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The benefits of salt therapy (also called Halotherapy) or speleotherapy are well known and documented in Europe. Halotherapy uses dry aerosol micro particles of salt and minerals to treat respiratory diseases and seeks to replicate the conditions of speleotherapy (from Greek speleos=cave), a treatment that has been practiced in old s

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

alt mines of Eastern Europe since the early 19th century.

In the mid 18th Century a Polish health official Felix Botchkowski, noticed that the workers of salt mines did not get ill with lung diseases. He wrote a book about the effects of salt dust in 1843. His successor M. Poljakowski founded a Salt Spa in Velicko near Krakow, which

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

Examples of combination products may in

is still in operation. During the Second World War salt mines were often used as bombproof shelters. After spending time there many people who suffered from asthma felt that their health had gotten better! Today there are many salt sanatoriums in Europe (Austria, Hungary, Poland, Romania, Russia...).

The Halotherapy belongs to the

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

ategory of the physical therapies non-drug and non invasive treatments of diseases. In the former Soviet Union, medical researchers engaged in a concerted effort to develop physical therapies in order to avoid the costs and side effects of drug therapy as well as microbial and tumour resistance. Russia has become the world leader in

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

developing and testing new and increasingly effective physical therapies. Many of the clinical trials have focused on Halotherapy as a treatment of asthma and chronic bronchitis and also very effective as a main or adjuvant therapy across the entire range of upper and lower respiratory tract diseases.

Respiratory diseases are a majo

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

Combination pro

r cause of morbidity and mortality worldwide. Most drug therapies of respiratory diseases have only palliative effects, and many have significant side effects, especially those with corticoids or steroids. So, a physical therapy like Halotherapy is greatly needed.

Speleotherapy also makes a great demand on patients' time. The mines

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

re not conveniently located for most people and the total cost is fairly significant.

The effectiveness of speleotherapy is not acknowledged in all countries of the world, but in countries like Romania (Praid, Tg.Ocna,Seiged, Sovata, Slanic, Ocna), Poland (Wieliczka), Germany (Teufelsh?hle), Austria (Hallen, Solzbad-Salzeman), Armen

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

ia, Belarus, Bulgaria, Hungary, Russia, Slovenia, Ukraine, Nakhichevan mines in Azerbaijan, the salt aerosol plays an important role in the treatment of chronic respiratory diseases, working well with or without medical treatment and without any known side effects. Because of these, pregnant women with asthma or other respiratory dis

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

eases could use this therapy without any harm to the child. Very well known and appreciated in these middle-eastern European countries, this therapy is covered by the public health care system. In Romania there are also many salt lakes - Sovata with 7 salt lakes, Ocna Sibiului with 52 salt lakes in S-W of Transilvania, very well know

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

in the treatment of infertility, metabolic diseases,skin diseases. These salt lakes were usually formed by collapsing of salt caves ceilings. All these salt lakes have different salinity, increasing with deepness – from 9g/l to 320g/l.

This salt therapy being very well known for its beneficial effects, a Romanian inventor puts his

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

mind at work and developed a device that is able to reproduce a speleotherapy micro environment in your home in an affordable and convenient way. Internationally recognized, with Gold and Silver medal at “Salon International des Inventions”,Geneva and “World Exhibition of Innovation, Research and New Technology”, Brussels, this Roman

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

Following aspects would a

ian invention brings new hopes in the natural treatment of chronic respiratory diseases.

The inventor thought this device as an air salinizer that uses forced ionization of the indoor air by salt sublimation creating a micro climate of dry aerosol salt therapy in your living space. He used a natural process of salt crystallization t

dd to the challenges in developing combination products:

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

obtain salt micro crystals under 5µm in diameter, invisible to human eyes, being able to penetrate deep into the lung. The device uses only natural salt from within the mountain of salt, untreated or touched by the human processing technology.

Based on clinical studies, the inhaled saline has bactericide, mucokinetic, hydrophilic,

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

anti inflammatory properties, reducing inflammation in the whole respiratory tract, absorbing edema from the mucosa lining the airway passages leading to widening of the airway passages, restoring the normal transport of mucus and unclog blockages in the bronchi and bronchioles leading to rapid elimination of the residual tar and for

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

eign allergens, all of these in a natural process.

Edema of the nasal mucosa and the oropharynx and soft palate, causing nasal obstruction and snoring is diminished, leading to widening of the airway passage in the nose and the tubes of the sinuses and improving the sinuses drainage and reducing snoring.

In the auditory tube, edema

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

of the Eustachian tube causing ear infection, is also diminished, leading to widening of the airway passages, better drainage and better aeration behind the tympanic membrane.

The salt therapy was found to have beneficial effects in the treatment of:

Asthma and Chronic Bronchitis

COPD (Chronic Obstructive Pulmonary Disease)

Aller

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

Professional from academic institutions, pharmaceutical industries, health care indust

gic Rhinopathy or Hay Fever

Cystic Fibrosis

Sinusitis

Ear Infections

Smoking Cough

Various acute or chronic respiratory disease

Reduce snoring and activates better sleep by clearing the airway passages in oropharyngeal region

Increased resistance to Cold & Flu by opening and clearing the nasal airway and improving the drainage

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

of the sinuses

Humidifies the bronchial secretions reducing broncho-spasm and facilitating elimination of the smoke residual tar, phlegm expel and other allergens

Improves the quality of the indoor air by eliminating the dust, cigarette smoke, bad odours, mould and mites, having bactericide reduction properties.

The salt therapy

.

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

s a natural method of therapy and does not involve any risk and is finally adapted to the living space. However, this is not a substitute for medical treatment and should only be used as an adjuvant helping to improve the quality of patients’ life, reducing the antibiotics and corticoids or steroids intake, reducing the rate of annua

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

Companies that provide selfless information through particip

l hospitalizations and decrease the frequency of respiratory diseases attacks. For more information, clinical studies and testimonials you can visit the web site.

NB: The author grants reprint permission to opt-in publications and websites so long as the copyright and by-line are included intact and the article is not used in spam

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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