# US 2019/0167595 A1 · Compositions of pharmaceutical product with ingestible event marker

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- Number: US 2019/0167595 A1
- Document ID: US20190167595A1
- Status: Published application
- Kind: A1
- Application number: 16/170,418
- Filed: 2018-10-25
- Published: 2019-06-06
- Earliest claimed: 2016-04-25
- Assignees: Otsuka Pharmaceutical Co., Ltd.
- Applicants: Otsuka Pharmaceutical Co., Ltd.
- Inventors: Mark ZDEBLICK; Markus CHRISTEN; Nikhil PARGAONKAR; Nikolaus LEIST; Kurt SCHEINPFLUG; Patricia JOHNSON; Benedict COSTELLO
- Web page: https://patentgrep.com/patent/US20190167595A1

## CPC

- A61K 9/2009: {Inorganic compounds}
- A61B 5/07: Endoradiosondes
- A61J 3/06: into the form of pills, lozenges or dragees
- A61J 7/00: Devices for administering medicines orally, e.g. spoons (calibrated capacity measures for fluids or fluent solid material G01F19/00; weighing spoons G01G19/56); Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 49/00: Preparations for testing in vivo
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

In some embodiments, a composition of matter includes aripiprazole, a metal selected from the group consisting of magnesium, zinc, sodium, lithium, iron, or alloys thereof, or combinations thereof and a copper salt selected from the group consisting of copper iodide, copper chloride, copper bromide, copper sulfate, copper formate, or combinations thereof.

## Claims

### Claim 1

A composition of matter for the ingestible administration of aripiprazole, the composition comprising:
aripiprazole;
a metal selected from the group consisting of magnesium, zinc, sodium, lithium, iron, or alloys thereof, or combinations thereof; and
a copper salt selected from the group consisting of copper iodide, copper chloride, copper bromide, copper sulfate, copper formate, or combinations thereof.

### Claim 2 (depends on 1)

The composition of claim 1, further comprising an iron salt selected from the group consisting of iron(III) phosphate, iron(III) pyrophosphate, and combinations thereof.

### Claim 3 (depends on 1)

The composition of claim 1, further comprising an element selected from the group consisting of Au, Ti, TiW, or Cr, or combinations thereof.

### Claim 4 (depends on 3)

The composition of claim 3, comprising an adhesion layer comprising Au, Ti, TiW, or Cr, wherein the adhesive layer has a thickness from 50 Å to 100 Å and up to 1 μm.

### Claim 5 (depends on 1)

The composition of claim 1, further comprising silicon.

### Claim 6 (depends on 5)

The composition of claim 5, further comprising 0.09-0.9 mg of Si.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the copper salt comprises 0.02-0.2 mg of Cu.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the metal comprises 0.001-0.01 mg of Mg.

### Claim 9 (depends on 1)

The composition of claim 1, further comprising oxygen dissolved in a conducting fluid and reduced to OH— at a catalytic surface.

### Claim 10 (depends on 1)

The composition of claim 1, further comprising dissolved hydrogen in a hydrogen reduction reaction.

### Claim 11 (depends on 1)

The composition of claim 1, further comprising an intercalation compound.

### Claim 12 (depends on 11)

The composition of claim 11, wherein the intercalation compound comprises graphite intercalated with an element selected from the group consisting of lithium, potassium, calcium, sodium, magnesium, and combinations thereof.

### Claim 13 (depends on 1)

The composition of claim 1, further comprising vanadium oxide or manganese oxide.

### Claim 14 (depends on 1)

The composition of claim 1, comprising 2-30 mg of aripiprazole.

### Claim 15 (depends on 1)

The composition of claim 1, comprising 2 mg aripiprazole.

### Claim 16 (depends on 1)

The composition of claim 1, comprising 5 mg aripiprazole.

### Claim 17 (depends on 1)

The composition of claim 1, comprising 10 mg aripiprazole.

### Claim 18 (depends on 1)

The composition of claim 1, comprising 15 mg aripiprazole.

### Claim 19 (depends on 15, 16)

The composition of any of claims 15, 16, and 18, having a weight of 94.1-104 mg.

### Claim 20 (depends on 15, 16)

The composition of any of claims 15, 16, and 18, having a weight of 99 mg.

### Claim 21 (depends on 15, 16)

The composition of any of claims 15, 16, and 18, having a disintegration time of not more than 5 minutes.

### Claim 22 (depends on 1)

The composition of claim 1, comprising 20 mg aripiprazole.

