Social Space - Food and Drink

Morinda Citrifolia popularly called Noni is a less known fruit in the America’s but very popular in south Asia a

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

nd Polynesia. The Noni fruit is believed to have many medicinal properties over many centuries. It is one of the

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

Examples of combination products may in

plants where every part of it is used for its medicinal claims. The Noni Juice is a common form available everyw

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

ere and it comes in many varieties the popular one is the soy sauce like dark thick fermented version. In place

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

where it is more prevalent it is taken unfermented in sweet form. This article takes a look at the many ways th

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

Combination pro

juice is extracted and made available for consumption.

The ripe fruits are more juicy and easy to extract than

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

the un-ripe ones. The unripe fruits are thick skinned and highly durable. The ripe fruit is more sweeter and jui

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

cy and are consumed raw in many countries. Like grapes that turn into wine, Noni turns into a fermented Noni Jui

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

e by careful preparation. To get 1 gallon juice you got to process almost 20 pounds of fruit. There are many way

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

the juice is extracted but the popular version is the hard press method. The fruit along with pulp is allowed t

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

ferment in special containers made for this purpose usually in plastic. The pH is maintained at optimum levels.

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

Following aspects would a

The fermentation goes on for almost 2 months, this allows the juice to separate from the pulp and drip extractio

dd to the challenges in developing combination products:

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

is employed. The fermented juice gets its characteristic sour taste. The Noni juice can come pasteurized or non

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

pasteurized.

The other popular form the juice is available is the freshly squeezed unfermented sweeter version.

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

Typically a hydraulic fruit press is employed to extract the juice from the pulp. The pulp and seeds are typica

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

ly employed to prepare Noni Products. The fresh juice has a golden color and may be further diluted and sweetene

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

Professional from academic institutions, pharmaceutical industries, health care indust

by bottlers. The Noni juice is a refreshing delight in south Asian countries. People call it in totally differe

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

t names in different countries hence you may not know which is the famed Noni. Unlike other fruits the juice yie

.

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

d is much high. The Noni fruit juice figures in the shopping aisles with alterations usually with raspberry, or

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

Companies that provide selfless information through particip

rape flavor. The other form the juice is available is in the form of powder and it is added in many preparations

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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