Dosage form articles

• US 9,980,905 B2
• Filed: 12/03/2014
• Issued: 05/29/2018
• Est. Priority Date: 12/03/2013
• Status: Active Grant

• Current Assignee: Capsugel Belgium NV (Lonza Group AG)
• Original Assignee: Capsugel Belgium NV (Lonza Group AG)
• Inventors: Buydts, Hilde, Vanquickenborne, Stefaan Jaak
• Primary Examiner(s): Bolourchi, Nader
• Application Number:
  US15/032,601
• Publication Number:
  US 20160256384A1
• Time in Patent Office: 1,273 Days
• Field of Search: 3405731
• CPC Class Codes: A61J 7/04 Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: 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
• CPC Class Codes: G08B 21/24 Reminder alarms, e.g. anti-loss alarms
• CPC Class Codes: G16H 20/13 delivered from dispensers

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

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 each compartment comprises a definite volume for storing a drug, or signaling means therein, formed and delimited by the plurality of distinct segments when connected to each other, wherein said signaling means and said drug are each stored in different compartments physically separated from one another, wherein both the drug and the signaling means are 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, and 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. A dosage form article according to claim 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.

9. A dosage form article according to claim 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.

10. 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.

11. 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.

12. 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.

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 article according to claim 1;

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 portable 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.

14. A method for determining whether it is safe to ingest a medicament comprising the steps of:

providing a dosage form according to claim 1;

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.

15. The method of claim 13 wherein the warning is de-activated only when the signaling means is detected by the receiver, only after the dosage form article is ingested.

16. A dosage form article 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

wherein the compartments define a volume for storing the drug or signal emitter therein, each volume formed by the plurality of the segments when connected to one another 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 signaling emitter are wholly incorporated within the dosage form article, the respective compartments being arranged to fully enclose the drug and signaling emitter only when at least two of the plurality of distinct segments are connected, wherein the signal emitter is insertable into the compartment prior to connection of the at least two of the plurality of distinct segments, and wherein each distinct segment includes of a cap part or a body part and the cap and/or body parts are hard capsule shells.

17. A dosage form article suitable for oral administration, the dosage form article comprising:

first, second and third distinct segments of the dosage form article;

a plurality of compartments, each formed by at least two of the first, second and third distinct segments of the dosage form article;

a signaling means stored in a signaling means compartment in the first segment; and

a drug compartment configured to maintain a drug in the second segment;

wherein the signaling means compartment and the drug compartment are wholly incorporated within the dosage form article, the respective compartments being arranged to fully enclose the drug and signaling means only when the first, second and third distinct segments are connected, wherein each of the first, the second, and the third segments include a cap part or a body part and the cap and/or body parts are hard capsule shells.