Article Dump - Health and Fitness

Acute infections of the respiratory tract-nose, throat, larynx, trachea, bronchi and alveoli are a common cause of morbidity in children. Though deaths due to acute respiratory infections have become rare due to availability of pow

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

erful antimicrobials and good supportive care many children do suffer from severe diseases requiring hospitalization. Air enters the body through the nose where filtration and humidification take place, into the lungs via the wind

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

Examples of combination products may in

pipe (trachea). The trachea divides into two branches each entering a lung in the cavity of chest. The bronchi go on dividing and subdividing till they end up in small sac like structures called alveoli where gas exchange-absorptio

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

of oxygen and carbon dioxide elimination-takes place.

Infections of airways result in swelling of the wall of the airways. As the airways are narrow in children even slight swelling can cause significant narrowing of airways and

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

difficulty in breathing. Infections of respiratory tract are classified as upper and lower respiratory infections. Upper respiratory infections are more common but less serious and include infections of nose, throat and ear. The us

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

Combination pro

al manifestations one cough, cold and fever. Sometimes nasal block can be quite troublesome.

Viral infections are more common than bacterial. Antibiotics are unnecessary if there is no evidence of bacterial infection. Fever may be

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

controlled with paracetamol which can be given every six hours if necessary. Antitussives (drugs for suppressing cough) may be given if the cough is dry in older children. Nasal decongestants may be given for watery nasal discharg

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

. Medicated steam inhalation is very useful if there is nasal block. Capsules containing liquid medication are available. A capsule can be punctured and the medicine squeezed on the pillow or dress of young children. The vapor from

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

the medicine will have a soothing effect. Infection of the middle ear is very painful and babies go on crying continuously while older children complain of ear ache. If it is not treated promptly the tympanic membrane can rupture

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

ue to increased pressure resulting in discharge of pus from the ear.

Lower respiratory infections involve epiglottis (a lid like structures which prevents food from entering the wind pipe), trachea (wind pipe) its divisions and al

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

veoli. They are more dangerous and even life threatening. Epiglottitis (infection of epiglottis) is a serious and potentially fatal disease because the swelling can result in obstruction to flow of air into lungs. The condition man

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

Following aspects would a

ifests as fever, drooling of saliva and a noise when the child breathes in (stridor). The condition requires hospitalization and intravenous medication. Sometimes it may be necessary to put a tube inside the trachea (endotracheal i

dd to the challenges in developing combination products:

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

tubation) so that the child can breathe.

The term pneumonia refers to infection within the lung affecting a considerable portion of the lung. On x-ray the affected part is seen as a white patch whereas the normal lung appears dark

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

. This is also a serious condition but fortunately deaths have become rare due to the availability of powerful antibiotics. Children with pneumonia usually need hospitalization and intravenous administration of antibiotics. They ma

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

also require oxygen, intravenous fluids if they are not able to take orally and drugs to liquefy the thick secretion inside the lungs so that it can be coughed up easily. Medicines to suppress cough should not be given to children

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

with pneumonia as the infected secretion stays in the lungs instead of getting eliminated and can even cause an abscess (collection of pus).

Indications for immediate consultation
Young infants below

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

Professional from academic institutions, pharmaceutical industries, health care indust

three months in whom infection of the respiratory tract can progress rapidly causing serious disease

High fever of 39 degree centigrade or more

Rapid breathing and difficulty in feeding-the rate of breathing is more in infants an

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

d young children and if the child appears to breathe faster than usual it indicates significant disease. If the breathing becomes faster the baby will find it difficult to take feeds.

Chest retraction in infants and young children

.

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

If the lungs are not expanding normally due to disease the chest is drawn in when the child takes a breath because the negative pressure inside the chest causes the soft and pliant chest wall of young children to cave in.

Frequent

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

Companies that provide selfless information through particip

vomiting-Any illness causes vomiting in children. If vomiting is frequent the child will not be able to take anything orally and becomes dehydrated which causes drying up of secretions inside the lungs and worsening of the disease

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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