System and methods for the production of personalized drug products

• US 10,189,616 B2
• Filed: 08/15/2011
• Issued: 01/29/2019
• Est. Priority Date: 08/13/2010
• Status: Active Grant

• Current Assignee: Daniel L. Kraft
• Original Assignee: Daniel L. Kraft
• Inventors: Kraft, Daniel L.
• Primary Examiner(s): Ng, Jonathan
• Assistant Examiner(s): Lultschik, William G
• Application Number:
  US13/210,333
• Publication Number:
  US 20120041778A1
• Time in Patent Office: 2,724 Days
• Field of Search: None
• CPC Class Codes: A61J 1/03 for pills or tablets containers for pills or tablets with special dispensing means therefor B65D83/04
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: B65D 51/2828 said element being a film or a foil B65D51/2821, B65D51/2842 take precedence
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A system and method for determining an optimal combination drug product for a particular patient includes a processor that receives patient information and determines an optimal combination drug product based on the received information. A system which can provide information regarding predicted events or pathologies based on received patient information and guidance on subsequent steps to ameliorate, treat or intervent. A drug production device includes a plurality of drug containers, each of which are coupled to a drug dispensing channel. A controller controls the dispensing of drug through each channel, and a combination drug product is produced from the dispensed drugs. A combination drug product includes a plurality of discrete units of a first drug, and a plurality of discrete units of a second drug. A transdermal patch includes a plurality of drug compartments, each containing a quantity of drug product, and a controller for controlling the release of drugs from each compartment. Feedback loop elements can enable iterations to optimized personalized doses.

Claims

1. A system for producing a drug product for an individual patient, comprising:

a computer processor configured to receive information relating to the patient and to predict, based on the received patient information, an optimal drug selection, combination drug product comprising a plurality of discrete units of a first drug and a plurality of discrete units of a second drug, and dosage for the patient; and

a drug production device, in communication with the processor, for producing the drug product based on the predicted optimal drug selection, combination drug product, and dosage, wherein the drug production device comprises;

a plurality of drug containers, each configured to hold a quantity of a drug in the form of microtablets, each microtablet containing an equal sized dose of a particular drug, each microtablet being coated so as to enable drugs of different pH to be in close locality without interaction of components of the combination drug product, and each having a unique coupling element to couple the drug container to the drug production device;

a plurality of drug dispensers, each of said drug dispensers coupled to one of said drug containers;

a supply of empty ingestible capsules;

a controller, which controls dispensing by count of said microtablets of a drug by each drug dispenser into the ingestible capsules;

a verification unit including a scanner for scanning identifying indicia provided on the drug containers and comparing the indicia to the predicted optimal drug selection and combination drug product, wherein the combination drug product comprises at least a first coated microtablet of a first drug and a second coated microtablet of a second drug, wherein the second drug is distinct from the first drug, in a closed unitary ingestible capsule package customized for the patient produced from selected dispensed drugs, wherein the patient information includes information selected from (1) at least one of the group consisting of;

weight;

age;

sex;

BSA (body surface area);

body mass index;

lean body mass, percentage body fat, metabolism;

renal function;

liver enzymes;

proteomics/biomarkers, blood chemistries, pharmacokinetics;

risk factors for disease;

partial or full genome SNP screening data;

whole or partial genome analysis;

vitamin deficiencies;

vitamin and micronutrient levels;

diet;

environmental, toxin or other allergy history;

the patient'"'"'s medical history;

diagnostic information;

exercise activity;

sleep activities;

tissue expression profiling;

hormonal cycles, biomarker information;

radiologic/imaging information, demographic information;

monthly reproductive cycle;

geolocation, social network, consumer information, habits, physiologic data, electroencephalogram (EEG) recordings, behavioral history, geographic history, exposures or potential exposures to toxins and other environmental factors including exposure to radiation, compliance history and personality testing from body measurement devices, and (2) at least one of the group consisting of current medications;

other medications/supplements;

history of prior side effects to one or more medications;

analysis of pharmacogenomic and/or pharmacogenetic profile;

drug-drug interaction information;

drug-diet interaction information; and

drug allergies and/or sensitivities; and

a conveyor for moving an ingestible capsule to successive drug dispensers, wherein a determined quantity of each drug is dispensed into the ingestible capsule from each drug dispenser.

2. The system of claim 1, wherein the biomarker information comprises information obtained from the at least one of the group consisting of the patient'"'"'s blood, urine, sweat, saliva, body tissue, biopsy or bodily fluid.

3. The system of claim 1, wherein the processor further receives reference information and predicts the optimal drug selection, combination drug product, and dosage for the patient based on the received patient information and reference information.

4. The system of claim 1, further comprising an external measurement device, said external measurement device being configured to measure at least one element of patient information, and to transmit said measured element of patient information to the processor.

