E-Articles - Health and Fitness

Lower back pain is most commonly from spinal nerve root L5 irritation followed by the S1 nerve root. Both nerve roots are strongly represented in the buttock muscle (gluteus maximus: predominan

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

t S1) and the inner thigh muscle (adductor magnus: the lower part L5, S1), hamstring muscles (L5 and S1), gluteus medius (predominant L5) and tensor fascia lata (predominant L5). There are t

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

Examples of combination products may in

o parts tto the long hamstring muscles, the outer part (has one lateral muscle) and the inner part has (two medial) muscles. There is also another muscle known as the short hamstring muscle. T

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

he long hamstring muscles arise from the pelvic bone area known as the ischial tuberosity (this bone is under the buttock muscle and we place pressure on this bone when we sit). Thus the long ha

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

string muscles come from above the hip. They end (insert) on the leg bones. The short hamstring muscle arises from below the hip from the thigh bone. The long hamstring muscles receive their ne

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

Combination pro

rve supply through the sciatic nerve whereas the short hamstring muscle is supplied by the common peroneal nerve.

Whenever a muscle is tight, you must always consider the balance in strength 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

ween the muscles on opposite sides of the joint. In the case with the hamstrings, they act from behind to straighten the hip joint (extend) and bend the knee joint (flex). So the strength of th

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

e muscles in the front of the hip that bend the hip and thigh up (flex) and the muscles in the front of the knee that will straighten the knee (extend) are important to balance the action of the

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

hamstrings. Therefore, if the muscles that straighten the hip joint (extensors) are weak, the muscles that bend the hip and thigh upward (flexors) will be automatically stronger. This itself

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

will make the hip extensors (gluteus maximus, adductor magnus) weaker since they will now be stretched beyond their optimal length.

Hamstring muscles do have an effect on straightening the hip,

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

provided the knee is straight. However, when we are sitting down, the hamstring muscles do not have much effect on straightening the hip (extension). The action of the hamstrings will therefore

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

Following aspects would a

be most prominent for bending the knee. The sitting position with knees bent thus puts the hamstring muscles to become short and tight behind the knee.

The sitting position also puts the rectu

dd to the challenges in developing combination products:

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

s femoris and tensor fascia lata muscle at the front of the knee to be stretched across the knee. Since these muscles straighten the knee, they will be stretched beyond optimal length when the

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

nee is in a bent position such as in sitting. This stretch effect is made worse since both these muscles are already shortened when the person sits since these two muscles are responsible for b

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

ending the hip also.

The setting for the tightness of the hamstrings at the knee thus stems from weakness of the lower back muscles and the muscles that surround the hip from behind (gluteus ma

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

imus, adductor magnus) and from the outer aspect (gluteus medius and tensor fascia lata).

Therefore tightness of the hamstring muscles cannot be accomplished just by stretching the hamstring mu

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

Professional from academic institutions, pharmaceutical industries, health care indust

scles. Shortening contractions have to be performed to muscles constantly exposed to lengthening contractions. These include perform shortening contractions to the spinal muscles from neck to t

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

e base of the spine. At the hip, shortening contractions have to be performed to the gluteus maximus and adductor magnus muscles which have nerve related muscle weakness in the presence of cons

.

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

tant exposure to lengthening contractions.

Shortening contractions have to be performed also for the tensor fascia lata and the rectus femoris muscles. Since these muscles have to be selective

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

Companies that provide selfless information through particip

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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