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Bipolar depression, manic depression and bipolar affective disorder are all terms used to describe a highly complex and serious mood disorder that is characterised by extreme manic episodes (highs) and severe depressive episodes (lows). It usually begins in young ad

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

ulthood, although not always, and continues for life.

According to the Royal College of Psychiatrists leaflet on depression, one in ten people suffer from Bipolar disorder. No one really knows what causes it, but genetics is thought to play a major role as it has

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

Examples of combination products may in

a tendency to run in families.

Symptoms of a depressive episode

A depressive episode can be diagnosed if five or more of the following symptoms are present for most of the time for a period of at least 2 weeks.

• feeling sad, anxious, or empty mood
• Feeling

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 of hopelessness, pessimism
• Feelings of guilt, worthlessness, helplessness
• Loss of pleasure in activities once enjoyed, including sex
• Decreased energy, a feeling of fatigue or of being "slowed down"
• Difficulty concentrating, remembering,

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

making decisions
• Restlessness or irritability
• Sleeping too much, or can't sleep
• Change in appetite and/or unintended weight loss or gain
• Chronic pain or other persistent bodily symptoms that are not caused by physical illness or injury <

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

Combination pro

br>• Thoughts of death or suicide, or suicide attempts

Symptoms of a manic episode

A manic episode can be diagnosed if at least 3 of the symptoms occur along with an elevated mood for most of the time for at least a week, which is not related to alcohol or substan

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

ce abuse or a medical condition. If the overall mood is one of irritability then another 4 symptoms must be present.

• Increased energy, activity, and restlessness
• Excessively "high," euphoric mood
• Extreme irritability
• Racing thoughts, talking

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

quickly, jumping from one idea to another
• Distractibility, lack off concentration
• Little sleep needed
• Unrealistic beliefs in one's abilities and powers
• Poor judgment
• Spending sprees
• A lasting period of behaviour that is dif

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

erent from usual
• Increased sexual drive
• Alcohol and drug abuse
• Provocative or aggressive behaviour
• Denial that anything is wrong

Types of Bipolar disorder

The frequency and severity of each episode and the gaps in between them will vary

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

significantly from person to person with no clear pattern that is applicable to all. If we consider that at one end of the scale there is severe depression and at the other end of the scale there is full blown mania, in between there are progressive stages of mode

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

rate to mild depression, then normal moods, following on up the scale to hypomania and then mania.

Some people will have many depressive episodes and the odd spell of hypomania; others can experience mania much more often with a depressive episode only happening fr

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

Following aspects would a

om time to time. Others may have both together, which is known as mixed state bipolar. Other types of Bipolar include Bipolar 1, Bipolar 2, Rapid Cycling and Cyclothymia.

The symptoms of Bipolar 1 involve recurrent manic and depressive episodes with either stable p

dd to the challenges in developing combination products:

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

riods in between or going directly from a depressive episode into a manic phase or vice versa. Periods of depression can last for only a short time or for months. Bipolar 11 usually involves mild manic periods, or even no mania, but more depressive episodes. When

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

an individual experiences many manic or depressive episodes or fluctuations between both within a relatively short space of time it is known as rapid cycling, and Cyclothymia is where the mood swings are not as severe as other types but the episodes can last for muc

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

h longer.

Each person's experience is unique and because it happens in episodes, there are periods where the individual behaves perfectly normal which can make diagnosis problematic. Some people can have bipolar disorder for years before they seek help and others

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

may not seek help at all. Without treatment, bipolar disorder can have a devastating effect on relationships and work; can result in huge debts being run up, crimes committed, alcohol and substance abuse and even suicide.

Living with Bipolar

Medication will usual

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

Professional from academic institutions, pharmaceutical industries, health care indust

y be prescribed to deal with the different aspects of the disorder. For example, Lithium is often used to stabilise the mood, as it can effectively control and help prevent both manic and depressive episodes.

Other drugs may be prescribed in conjunction with Lithi

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

um to treat symptoms such as insomnia and those of depression. During manic episodes it might be necessary to use antipsychotic medication such as haloperidol or chlorpromazine. In particularly severe episodes, the sufferer may be admitted to hospital for treatmen

.

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

t. Various forms of psychotherapy may also be offered in addition to medication.

Bipolar disorder is a lifelong disorder that affects not only the sufferer but their family and friends too so learning about the different mood states, the symptoms that accompany th

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

Companies that provide selfless information through particip

em and the type of event or situation that might trigger an episode can be invaluable in helping to prevent future relapses. It allows the individual to take preventative measures, and to recognise the signs of any impending episode so they can seek appropriate help

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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