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Method of increasing bone volume

A capacity and bone disease technology, applied in bone diseases, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve side effects and other problems

Inactive Publication Date: 2000-10-11
THE PROCTER & GAMBLE COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Systemic administration of nonselective prostaglandin analogs also causes side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A 65-year-old woman with osteopenia and a physician-diagnosed osteoporosis was given the FP agonist fluprostinol. She was treated daily with a transdermal patch that delivered 10 μg / kg (body weight) of fluprostinol over a 24-hour period. The treatment was continued for 24 months. At this time, as measured by dual energy X-ray absorptiometry (DXA), the vertebral bone mass increased significantly compared with that at the beginning of the treatment.

Embodiment II

[0053] A 63-year-old woman with osteopenia and a physician-diagnosed osteoporosis was given the FP agonist fluprostinol. She was treated with an implantable subcutaneous pump that delivered 10 micrograms per kilogram (body weight) of fluprostinol over a 24-hour period. The treatment was continued for 12 months, at which point the vertebral bone mass had increased substantially compared to the vertebral bone mass at the start of the treatment, as measured by dual energy X-ray absorptiometry.

[0054] drug formulation

[0055] The pharmaceutical formulation of the present invention comprises a safe and effective amount of a non-naturally occurring FP agonist and a pharmaceutically acceptable carrier.

[0056] "Safe and effective amount" means herein, within the scope of reasonable medical evaluation, the amount of the compound or composition is high enough to significantly improve the symptoms and / or conditions being treated, but low enough to avoid serious side effects (reason...

Embodiment III

[0067] A pharmaceutical formulation (composition) in tablet form is prepared by conventional methods, such as mixing and direct compression, and its formulation is as follows:

[0068] Component Dosage (mg / tablet)

[0069] Fluprostinol 5

[0070] Microcrystalline Cellulose 100

[0071] Sodium Starch Glycolate 30

[0072] Magnesium stearate 3

[0073] Oral administration of the above-mentioned tablet once a day for 6 months resulted in a significant increase in bone volume in patients suffering from osteoporosis.

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PUM

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Abstract

The present invention relates to novel methods of increasing bone volume comprising activating the osteoblastic protein kinase C / intracellular calcium pathways of a subject. This invention further relates to a method of treating or preventing bone disorders wherein activation occurs by the administration of a FP agonist.

Description

technical field [0001] The present invention relates to novel methods of increasing bone volume comprising activating the osteoblast protein kinase C / intracellular calcium pathway in a subject. The present invention also relates to a method of treating or preventing a bone disease, wherein the activation is produced by administering an agonist of FP. Background of the invention [0002] In osteoporosis, an imbalance is created in the bone remodeling process, with bone resorption occurring faster than bone formation. Although in most individuals (both men and women) some degree of this imbalance develops as they age, it is more severe in younger people with osteoporosis, especially those with Among those patients with postmenopausal forms of osteoporosis. Accelerated bone loss may also be caused by medications (eg, corticosteroids), prolonged bed rest, disuse of extremities, and microgravity. The consequence of bone loss is the complete removal ...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K31/557A61K31/5575A61P19/10
CPCA61K31/557A61P19/10
Inventor J·R·哈特基M·W·伦迪M·A·德隆
Owner THE PROCTER & GAMBLE COMPANY
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