I Advice - Health and Fitness

The traditional wisdom has been that dietary calcium is one of the major causes of kidney stones, and to prevent kidney stones patients have been advised t

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

o limit dietary calcium. Research has proved this wrong, however. Normal dietary calcium intake, along with reduced salt and protein, is now advised.1

Doc

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

Examples of combination products may in

tors used to prescribe a low calcium diet for preventing kidney stones. This approach makes little sense if you understand how calcium is managed in the bo

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

dy. Calcium levels in the blood are kept pretty steady by balancing the absorption of calcium from diet and taking calcium from bones when needed. Changing

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

the amount of calcium in the diet causes very little change in the blood level of calcium The kidney filters substances from the blood, so changing the di

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

Combination pro

etary intake of calcium does not change the amount of calcium that is filtered by the kidneys. In fact calcium and protein intake is reccomended in therapy

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

aimed at decreasing kidney stones. Calcium restriction in stone formers is not recommended because it can have adverse effects on bone and the incidence 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 stones.2

The recommended daily intake of calcium for adults is 1000 mg per day, but research shows the average American adult is getting 600 mg of calci

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

um daily from their food.3-4 Any nutritionist, doctor or text suggesting calcium reduction is in serious error. It has even been suggested that low calcium

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

may be a cause of kidney stones.5

There are also competitors that claim any calcium supplement which is not completely absorbed contributes to kidney sto

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

es. The truth is that unabsorbed calcium binds to oxalate from digested food in the intestine and decreases the elimination of oxalate in the urine, which

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

Following aspects would a

is how kidney stones form. To prevent kidney stones it is recommended to follow a calcium rich diet and avoid oxalates. If calcium is present in the diet w

dd to the challenges in developing combination products:

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

ith oxalate, then calcium and oxalate bind in the intestine. This way, less calcium and oxalate enter the blood so that oxalates are not available to bind

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

with calcium in the kidney.

If you are not maintaining the recommended calcium in your diet you may need calcium supplementation. Learn more about AlgaeCa

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

l calcium supplement

References

1. Hall PM. Related Articles, Links Preventin

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

g kidney stones: calcium restriction not warranted. Cleve Clin J Med. 2002 Nov;69(11):885-8

2. Martini LA, Wood RJ. Related Articles, Links Shoul

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

Professional from academic institutions, pharmaceutical industries, health care indust

d dietary calcium and protein be restricted in patients with nephrolithiasis? Nutr Rev. 2000 Apr;58(4):111-7

3. Standing Committee on the Scienti

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

fic Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium,

.

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

Vitamin D and Fluoride. Washington DC: The National Academies Press,1997.

4. US Department of Agriculture, Continuing Survey of Food Intakes of

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

Companies that provide selfless information through particip

Individuals, 1994-96

5. L. H. Smith, et al, "Medical Evaluation of Urolithiasis" Urological Clinics of North America 1:2, 241-260, June 1974

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

I Advice - What Causes Kidney Stones? Not Calcium Supplements

Related Articles: