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We use soap each day in our lives in the form of detergents, shampoo, shower cr?me, hand soap or bar soap. We are so used to using soap that we rarely stop and wo

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

nder how this wonderful compound manages to help us clean ourselves day after day. Have you ever thought about what would happen if there were no soap? How else c

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

Examples of combination products may in

an we rid the dirt off our bodies or our clothes?

Most of the time, dirt comes in the form of grease or oil which sticks itself onto surfaces and will not come o

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

f if only water is just used. This is because oil and grease are non-polar, which means that the oil molecules are not charged and therefore are not attracted to

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

polar substances such as water. Because of this, oil tends to stick with its own molecules or other non-polar substances.

On the other hand, water is a polar sub

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

Combination pro

stance which is made up of one positive and one negative charge, and therefore is a fragmented substance. With this, water dissolves salt easily because salt is m

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

de up of charged ions in which the positive charge will be attracted to the negative ions in water.

Due to the fact of the nature of oil and water, you will see

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

that oil will not dissolve in water but remain clustered on the surface. Also, oil and grease will stick onto plates and cutlery during cleaning, and no amount of

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

water can completely remove it. That’s when soap comes in. All it takes is just one layer of soap with water and the oil will be removed. How does this happen?

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

ell, soap is a unique substance of potassium fatty acid salts, produced through a chemical reaction called saponification. Its molecules are made up of a hydrocar

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

bon chain, which is non-polar, as well as a carboxylate molecule which is polar. Therefore, the non-polar part of the soap – the hydrocarbon chain, is not attract

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

Following aspects would a

ed to water but to oil (lipophilic). On the other hand, the carboxylate molecules which are negatively charged, are attracted to the positively charged water mole

dd to the challenges in developing combination products:

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

ules (hydrophilic).

In this case, when soap is applied to oil and grease, the lipophilic parts of soap will attach itself to the non polar molecules of oil. Howe

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

ver, the other component of soap, the hydrophilic component, will be left on the surface. When water is applied onto this surface with a sponge, the hydrophilic c

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

omponent will be attracted to the water molecules and is lifted from the surface, together with the oil. This way, both oil and soap is removed with the wipe of t

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 sponge. At the same time, because soap molecules have been combined with oil, other soap molecules will also be attracted to it. This is why you can see cluste

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs of oil that are surrounded by soap within the water that has been used for washing. Of course, once soap has been used up to attract the oil, more soap would n

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

eed to be added to work on the access oil.

In conclusion, our lives have been made cleaner and easier through the wonders of a simple substance called soap. With

.

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

ut it, we would be having a difficult time removing dirt, oil and grease in our everyday cleaning.

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

Companies that provide selfless information through particip

/www.chemicool.com for knowledge on chemical elements,chemistry directory,chemistry tools and much more

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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