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US4252794A Expired / Lapsed US ⏱️ 0.0 years remaining

Gamma-sorbitol polymorph

Assignee: SPI Polyols Inc
•
Filing: 1979-12-20
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Granted: 1981-02-24
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Expires: 1999-12-20
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Abstract

Abstract A modified gamma-sorbitol polymorph having improved compressibility and hardness characteristics when formulated into a tablet while also exhibiting an absence or low degree of grit. Under a scanning electron microscope, the sorbitol polymorph of the invention is found to have a disrupted crystalline structure, substantial amounts of relatively large crystals not being coplanar with each other.

Inventors

  • 👤 James W. DuRoss

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-02 23:07
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2013; A61K9/2018; C; C07; C07C; C07C29/00; C07C29/74; C07C31/00; C07C31/18; C07C31/26

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 160 words
A modified gamma-sorbitol polymorph having improved tableting properties characterized in that the modified gamma-sorbitol has: (a) a disrupted and loose crystal structure visible on a scanning electrom microscope at 2000X power; (b) a surface area value for a -20/+60 mesh powder of the polymorph of at least about 1.0 square meter per gram; (c) a compression value of about 3.82 mm or less, said compression value being the thickness in millimeters of a round, flat, beveled edge tablet which is 5/8 inch in diameter and which is formed under 3.2 tons pressure on a 1.00±0.05 gram charge consisting of 99.5% by weight of a -20/+60 mesh powder of the polymorph and 0.5% by weight of magnesium stearate; (d) a Strong Cobb Arner hardness value of at least about 22 kilograms for the round tablet of paragraph (c); (e) a gamma-sorbitol crystal content of at least about 80% by weight; and (f) a melting point of about 100° to 101° C.
Claim 2
Dependent Claim 160 words
A modified gamma-sorbitol polymorph having improved tableting properties characterized in that the modified gamma-sorbitol has: (a) a disrupted and loose crystal structure visible on a scanning electrom microscope at 2000X power; (b) a surface area value for a -20/+60 mesh powder of the polymorph of at least about 1.0 square meter per gram; (c) a compression value of about 3.82 mm or less, said compression value being the thickness in millimeters of a round, flat, beveled edge tablet which is 5/8 inch in diameter and which is formed under 3.2 tons pressure on a 1.00±0.05 gram charge consisting of 99.5% by weight of a -20/+60 mesh powder of the polymorph and 0.5% by weight of magnesium stearate; (d) a Strong Cobb Arner hardness value of at least about 22 kilograms for the round tablet of paragraph (c); (e) a gamma-sorbitol crystal content of at least about 80% by weight; and (f) a melting point of about 100° to 101° C.
Claim 3
Dependent Claim 32 words
The modified gamma-sorbitol polymorph of claim 1, wherein said polymorph is further characterized by crystals widths of at least about 1.0 micron as visible on a scanning electron micrograph at 2000X magnification.
Claim 4
Dependent Claim 20 words
The modified gamma-sorbitol polymorph of claim 1, wherein said surface area is at least about 1.1 square meters per gram.
Claim 5
Dependent Claim 18 words
The modified gamma-sorbitol polymorph of claim 1, wherein said crystal content is at least about 90% by weight.
Claim 6
Dependent Claim 16 words
The modified gamma-sorbitol polymorph of claim 4, wherein said crystal content is about 100% by weight.
Claim 7
Dependent Claim 20 words
The modified gamma-sorbitol polymorph of claim 1, wherein said Strong Cobb Arner hardness value is at least about 24 kilograms.
Claim 8
Dependent Claim 15 words
A confectionary composition comprising the modified gamma-sorbitol polymorph of claim 1 and a flavoring agent.
Claim 9
Dependent Claim 12 words
The composition of claim 7, wherein said confectionary composition is a tablet.
Claim 10
Dependent Claim 13 words
The composition of claim 7, wherein said confectionary composition is a chewing gum.
Claim 11
Dependent Claim 15 words
A pharmaceutical composition comprising the modified gamma-sorbitol polymorph of claim 1 and a pharmaceutical agent.

References Cited (Backward Citations)

US2755220A Cited
US3039927A Cited
US3445528A Cited
DE2409107A1 Cited
US3973041A Cited
DE2727778A1 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1984-02-24 1984-08-25 1985-02-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1988-02-24 1988-08-25 1989-02-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1992-02-24 1992-08-25 1993-02-24 $7700.00 Window Closed / Lapsed

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