CA2464478A1 - A system and method for uniaxial compression of an article, such as a three-dimensionally printed dosage form - Google Patents

A system and method for uniaxial compression of an article, such as a three-dimensionally printed dosage form Download PDF

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Publication number
CA2464478A1
CA2464478A1 CA002464478A CA2464478A CA2464478A1 CA 2464478 A1 CA2464478 A1 CA 2464478A1 CA 002464478 A CA002464478 A CA 002464478A CA 2464478 A CA2464478 A CA 2464478A CA 2464478 A1 CA2464478 A1 CA 2464478A1
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CA
Canada
Prior art keywords
dosage form
ram
lower die
powder
api
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
CA002464478A
Other languages
French (fr)
Other versions
CA2464478C (en
Inventor
Wendy E. Pryce Lewis
Charles William Rowe
Michael J. Cima
Peter A. Materna
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
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
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Priority to CA2763676A priority Critical patent/CA2763676C/en
Publication of CA2464478A1 publication Critical patent/CA2464478A1/en
Application granted granted Critical
Publication of CA2464478C publication Critical patent/CA2464478C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/165—Processes of additive manufacturing using a combination of solid and fluid materials, e.g. a powder selectively bound by a liquid binder, catalyst, inhibitor or energy absorber
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor

Abstract

A uniaxially compressed dosage form manufactured by three-dimensional printi ng that preserves the predetermined internal architecture of the dosage form while producing an improved surface finish. The compression compacts the dosage form, eliminating at least some of the void space that remains at the end of conventional three-dimensional printing. Surface finish obtained as a result of the uniaxial compression process can be essentially equal to that obtained from conventional tablet pressing. Additionally, the internal structure or spatial variation of composition of the dosage form is preserve d during the pressing operation, with geometric shrinkage occurring mostly in the direction of the axis of pressing. Further, as a result of compression, a greater quantity of API can be packed into a given final volume of dosage fo rm.

Claims (53)

