Methods of Making Pharmaceutical Components for Customized Drug Products

• US 20100015184A1
• Filed: 12/13/2007
• Published: 01/21/2010
• Est. Priority Date: 12/13/2006
• Status: Abandoned Application

• Current Assignee: Stephen M. Tuel
• Original Assignee: Stephen M. Tuel
• Inventors: Tuel, Stephen M.
• Application Number:
  US12/518,311
• Publication Number:
  US 20100015184A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61K 9/00 Medicinal preparations characterised by special physical form nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/04 Manufacturing
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: Y02P 90/30 Computing systems specially adapted for manufacturing

Abstract

Methods and systems for developing and manufacturing componentized drug product precursor modules that can be simply assembled to create customized drug products are disclosed. Each module contains components of a final drug product (e.g., active pharmaceutical ingredients, nutritional ingredients, and/or excipients) in a fixed mixture selected to maximize desired pharmaceutical characteristics (e.g., stability, manufacturing efficiency) and minimize cost. The modules can be extensively tested for quality and assembled immediately, or at a later time, in multiple combinations to customize the final drug product characteristics (e.g., multiple active ingredients, doses, flavor, viscosity, etc.) to meet individual patient/consumer needs and/or preferences while assuring high quality. Permitted combinations may be maintained in a database to enable networked drug product selection, prescribing, and ordering. Each resulting customized drug product dose can be labeled to facilitate compliance and reduce the number of drug products administered per day.

Claims

1. A method for manufacturing a final drug product, comprising:

selecting a first API module comprising

at least one first active pharmaceutical ingredient and

at least one first excipient;

determining a number of the first API module;

choosing a first excipient module comprising

at least one second excipient;

determining a number of the first excipient module; and

combining the number of the first API module and the number of the first excipient module to manufacture the final drug product.

2. The method of claim 1, wherein:

the number of the first API module is greater than one.

3. The method of claim 2, wherein:

the number of the first API module is greater than five.

4. The method of claim 1, implemented by computer-executable instructions stored on one or more computer-readable media.

5. The method of claim 1, further comprising:

selecting a second API module comprising

at least one second active pharmaceutical ingredient and

at least one third excipient;

determining a number of the second API module;

combining the number of the second API module with the number of the first API module and the number of the first excipient module to manufacture the final drug product.

6. The method of claim 5, further comprising:

selecting a second excipient module comprising

at least one fourth excipient;

determining a number of the second excipient module; and

combining the number of the second excipient module with the number of the second API module, the number of the first API module, and the number of the first excipient module to manufacture the final drug product.

7. The method of claim 5, implemented by computer-executable instructions stored on one or more computer-readable media.

8. A final drug product, made by a process comprising:

combining at least one API module comprising at least one active pharmaceutical ingredient, and at least one excipient module, to make the final drug product;

wherein the at least one active pharmaceutical ingredient is present in the final drug product in an amount effective for treating at least one disease, at least one disorder, at least one condition, or a combination thereof, in at least one human or animal patient in need thereof.

9. A final drug package, comprising:

at least one API module, which comprises

at least one first excipient, and

at least one active pharmaceutical ingredient; and

at least one excipient module, which comprises

at least one second excipient;

wherein the at least one second excipient is compatible with the at least one active pharmaceutical ingredient;

wherein the at least one active pharmaceutical ingredient is present in the final drug package in an amount effective for treating at least one disease, at least one disorder, at least one condition, or a combination thereof, in at least one human or animal patient in need thereof; and

wherein the at least one API module and the at least one excipient module are adapted to form a final drug product.

10. An API module, comprising:

at least one excipient in a first fixed amount, and

at least one active pharmaceutical ingredient in a second fixed amount of at least a dose escalation interval or a fraction thereof.

11. The API module of claim 10, wherein the second fixed amount is greater than the dose escalation interval.

12. The API module of claim 10, wherein the second fixed amount is less than a dose of the at least one active pharmaceutical ingredient.

13. The API module of claim 12, wherein the second fixed amount is less than the minimum dose of the at least one active pharmaceutical ingredient.

14. The API module of claim 13, wherein the second fixed amount is less than about 80% of the minimum dose of the at least one active pharmaceutical ingredient.

15. An excipient module, comprising:

at least one first excipient in a first fixed amount; and

at least one second excipient in a second fixed amount;

wherein the at least one first excipient and the at least one second excipient are compatible with at least one active pharmaceutical ingredient.

16. The excipient module of claim 15, wherein the at least one first excipient and the at least one second excipient are compatible with two or more active pharmaceutical ingredients.

17. A system for manufacturing at least one final drug product, at least one final drug package, or both, comprising:

at least one API module portfolio comprising a plurality of different API modules; and

at least one excipient module portfolio comprising a plurality of different excipient modules;

wherein the at least one API module portfolio and the at least one excipient module portfolio are operatively connected to manufacture the at least one final drug product, the at least one final drug package, or both.

18. The system of claim 17, further comprising one or more means for storing compatibility information for at least one API module and at least one excipient module.

19. A computer-readable medium having computer executable components implementable in a system operable to manufacture at least one final drug product, at least one final drug package, or both, comprising:

a computer-executable component for providing one or more of compatibility information, dose information, and dose escalation interval information for at least one API module; and

a computer-executable component for providing compatibility information for at least one excipient module.