CA2408956A1 - Method and form of a drug delivery device,such as encapsulating a toxic core within a non-toxic region in an oral dosage form - Google Patents

Method and form of a drug delivery device,such as encapsulating a toxic core within a non-toxic region in an oral dosage form Download PDF

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Publication number
CA2408956A1
CA2408956A1 CA002408956A CA2408956A CA2408956A1 CA 2408956 A1 CA2408956 A1 CA 2408956A1 CA 002408956 A CA002408956 A CA 002408956A CA 2408956 A CA2408956 A CA 2408956A CA 2408956 A1 CA2408956 A1 CA 2408956A1
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CA
Canada
Prior art keywords
toxic
dosage form
region
pharmaceutical
pharmaceutical dosage
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002408956A
Other languages
French (fr)
Other versions
CA2408956C (en
Inventor
Francis C. Payumo
Chen-Chao Wang
Jill K. Sherwood
Michael J. Cima
Christopher M. Gaylo
Donald C. Monkhouse
Jaedeok Yoo
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Massachusetts Institute of Technology
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2408956A1 publication Critical patent/CA2408956A1/en
Application granted granted Critical
Publication of CA2408956C publication Critical patent/CA2408956C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Abstract

A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Claims (32)

1. A pharmaceutical dosage form, comprising:
a core region containing a first toxic or potent pharmaceutical active;
a transitional region wherein the transitional region encapsulates the core region; and a shell region wherein the shell region encapsulates the transitional region and wherein the shell region is not toxic or potent.
2. The pharmaceutical dosage form of claim 1 wherein the transitional region includes unbound powder.
3. The pharmaceutical dosage form of claim 1 wherein the first toxic or potent pharmaceutical active is dispensed as a solution or a suspension or by solubilization.
4. The pharmaceutical dosage form of claim 1, further including a second toxic or potent active contained in the core region independent from the first toxic or potent active.
5. The pharmaceutical dosage form of claim 4 wherein the second toxic or potent active encapsulates the first toxic or potent active.
6. The pharmaceutical dosage form of claim 1 wherein the first pharmaceutical active is an anti-cancer drug, a steroid, a hormone, a narcotic or another compound having a high toxicity or potency.
7. The pharmaceutical dosage form of claim 1 wherein the first pharmaceutical active is camptothecin or 9-nitrocamptothecin or triiodothyronine or tetraiodothyroxine.
8. The pharmaceutical dosage form of claim 1 wherein the shell region is pharmaceutically inert.
9. The pharmaceutical dosage form of claim 1 wherein the shell region includes one or more pharmaceutical excipients.
10. The pharmaceutical dosage form of claim 1, further comprising a capsule that completely surrounds the shell region.
11. The pharmaceutical dosage form of claim 1 wherein the shell region includes a release-controlling substance.
12. A pharmaceutical dosage form manufactured by three-dimensional printing comprising:

