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Bipolar Disorder, also known as Manic Depressive Illness, causes dramatic changes in a person’s mood, energy, and ability to function. Most people experience moderate mood swin

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

gs, this is normal, although more drastic changes in mood could be a symptom of Bipolar Disorder. 1-2% of the population suffers from bipolar disorder, about 4 million people.

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

Examples of combination products may in

Anxiety
Anxiety may be a symptom of Bipolar Disorder, or it could be a separate condition. Anxiety as a Bipolar symptom is usually more described as “agitation”. The pati

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

nt experiences a need to keep moving, standing up pacing around, racing thoughts, and a lack of focus. Patients race from thought to thought without really finishing anything.

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

When these symptoms are present with irritability it can be a horrible experience people feel desperate to get out of.

Depression
Depression can be a symptom or an effect

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

Combination pro

f Bipolar disorder. Clearly as shown above the mix of emotions can lead to a feeling of hopelessness. This is the “low” associated with Bipolar disorder. Abnormal lows lead t

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

decreased output at work, poorer over functioning, lower quality of life, and even suicide. If you feel your depression is more than you can handle see your doctor, he/she can

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

help.

Note: Suicide is an option. If you have these thoughts talk to somebody immediately. A friend or family member if possible, or call the suicide hotline at 1-800-784-243

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

.

Manic
Manic behavior is described as the “high” of Bipolar disorder. Activities with a negative consequence are normal during this period. Excessive shopping, sexual i

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

discretions, even talking too much can be associated with a Manic episode. During a Manic episode you may focus on setting goals, have inflated self esteem, or grandiosity. Th

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

differences between a depression cycle and a manic cycle are at the heart of the problem, one second you are building a better future and the next second you find it hard to fi

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

Following aspects would a

gure out what direction to go.

Bipolar I
Bipolar I Disorder is the sixth leading cause of disability in the developed world (for ages 15-44). The first episode may occur a

dd to the challenges in developing combination products:

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

any age from childhood to old age. The average age at onset is 21. Bipolar I Disorder is characterized by recurrent episodes of mania and (more often) depression. Untreated pat

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

ents with Bipolar I Disorder typically have 8 to 10 episodes of mania and depression in their lifetime.

Manic episodes are characterized by elated mood, over-talkative or racin

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

speed, and hyperactivity or agitation. The average depressive episode lasts 6 months, and the average manic episode lasts 4 months. Initially, the individual is usually diagnos

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

d as having Major Depressive Disorder. However, once the individual has a manic episode, the diagnosis is changed to Bipolar I Disorder.

Bipolar II
Bipolar (II) presumes a

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

Professional from academic institutions, pharmaceutical industries, health care indust

least one major depressive episode, plus at least one hypomanic episode over at least four days. The same characteristics as mania are present, with the disturbance of mood obs

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

rvable by others, but the episode is not enough to disrupt normal functioning or necessitate hospitalization, and there are no psychotic features.

Those in a state of hypomania

.

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

are typically the life of the party, the salesperson of the month, and more often than not the best-selling author or Fortune 500 mover and shaker, which is why so many refuse t

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

Companies that provide selfless information through particip

seek treatment. But the same condition can also turn on its victim, resulting in bad decision-making, social embarrassments, wrecked relationships, and projects left unfinished

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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