Methods of interfacing nanomaterials for the monitoring and execution of pharmaceutical manufacturing processes

• US 20080221722A1
• Filed: 03/08/2007
• Published: 09/11/2008
• Est. Priority Date: 03/08/2007
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Granted Patent: US 7,680,553 B2
• Time in Patent Office: Days
• US Class Current: 700/110
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility drug screening with animal cells G01N33/5008
• CPC Class Codes: Y10S 977/953 Detector using nanostructure

Abstract

Methods of interfacing nanomaterials used to monitor and execute the pharmaceutical manufacturing process are disclosed herein. The nanomaterials are useful to provide a plurality of analysis to the manufacturing process. Consequently, the methods provide a means to perform validation and quality manufacturing on an integrated level whereby pharmaceutical manufacturers can achieve data and product integrity and ultimately minimize cost.

Claims

1. A method of interfacing a nanomaterial with a pharmaceutical manufacturing process said method comprising,

a) contacting a functional nanomaterial to a device used in a pharmaceutical manufacturing process wherein said functional nanomaterial monitors a critical control point;

b) monitoring data generated by said nanomaterial during pharmaceutical manufacture;

c) analyzing the data to determine if the critical control point has an adverse effect on a finished pharmaceutical.

2. The method of claim 1, wherein the nanomaterial is selected from the group consisting of a nanocrystal, nanopowder, and nanocomposite.

3. The method of claim 1, wherein the functional nanomaterial is optically enhanced.

4. The method of claim 1, wherein the device is a pharmaceutical manufacturing software system selected from the group consisting of user-independent audit trails, time-stamped audit trails, data security, confidentiality systems, limited authorized system access, electronic signatures, bar codes, dedicated systems, add-on systems, control files, Internet, and LAN'"'"'s.

5. The method of claim 1, wherein the device is a tablet press or powder blending device.

6. The method of claim 1, wherein the pharmaceutical manufacturing process is selected from the group consisting of crystallization, chromatography, and downstream processing.

7. The method of claim 1, wherein the data is generated during production of an active ingredient.

8. A method of monitoring a filtration system used on a pharmaceutical manufacturing process said method comprising,

a) scanning a filter membrane with an optically enhanced nanomaterial;

b) monitoring data generated by the nanomaterial;

c) analyzing the data for determination of quality or yield parameters against a predetermined quality or yield parameter.

9. The method of claim 8, wherein the membrane is a biosensor.

10. The method of claim 9, wherein the biosensor is selected from the group consisting of a thermal biosensor, optical biosensor, and acoustic biosensor.

12. The method of claim 8, wherein the data is generated by a crystallization system.

11. (canceled)

13. A functional nanomaterial comprising, a nanomaterial operably linked to an electronic circuit whereby the electronic circuit is programmed with a logic function and whereby said logic function is interfaced with a software program used in a pharmaceutical manufacturing process wherein the pharmaceutical manufacturing process is selected from the group consisting of crystallization, chromatography, and downstream processing.

14. The nanomaterial of claim 13, wherein the nanomaterial is a nanocomposite.

15. The functional nanomaterial of claim 13, wherein the electronic circuit is a combinational logic circuit having an I/O function and a power supply.

16. The nanomaterial of claim 13, wherein the nanomaterial is chemically assembled.

17. The nanomaterial of claim 13, wherein the nanomaterial is designed via a bottom-up design.

18. (canceled)