are proteins in nature. Also vit.B complex considered essential for healthy liver functions and for liver cells reformation.

Lack of vit B complex exposes liver for some disorders in proteins assimilation and in liver ezymes functions which formed from protein metapolism.

Vit.A and Zinc help in use and production of proteins because proteins cannot be used without vit.A which is decreased during treatment by cortisone drugs. Amino-acids resulting from protein assimilation like Argenin,Ornitin and Glutatheon are essential for liver enzymes and functions.

Also vit.A and Zinc are anti-oxidant factors keep liver cells safe from destruction by effect of free radicals.

Vit.A and Zinc help in protein production and decreased during treatment by cortisone and they are a anti-oxidant protect liver cells from free radicals.

Also Calcium which decreased during treatment by cortisone enters in activation of many enzymes, important for blood clotting and helps in protection from heart and blood vessels diseases.

Claims

* The drug (Corti-safe ) is a new addition to cortisone drugs will be protective from many complications of cortisone

* It's a combination of Methyprednisolone and effective elements affect and protect firom Complications of prednisolone.

* According to use this drug consists of following components and their concentrations.

A) Methyl prednisolone 4 - 16 mg

1- Folic Acid 200 meg

2-Vit.B6 100 mg

3- Vit.B12 200 meg

4- Vit.C 80 mg

5- Vit.A 3000 units

6- VitD 200 mg

7- Calcium 400 mg

8 -Potassium 50 mg

9- Zinc 10 mg

10- L-Methonin 30 mg

B) Methyl prednisolone 32 - 100 mg

1- Folic Acid 400 meg

2-Vit.B6 100 mg

3- Vit.B12 300 meg

4- VitC 160 mg

5- Vit.A 3500 units

6- Vit.D 400 mg

7- Calcium 500 mg

8 -Potassium 80 mg 9- Zinc 25 mg

10- L-Methonin 30 mg

And these above amounts are measured on the base these are lost in the body during treatment by cortisone

Which are needed so much by the body to prevent complications of bad side effects of treatment by cortisone drugs.

* Forms, ways of administration and packages of the drug will be as follows :-

- Concentration (Tablets.4 mg )

- Concentration ( Tablets.16 mg)

- Concentration ( Tablets. 32 mg)

- Concentration (Tablets.100 mg)

Added to it the previous elements of vits.A,C,B5,B6,B12,D,Folic

Acid,Zinc,potassium and Calcium. in addition to additional fixing and lubricative substances required for the manufacturing process.

AMENDED CLAIMS received by the International Bureau on 18 march 2008 (18.03.2008)

ELEMENTS OF PROTECTION:

L The drug (cord-safe) is a new addition to cortisone drugs ofdifierentkmds. lt is a protection and precaution from many side symptoms accompanying cortisone treatment.

According to the use, this drug and formula are composed as the following ratios:

Methyl predisolone • 5 mg

Vitamin B6 lOO mg

Vitamin B5 100 mg

Vitamin B12 ' 200 microgram

VolicAcid . 200 microgram

Vitamin C lOOmg

Potashm 100 mg

Calsium 400 mg

Vitamin D 200 universal unit

Zinc 10 mg

Coenzyme SD )0 . - 10 mg

Vitamin A 2,500 universal unit

L. Methonin 30 mg This formula is found in a composition of 5 mg, 10 mg, 15 mg, 20 mg- 50 mg.

2. (Cαrti-safe) drug is mamnactured by the way (ϊntero-coating) Bs composition is according to the new idea

(Twins). The strip of drug is divided in to sections, each one contains similar small two capsules like (Twins) intake from the strip simultaneously inside the two capsules the first essential active element is put all together with the other secondary elements in two capsules to avoid the big size of a capsule because it contains many several elements.

We can keep the stability of the active elements and adding other elements in the shape of grains and cover these grains with some palmers as an isolation between the effective elements and other elements. We can choose some palmers which have the characteristic of not dissolving in the stomach acid medium like (cellulose acetate phathalat CPA). Clothing some effective grain elements which are affected by the stomach add like (some vitamins) to delay the rashness of these elements until its arrival to the intestine of a medium acid. The idea of (Twins) is the manufacturing of grains by the (interc-coating) method and to mix the effective elements with other elements in a scientific way in order not to integrate the elements. This realizes a healthy, scientific benefits to the humanity. So, a lot of people avoid the side effects of chemical drugs where the body lose much elements and nutrition's to avoid many symptoms and diseases caused by side effects.

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