1. A method of manufacturing a dosage form, comprising:
manufacturing a dosage form using a three-dimensional printing process; and uniaxially compressing the dosage form.
2. The method of claim 1 wherein the uniaxial compression comprises placing the manufactured dosage form in a die assembly having confining surfaces which substantially surround the dosage form from all directions except for one direction and in that direction having an opening which defines an axis of pressing.
3. The method of claim 2 wherein the manufacturing using three-dimensional printing comprises moving a ram along the axis of pressing into the opening to uniaxially compress the dosage form.
4. The method of claim 1 further comprising, dissolving at least one Active Pharmaceutical Ingredient (API) into a binder liquid used in the three-dimensional printing process.
5. The method of claim 1 comprising, dispensing differing concentrations or different amounts of API or other substances in different places in the dosage form during the three-dimensional printing process, so as to create a spatially nonuniform composition.
6. The method of claim 5 wherein the dispensing comprises variable drop volume printing.
7. The method of claim 5 further comprising, creating an interior region in the dosage form during the three-dimensional printing process, the interior region having an interior composition surrounded by a shell having a shell composition.
8. The method of claim 7 further comprising, dispensing binder liquid during the three-dimensional printing process wherein the shell has a shell void fraction and the interior has an interior void fraction, and the shell void fraction and the interior void fraction are approximately equal to each other.
9. The method of claim 5 further comprising, dispensing binder liquid to create a plurality of regions each having an individual composition within the dosage form.
10. The method of claim 9 wherein dispensing the binder liquid further includes creating a plurality of regions that are nested within each other in the dosage form.
11. The method of claim 9 wherein each region of the dosage form has a void fraction, and all of these void fractions are approximately equal to each other.
12. The method of claim 5 further comprising, dispensing binder liquid to create a gradient of concentration of one or more substances in the dosage form.
13. The method of claim 12 wherein the dosage form has a geometric center, and wherein the binder liquid is dispensed so that the concentration of one or more substances varies as a function of distance from the geometric center of the dosage form.
14. The method of claim 12 wherein the binder liquids are dispensed so that the void fraction in the dosage form is approximately the same everywhere.
15. The method of claim 1 wherein manufacturing the dosage form by three-dimensional printing includes dispensing one or more binder liquids onto layers of powder.
16. The method of claim 15 wherein at least one binder liquid is dispensed onto a layer of powder more than one time before a next layer of powder is spread, the binder liquid containing a volatile component, the volatile component being allowed to substantially evaporate before binder liquid is re-dispensed onto the layer.
17. The method of claim 1 further comprising, applying a coating to the dosage form or enclosing the dosage form in a capsule.
18. The method of claim 1, wherein the dosage form is an implantable delivery device.
19. The method of claim 1, wherein the dosage form is an oral dosage form.
20. A dosage form having predetermined spatially nonuniform internal composition and having a void fraction less than 5%.
21. The dosage form of claim 20 wherein the dosage farm is manufactured by three-dimensional printing.
22. The dosage form of claim 20 wherein the dosage form has a surface finish having a peak-to-valley dimension wherein the peak-to-valley dimension is less than or approximately equal to 3 microns.
23. The dosage form of claim 20 further comprising depressed or raised markings on one or more of its surfaces.
24. The dosage form of claim 20 wherein the dosage form has a shape selected from the group consisting of: cylindrical with flat ends, cylindrical with curved ends, rectangular prismatic with flat ends, rectangular prismatic with curved ends, elliptical prismatic with flat ends, elliptical prismatic with curved ends, ellipsoidal, and spherical.
25. The dosage form of claim 25 wherein the dosage form comprises powder particles bound together by a binding substance.
26. The dosage form of claim 25 wherein the powder comprises one or more substances selected from the group consisting of a methacrylic acid copolymer, microcrystalline cellulose, hydroxypropylmethylcellulose, mannitol, xylitol, sorbitol, dicalcium phosphate, lactose, glucose, dextrose, fructose and other sugars.
27. The dosage form of claim 25 wherein the binding substance is one or more substances selected from the group consisting of hydroxypropylmethylcellulose, Eudragit L-100, Eudragit E-100, Eudragit RSPO, Eudragit RLPO, and polyvinyl pyrrolidone.
28. The dosage form of claim 20 comprising an API which is selected from the group consisting of pain-relievers for cancer; pain-relievers for arthritis; pain-relievers for other diseases; hormones; API to combat hypertension; API to combat Parkinson's disease; API to combat Attention Deficit Disorder; API to combat asthma; and API to combat other diseases.
29. The dosage form of claim 20 wherein the dosage form comprises predetermined compositional nonuniformity on a size scale larger than the size of the powder particles.
30. The dosage form of claim 20 wherein the dosage form comprises an interior region having an interior composition surrounded by a shell having a shell composition.
31. The dosage form of claim 30 wherein the shell comprises a substance selected to influence the release characteristics of the API.
32. The dosage form of claim 30 wherein the shell has a shell non-powder fraction and the interior has an interior non-powder fraction, and the shell non-powder fraction and the interior non-powder fraction are approximately equal to each other.
33. The dosage form of claim 29 comprising, a plurality of regions each having its own composition.
34. The dosage form of claim 33 wherein the regions are nested within each other.
35. The dosage form of claim 32 wherein each region of the dosage form has a respective non-powder fraction, and all of these non-powder fractions are approximately equal to each other.
36. The dosage form of claim 30 wherein the dosage form comprises a gradient in the composition of one or more ingredients, on a size scale greater than the powder particle size.
37. The dosage form of claim 36 wherein the dosage form has a geometric center, and wherein the concentration of one or more substances varies as a function of distance from the geometric center of the dosage form.
38. The dosage form of claim 36 wherein each local place in the dosage form has a respective non-powder fraction, and all of these non-powder fractions are approximately equal to each other.
39. The dosage form of claim 20 further comprising a coating covering the dosage form or a capsule enclosing the dosage form.
40. The dosage form of claim 20 wherein the dosage form is an implantable API delivery device.
41. The dosage form of claim 20 wherein the dosage form is an oral dosage form.
42. A uniaxially compressed dosage form manufactured by three-dimensional printing.
43. The dosage form of claim 42 wherein the dosage form has a void fraction chosen to produce a desired release characteristic of an API.
44. The dosage form of claim 42 wherein the dosage form is uniaxially compressed by a die assembly comprising a lower die having a lower die outside geometry, and a sleeve having a sleeve inside geometry, and wherein a ram having a ram outside geometry, and wherein the lower die outside geometry and the ram outside geometry are both closely fitting with respect to the sleeve inside geometry.
45. The dosage form of claim 44 wherein the ram outside geometry, the lower die outside geometry and the sleeve inside geometry are all cylindrical.
46. The dosage form of claim 44 wherein the lower die has a lower die surface facing the dosage form and the ram has a ram surface facing the dosage form, and the lower die surface or the ram surface or both are generally curved.
47. The dosage form of claim 44 wherein the lower die has a lower die surface facing the dosage form and the ram has a ram surface facing the dosage form, and the lower die surface or the ram surface or both are generally flat.
48. The dosage form of claim 44 wherein the lower die surface and the sleeve inner surface and the ram have surface finishes which are smoother than or approximately equal to 2 microns rms.
49. The dosage form of claim 44 further comprising depressed or raised markings on the lower die surface or ram surface or both.
50. The dosage form of claim 44 wherein the dosage form has a shape selected from the group consisting of: cylindrical with flat ends, cylindrical with curved ends, rectangular prismatic with flat ends, rectangular prismatic with curved ends, elliptical prismatic with flat ends, elliptical prismatic with curved ends, ellipsoidal, spherical.
51. The dosage form of claim 44 wherein the die and the ram and the sleeve all have respective hardnesses, and the dosage form has a hardness, and the hardnesses of the die and the ram and the sleeve are all greater than the hardness of the dosage form.
52. The dosage form of claim 44 wherein the lower die has a lower die surface and the ram has a ram surface, and the dosage form has an dosage form top surface and an dosage form bottom surface, and the lower die surface approximately matches the dosage form bottom surface, and the ram surface approximately matches the dosage form top surface.
53. The dosage form of claim 44 wherein the lower die and the sleeve are integral components.
CA2464478A 2001-10-29 2002-10-29 A system and method for uniaxial compression of an article, such as a three-dimensionally printed dosage form Expired - Lifetime CA2464478C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2763676A CA2763676C (en) 2001-10-29 2002-10-29 A system and method for uniaxial compression of an article, such as a three-dimensionally printed dosage form

