Cases - Business

Soap: In our daily life we use different forms of soap. We can’t imagine a single day without the use of soap. It is an essential part of cleanliness

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

in our civilized society.

There are three different forms of soap available in the market. These are Soap Bars, Detergent Powders and Liquid Soaps. N

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

Examples of combination products may in

w we will discuss how these are manufactured in detail.

Bar Soap: The raw materials in bar soaps are fats, fatty acids and inorganic water-soluble ba

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

es. Fats are extracted from mutton tallow, beef, coconut, palm and palm kernel oils. After extracting the raw material it goes to a treatment plant 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

make it pure.

A continuous process makes it into a liquid form of soap. During the process glycerin is produced as a byproduct. The neat liquid soap

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

Combination pro

hen goes through a process called vacuum spray drying, to form dry soap palette.

In the final phase the dry palettes go to the finishing line. An ama

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

gamator blends soap palettes with all other ingredients, colorants and fragrance. In a rolling mill and refining plodder the soap palettes are then ho

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

ogenized and refined. In this section the soaps palettes get the desired texture. Then the palettes are cut into the bar size and in a press unit the

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

tamping process is done.

Detergent Soaps: In the case of powder detergents three processes are used. These are dry mixing, spray mixing and agglomera

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

ion. Spray drying process combines all constituents into a thick suspension in a big tank. The thick suspension is then heated and lifted to the top o

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

a tower by pumping it. At the top of the tower small nozzles spray the suspension with high pressure. It creates small droplets. These droplets fall

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

Following aspects would a

rom the top of the tower. When they fall, they pass through hot air. This converts the droplets into dry granules. These granules are then collected f

dd to the challenges in developing combination products:

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

om the base of the tower and run through a screening process. This process makes all the granules uniform in size. These uniform sized granules are co

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

led and some enzymes, fragrance and bleach are added.

Using new and latest technology soap manufacturers now make high-density granules. In these gra

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

ules percentage of air is very low, hence the granules can be packed in a smaller packet.

Liquid Detergents: To make Liquid Soaps two processes are

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

sed. These are continuous blending process and batch kettle boiling process. Added stabilizers ensure the stability and uniformity of the end product.

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

Professional from academic institutions, pharmaceutical industries, health care indust

During the continuous blending process in a mixer dry and liquid ingredients are blended to make a stable and uniform mixture. In recent times, high-

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

nergy mixing processes have been introduced. In this process some stabilizing agents are used.

Packaging: Packaging is the final step of .

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

ew" href="http://www.askaquery.com/Answers/qn562.html">soap making. Bar soaps are first packed in single packs. Large numbers are packed in carton

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

Companies that provide selfless information through particip

. Detergent powders are packed in pouches, cans or bags. Good packaging can increase sales and hence soap manufacturers lay emphasis on good packaging

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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