US4904478A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Slow-release sodium fluoride tablet and method for treatment of osteoporosis
Assignee: The University of Texas System
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Filing: 1987-10-22
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Granted: 1990-02-27
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Expires: 2007-10-22
Abstract
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.
Inventors
- 👤 Neill B. Walsdorf
- 👤 Charles Y. C. Pak
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 21:49
CPC Classifications
A; A61; A61K; A61K33/00; A61K33/16; A61K9/00; A61K9/20; A61K9/2004; A61K9/2013
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
54 words
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.
Claim 2
Dependent Claim
54 words
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.
Claim 3
Dependent Claim
11 words
The tablet of claim 1 wherein the lubricant is magnesium stearate.
Claim 4
Dependent Claim
21 words
The tablet of claim 1 defined further as comprising about 5% talc, about 40% compressible sugar and about 11% sodium fluoride.
Claim 5
Dependent Claim
14 words
The tablet of claim 1 defined further as comprising about 25 mg. sodium fluoride.
Claim 6
Dependent Claim
55 words
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.
Claim 7
Dependent Claim
55 words
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.
Claim 8
Dependent Claim
76 words
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.
Claim 9
Dependent Claim
76 words
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.
Claim 10
Dependent Claim
85 words
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.
Claim 11
Dependent Claim
85 words
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.
Claim 12
Dependent Claim
11 words
The process of claim 7 wherein the lubricant is magnesium stearate.
Claim 13
Dependent Claim
15 words
The process of claim 5, 6 or 7 wherein the administration is for intermittent periods.
Claim 14
Dependent Claim
39 words
The process of claim 5, 6 or 7 wherein the tablet of claim is defined further as comprising about 5% talc, about 45% carnauba wax, about 2% magnesium stearate lubricant, about 40% compressible sugar and about 11% sodium fluoride.
Claim 15
Dependent Claim
17 words
The process of claim 5, 6 or 7 wherein the tablet comprises about 25 mg sodium fluoride.
Claim 16
Dependent Claim
43 words
A process of making more of adequately mineralized bone and inhibiting fractures, said process being accomplished by long-term maintenance of serum fluoride at a safe and therapeutic level using a slow-release preparation of sodium fluoride prepared according to claim 5, 6 or 7.
Claim 17
Dependent Claim
26 words
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.
Claim 18
Dependent Claim
26 words
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.
Claim 19
Independent Claim
59 words
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.
Claim 20
Independent Claim
59 words
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.
Claim 21
Independent Claim
84 words
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.
Claim 22
Independent Claim
84 words
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.
Claim 23
Dependent Claim
34 words
The method of claim 14 wherein the finely powdered carnauba wax of step (a) has the following meshed screen characteristics: ______________________________________
Mesh Percent Retained
______________________________________
60 1
100 1
150 60
200 37
______________________________________
Claim 24
Dependent Claim
31 words
The method of claim 15 wherein the mixture of step (a) has a ratio of sodium fluoride/wax or (sodium fluoride +binder) /wax in the range of between about 1.24 and 5.9.
Claim 25
Dependent Claim
30 words
The method of claim 15 wherein the tablet is further defined by the addition of a lubricant to the mixture, and the lubricant is defined further as being magnesium stearate.
Claim 26
Dependent Claim
14 words
The method of claim 18 wherein the tablet comprises about 1-5 parts/100 magnesium stearate.
Claim 27
Dependent Claim
19 words
The method of claim 18 wherein the tablet comprises magnesium stearate further defined as passed through a 20-mesh screen.
Claim 28
Dependent Claim
12 words
The method of claim 15 wherein the binder is a compressible sugar.
Claim 29
Dependent Claim
14 words
The method of claim 21 wherein the tablet comprises about 20-65 parts/100 compressible sugar.
Claim 30
Dependent Claim
37 words
The method of claim 14 or 15 wherein the tablet sodium-fluoride, carnauba wax and talc are in the following proportions on a 100-parts-by-weight basis: ______________________________________
sodium fluoride 8-12 parts
talc 1-10 parts
carnauba wax 35-70 parts
______________________________________
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1993-02-26 | 1993-08-28 | 1994-02-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1997-02-26 | 1997-08-28 | 1998-02-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2001-02-26 | 2001-08-28 | 2002-02-27 | $7700.00 | Window Closed / Lapsed |