Your Space - Health and Fitness

Acid reflux is regurgitation of acidic contents from the stomach into the esophagus. Reflux is prevented by the lower esophageal sphincter (LES) which remains tightly closed and op

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

ens when peristaltic waves herald the imminent arrival of swallowed food. When the LES becomes incompetent acid reflux will result.

So can you control your acid reflux? If it is d

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

Examples of combination products may in

e to true LES incompetence, then there is no cure. You will need maintenance treatment with acid suppressants like omeprazole, or if very severe or you develop secondary problems t

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

en fundoplication will relieve your symptoms.

There are, however, various factors that can affect the efficiency of the LES and acid reflux. Consider eliminating these factors tha

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

may impact on GERD before seeing your doctor or taking over the counter acid suppressants. Sometimes all you need is a change of lifestyle.

Obesity can cause or contribute to aci

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

Combination pro

reflux. This is especially so in the apple type distribution of weight. The extra weight increases bulk in the upper abdomen and makes it difficult for the esophagus to discharge

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

ood effectively into the stomach. In addition obese individuals are prone to developing hiatus hernias. A hiatus hernia can weaken the LES. Losing weight is an important aspect of

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

cid reflux treatment.

Wearing tight fitting clothes can cause acid reflux especially if it is two sizes too small. The increased pressure in the stomach may force acid back up int

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

the esophagus. Wear loose clothes and your reflux symptoms will go away.

Large volume of food in the stomach will put pressure on the LES and can trigger acid reflux. It has happ

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

ned to us all at some time or other. The large volume also reduces gastric clearance time allowing more opportunity for reflux. Eating smaller portions more frequently will counter

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

this problem.

Certain foods can affect GERD. Cow's milk protein intolerance can cause esophagitis. It is called Allergic Eosinophilic Esophagitis. This is controlled by removing c

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

Following aspects would a

w's milk protein from the diet. Other foods that can affect the LES include fats, coffee, tea, alcohol, and some spices.

Some drugs can affect the LES and cause acid reflux. These

dd to the challenges in developing combination products:

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

drugs include broncho-dilators such as theophylline, non-steroidal anti-inflammatory drugs (NSAID), tri-cyclic antidepressants ie amitriptylline and drugs for Parkinson's disease.

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

Female hormones can affect acid reflux. In a Scandinavian Study, women on hormones had increased risk of GERD. These drugs include the contraceptive pill and hormone replacement th

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

rapy (HRT). Sedatives and tranquillisers can slow down peristaltic waves in the esophagus affecting clearance of food from the esophagus.

If you are on medication and you have GER

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

, opt for liquid medication. Certain drugs ie tetracycline are corrosive to the esophageal lining. Tablets and capsules (gelcaps) can lodge in the esophagus. Always drink a glass o

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

Professional from academic institutions, pharmaceutical industries, health care indust

water after medication to wash it down into the stomach. Avoid taking medication while lying down. GERD patients should always take medication sitting up or standing and avoid lyi

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

g down immediately after.

Smoking relaxes the LES and nicotine is corrosive to esophageal lining. Stop smoking and your GERD might improve.

Certain exercises can increase the ris

.

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

of GERD. This is the case in competitive weightlifting and cycling. Joggers can develop acid reflux symptoms.

If you have acid reflux symptoms, look at all the potential risk fac

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

Companies that provide selfless information through particip

ors and eliminate them. If by doing so, your symptoms disappear, you have actually cured your acid reflux. However, if the symptoms persist, the next step is a visit to your doctor

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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