Patent US4159345A successfully refreshed from Google Patents.
US4159345A
Expired / Lapsed
US
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Novel excipient and pharmaceutical composition containing the same
Assignee: FMC Corp
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Filing: 1978-01-31
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Granted: 1979-06-26
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Expires: 1998-01-31
Abstract
Abstract An excipient for use in manufacture of tablets, capsules, powders, microgranules and granules which consists essentially of a microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a celulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, a repose angle of 35° to 42°, a 200-mesh sieve residue of 2 to 80% by weight and a tapping apparent specific volume of at least 1.4 cc/g and a pharmaceutical composition comprising a pharmaceutically active ingredient and the excipient. This excipient has improved flowability and moldability or compressibility whereby excellent pharmaceutical preparations may be easily provided. In addition, pharmaceutical compositions obtained using such excipient are excellent in various pharmaceutical characteristics such as rate of disintegration, rate of dissolution, etc.
Inventors
- 👤 Kimihiko Takeo
- 👤 Tetuya Aoyagi
- 👤 Akimitsu Tamada
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 19:56
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/30; A61K47/36; A61K47/38; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
64 words
An exipient consisting essentially of a microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a cellulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, and a repose angle of 35 to 42°.
Claim 2
Dependent Claim
64 words
An exipient consisting essentially of a microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a cellulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, and a repose angle of 35 to 42°.
Claim 3
Dependent Claim
28 words
An excipient as set forth in claim 1 wherein the average degree of polymerization is 70 to 180 and the apparent specific volume is 1.9 to 2.8 cc/g.
Claim 4
Dependent Claim
16 words
An excipient as set forth in claim 1 wherein the repose angle is 38 to 42°.
Claim 5
Dependent Claim
74 words
A pharmaceutical composition comprising a pharmaceutically active ingredient and an excipient which consists essentially of a microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a cellulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, and a repose angle of 35 to 42°.
Claim 6
Dependent Claim
74 words
A pharmaceutical composition comprising a pharmaceutically active ingredient and an excipient which consists essentially of a microcrystalline cellulose having an average degree of polymerization of 60 to 375 and obtained through acid hydrolysis or alkaline oxidative degradation of a cellulosic substance selected from linters, pulps and regenerated fibers, said microcrystalline cellulose being a white cellulosic powder having an apparent specific volume of 1.6 to 3.1 cc/g, and a repose angle of 35 to 42°.
Claim 7
Dependent Claim
28 words
A pharmaceutical composition as set forth in claim 4 wherein said excipient is present in an amount of 2 to 40% by weight based on the pharmaceutical composition.
Claim 8
Dependent Claim
28 words
A pharmaceutical composition as set forth in claim 4 wherein said excipient is present in an amount of at least 10% by weight based on the pharmaceutical composition.
Claim 9
Dependent Claim
22 words
A pharmaceutical composition as set forth in claim 6 wherein said pharmaceutically active ingredient has a repose angle not larger than 50°.
Claim 10
Dependent Claim
40 words
A pharmaceutical composition as set forth in claim 6 wherein said pharmaceutically active ingredient has a repose angle of at least 50° and is present in an amount of not higher than 65% by weight based on the pharmaceutical composition.
Claim 11
Dependent Claim
58 words
A pharmaceutical composition as set forth in claim 4 wherein said excipient is present in an amount of 15 to 35% by weight based on the pharmaceutical composition, and the pharmaceutically active ingredient has a repose angle of at least 50° and is present in an amount of 65 to 85% by weight based on the pharmaceutical composition.
Claim 12
Dependent Claim
14 words
A pharmaceutical composition as set forth in claim 4 which further comprises other additives.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1982-06-25 | 1982-12-25 | 1983-06-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1986-06-25 | 1986-12-25 | 1987-06-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1990-06-25 | 1990-12-25 | 1991-06-26 | $7700.00 | Window Closed / Lapsed |