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    Prologue and Rationale

    When the level of blood glucose rises above normal it gives rise to a condition called diabetes. The food we eat gets converted into glucose or fat in our body to provide energy for work. The organ lying near the stomach known as pancreas secretes a hormone, insulin
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    that helps the glucose to get stored in the body cells. When pancreas are not able to produce insulin in required amounts or is not able to use insulin the glucose is not able to get store in the cells, as a result the sugar gets stored in the blood causing diabetes. The cases of diabete
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    are much higher these days as compare to the past. It occurs in all age groups but the most common sufferers are obese people in middle or older age. The most commonly used screening tests are the determination of the fasting blood glucose level and the blood glucose level tested two hour
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s after a meal. The normal fasting blood sugar content is 80-120mg.per 100 ml of blood, this can go up to a level of 160 mg. per 100 ml of blood two hours after meals. Anything above these levels can be termed as diabetic levels.

    Types of diabetes

    · Type 1 diabetes

    In this type 1 diabet
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s the body stops producing insulin or produces less to regulate the level of blood glucose. It was previously called insulin-dependent diabetes mellitus (IDDM) or juvenile onset diabetes. The people suffering from types 1 diabetes require insulin treatment daily to sustain life.

    · Type 2
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    iabetes

    In this type of diabetes the pancreas secrete insulin but the body is not able to use the insulin. This condition is also referred to as insulin resistance. This insulin resistance results in type 2 diabetes when enough amounts of insulin is not secreted to cope up with the higher
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    demands. It was previously known as non-insulin dependent mellitus (NIDDM) or adult onset diabetes. It doesn’t occur in younger people. It can be controlled with proper diet, weight loss and exercise.

    · Gestational diabetes

    It usually occurs during the second half of pregnancy. It can c
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    use problems for the mother and babies if proper medication is not done. It disappears after the delivery. The women who suffer from this diabetes in pregnancy have more chances to suffer from type 2 diabetes in the later years of life.

    Symptoms

    The various symptoms of diabetes are:
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    · Dry skin
    · Slow recovery from an injury
    · Frequent urination
    · Fatigue
    · Blurred vision
    · Excessive thirst and hunger
    · Sudden weight loss
    · Intense hunger
    · Weak appearance
    · Numbness of hands and feet
    · Stomach pains

    Causes

    Sy
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    tematic overeating and obesity mainly cause diabetes. This overeating is just not if sugar and refined carbohydrates but also high intake of proteins and fats. Grief, worry and anxiety are also the causes of diabetes that affects the metabolism and cause sugar to appear in the urine. It ma
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    also be caused due to some disorders like cancer, tuberculosis and cerebral disease. Diabetes is a heredity disease, which can affect many generations. It can also be caused due to many nutritional deficiencies and use of certain medicines for longer period of time.

    Treatment

    1. Soybean
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is a very good source of emery for diabetic patients. It is full of proteins, iron, calcium, vitamin A and fibre
    2. Fenugreek seeds are very useful in diabetes. Soak about 90-100 seeds in 250 grams of water and leave it overnight. Mash them in the morning and sieve in a cloth and dr
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    nk mixture regularly. Use for at least 2 months to cure diabetes.
    3. Fruit, leaves, seeds and juice of jamun are also useful. Its seeds prevent conversion of starch into sugar. Drink half cup of water mashed with 3-4 leaves of jamun tree. Take it for 5-10 days.
    4. Roast barley, m
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ake its powder and eat chapatti made out of it.
    5. Bitter gourd ( karela) is one of the best options. These can be simply fried with salt and other condiments and can be taken 2-3 daily.
    6. Regular moderate exercise helps to control diabetes.
    7. Diabetes can be controlled w
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    th specific yogaasana like shashankasana.
    8. Juice of bilva and parijataka leaves in equal parts, 2 teaspoons taken twice a day also helps in the reduction of sugar.
    9. Half-cup karela juice can also be taken.
    10. Regular juice of grape fruit cures diabetes.
    11. Patola
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    snake gourd) and bimbi are also beneficial for diabetic patients
    12. Leaves of mango tree also fight diabetes. Boil 3-4 fresh leaves of mango tree in the morning and drink.
    13. Chew 3-4 leaves of jamun morning and evening in the early stages.
    14. Supplementation of cereals
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    with gram is highly beneficial. Make a chapatti of gram flour and barley flour.
    15. Regular intake of two tender leaves each of neem and bilva in the morning reduces blood sugar.
    16. Soaked almonds are also beneficial.
    17. Take 60 grams of fresh ripe fruit of jamun and dip i
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    300 grams of boiling water and then cover it. Mash it after half an hour and sieve. Divide into three parts and drink each part thrice a day. Diet

    Celery, cucumbers, string beans, onion and garlic are highly beneficial for diabetes patients. Onion and garlic have been proved beneficial
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    in reducing blood sugar in diabetes. Upon arising the patient must have a glass of Luke warm water with fresh lemon juice. In the breakfast the patients should include any fresh fruit except bananas. Steamed or lightly cooked green vegetables such as cabbage, spinach, cauliflower, turnip a
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d mushrooms are the best for the lunch. Cooked starchy foods should be avoided as in the process of cooking the cellulose envelops of the starch granules burst and the starch is easily absorbed in the system. Emphasis should be on raw foods as they stimulate and increase insulin productio


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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