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33992001P 2001-10-29 2001-10-29
US60/339,920 2001-10-29
PCT/US2002/034836 WO2003037607A1 (en) 2001-10-29 2002-10-29 A system and method for uniaxial compression of an article, such as a three-dimensionally printed dosage form

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CA2464478A1 true CA2464478A1 (en) 2003-05-08
CA2464478C CA2464478C (en) 2012-03-20

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US (2) US7931914B2 (en)
EP (1) EP1439945B1 (en)
JP (2) JP4845340B2 (en)
AT (1) ATE322972T1 (en)
CA (1) CA2464478C (en)
DE (1) DE60210650T2 (en)
ES (1) ES2262851T3 (en)
WO (1) WO2003037607A1 (en)

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Also Published As

Publication number Publication date
EP1439945B1 (en) 2006-04-12
CA2464478C (en) 2012-03-20
JP4845340B2 (en) 2011-12-28
JP2005507723A (en) 2005-03-24
DE60210650D1 (en) 2006-05-24
DE60210650T2 (en) 2007-01-25
ATE322972T1 (en) 2006-04-15
JP2010227590A (en) 2010-10-14
US8758658B2 (en) 2014-06-24
EP1439945A1 (en) 2004-07-28
US20030143268A1 (en) 2003-07-31
WO2003037607A1 (en) 2003-05-08
US20110187015A1 (en) 2011-08-04
US7931914B2 (en) 2011-04-26
ES2262851T3 (en) 2006-12-01

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