Method and apparatus for compouding individualized dosege forms

• US 20040172169A1
• Filed: 04/23/2004
• Published: 09/02/2004
• Est. Priority Date: 03/02/2001
• Status: Abandoned Application

• Current Assignee: Euroceltique SA
• Original Assignee: Euroceltique SA
• Inventors: Wright, Curtis IV, Oshlack, Benjamin
• Application Number:
  US10/469,799
• Publication Number:
  US 20040172169A1
• Time in Patent Office: Days
• US Class Current: 700/265
• CPC Class Codes: A61J 2200/74 for weight
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61J 3/10 into the form of compressed tablets tablet presses B30B11/00
• CPC Class Codes: A61K 9/1617 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00

Abstract

The present invention provides a computer-controlled apparatus 5 and method for compounding individualized dosage forms to fill an individual patient prescription. The apparatus 5 includes a dosing unit 30 and an automated compounder 25 for compounding bulk drugs 10 into dosage forms. The apparatus 5 may also include integrated quality assurance devices 45. This method and apparatus 5 allows a pharmacist to compound dosage forms having individualized release characteristics or unique combinations of drugs that are not commercially available.

Claims

1. An apparatus for compounding drugs into a dosage form to fill an individual patient prescription comprising:

a central computer for receiving an individual patient prescription;

a plurality of containers for storing bulk drugs;

a dosing unit coupled to the central computer; and

an automated compounder controlled by the central computer and connected to the dosing unit for compounding one or more of the bulk drugs into a dosage form for the individual patient prescription wherein the dosing unit transfers the bulk drugs to the automated compounder.

2. The apparatus of claim 1 wherein the bulk drug is a bulk drug product or bulk drug intermediate.

3. The apparatus of claim 1 wherein the bulk drugs have immediate, delayed, sustained, or controlled release characteristics.

4. The apparatus of claim 1 wherein the bulk drug is in the form of pharmaceutical granulations or micro-particulates for immediate or controlled release.

5. The apparatus of claim 1 wherein the dosage form is a capsule or tablet.

6. The apparatus of claim 1 further comprising an input device for receiving the individual patient prescription and transmitting the prescription to the central computer via an input interface.

7. The apparatus of claim 6 wherein the input device is a pharmacy computer.

8. The apparatus of claim 6 wherein the input device includes a self-testing means for testing the operation of the apparatus prior to use thereof.

9. The apparatus of claim 1 wherein the automated compounder is a tableter or a capsule filler.

10. The apparatus of claim 1 wherein the dosing unit measures and dispenses the bulk drugs.

11. The apparatus of claim 10 further comprising a raw materials sensor connected to the dosing unit for verifying that the position of the containers in the dosing unit and identity of the bulk drugs in the containers are correct before the bulk drugs are measured and dispensed.

12. The apparatus of claim 10 further comprising a manufacturing sensor connected to the dosing unit for verifying that the right amounts of the bulk drugs were dispensed.

13. The apparatus of claim 1 further comprising a quality assurance device coupled to the compounder for performing a quality assurance test to verify the chemical identity of the dosage form in order to accept or reject the dosage form.

14. The apparatus of claim 13 further comprising a counter attached to the quality assurance device and coupled to the central computer for counting the accepted dosage form.

15. The apparatus of claim 13 further comprising a storage unit coupled to the quality assurance device for electronic storage of manufacturing records for the dosage form.

16. The apparatus of claim 1 further comprising an output device for receiving and storing prescription information from the central computer via an output interface.

17. The apparatus of claim 16 wherein the output device is a computer for generating individual bills.

18. The apparatus of claim 16 wherein the output device is a printer for printing labels to place on a vial for an individual patient prescription.

19. The apparatus of claim 1 wherein the apparatus is desktop sized.

20. A method of compounding a dosage form for an individual patient prescription using an apparatus comprising:

receiving and storing an individual patient prescription at a central computer;

transferring one or more bulk drugs needed for the individual patient prescription to an automated compounder;

transmitting an instruction from the central computer to an automated compounder to compound the bulk drugs into a dosage form;

receiving an instruction from the central computer at the automated compounder to compound the bulk drugs; and

compounding the bulk drugs in the automated compounder.

21. The method of claim 20 further comprising:

transmitting a message to the central computer from the automated compounder that the bulk drugs were compounded into a dosage form.

