# US 2016/0256384 A1 · Dosage form articles

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- Number: US 2016/0256384 A1
- Document ID: US20160256384A1
- Status: Published application
- Kind: A1
- Application number: 15/032,601
- Filed: 2014-12-03
- Published: 2016-09-08
- Earliest claimed: 2013-12-03
- Assignees: Capsugel Belgium NV
- Applicants: Capsugel Belgium NV
- Inventors: Hilde Buydts; Stefaan Jaak Vanquickenborne
- Web page: https://patentgrep.com/patent/US20160256384A1

## CPC

- G16H 20/13: delivered from dispensers
- A61J 7/04: Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
- A61K 9/0009: {involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis}
- 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 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- G08B 21/24: Reminder alarms, e.g. anti-loss alarms
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- 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
- 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)
- G08B: SIGNALLING SYSTEMS, e.g. PERSONAL CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS

## Abstract

A dosage form article suitable for oral administration may include more than one compartment, each formed by a plurality of distinct segments of the dosage form article. The dosage form article may also include a signaling means and a drug, wherein the signaling means and the drug are each stored in different compartments physically separated from one another. Both the drug and the signaling means may be wholly incorporated within the dosage form article, the respective compartments being arranged to fully enclose the drug and signaling means only when at least two of the plurality of distinct segments are connected.

## Claims

### Claim 1

A dosage form article suitable for oral administration, comprising more than one compartment each formed by a plurality of distinct segments of the dosage form article, said dosage form article comprising a signaling means and a drug, wherein said signaling means and said drug are each stored in different compartments physically separated from one another, and wherein both said drug and said signaling means are wholly incorporated within said dosage form article, each respective compartment being arranged to fully enclose said drug or signaling means only when at least two of said plurality of distinct segments are connected, wherein each said distinct segment consists of a cap part or a body part and said cap and/or body parts are hard capsule shells.

### Claim 2 (depends on 1)

A dosage form article according to claim 1, wherein at least a portion of the dosage form article is translucent such that the signaling means is visible through said dosage form.

### Claim 3 (depends on 1)

A dosage form article according to claim 1, wherein the compartment storing the signaling means and the compartment storing the drug have different dissolution properties, wherein the compartment storing said signaling means is arranged to disintegrate faster than the compartment storing the drug.

### Claim 4 (depends on 1)

A dosage form article according to claim 1, wherein the dosage form article comprises:
at least one first body part and at least one first cap part, wherein said first body and cap parts are telescopically engageable to provide a first compartment; and
at least one second body part and at least one second cap part, wherein said second body and cap parts are telescopically engageable to provide a second compartment;
wherein said second compartment is stored within said first compartment, the signaling means being stored within the first or second compartment and the drug being stored within the first or second compartment, and wherein said signaling means and said drug are stored in different compartments.

### Claim 5 (depends on 4)

A dosage form article according to claim 4, wherein the signaling means is stored within the first compartment and the drug is stored within the second compartment, wherein the first body and/or cap parts are translucent such that the signaling means may be seen through the first compartment.

### Claim 6 (depends on 1)

A dosage form article according to claim 1, wherein the dosage form article comprises:
at least one first body part and at least one first cap part, wherein said first body and cap parts are telescopically engageable; and
at least one second body or cap part telescopically engageable with said at least one first body or cap parts or both, to provide one or more compartments.

### Claim 7 (depends on 6)

A dosage form article according to claim 6, wherein the second cap or body part is solely telescopically engageable with the first body part or first cap part.

### Claim 8 (depends on 6)

A dosage form article according to claims 6, wherein the second body part is telescopically engageable with the first body part, or the second cap part is telescopically engageable with the first cap part.

### Claim 9 (depends on 6)

A dosage form article according to claims 6, wherein a first compartment is formed between the first body part and second body part, or first cap part and second cap part, for storing the signaling means therein, and wherein a second compartment is formed between the second body part and the first cap part, or first cap part and first body part, for storing the drug therein.

### Claim 10 (depends on 9)

A dosage form article according to claim 9, wherein the first body part or second cap part is translucent such that the signaling means can be seen through said first body part or second cap part.

### Claim 11 (depends on 9)

A dosage form article according to claim 9, wherein the second body part is translucent such that the signaling means can be seen through said second body part or second cap part.

### Claim 12 (depends on 1)

A dosage form article according to claim 1, wherein the signaling means is selected from the group consisting of an ingestible passive micro-electronic system; ingestible indicia; and combinations thereof.

### Claim 13

A method for the automatic prompting of a subject to take a medicament, the method comprising the steps of:
providing a portable communication device arranged to provide a warning selected from visual, sound, and combinations thereof, to a subject when it is time to ingest a medicament;
providing a dosage form according to any of the preceding claims;
providing a receiver capable of detecting a signal generated by the signaling means, the receiver being arranged to provide a further signal to a processing device, the processing device capable of recording said further signal and to instruct the communication device to stop providing said warning; and
allowing said receiver to detect said signaling means;
wherein said warning is de-activated only when the subject places said receiver proximal to said dosage form, and the signaling means stored therein is detected, typically wherein the signaling means is detected by the receiver only after the dosage form article is ingested.

### Claim 14

A method for determining whether it is safe to ingest a medicament comprising the steps of:
providing a dosage form according to any of the preceding claims;
comparing a signal received by the signaling means to a predetermined scale to instruct a subject whether he should or should not ingest said dosage form.

### Claim 15

(canceled)

### Claim 16

A dosage form comprising:
an article suitable for oral administration, the article having
a plurality of compartments each formed by a plurality of distinct segments of the article;
a signal emitter; and
a drug, wherein the signal emitter and the drug are each stored in different compartments physically separated from one another, and wherein both the drug and the signal emitter are wholly incorporated within the dosage form article, each respective compartment being arranged to fully enclose the drug or signal emitter only when at least two of the plurality of distinct segments are connected, wherein each distinct segment includes of a cap part or a body part and the cap and/or body parts are hard capsule shells.
