Slow-release sodium fluoride tablet and method for treatment of osteoporosis
AssigneesMission Pharmacal Company, Board of Regents, The University of Texas System
InventorsNeill B. Walsdorf, Charles Y. C. Pak
Life of this patent
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Abstract
A novel slow-release sodium fluoride preparation and its use. Such slow-release sodium preparation comprises carnauba wax and talc and may be used to provide a safe but effective level of fluoride in serum, optimal for the treatment of osteoporosis. Gastrointestinal side effects are minimized by limiting the amount of fluoride released in the stomach and rheumatic complications are reduced by avoiding toxic levels of fluoride is serum. The amount of fluoride absorbed is nevertheless sufficient to stimulate bone formation and prevent fractures. Thus, the maintenance of serum fluoride as encompassed in this invention, allows for a safe and effective treatment of osteoporosis.
Claims23
A tablet adapted for slow gastrointestinal release of fluoride, the tablet comprising by weight 1% to 10% talc, 1% to 5% lubricant, 20% to 65% compressible sugar and 8% to 12% sodium fluoride dispersed substantially homogeneously throughout a carnauba wax matrix, said carnauba wax being between 35% to 70% by weight of the tablet.
A process for maintaining an individual's serum fluoride at a therapeutic and safe level between about 95 ng/ml and about 190 ng/ml, the process comprising administering to the individual twice daily a tablet adapted for slow gastrointestinal release of fluoride, the tablet comprising talc and sodium fluoride dispersed substantially homogeneously throughout a carnauba wax matrix.
A process for maintaining an individual's serum fluoride at a therapeutic and safe level between about 95 ng/ml and about 190 ng/ml, the process comprising administering twice daily to the individual, a tablet adapted for slow gastrointestinal release of fluoride, the tablet comprising by weight 1% to 10% talc, and 8% to 12% sodium fluoride dispersed substantially homogeneously throughout a carnauba wax matrix, said carnauba wax being between 35% to 70% by weight of the tablet.
A process for maintaining an individual's serum fluoride at a therapeutic and safe level between about 95 ng/ml and about 190 ng/ml, the process comprising administering twice daily to the individual, a tablet adapted for slow gastrointestinal release of fluoride, the tablet comprising by weight 1% to 10% talc, 1% to 5% lubricant, 20% to 65% compressible sugar and 8% to 12% sodium fluoride dispersed substantially homogeneously throughout a carnauba wax matrix, said carnauba wax being between 35% to 70% by weight of the tablet.
A tablet adapted for slow gastrointestinal release of fluoride, the tablet comprising by weight about 5% talc, about 45% carnauba wax, and about 11% sodium fluoride.
A method of producing a slow release sodium fluoride tablet comprising the steps of:
- (a) blending a combination comprising finely powdered carnauba wax, talc and sodium fluoride to form a mixture;
- (b) passing the mixture of step (a) through a mesh screen;
- and
- (c) tableting the screened mixture of step (b) to form the slow release sodium fluoride tablet.
A method of producing a slow release sodium fluoride tablet comprising the steps of:
- (a) measuring a quantity of finely powdered carnauba wax;
- (b) measuring a quantity of sodium fluoride, or sodium fluoride with a binder, and talc;
- (c) blending the quantity of carnauba wax with the quantity measured in step (b) to form a mixture;
- (d) passing the mixture of step (a) through a mesh screen;
- and
- (f) tableting the screened mixture of step (d) to form a slow release sodium fluoride tablet.
Dependencies are inferred from the claim text.