# US 10,245,323 B2 · Drug device configured for wireless communication

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- Number: US 10,245,323 B2
- Document ID: US10245323B2
- Status: Granted
- Kind: B2
- Application number: 15/987,462
- Filed: 2018-05-23
- Published: 2018-09-27
- Granted: 2019-04-02
- Earliest claimed: 2014-06-03
- Assignees: Pop Test Abuse Deterrent Technology LLC
- Applicants: Pop Test Abuse Deterrent Technology LLC
- Inventors: Randice Lisa Altschul; Neil David Theise; Razvan Andrei Ene; Myron Rapkin; Rebecca O'Brien
- Web page: https://patentgrep.com/patent/US10245323B2

## CPC

- G16H 20/13: delivered from dispensers
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/073: {Intestinal transmitters}
- A61B 5/14539: {for measuring pH}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4343: {Pregnancy and labour monitoring, e.g. for labour onset detection}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/4845: {Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0097: {Medicinal compositions released by microdevices, e.g. microelectromechanical systems [MEMS], microdevices comprising chips or microdevices on silicon}
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/30: for treating abuse or dependence
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0531: Measuring skin impedance
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 2560/0214: of power generation or supply
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3303: Using a biosensor
- A61M 2205/3306: Optical measuring means
- A61M 2205/3523: using telemetric means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8206: battery-operated
- A61M 2205/8268: Fuel storage cells
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/20: Blood composition characteristics
- A61M 2230/201: Glucose concentration
- A61M 2230/208: pH-value
- A61M 2230/50: Temperature
- A61M 2250/00: Specially adapted for animals
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/63: for local operation
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices.

## Claims

### Claim 1

A method for treatment of withdrawal from narcotics and subsequent prevention of relapse of narcotic use in a patient in need of such treatment, said method comprising:
(a) forming an ingestible drug delivery device by a device manufacturer, said ingestible drug delivery device comprising:
a capsule body comprising:
a bioactive substance module comprising a container for holding a volume and/or quantity of bioactive substance therein and a microactuator for dispensing said bioactive substance from said container to a location outside of said capsule body, wherein said bioactive substance is a composition comprising:
i) a first therapeutic agent which is a GCR antagonist, or pharmaceutically acceptable salts thereof;
ii) separated from the first therapeutic agent, at least one additional therapeutic agent(s) selected from the group consisting of opioid analgesics and combinations thereof; and
iii) at least one pharmaceutically acceptable carrier, wherein the first therapeutic agent and said at least one additional therapeutic agent(s) are each present in an amount which, in combination, is a therapeutically effective amount for treatment of withdrawal from narcotics and subsequent prevention of relapse of narcotic use in a patient in need of such treatment;
an electronics module, coupled to said bioactive substance module, said electronics module comprising a processor, a transponder and a memory, said memory configured for storing data related to said bioactive substance;
a power source coupled to said bioactive substance module and said electronics module;
(b) establishing a unique device ID in said memory by the manufacturer and setting a first flag in said memory by the manufacturer;
(c) conveying said ingestible drug delivery device to a pharmacist, the pharmacist communicating with said ingestible drug delivery device using a programming terminal to store data related to the pharmacist and a patient ID authorized to ingest said ingestible drug delivery device in said memory and to set a second flag in said memory;
(d) selecting a patient in need of treatment of withdrawal from narcotics and subsequent prevention of relapse of narcotic use;
(e) administering said at least one ingestible delivery device to the patient based on need of treatment of withdrawal from narcotics and subsequent prevention of relapse of narcotic use, the patient having a patient interface device that communicates with said ingestible drug delivery device to provide said patient ID to said ingestible drug delivery device;
(f) analyzing, by said processor, to determine:
(i) that said first flag is set;
(ii) that said second flag is set; and
(iii) that said patient ID provided by said patient interface device matches said patient ID provided by the pharmacist; and
(g) dispensing said at least one bioactive substance to the patient only if said first and second flags are set and said patient ID provided by said patient interface device matches said patient ID provided by the pharmacist and disabling the dispensing of said at least one bioactive substance if either one of said first or second flags is not set or if no match is determined by said processor between said patient ID provided by said patient interface device and said patient ID provided by the pharmacist; and
wherein subsequent to the administration, the patient withdrawal from narcotics is treated and subsequent relapse of narcotic use is prevented.

### Claim 2 (depends on 1)

The method of claim 1 wherein the second therapeutic agent is selected from the group consisting of at least one narcotic selected from the group consisting of opioid analgesics, morphine, codeine, buprenorphine, tramadol, fentany, hydromonorphone, morphine, oxycodone/naloxone, opiate, opium, acetyldihydrocodeine, alfentani, allylprodine, alphamethylfentanyl, alphaprodine, benzylmorphine, betaprodine, bezitriamide, buprenorphine, butorphanol, bremazocine, carfentan (carfentanyl), contin, dextromoramide, dextropropoxyphene, dezocine, diacetylmorphine, diamorphine, dihydrocodeine, dihydromorphine, dihydromorphone, diphenoxylate, dipipanone, enadoline, ethylketazocine, ethylmorphine, etonitazene, etorphine, fentanyl, heroin, hydrocodone, hydromorphin (hydromorphine), hydromorphone, ketazocine, ketobemidone, lefetamine, levomethadon, levomethadyl, levomethorphan, levor-phanol, loperamide, meperidine, meptazinol, methadone, methadyl, methylmorphine, morphin (morphine), nalbuphine, narcotic, nicocodeine, nicomorphine, normorphine, noscapin, ohmefentanyl, oripavine, oxycodone, oxycontin, oxymorphone, papaveretum, papaverin, pentazocine, percocet, peronine, pethidine, phenazocine, phencyclidine, pholcodine, piritramid (priitramidine), prodine, promedol, propoxyphene, remifentanil, sufentanil, tapentadol, thebaine, tilidine, tramadol, ultracet, and combinations thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the GCR antagonist is selected from the group consisting of ORG 34517, 11-(substituted phenyl)-estra-4,9-diene derivatives, and 11-(substituted phenyl)-estra-4,9-diene derivatives of formula I
wherein A is a residue of a 5- or 6-membered ring containing 2 heteroatoms which are not connected to each other and independently selected from O and S, the ring being optionally substituted with one or more halogen atoms, or A is a residue of a 5- or 6-membered ring wherein no double C—C bonds are present, containing 1 heteroatom selected from O and S, which heteroatom is connected to the phenyl group at the position indicated with an asterisk, the ring being optionally substituted with one or more halogen atoms; R1 is H or 1-oxo(1-4C)alkyl; R2 is H, (1-8C)alkyl, halogen or CF3; X is selected from (H, OH), O, and NOH; and the interrupted line represents an optional bond.

### Claim 4 (depends on 1)

The method of claim 1 wherein the GCR antagonist is ORG34517.