5. The system of claim 1, further comprising a database configured to store a plurality of categories of information that relates patient information to optimal dosages of different drugs, and said processor predicts an optimal drug selection, combination drug product, and dosage for the patient by comparing the received patient information with the information stored in the database.

6. The system of claim 1, wherein the predicted optimal drug selection, combination drug product, and dosage is output to a display.

7. The system of claim 1, wherein the processor is housed within the drug production device.

8. The system of claim 1, wherein the predicted optimal drug selection, combination drug product, and dosage is transmitted to the patient'"'"'s electronic medical record.

9. The system of claim 1, wherein the predicted optimal drug selection, combination drug product, and dosage is transmitted to a pharmacy.

10. The system of claim 1, wherein the processor is configured to communicate with the drug production device over a wireless network.

11. The system of claim 1, wherein the processor further receives patient feedback information and predicts the optimal drug selection, combination drug product, and dosage for the patient based on the received patient information and the patient feedback information.

12. The system of claim 1, wherein said combination drug product is produced based on information received from a processor relating to a predicted optimal drug selection, combination drug product, and dosage.

13. The system of claim 1, wherein each of said drug dispensers are coupled to one another.

14. The system of claim 1, wherein the microtablets are colored.

15. The system of claim 1, wherein the microtablets are patterned.

16. A method for producing a custom, optimal combination drug product for an individual patient, comprising:

receiving, by a processor, information relating to the patient;

predicting, by the processor, an optimal drug selection, combination drug product comprising a plurality of discrete units of a first drug and a plurality of discrete units of a second drug, and dosage for the patient, based on said received patient information;

outputting the predicted optimal drug selection, combination drug product, and dosage for the particular patient to a drug production device which comprises;

a plurality of drug containers, each configured to hold a quantity of a drug in the form of microtablets, each microtablet containing an equal sized dose of a particular drug, each microtablet being coated so as to enable drugs of different pH to be in close locality without interaction of components of the combination drug product, and each drug container having a unique coupling element to couple the drug container to the drug production device;

a plurality of drug dispensers, each of said drug dispensers coupled to one of said drug containers;

a supply of empty ingestible capsules;

a controller, which controls dispensing by count of said microtablets of a selected drug or drugs by each drug dispenser into the ingestible capsules;

a conveyor for moving an ingestible capsule to successive drug dispensers, wherein a determined quantity of each drug is dispensed into the ingestible capsule from each drug dispenser; and

a verification unit including a scanner for scanning identifying indicia provided on the drug containers and comparing the indicia to the predicted optimal drug selection and combination drug product,

dispensing a controlled amount of selected drugs comprising at least a first coated microtablet of a first drug and a second coated microtablet of a second drug, wherein the second drug is distinct from the first drug, via the controller, into an empty ingestible capsule,

closing the capsule using the drug production device to produce a closed unitary ingestible capsule package comprising the combination drug product customized for said individual patient, wherein the patient information includes information selected from (1) at least one of the group consisting of;

weight;

age;

sex;

BSA (body surface area);

body mass index;

lean body mass, percentage body fat, metabolism;

renal function;

liver enzymes;

proteomics/biomarkers, blood chemistries, pharmacokinetics;

risk factors for disease;

partial or full genome SNP screening data;

whole or partial genome analysis;

vitamin deficiencies;

vitamin and micronutrient levels;

diet;

environmental, toxin or other allergy history;

the patient'"'"'s medical history;

diagnostic information;

exercise activity;

sleep activities;

tissue expression profiling;

hormonal cycles, biomarker information;

radiologic/imaging information, demographic information;

monthly reproductive cycle;

geolocation, social network, consumer information, habits, physiologic data, electroencephalogram (EEG) recordings, behavioral history, geographic history, exposures or potential exposures to toxins and other environmental factors including exposure to radiation, compliance history and personality testing from body measurement devices, and (2) at least one of the group consisting of current medications;

other medications/supplements;

history of prior side effects to one or more medications;

analysis of pharmacogenomic and/or pharmacogenetic profile;

drug-drug interaction information;

drug-diet interaction information; and

drug allergies and/or sensitivities.

17. The method of claim 16, wherein the biomarker information comprises information obtained from the at least one of the patient'"'"'s blood, urine, sweat, saliva, body tissue, biopsy or bodily fluid.

18. The method of claim 16, wherein at least a portion of said received patient information is received from an external measurement device, said device being configured to measure at least one element of patient information, and to transmit said measured element of patient information to the processor.

19. The method of claim 16, wherein at least a portion of said received patient information includes patient-reported information relating to the severity of symptoms and/or side effects.

20. The method of claim 16, wherein said processor predicts the optimal drug selection, combination drug product, and dosage by comparing the received patient information with information stored in a database that relates patient information to optimal dosages of different drugs.

