MFP-Fluorides for Osteoporosis
Introduction
Since 1960, many clinical studies on the use of Fluoride to treat osteoporosis
have been reported, with conflicting results, such that general worldwide
acceptance of Fluoride Therapy has not been forthcoming. Nevertheless,
the unique stimulating action of Fluoride on bone formation has provided
the impetus for continued research and finally, in 1995, a breakthrough
was achieved when it was discovered that a very low,1
slow-dosage provides complete safe protection against vertebral fractures in mild-moderate
osteoporotic patients.
In previous studies, patients had usually absorbed two-to-four times
as much fluoride per day for periods of several years, resulting in daily
high peak blood levels and toxic retention of fluoride by the bones. Furthermore,
in the past, patient populations have included severe osteoporotics who
have lost such excessive amounts of bone structure that an inadequate framework
exists on which to build new bone. This accounts for the failure of bone-former
stimulants like Fluoride in this type of patient.
The preferred source of the new slow-fluoride regimen is MFP (Disodium-monofluorophosphate),
because MFP unlike sodium fluoride (NaF) is very compatible with concomittant
calcium supplements and dietary calcium which are essential for successful
results. Furthermore, MFP is better tolerated and therefore its usage is
more conducive to patient compliance. These features of slow MFP were recognized
several years ago and have resulted in the granting of worldwide patents,
which have now become available for licensing or sale to appropriate pharmaceutical
marketers.
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Unique stimulant-action on bone formation, harnessed by low-slow
dosage system. Additive benefits to use of estrogens, phosphonates, calcitonin
(inhibitors of bone loss).2
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UK Patent #2195245/Claim #1: A medication providing fluoride
ion for the treatment and prevention of bone loss disease including osteoporosis
and alveolar bone loss, which comprises a solid, unitary dosage tablet,
lozenge, or capsule containing from about 20 to 100 milligrams of sodium
monofluorosphosphate and further containing means for controlling the release
of the monofluorophosphate over a period extending up to eight hours after
swallowing, whereby the quantity of fluoride ions at any given time is
below the threshold value at which gastric irritation will occur.
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Analogous Patents in Germany, France, Italy, Belgium, Switzerland
where fluoride therapy already has received regulatory approval. Also,
in U.S., where FDA approval is still pending.
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Potential Market: Estimated 75 million osteoporosis patients in
U. S., Europe, and Japan (Osteoporosis International 7:1, 1997)
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1. The biodosage (bioavailable or absorbed dosage)
was found to be only 5-10 mgF per day (A quart of fluoridated drinking water
contains only 1 mgF). Inspired the safety slogan: "go low and slow to get no woe."
2. "There is no medication like fluoride, when properly
used, which is able to increase lumbar BMD and to prevent further crush
fractures without systemic side effects in osteoporosis type I." (Nagant,
1996, p.249)
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