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Lyme disease is caused by the bacterium Borrelia burgdorferi which is most often acquired from the bit

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

e of an infected Ixodes, or black-legged, tick, also known as a deer tick. Borrelia is a gram negative

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

Examples of combination products may in

bacterium. Lyme disease in Europe is more often caused by Borrelia afzelii or Borrelia garinii. areas

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 New York, where Lyme disease is common, over half of the ticks are infected. Lyme disease has been

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

reported most often in the Northeastern United States, but has been reported in all 50 states as well

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

Combination pro

as China, Europe, Japan, Australia and the parts of the former Soviet UnionIt is transmitted to human

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

s by the bite of infected blacklegged ticks.

Borrelia burgdorferi sensu stricto is the predominant ca

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

use of Lyme disease in the U.S. Lyme has at least 37 known species, 12 of which are Lyme related, and

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

an unknown amount genomic strains. Hard-bodied (Ixodes) ticks are the primary Lyme disease vectors. I

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

n Europe, Ixodes ricinus (known commonly as the sheep tick, castor bean tick, or European castor bean

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

tick) is the transmitter.It is important to note that the majority of infections are caused by ticks i

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

Following aspects would a

n the nymph stage, as adult ticks do not become infected through feeding. Ixodes scapularis (black-leg

dd to the challenges in developing combination products:

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

ed tick or deer tick) has been identified as the key to the disease's spread on the east coast, while

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

on the west coast the primary vector is Ixodes pacificus.

Causes of Lyme Disease

1. Bacterium ( Borr

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

elia burgdorferi ).

Symptoms of of Lyme Disease

1.Fever

2.Headache

3.Lethargy

4.Muscle pains

5.S

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

tiff neck

6.Joint inflammation

Treatment of Lyme Disease

1.Oral antibiotics Doxycycline - bacterio

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

Professional from academic institutions, pharmaceutical industries, health care indust

tatic properties stops synthesis of bacteria replication.

2.Amoxicillin - bactericidal properties kil

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

l bacterium, Beta-lactam properties inhibit the synthesis of bacterial cell walls.

3.Ceftriaxone - (i

.

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

ntravenous therapy) bactericidal properties kill bacterium. Has central nervous system penetration.

4

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

Companies that provide selfless information through particip

.Anti-inflammatory medications, such as ibuprofen, are sometimes prescribed to relieve joint stiffness

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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