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Considered as the most dangerous form of acute arthritis, septic arthritis is caused by a bacterial infection in the joint cavity. Usually there is a primary site of infection f

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

rom where bacteria spread. The site of infection is often along adjacent bone or soft tissue. Bacterial spread is usually through the bloodstream going to the joints. It is es

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

Examples of combination products may in

timated that in the general population of 100,000 people, about 2 to 10 of them suffer from septic arthritis. On the other hand, 30 to 70 cases of septic arthritis can be seen i

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

a population of 100,000 rheumatoid arthritis patients. A variety of factors can predispose a person to septic arthritis. Any simultaneous presence of bacterial infection such

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

as genitourinary tract or upper respiratory tract infection can increase a person’s vulnerability to septic arthritis. Additionally, serious chronic illnesses including renal fa

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

Combination pro

ilure, malignancy, cirrhosis and diabetes can increase septic arthritis susceptibility. Susceptibility increases with people who have a depressed immune system, or those who hav

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

previous immunosuppressive therapy. Accordingly, elderly individuals and alcoholics are also at higher risk of developing septic arthritis. People who are into prolonged use 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 intravenous drugs, including those who are addicted to heroin, have higher chance of contracting septic arthritis as well.

Septic arthritis comes suddenly with symptoms like i

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

ntense pain, inflammation and swelling of the affected joint. These symptoms are often accompanied with fever and chills. The infected joint may cause voluntary immobility of t

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

e limb. Septic arthritis often affects large joints; specifically the knee. New born or infants who are affected with acute septic arthritis may become irritable and cry relent

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

lessly whenever there is movement; especially when there is hip involvement. Pain is usually present in the groin, upper thigh and buttocks when septic arthritis affects the hip

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

Following aspects would a

. In adults, knee involvement affects around 50 percent of all cases. The hips, wrist and ankles are also commonly affected with septic arthritis. Some patients may not show e

dd to the challenges in developing combination products:

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

ternal signs of inflammation. Sometimes there is the presence of polyarthritis before the localization of infection. Muscle spasms are a very common occurrence of septic arthri

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

tis.

Doctors use several methods to diagnose septic arthritis. Positive identification of the presence of the causative microorganism in the joint fluid using Gram’s stain sugg

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

ests septic arthritis. There are also other additional methods used to diagnose septic arthritis. These measures include x-ray, radioisotope joint scan and white blood cell cou

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

t. X-rays detect changes in the joint between 1 and 2 weeks after the onset of infection. On the other hand, radioisotope joint scan is used to check for changes and the presen

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce of infection and inflammation in the less accessible joints like the spinal articulations.

Antibiotic therapy is generally the choice of treatment for septic arthritis. This

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

should commence as soon as the causative microorganisms are identified. Elimination of the infection through antibiotic therapy is the primary goal of treatment. It has been o

.

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

served that patients who were immediately treated with doses of antibiotic within 7 days from the onset of infection had higher cure rate compared with those who were treated a m

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

Companies that provide selfless information through particip

onth after infection started. There is an arrest of infection if samples from the synovial fluid show a decreased white blood cell count within 5 to 7 days of antibiotic therapy

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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