Advice Pool - Health and Fitness

There are number of health conditions that could develop owing to infections. Ear infection is one of such infectious condition. Ear infec

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

tions are referred to as otitis media in medical terminology. In simple words, inflammation of ear (specifically middle ear) is called as

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

Examples of combination products may in

ar infection. Ear infection may affect either one ear or both ears. Ear infections are most common amongst children. However, some adult

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

may also experience ear infections. Though mild in nature, prolonged ear infections can lead to serious complications such as intense ear

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

aches and hearing loss. Further, if left untreated, ear infection may spread to other parts like mastoid.

Symptoms: Children and adults

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

Combination pro

face varying symptoms. Symptoms faced by children include hearing difficulties, scratching or pulling of ear, fever, vomiting and drainage

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

from ear. Symptoms in adults (including adolescents and young children) include pain in ear (earache), hearing difficulties, and feeling o

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

f fullness/pressure in ear, fever, nausea, dizziness, omitting and drainage from ear.

Causes of Ear Infections: Blockage of Eustachian tu

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

e is considered as the main cause behind occurrence of ear infections. Such blockage may be resulted from factors like allergy, cold, accu

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

ulation of fluid (due to presence of viruses and bacteria) in the eardrum and infections of upper respiratory system. When the infection i

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

caused as a result of accumulation of pus and mucus, due to viral or bacterial factors, behind the eardrum such a condition is referred to

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

Following aspects would a

as acute otitis media. Accumulation of fluids in the eardrum leads to swelling, redness and earache. As a result of malfunctioning of ea

dd to the challenges in developing combination products:

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

drum we experience hearing problems. As the Eustachian tube is swollen and inflamed during infections, this creates hindrance in draining

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

ut of mucus and pus. This is termed as serous otitis media or middle ear effusion. Usually, such effusion remains even after infection ha

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

s passed and may persist for prolonged periods. These effusions also increase the risk of recurrent infections and patient faces hearing p

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

oblems.

Tests like audiogram and Tympanogram are conducted to diagnose the occurrence of ear infections.

Treatment: Generally, antibioti

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

Professional from academic institutions, pharmaceutical industries, health care indust

s are prescribed for treating ear infections. In some cases antihistamines and decongestants may be prescribed. Apart from the above medi

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

cations your physician may prescribe pain relievers (usually ear drops) and other medications to relieve fever. Surgery is recommended rar

.

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

ly, only in cases where infections do not respond the medications. Use of liquid life supplements such as colloidal silver, colloidal gold

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

Companies that provide selfless information through particip

etc may help in prevention and early relief from ear infections owing to their properties of ‘bacteria killing’ and immune system enhancing

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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