US5030447A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Pharmaceutical compositions having good stability
Assignee: ER Squibb and Sons LLC
•
Filing: 1988-03-31
•
Granted: 1991-07-09
•
Expires: 2008-03-31
Abstract
Abstract A pharmaceutical compositions is provided which has excellent stability, when dispersed in water has a pH of at least about 9, and includes a medicament which is sensitive to a low pH environment such as pravastatin, one or more fillers such as lactose and/or microcrystalline cellulose, one or more binders, such as mirocrystalline cellulose (dry binder) or polyvinylpyrrolidone (wet binder), one or more disintegrating agents such as croscarmellose sodium, one or more lubricants such as magnesium stearate and one or more basifying agents such as magnesium oxide.
Inventors
- 👤 Yatindra M. Joshi
- 👤 Pierina Chiesa
- 👤 Nemichand B. Jain
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 22:40
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/185; A61K31/19; A61K9/00; A61K9/20; A61K9/2004; A61K9/2009
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
64 words
A pharmaceutical composition in the form of a tablet which has enhanced stability comprising medicament which is sensitive to a low pH environment and is pravastatin, one of more fillers, one or more binders, one or more disintegrants, one of more lubricants and one or more basifying agents to impart a desired pH of at least 9 to an aqueous dispersion of said composition.
Claim 2
Dependent Claim
64 words
A pharmaceutical composition in the form of a tablet which has enhanced stability comprising medicament which is sensitive to a low pH environment and is pravastatin, one of more fillers, one or more binders, one or more disintegrants, one of more lubricants and one or more basifying agents to impart a desired pH of at least 9 to an aqueous dispersion of said composition.
Claim 3
Dependent Claim
31 words
The pharmaceutical composition as defined in claim 1 wherein said medicament is present in an amount within the range of from about 1 to about 60% by weight of the composition.
Claim 4
Dependent Claim
32 words
The pharmaceutical composition as defined in claim 1 wherein the basifying agent is present in an amount within the range of from about 1 to about 75% by weight of the composition.
Claim 5
Dependent Claim
25 words
The pharmaceutical composition as defined in claim 1 wherein the basifying agent is an alkali metal hydroxide, an alkaline earth metal hydroxide or ammonium hydroxide.
Claim 6
Dependent Claim
30 words
The pharmaceutical composition as defined in claim 5 wherein the basifying agent is MgO, Mg(OH) 2 , Ca(OH) 2 , NaOH, KOH, LiOH, NH 4 OH, Al(OH) 3 or magaldrate.
Claim 7
Dependent Claim
28 words
The pharmaceutical composition as defined in claim 1 wherein the filler is present in an amount within the range of from about 5 to about 90% by weight.
Claim 8
Dependent Claim
30 words
The pharmaceutical composition as defined in claim 6 wherein the filler is lactose, sugar, corn starch, modified corn starch, mannitol, sorbitol, wood cellulose, microcrystalline cellulose, calcium carbonate or mixtures thereof.
Claim 9
Dependent Claim
28 words
The pharmaceutical composition as defined in claim 1 wherein the binder is present in an amount within the range of from about 5 to about 35% by weight.
Claim 10
Dependent Claim
32 words
The pharmaceutical composition as defined in claim 8 wherein the binder is microcrystalline cellulose, polyvinylpyrrolidone, lactose, corn starch, modified corn starch, sugars, gum acacia, carnauba wax, paraffin, spermaceti, polyethylenes or microcrystalline wax.
Claim 11
Dependent Claim
28 words
The pharmaceutical composition as defined in claim 1 wherein the disintegrant is present in an amount within the range of from about 0.5 to about 10% by weight.
Claim 12
Dependent Claim
23 words
The pharmaceutical composition as defined in claim 10 wherein the disintegrant is croscarmellose sodium, crospovidone, sodium starch glycolate, corn starch or microcrystalline cellulose.
Claim 13
Dependent Claim
83 words
The pharmaceutical composition as defined in claim 1 having the following formulation: from about 3 to about 50% by weight pravastatin, from about 2 to about 70% by weight magnesium oxide, to impart a pH of at least about 9.5, from about 1 to about 85% by weight lactose, from about 10 to about 30% by weight microcrystalline cellulose or polyvinylpyrrolidone, from about 2 to about 8% by weight of croscarmellose sodium; and from about 0.5 to about 2% by weight magnesium stearate.
Claim 14
Dependent Claim
17 words
The pharmaceutical composition as defined in claim 1 having a pH in water of at about 10.
References Cited (Backward Citations)
US3865935A
Cited
US3891755A
Cited
US4342767A
Cited
US4346227A
Cited
US4609675A
Cited
US4681759A
Cited
US4755385A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-07-08 | 1995-01-07 | 1995-07-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-07-08 | 1999-01-07 | 1999-07-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-07-08 | 2003-01-07 | 2003-07-09 | $7700.00 | Window Closed / Lapsed |