a core region containing at least one toxic or potent pharmaceutical contained in a first liquid deposited on a powder bed;
a transitional region wherein the transitional region encapsulates the core region; and a shell region wherein the shell region encapsulates the transitional region, wherein the shell region is non-toxic and wherein the shell region comprises a second liquid deposited on the powder bed.
13. The pharmaceutical dosage form of claim 12 wherein the toxic or potent pharmaceutical is dissolved in the first liquid.
14. The pharmaceutical dosage form of claim 12 wherein the toxic or potent pharmaceutical is present in the first liquid as suspended particles.
15. The pharmaceutical dosage form of claim 14 wherein the average size of the suspended particles is approximately 0.5 micron or less.
16. The pharmaceutical dosage form of claim 14 wherein the first liquid is dispensed through an orifice having a diameter, and the maximum size of the suspended particles is less than approximately one-tenth the diameter of the orifice.
17. The pharmaceutical dosage form of claim 14 wherein the suspension further comprises a steric hindrant or a suspending agent or both.
18. The pharmaceutical dosage form of claim 12 wherein the device is made from powder that is one or more pharmaceutical excipients.
19. The pharmaceutical dosage form of claim 18 wherein the powder further comprises a gelatin agent that forms a gel when it interacts with the first liquid, whereby the migration of first liquid through the powder is slowed.
20. The pharmaceutical dosage form of claim 19 wherein the gelation agent comprises hydroxypropylmethylcellulose or other hydrophilic polymer.
21. The pharmaceutical dosage form of claim 12 wherein the shell region includes a release-controlling substance.
22. The pharmaceutical dosage form of claim 12 further comprising a capsule that completely surrounds the shell.
23. The pharmaceutical dosage form of claim 12 wherein the second liquid is a solvent for a powder in the powder bed.
24. The pharmaceutical dosage form of claim 12 wherein the second liquid comprises adhesive or plasticizes.
25. The pharmaceutical dosage form of claim 12 wherein the powder comprises solid particles of an adhesive that interacts with the first or the second liquid.
26. A method of manufacturing a pharmaceutical delivery device comprising a core region containing a pharmaceutical active and a shell region surrounding the core region, comprising:
spreading a layer of powder;
dispensing a first fluid containing a pharmaceutical active onto the powder in selected places forming a core region;
dispensing a second fluid onto the powder in places such as to completely surround the places where the first fluid is deposited and forming a shell region; and repeating the process as many times as needed, wherein the first liquid is dispensed only into a region that is encapsulated by the surrounding shell region formed by the second liquid.
27. The method of claim 26 wherein the first or the second liquid further include a binding agent.
28. The method of claim 26 wherein the pharmaceutical active is a anti-cancer drug, a steroid, a hormone, a narcotic, or another compound having high toxicity or potency.
29. The method of claim 26 wherein the pharmaceutical active is camptothecin or 9-nitrocamptothecin or other derivatives of camtothecin or triiodothyronine or tetraiodothyroxine.
30. The method of claim 26 wherein the first liquid contains the pharmaceutical active in solution.
31. The method of claim 26 wherein the first liquid contains the pharmaceutical active as solid particles suspended in the first liquid.
32. A method of manufacturing a dosage form containing an encapsulated toxic or potent core, comprising: dispensing a first binder fluid which contains neither a toxic or potent excipient onto a layer of bulk material;
dispensing a second binder fluid containing a toxic or potent active within the footprint of the first binder fluid on at least one subsequent layer of bulk material; dispensing a binder fluid which contains neither a toxic or potent excipient around a perimeter region of the dispensed toxic binder on the at least one subsequent layer of bulls material wherein the perimeter region is bound to the adjacent layer; dispensing a binder fluid which contains neither a toxic or potent excipient over at least one subsequent layer of bulk material thereby enclosing the toxic or potent binder region with an encapsulating region which contains neither a toxic or potent excipient.
CA2408956A 2000-05-18 2001-05-18 Method and form of a drug delivery device,such as encapsulating a toxic core within a non-toxic region in an oral dosage form Expired - Fee Related CA2408956C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US20589600P 2000-05-18 2000-05-18
US60/205,896 2000-05-18
PCT/US2001/040763 WO2001087272A2 (en) 2000-05-18 2001-05-18 Encapsulating a toxic core within a non-toxic region in an oral dosage form

Publications (2)

Publication Number Publication Date
CA2408956A1 true CA2408956A1 (en) 2001-11-22
CA2408956C CA2408956C (en) 2011-07-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2408956A Expired - Fee Related CA2408956C (en) 2000-05-18 2001-05-18 Method and form of a drug delivery device,such as encapsulating a toxic core within a non-toxic region in an oral dosage form

Country Status (9)

Country Link
US (2) US7276252B2 (en)
EP (1) EP1286663B1 (en)
JP (2) JP5178982B2 (en)
AT (1) ATE315930T1 (en)
AU (1) AU2001263506A1 (en)
CA (1) CA2408956C (en)
DE (1) DE60116758T2 (en)
ES (1) ES2257412T3 (en)
WO (1) WO2001087272A2 (en)

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Also Published As

Publication number Publication date
US20020015728A1 (en) 2002-02-07
US20060110443A1 (en) 2006-05-25
US7276252B2 (en) 2007-10-02
US7875290B2 (en) 2011-01-25
WO2001087272A3 (en) 2002-04-18
JP2012082224A (en) 2012-04-26
ATE315930T1 (en) 2006-02-15
CA2408956C (en) 2011-07-12
JP2003533470A (en) 2003-11-11
EP1286663A2 (en) 2003-03-05
ES2257412T3 (en) 2006-08-01
DE60116758T2 (en) 2006-11-02
AU2001263506A1 (en) 2001-11-26
DE60116758D1 (en) 2006-04-06
EP1286663B1 (en) 2006-01-18
JP5178982B2 (en) 2013-04-10
WO2001087272A2 (en) 2001-11-22

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