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Depression can affect any one of us at any time of our lives and is more than just feeling a bit fed up or down in the dumps. When you cannot just snap out of it and the symptoms of depression persist for more than a couple of weeks, and interfere with your ability t

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

o carry out your normal routines on a daily basis, then your health care provider or GP may prescribe some form of medication to help you combat the depression.

There are many different types of anti-depressants available and the earlier ones include Tricyclic antid

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

Examples of combination products may in

pressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs). Newer types include Selective Serotonin Reuptake Inhibitors (SSRIs) and others, which may not fall into one specific category but which all work by impacting on the chemicals in the brain that are responsible

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

for our mood and how we feel.

The following list represents the most commonly prescribed drugs for depression, their brand names and the name of the pharmaceutical company producing them (in brackets), as well as a brief description of how the different types are be

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

ieved to work.

Tricyclic Antidepressants (TCAs)

Tricyclic antidepressants are so called because of their molecular structure in that they contain three rings of atoms. Although no one understands exactly how they work, it is thought that the beneficial effects are

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

Combination pro

ue to their ability to balance the natural neurotransmitter chemicals in the brain. The most common side effects are dry mouth and drowsiness and possibly blurred vision, sweating, and a slight hesitancy when passing urine. The following list represents some of the

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

ost commonly prescribed Tricyclic antidepressants:

• Doxepin - Brand names: Adapin (Lotus Biochemical Corporation) and Sinequan (Pfizer Inc)
• Clomipramine - Brand names: Anafranil (Geneva Pharmaceuticals)
• Nortriptylene - Brand Names: Aventyl (Eli & Lill

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

y) and Pamelor (Novartis Pharmaceuticals)
• Imipramine - Brand Names: Tofranil (Novartis Pharmaceuticals)
• Protriptyline - Brand Names: Vivactil (Merck & Co)
• Trimipramine - Brand Names: Surmontil (Wyeth-Ayerst Pharmaceuticals)

Monoamine Oxidase Inh

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

bitors (MAOIs)

This type of medication works by inhibiting the activity of the enzyme monoamine oxidase, which in turn increases the levels of the neurotransmitters serotonin and norepinephrine. They are not prescribed as often as they used to be as the newer type

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

f medication known as SSRIs have become more popular. MAOIs would usually be prescribed when other medications have proved ineffective. MAOIs can interact with foods containing tyramine and raise blood pressure; they can also interact unfavourably with many other dr

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

gs and over the counter preparations. Some MAOIs include:

• Isocarboxazid - Brand Name: Marplan (Oxford Pharmaceutical Services)
• Phenelzine - Brand Name: Nardil (Pfizer Inc)
• Tranylcypromine - Brand Name: Parnate (Glaxo Smith Kline)

Selective Serotonin

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

Following aspects would a

Reuptake Inhibitors (SSRIs)

SSRIs work by selectively inhibiting the reuptake of the neurotransmitter serotonin in the brain so that levels of serotonin are increased. They are generally considered safer than other types. Side effects include nausea, anxiety, sleep

dd to the challenges in developing combination products:

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

isturbances and sexual dysfunction. They can also interact with other drugs. Some of the more commonly prescribed SSRIs include:

• Citalopram - Brand Name: Celexa (Forest Pharmaceuticals)
• Escitalopram - Brand Name: Lexapro (Forest Pharmaceuticals)
• Fl

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

oextine - Brand Name: Prozac (Eli & Lilly)
• Fluvoxamine - Brand Name: Luvox (Solvay Pharmaceuticals)
• Paroxetine - Brand Name: Paxil (Glaxo Smith Kline)
• Setraline - Brand Name: Zoloft (Pfizer Inc)

Some other types of medication

There are other ty

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

pes of medication available for depression which are not included in the previous categories but which all work in various ways to alter the balance of chemicals in the brain to alleviate depression. For example:

• Bupropion – works by inhibiting the reuptake of bot

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

norepinephrine and dopamine. Often used to treat the type of depression known as Seasonal Affective Disorder (SAD), as well as ADHD and as part of a stopping smoking programme. Brand Name: Wellbutrin (Glaxo Smith Kline)

• Duloxetine – works by inhibiting the reupt

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

Professional from academic institutions, pharmaceutical industries, health care indust

ke of both serotonin and noradrenaline (SNRI). Brand Name: Cymbalta (Eli & Lilly)

• Venlafaxine – Also an SNRI. Brand Name: Effexor (Wyeth-Ayerst Pharmaceuticals)

• Maprotiline – Known as a tetracyclic antidepressant because its molecular structure consists of 4 r

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

ngs in a T shape. Brand Names: Ludiomil (Novartis Pharmaceuticals)

Which type medication is most suitable?

The type of medication prescribed by your GP will depend on many factors including the kind of depression diagnosed, the severity of the symptoms, other medic

.

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

tion that you may be taking and of course the potential risk of any side effects.

It is not possible to predict with any degree of accuracy which one will be most effective and it can take a number of weeks for any effects to be noticed. If after six weeks or so the

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

Companies that provide selfless information through particip

e is no improvement, then another medication may be prescribed until you find the most appropriate one for you.

Regardless of the type of depression diagnosed, the right medication can alleviate the symptoms of depression and help you get back to your old self again

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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