IP Library Granted Patent US 11,324,830
Granted Patent B2
US 11,324,830 · App. 16/272,526 · Granted May 10, 2022

Processes for producing pharmaceutical excipients from lignocellulosic biomass, and pharmaceutical excipients obtained therefrom

Inventors: Kimberly Nelson (Atlanta, GA); Theodora Retsina (Atlanta, GA); Vesa Pylkkanen (Atlanta, GA)
Assignee: GranBio Intellectual Property Holdings, LLC
A61K47/38C08B37/0057C08H6/00C08H8/00
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Quick Facts
Patent No.
US 11,324,830
App. No.
16/272,526
Granted
May 10, 2022
Kind
B2
Abstract

In some variations, the invention provides a process for producing a microcrystalline cellulose material, comprising: fractionating lignocellulosic biomass feedstock in the presence of an acid, a solvent for lignin, and water, to generate cellulose-rich solids and a liquid containing hemicellulose and lignin; chemically and/or mechanically treating the cellulose-rich solids to form microcrystalline cellulose having an average crystallinity of at least 60%; and recovering the microcrystalline cellulose as a pharmaceutical excipient. The pharmaceutical excipient may function as an antiadherent, a binder, a coating, or a disintegrant. In some embodiments, the pharmaceutical excipient further comprises a lignin-derived lubricant, glidant, sorbent, preservative, or other component. The pharmaceutical excipient may be present in a pill, tablet, capsule, powder, slurry, or other pharmaceutically effective and acceptable form.

Claims (20)

1. A process for producing a pharmaceutical excipient, said process comprising:

(a) providing a lignocellulosic biomass feedstock;

(b) fractionating said feedstock in the presence of a sulfur-containing compound, a solvent for lignin, and water, to generate cellulose-rich solids and a liquid containing hemicellulose and lignin;

(c) chemically and/or mechanically treating said cellulose-rich solids to form microcrystalline cellulose having an average crystallinity of at least 60%; and

(d) recovering said microcrystalline cellulose as a pharmaceutical excipient, wherein said sulfur-containing compound is selected from the group consisting of sulfur dioxide, sulfurous acid, sulfur trioxide, sulfuric acid, lignosulfonic acid, and combinations thereof,

wherein during step (c), said cellulose-rich solids are chemically treated in a common reactor or vessel with said fractionating in step (b).

2. The process of claim 1 , wherein said sulfur-containing compound is sulfur dioxide.

3. The process of claim 1 , wherein during step (c), said cellulose-rich solids are mechanically treated with a total mechanical energy of less than about 1000 kilowatt-hours per ton of said cellulose-rich solids.

4. The process of claim 1 , wherein step (c) comprises treatment of said cellulose-rich solids with one or more compounds selected from the group consisting of sulfur dioxide, sulfurous acid, lignosulfonic acid, acetic acid, formic acid, and combinations thereof.

5. The process of claim 1 , wherein step (c) comprises treatment of said cellulose-rich solids with heat.

6. The process of claim 1 , said process further comprising bleaching said cellulose-rich solids prior to step (c) and/or as part of step (c).

7. The process of claim 1 , said process further comprising bleaching said microcrystalline cellulose during step (c) and/or following step (c).

8. The process of claim 1 , wherein said crystallinity of said microcrystalline cellulose is at least 70%.

9. The process of claim 8 , wherein said crystallinity of said microcrystalline cellulose is at least 80%.

10. The process of claim 1 , wherein said pharmaceutical excipient is a pharmaceutically effective antiadherent in a pill, tablet, capsule, powder, or slurry.

11. The process of claim 1 , wherein said pharmaceutical excipient is a pharmaceutically effective binder in a pill, tablet, capsule, powder, or slurry.

12. The process of claim 1 , wherein said pharmaceutical excipient is a pharmaceutically effective coating in a pill, tablet, capsule, powder, or slurry.

13. The process of claim 1 , wherein said pharmaceutical excipient is a pharmaceutically effective disintegrant in a pill, tablet, capsule, powder, or slurry.

14. The process of claim 1 , wherein said pharmaceutical excipient further comprises a lignin-derived lubricant, glidant, sorbent, or preservative.

15. The process of claim 14 , wherein said lignin from step (b) is utilized in said lignin-derived lubricant, glidant, sorbent, or preservative.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 15, 2020
From: NELSON, KIMBERLY; PYLKKANEN, VESA; RETSINA, THEODORA
To: GRANBIO INTELLECTUAL PROPERTY HOLDINGS, LLC
Reel/Frame 054063/0191 →
CHANGE OF NAME Recorded Apr 15, 2019
From: API INTELLECTUAL PROPERTY HOLDINGS, LLC
To: GRANBIO INTELLECTUAL PROPERTY HOLDINGS, LLC
Reel/Frame 050267/0518 →
Continuity (4)
Continuation 16010546 · Jun 18, 2018
Continuation 14980065 · Dec 28, 2015
Provisional Application 62097302 · Dec 29, 2014
Related Publication 20190298838A1 · Oct 3, 2019