### Claim 23 (depends on 22)

The composition of claim 22, having a weight of 184.3-203.7 mg.

### Claim 24 (depends on 22)

The composition of claim 22, having a weight of 194 mg.

### Claim 25 (depends on 1)

The composition of claim 1, comprising 30 mg aripiprazole.

### Claim 26 (depends on 25)

The composition of claim 25, having a weight of 274.6-303.5 mg.

### Claim 27 (depends on 25)

The composition of claim 25, having a weight of 289 mg.

### Claim 28 (depends on 22, 25)

The composition of claim 22 or 25, having a disintegration time of not more than 7 minutes.

### Claim 29 (depends on 1)

The composition of claim 1, wherein the composition is in the form of a tablet.

### Claim 30 (depends on 29)

The composition of claim 29, wherein the tablet has a rectangular shape.

### Claim 31 (depends on 30)

The composition of claim 30, wherein the tablet has a size of 4.5 mm×8 mm.

### Claim 32 (depends on 29)

The composition of claim 29, wherein the tablet has a round shape.

### Claim 33 (depends on 32)

The composition of claim 32, wherein the tablet has a diameter of 6-9 mm.

### Claim 34 (depends on 32)

The composition of claim 32, wherein the tablet has a diameter of 6 mm.

### Claim 35 (depends on 32)

The composition of claim 32, wherein the tablet has a diameter of 7.8 mm.

### Claim 36 (depends on 32)

The composition of claim 32, wherein the tablet has a diameter of 9 mm.

### Claim 37 (depends on 29)

The composition of claim 29, wherein the tablet has a thickness of 2.59-4.24 mm.

### Claim 38 (depends on 29)

The composition of claim 29, wherein the tablet has a thickness of 2.59-2.81 mm.

### Claim 39 (depends on 29)

The composition of claim 29, wherein the tablet has a thickness of 2.73-3.03 mm.

### Claim 40 (depends on 29)

The composition of claim 29, wherein the tablet has a thickness of 3.35-3.61 mm.

### Claim 41 (depends on 29)

The composition of claim 29, wherein the tablet has a thickness of 3.88-4.24 mm.

### Claim 42 (depends on 29)

The composition of claim 29, having a hardness of 4-11.2 kp.

### Claim 43 (depends on 29)

The composition of claim 29, having a hardness of 4-6 kp.

### Claim 44 (depends on 29)

The composition of claim 29, having a hardness of 5 kp.

### Claim 45 (depends on 29)

The composition of claim 29, having a hardness of 5.7-8.6 kp.

### Claim 46 (depends on 29)

The composition of claim 29, having a hardness of 7.1 kp.

### Claim 47 (depends on 29)

The composition of claim 29, having a hardness of 7.4-11.2 kp.

### Claim 48 (depends on 29)

The composition of claim 29, having a hardness of 9.3 kp.

### Claim 49 (depends on 29)

The composition of claim 29, having a friability of 0.06-0.11%.

### Claim 50

An apparatus, comprising:
an active agent comprising aripiprazole;
a substrate with a first surface and a second surface;
a partial power source comprising
a first material provided on the first surface of the substrate, wherein the first material is selected from the group consisting of magnesium, zinc, sodium, lithium, iron, and alloys thereof, an intercalation compound, vanadium oxide, manganese oxide, and combinations thereof, and
a second material provided on the second surface of the substrate, wherein the second material is selected from copper iodide, copper chloride, copper bromide, copper sulfate, copper formate, iron(III) phosphate, iron(III) pyrophosphate, oxygen, hydrogen, vanadium oxide, manganese oxide, and combinations thereof,
wherein the partial power source is configured to generate power upon contact of the first material and the second material with a fluid; and
a control unit electronically coupled with the partial power source, wherein the control unit is configured to be activated by receiving the power from the partial power source and to encode information in a current flow through the fluid.

### Claim 51

A composition of matter for the ingestible administration of aripiprazole, the composition comprising:
aripiprazole; and
silicon having a mass equivalent to a silicon substrate having dimensions of between 0.2×0.2×0.2 mm (0.008 mm3) and 0.3×0.3×0.3 mm (0.027 mm3).

### Claim 52 (depends on 51)

The composition of matter of claim 51, further comprising:
a metal selected from the group consisting of magnesium, zinc, sodium, lithium, iron, or alloys thereof, or combinations thereof; and
a copper salt selected from the group consisting of copper iodide, copper chloride, copper bromide, copper sulfate, copper formate, or combinations thereof.