22. The method of claim 20 wherein the bulk drug is a bulk drug product or bulk drug intermediate.

23. The method of claim 20 wherein the bulk drugs are immediate, delayed, sustained, or controlled release formulations.

24. The method of claim 20 wherein the bulk drug is in the form of pharmaceutical granulations or micro-particulates for immediate or controlled release.

25. The method of claim 20 wherein the bulk drugs are compounded to form a dosage form having individualized release characteristics.

26. The method of claim 20 wherein the dosage form is a capsule or tablet.

27. The method of claim 20 further comprising performing a self-test of the operation of the apparatus prior to use thereof.

28. The method of claim 20 further comprising cleaning the automated compounder and other areas of the apparatus where the bulk drugs and the dosage form come in contact using a cleaning excipient.

29. The method of claim 20 further comprising:

storing a plurality of containers containing bulk drugs in a dosing unit connected to the automated compounder;

transmitting an instruction from the central computer to the dosing unit to measure and dispense the bulk drugs;

receiving the instruction from the central computer at the dosing unit to measure and dispense the bulk drugs;

measuring and dispensing the bulk drugs;

transmitting a message to the central computer from the dosing unit that the bulk drugs were measured and dispensed;

receiving and storing at the central computer the message that the bulk drugs were measured and dispensed;

transmitting an instruction from the central computer to the dosing unit to transfer the measured bulk drugs to the automated compounder

receiving the instruction from the central computer at the dosing unit to transfer the bulk drugs to the automated compounder;

transferring the bulk drugs from the dosing unit to the automated compounder; and

transmitting a message from the dosing unit to the central computer that the bulk drugs have been transferred to the automated compounder.

30. The method claim 29 further comprising:

transmitting an instruction from the central computer to a manufacturing sensor to verify that the right amounts of the bulk drugs were dispensed;

receiving an instruction from the central computer at the manufacturing sensor to verify that the right amounts of the bulk drugs were dispensed;

verifying and transmitting a message to the central computer from the manufacturing sensor that the right amounts of the bulk drugs were dispensed; and

receiving and storing a message from the manufacturing sensor that the right amounts of the bulk drugs were dispensed.

31. The method of claim 29 further comprising:

transmitting an instruction from the central computer to the dosing unit to select and position the containers of the bulk drugs before the dosing unit measures and dispenses the bulk drugs;

receiving an instruction at the dosing unit from the central computer to select and position the containers of the bulk drugs;

selecting and positioning the containers of the bulk drugs in the dosing unit;

transmitting a message to the central computer that the containers were selected and positioned in the dosing unit; and

receiving and storing a message at the central computer that the containers were selected and positioned in the dosing unit.

32. The method of claim 31 further comprising:

transmitting an instruction to a raw material sensor to verify that the right containers contain the right bulk drugs and that the containers are in the right positions in the dosing unit;

receiving the instruction at the raw material sensor;

verifying and transmitting a message from the raw materials sensor to the central computer that the right containers contain the right bulk drugs and that the containers are in the right positions in the dosing unit; and

receiving and storing the message from the raw materials sensor at the central computer that the right containers contain the right bulk drugs and that the containers are in the right positions in the dosing unit.

33. The method of claim 20 further comprising:

transmitting an instruction from the central computer to a quality assurance device connected to the automated compounder to perform a quality control test to verify the chemical identity of a dosage form;

receiving the instruction from the central computer at the quality assurance device;

performing the quality control test and storing the results in the quality assurance device;

transmitting from the quality assurance device to the central computer the results of the quality control tests; and

receiving and storing in the central computer the results of the quality assurance test.

34. The method of claim 33 wherein the quality control test is mass spectrometry, near infra-red spectrometry, or optical resolution analysis.

35. The method of claim 33 further comprising:

transmitting an instruction from the central computer to the quality assurance device to accept or reject the dosage form wherein the quality assurance device discards the rejected pill or transfers the accepted pill to a counter for counting;

receiving an instruction from the central computer at the quality assurance device to accept or reject the dosage form;

transferring the accepted pill from the quality assurance device to a counter or transferring a rejected pill from the quality assurance device to a discard bin; and

transmitting a message to the central computer from the quality assurance device that the dosage form has been accepted or rejected.

36. The method of claim 33 further comprising storing electronic manufacturing records for the dosage forms in a storage unit attached to the quality assurance device.

37. The method of claim 20 further comprising transmitting the individual patient prescription data for the accepted dosage form from the central computer to an output device.

38. The method of claim 37 wherein the output device is a printer or a billing computer.