E-Articles - Health and Fitness

GERD and LPRD. They sound like top-secret government programs, or maybe the names of computer programs. But they’re actually very common medical conditi

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

ons, and chances are you’ve suffered one or both of them. What are they? And what’s the difference between them?

GERD stands for gastroesophogeal reflu

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

Examples of combination products may in

x disease, commonly known as acid reflux or just heartburn. LPRD is laryngopharyngeal reflux disease. To understand their causes and their relation to e

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

ch other, let’s look at how the body is assembled.

At the back of your throat is a sphincter (or muscle) that opens when you swallow something, allowin

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

g the material into the esophagus. Then, at the bottom of the esophagus, there is another sphincter that opens into the stomach. Both of these muscles a

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

Combination pro

e closed most of the time, opening only when something is supposed to pass through. There is no open-door policy with the esophagus; you have to knock e

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

very time.

One of the purposes of that lower sphincter is to keep the stomach’s digestive acids from splashing up into the esophagus. The stomach is li

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

ed with material to protect it from its own acids, of course, but the esophagus has no such protection. So when something happens to compromise that sph

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

incter, allowing acid to rise up where it doesn’t belong, you feel it. That’s heartburn, or GERD.

Now, if the acid comes up into the esophagus and then

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

KEEPS GOING, coming all the way up past the upper sphincter and into the back of the throat, that’s LPRD. In layman’s terms, you could consider LPRD to

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

be what happens when the acid from GERD doesn’t know when to quit bubbling up.

You’d think that you wouldn’t feel LPRD without feeling GERD first, but

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

Following aspects would a

in fact most people who suffer from LPRD don’t notice any significant heartburn. This is because for it to be LPRD, the acid must have passed all the wa

dd to the challenges in developing combination products:

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

through the esophagus and up into the back of the throat. Had it lingered in the esophagus, it would have done some damage and caused heartburn. But si

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

nce it kept going, it basically skipped that process altogether.

The symptoms of LPRD are hoarseness, frequent throat-clearing, problems with swallowin

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

, a bitter taste in the mouth, and a pain in the throat. It’s very much a throat-related syndrome, whereas GERD is felt more in the chest area.

However

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

, while GERD and LPRD have different symptoms, they can be prevented exactly the same way. They are both caused by acid rising up from the stomach, so i

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

Professional from academic institutions, pharmaceutical industries, health care indust

you can stop that from happening, you’ll prevent both conditions. Avoid eating huge meals or lying down immediately after eating. Avoid fatty foods, ca

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

ffeine, alcohol, tobacco and chocolate -- yeah, yeah, all the fun stuff, but it comes with a price. Tight clothes or belts can also cause reflux simply

.

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

y physically forcing acid up from the stomach.

If you find yourself burdened with either GERD or LPRD, don’t fret. In almost all cases, both ailments a

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

Companies that provide selfless information through particip

re fairly easily treated. Finding the cure that works for you specifically may take some doing, but it’s a small price to pay to keep your stomach happy

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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