21. The method of claim 16, further comprising:

outputting the predicted optimal drug selection, combination drug product, and dosage to a display.

22. The method of claim 16, wherein the processor is housed within the drug production device.

23. The method of claim 16, further comprising:

transmitting the predicted optimal drug selection, combination drug product, and dosage to the patient'"'"'s electronic medical record.

24. The method of claim 16, wherein the processor is configured to communicate with the drug production device over a wireless network.

25. The method of claim 16, wherein the microtablets are colored.

26. The method of claim 16, wherein the microtablets are patterned.

27. A non-transitory computer readable medium containing instructions to cause a computing device to perform a method comprising:

receiving, by a processor, information relating to a patient;

predicting, by the processor, an optimal drug selection, combination drug product comprising a plurality of discrete units of a first drug and a plurality of discrete units of a second drug, and dosage for said patient, based on said received patient information;

outputting the predicted optimal drug selection, combination drug product, and dosage for the particular patient to a drug production device which comprises;

a plurality of drug containers, each configured to hold a quantity of a drug in the form of microtablets containing equally sized doses of a particular drug, each microtablet being coated so as to enable drugs of different pH to be in close locality without interaction of components of the combination drug product, and each drug container having a unique coupling element to couple the drug container to the drug production device;

a plurality of drug dispensers, each of said drug dispensers coupled to one of said drug containers;

a supply of empty ingestible capsules;

a controller, which controls dispensing by count of said microtablets of a selected drug or drugs by each drug dispenser into the ingestible capsules;

a conveyor for moving an ingestible capsule to successive drug dispensers, wherein a determined quantity of each drug is dispensed into the ingestible capsule from each drug dispenser, and

a verification unit including a scanner for scanning identifying indicia provided on the drug containers and comparing the indicia to the predicted optimal drug selection and combination drug product,

dispensing a controlled amount of selected drugs comprising at least a first coated microtablet of a first drug and a second coated microtablet of a second drug, wherein the second drug is distinct from the first drug, via the controller, into an unfilled ingestible capsule, and

closing the capsule using the drug production device to produce a closed unitary ingestible capsule package comprising the combination drug product customized for said individual patient, wherein the patient information includes information selected from (1) at least one of the group consisting of;

weight;

age;

sex;

BSA (body surface area);

body mass index;

lean body mass, percentage body fat, metabolism;

renal function;

liver enzymes;

proteomics/biomarkers, blood chemistries, pharmacokinetics;

risk factors for disease;

partial or full genome SNP screening data;

whole or partial genome analysis;

vitamin deficiencies;

vitamin and micronutrient levels;

diet;

environmental, toxin or other allergy history;

the patient'"'"'s medical history;

diagnostic information;

exercise activity;

sleep activities;

tissue expression profiling;

hormonal cycles, biomarker information;

radiologic/imaging information, demographic information;

monthly reproductive cycle;

geolocation, social network, consumer information, habits, physiologic data, electroencephalogram (EEG) recordings, behavioral history, geographic history, exposures or potential exposures to toxins and other environmental factors including exposure to radiation, compliance history and personality testing from body measurement devices, and (2) at least one of the group consisting of current medications;

other medications/supplements;

history of prior side effects to one or more medications;

analysis of pharmacogenomic and/or pharmacogenetic profile;

drug-drug interaction information;

drug-diet interaction information; and

drug allergies and/or sensitivities.

28. The non-transitory computer readable medium of claim 27, wherein the biomarker information comprises information obtained from at least one of the patient'"'"'s blood, urine, sweat, saliva, body tissue, biopsy or bodily fluid.

29. The non-transitory computer readable medium of claim 27, wherein at least a portion of said received patient information is received from an external measurement device, said device being configured to measure at least one element of patient information, and to transmit said measured clement of patient information to the processor.

30. The non-transitory computer readable medium of claim 27, further comprising second program instructions, wherein said processor predicts the optimal drug selection, combination drug product, and dosage by comparing the received patient information with information stored in a database that relates patient information to optimal dosages of different drugs.

31. The non-transitory computer readable medium of claim 27, further comprising third program instructions for outputting the predicted optimal drug selection, combination drug product, and dosage to a display.

32. The non-transitory computer readable medium of claim 27, wherein the processor is housed within the drug production device.

33. The non-transitory computer readable medium of claim 27, further comprising fourth program instructions for transmitting the predicted optimal drug selection, combination drug product, and dosage to the patient'"'"'s electronic medical record.

34. The non-transitory computer readable medium of claim 27, wherein the processor is configured to communicate with the drug production device over a wireless network.

35. The non-transitory computer readable medium of claim 27, wherein the microtablets are colored.

36. The non-transitory computer readable medium of claim 27, wherein the microtablets are patterned.