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

• US 7,680,553 B2
• Filed: 03/08/2007
• Issued: 03/16/2010
• 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.
• Primary Examiner(s): Shechtman; Sean P
• Application Number:
  US11/715,627
• Publication Number:
  US 20080221722A1
• Time in Patent Office: 1,104 Days
• Field of Search: 700108-110, 700/117, 700/266, 702/19, 702/22, 977/708, 977/839, 977/953
• US Class Current: 700/108
• 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 system comprising:

an electronic circuit;

a filter membrane; and

an optically enhanced nanomaterial adapted to scan the filter membrane, said an optically enhanced nanomaterial operably linked to said electronic circuit, whereby the electronic circuit is programmed with a logic function and whereby said logic function is interfaced with a computer memory having computer executable instructions to continuously monitor data generating by scanning the filter membrane with the optically enhanced nanomaterial during a pharmaceutical crystallization manufacturing process and to analyze the data for determination of quality or yield parameters against a predetermined quality or yield parameter.

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

3. The system of claim 1, wherein the electronic circuit is a combinational logic circuit having an I/O function and a power supply.

4. The system of claim 1, wherein the nanomaterial is chemically assembled.

5. The system of claim 1, wherein the nanomaterial is designed via a bottom-up design.

6. A kit comprising the system of claim 1.

7. A method of interfacing the system of claim 1 with a pharmaceutical manufacturing process said method comprising,

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

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

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

8. The method of claim 7, wherein said system comprises an is optically enhanced nanomaterial.

9. The method of claim 7, 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.

10. The method of claim 7, wherein the device is a tablet press or powder blending device.

11. The method of claim 7, wherein the pharmaceutical manufacturing process is selected from the group consisting of crystallization, product isolation, product purification, product polishing, and chromatography.

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