E-Articles - Health and Fitness

Prologue and Rationale

Obesity is the bodily condition that has been characterized by excessive deposition or storage of fat in adipose tissue. It is the result of excessive consumption of food to meet the physiological needs. Its incidence is higher in persons who consum

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

e more food and lead sedentary lives. It can occur at any age and can affect both the sexes. A woman tends to be obese after pregnancy and at menopause. As in pregnancy the women usually gains about 12 kg weight and during that phase there is an increase in the adipose tis

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

sue, which serves as a store to meet the demands of lactation. Obesity is a serious health hazard as the extra fat put strain on the heart, kidneys and liver and joints of hips, knees and ankles bear the weight of the obese body are more affected. It is common among people

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

in western countries and also among higher income groups in India and other developing countries. Obese people have more chances to suffer from several diseases like heart failure, high blood pressure, diabetes, arthritis, gout and gall bladder disorders. Obese and to be o

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

verweight are not the same things. Overweight refers to an increase in weight of the total body that includes essential body tissues whereas obesity refers to excessive fat tissue only.

Causes

The main cause of obesity is overeating, when the intake of calories increases

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

Combination pro

the energy requirements of the body. Some people are in the habit of eating more when in stress or tension, this also cause obesity. It may also be caused due to the problem in the functioning of thyroid glands. When the thyroid gland is not functioning properly the basal

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

metabolic rate becomes low and they tend to gain weight unless a low calorie diet is followed.

Treatment
1. Certain yogic asanas like sarvangasana, halasana, bhujangasana, shalabhasnaa, dhanurasana, chakrasana, naukasana, ardhmatsyendrasana, paschimottasana, vajrasa

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

na, yogamudra and trikonasa are highly beneficial as these asanas improves the blood circulation and strengthens the weak areas which helps to melt the excess fat.
2. Yogic kriyas like kunjal and jalaneti and pranayamas such as kapalbhati and bhastrika are also helpfu

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

in normalizing the body weight.
3. Ingestion of honey is an excellent home remedy for obesity. 10 grams of honey should be taken with hot water while starting and the doze can be increased with the time.
4. Cabbage is considered to be an effective home remedy fo

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

r obesity. It contains a valuable content called tartroric acid, which inhibits the conversion of sugar and other carbohydrates into fat.
5. One spoon of fresh honey should be mixed with a juice of half a lime in a glass of Luke warm water and taken at regular interva

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s. It treats the obesity without the loss of energy and appetite. Diet

The patient should adopt a juice fast for 7010 days. Juices of lemon, grapefruit, orange, pineapple, cabbage, celery can be taken. Long juice fast up to 40 days can also be adopted but only under prop

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

Following aspects would a

er guidance. Short juice fast should be repeated at regular intervals of two months or so depending on the requirement. After fasting the patient should adopt a well-balanced low calorie diet consisting of three basic food groups and emphasis should be on raw fruits, veget

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ables and fresh juices. Before planning the diet on must know the normal weight and energy required according to height and age. The normal amount of calories required per day according to age is:
Infancy to 3 years 1200-1400
10 years 2500
20 years 2000

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

30 years 1900
40 years 1800
50-60 years 1700
70-80 years 1500

It is recommended to have more proteins as weight loss is often accompanied by loss of protein tissue as well as fat tissue. About 20 percent of the total energy should be provided from proteins

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

like low fat milk and whole pulses. Fats should provide 20 percent of the total energy. Fried foods like pakoras; paranthas, halwa, puries, mathi and chips should be avoided. High fat foods like butter, cheese, khoa, meats, chicken, cream, ice creams and chocolates should

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

e restricted. The rest 60percent of the energy should be provided from carbohydrates and it should be from dietary fibres like barley, maize, wheat flour, rajmah and dry peas. High carbohydrate foods such as breads, cakes, cookies, dry fruits, honey jam, syrups, potatoes

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

and sweet potatoes should be avoided. Fresh juices, water and lemon drinks are good as they contain fewer calories. Foods and vegetables that are a good source of vitamins and minerals should be included in the diet as they provide roughage that helps in relieving constipa

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

tion. Drumsticks, French beans, jackfruits, grapes, figs, peaches, phalsa and guava should be included in the diet. Intake of salt should not be restricted unless the obesity is accompanied by hypertension and heart disease. An exclusive lemon juice diet is also effective

.

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

n dealing with obesity. On the first day the patient should be given nothing except plenty of water. On the second day juice of three lemons mixed with equal amount of water should be given. One lemon should be increased each day till the juice of 12 lemons is consumed per

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

day. Then in the same manner the number of lemons should be decreased till three lemons are taken in a day. In the starting the patient may feel weak and hungry but the condition will be stabilized afterwards. After the lemon juice diet the patient can adopt a normal diet

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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