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US4264573A Expired / Lapsed US ⏱️ 0.0 years remaining

Pharmaceutical formulation for slow release via controlled surface erosion

Assignee: Rowell Laboratories Inc
•
Filing: 1979-05-21
•
Granted: 1981-04-28
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Expires: 1999-05-21
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Abstract

Abstract A pharmaceutical composition in tablet form for oral administration comprises: (a) 30-90% by weight of an active ingredient having a water solubility (20° C.) of about 1/10-1/500 (w/w); (b) 1-40% by weight of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/20 (w/w); (c) 0-20% by weight of a binder which is pharmaceutically acceptable in oral tablets; (d) 0-50% by weight of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/5 (w/w); (e) 0.5-5% by weight of a die wall lubricant pharmaceutically acceptable in oral tablets; (f) 0-5% by weight of a surface active agent pharmaceutically acceptable in oral tablets; and (g) 0-1.0% by weight of a disintegration agent pharmaceutically acceptable in oral tablets; whereby the active ingredient has a slow in vivo release rate due to controlled surface erosion of the tablet.

Inventors

  • 👤 David R. Powell
  • 👤 Vithal K. Patel

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 20:13
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004

Claims Analysis

Total Claims: 5
Claim 1
Independent Claim 156 words
A pharmaceutical composition in tablet form for oral administration consisting essentially of (a) 70-80 wt.% of lithium carbonate; (b) 5-15 wt.% of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/20 (w/w); (c) 2-7 wt.% of a binder which is pharmaceutically acceptable in oral tablets; (d) 5-15 wt.% of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/5 (w/w); (e) 0.9-3.3 wt.% of a dye wall lubricant pharmaceutically acceptable in oral tablets; (f) 0.1-0.2 wt% of a surface active agent pharmaceutically acceptable in oral tablets; and (g) 0.15-0.35 wt.% of a disintegration agent pharmaceutically acceptable in oral tablets; whereby the active ingredient has a slow zero order in vivo release rate and a plasma concentration/time curve of substantially the same shape as that of FIG. 1, due to controlled surface erosion of the tablet.
Claim 2
Dependent Claim 156 words
A pharmaceutical composition in tablet form for oral administration consisting essentially of (a) 70-80 wt.% of lithium carbonate; (b) 5-15 wt.% of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/20 (w/w); (c) 2-7 wt.% of a binder which is pharmaceutically acceptable in oral tablets; (d) 5-15 wt.% of an excipient which is pharmaceutically acceptable in oral tablets and which has a water solubility (20° C.) of about 1/1-1/5 (w/w); (e) 0.9-3.3 wt.% of a dye wall lubricant pharmaceutically acceptable in oral tablets; (f) 0.1-0.2 wt% of a surface active agent pharmaceutically acceptable in oral tablets; and (g) 0.15-0.35 wt.% of a disintegration agent pharmaceutically acceptable in oral tablets; whereby the active ingredient has a slow zero order in vivo release rate and a plasma concentration/time curve of substantially the same shape as that of FIG. 1, due to controlled surface erosion of the tablet.
Claim 3
Dependent Claim 45 words
The pharmaceutical composition of claim 1 consisting essentially of: 70-80 wt.% of lithium carbonate; 5-15 wt.% of sodium chloride; 2-7 wt.% of polyvinylpyrrolidone; 5-15 wt.% of sorbitol; 0.9-3.3 wt.% of calcium stearate; 0.1-0.2 wt.% of sodium lauryl sulfate; and 0.15-0.35 wt.% of sodium starch glycolate.
Claim 4
Dependent Claim 51 words
The pharmaceutical composition of claim 2 consisting essentially of the following approximate amounts of ingredients: 300 mg of lithium carbonate; 40 mg of sodium chloride; 15 mg of polyvinylpyrrolidone; 9.4 mg of calcium stearate; 0.6 mg of sodium lauryl sulfate; 40 mg of sorbitol; and 1 mg of sodium starch glycolate.
Claim 5
Dependent Claim 23 words
The pharmaceutical composition of claim 1, 2 or 3 which is in the form of a tablet of a hardness of 5-20 kg.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1984-04-27 1984-10-27 1985-04-28 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1988-04-27 1988-10-27 1989-04-28 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1992-04-27 1992-10-27 1993-04-28 $7700.00 Window Closed / Lapsed

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