1-40. (canceled)
41: A polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C.
42: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 130 Jg and with a recrystallization temperature of at least 150\xb0 C.
43: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C., and also has a BET surface area smaller than 6 m2g and a median grain diameter of from 40 to 120 \u03bcm.
44: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C., and also has a BET surface area smaller than 5 m2g and a median grain diameter of from 45 to 100 \u03bcm.
45: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C., and also has a BET surface area smaller than 5 m2g and a median grain diameter of from 50 to 70 \u03bcm.
46: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy, the selectivity being achieved via the application of susceptors, or inhibitors, or of absorbers, or via masks,
which
comprises at least one nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C., and also has a BET surface area smaller than 5 m2g and a median grain diameter of from 50 to 70 \u03bcm.
47: The polymer powder for use in a layer-by-layer process in which regions of the respective pulverulent layer are selectively melted via introduction of electromagnetic energy, the selectivity being achieved via the focusing of a laser beam,
which
comprises at least nylon-11 with an enthalpy of fusion of at least 125 Jg and with a recrystallization temperature of at least 148\xb0 C., and also has a BET surface area smaller than 5 m2g and a median grain diameter of from 50 to 70 \u03bcm.
48: The polymer powder as claimed in claim 41,
which
comprises at least nylon-11, prepared via polycondensation of \u03c9-aminoundecanoic acid.
49: The polymer powder as claimed in claim 41,
wherein
the polyamide powder has been obtained via precipitative crystallization.
50: The polymer powder as claimed in claim 41,
which
comprises unregulated nylon-11.
51: The polymer powder as claimed in claim 41,
which
comprises regulated nylon-11.
52: The polymer powder as claimed in claim 41,
which
comprises partially regulated nylon-11.
53: The polymer powder as claimed in claim 41,
wherein
the regulator used comprises a mono-, di-, or polyamine.
54: The polymer powder as claimed in claim 41,
wherein
the regulator used comprises a mono-, di-, or polycarboxylic acid.
55: The polymer powder as claimed in claim 41,
wherein
the polyamide powder has a solution viscosity of from 1.4 to 2.1.
56: The polymer powder as claimed in claim 41,
wherein
the polyamide powder has a solution viscosity of from 1.5 to 1.9.
57: The polymer powder as claimed in claim 41,
wherein
the polyamide powder has a solution viscosity of from 1.6 to 1.7.
58: The polymer powder as claimed in claim 41,
which
comprises auxiliaries andor filler.
59: The polymer powder as claimed in claim 58,
which
comprises powder-flow aids as auxiliary.
60: The polymer powder as claimed in claim 58,
which
comprises glass particles as filler.
61: The polymer powder as claimed in claim 58,
which
comprises metal soaps as auxiliary.
62: The polymer powder as claimed in claim 41,
which
comprises organic andor inorganic pigments.
63: The polymer powder as claimed in claim 62,
which
comprises carbon black.
64: The polymer powder as claimed in claim 62,
which
comprises titanium dioxide.
65: A process for the production of moldings via a layer-by-layer process in which regions of the respective pulverulent layer are melted via introduction of electromagnetic energy, the selectivity being obtained via the application of susceptors, of inhibitors, or of absorbers, or via masks,
which comprises
using at least one nylon-11 whose enthalpy of fusion is at least 125 Jg and whose recrystallization temperature is at least 148\xb0 C.
66: A process for the production of moldings via a layer-by-layer process in which regions of the respective pulverulent layer are melted via introduction of electromagnetic energy, the selectivity being achieved via the focusing of a laser beam,
which comprises
using at least one nylon-11 whose enthalpy of fusion is at least 125 Jg and whose recrystallization temperature is at least 148\xb0 C.
67: A process for the production of moldings via selective laser sintering of polymer powder as claimed in claim 41.
68: A molding, produced via claim 65,
which
comprises at least one nylon-11 whose enthalpy of fusion is at least 125 Jg and whose recrystallization temperature is at least 148\xb0 C.
69: The molding as claimed in claim 65,
which
comprises at least nylon-11, prepared via polycondensation of \u03c9-aminoundecanoic acid.
70: The molding as claimed in claim 65,
which
comprises polyamide powder which has been obtained via precipitative crystallization.
71: The molding as claimed in claim 65,
which
comprises a nylon-11 with a solution viscosity of from 1.4 to 2.1.
72: The molding as claimed in claim 65,
which
comprises a nylon-11 with a solution viscosity of from 1.5 to 1.9.
73: The molding as claimed in claim 65,
which
comprises a nylon-11 with a solution viscosity of from 1.6 to 1.7.
74: The molding as claimed in claim 65,
which
comprises auxiliaries andor filler.
75: The molding as claimed in claim 65,
which
comprises powder-flow aids as auxiliary.
76: The molding as claimed in claim 65,
which
comprises glass particles as filler.
77: The molding as claimed in claim 65,
which
comprises metal soaps as auxiliary.
78: The molding as claimed in claim 65,
which
comprises organic andor inorganic pigments.
79: The molding as claimed in claim 65,
which
comprises carbon black.
80: The molding as claimed in claim 65,
which
comprises titanium dioxide.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A pharmaceutical dosage form comprising at least one pharmaceutically active ingredient, and having a shape comprising a longitudinal axis and two opposite longitudinal edges, a transversal axis perpendicular to the longitudinal axis and two opposite transversal edges, a front side, an opposite back side and a circumferential rim between said front and back side, wherein the front side andor the back side comprise a basis area and wherein the front side andor the back side comprise at least one bulge which extends above said basis area, said at least one bulge being present at andor adjacent to at least a section of one or both longitudinal edges andor at andor adjacent to at least a section of one or both transversal edges andor between both longitudinal edges and both transversal edges.
2. The pharmaceutical dosage form according to claim 1, which is a tablet having an oblong shape.
3. The pharmaceutical dosage form according to claim 1, wherein the front side and the back side each comprise at least one bulge at least along a section at andor adjacent to both longitudinal edges andor at least along a section at andor adjacent to both transversal edges.
4. The pharmaceutical dosage form according to claim 1, wherein said front side and said back side comprise an at least essentially continuous bulge at andor adjacent to at least two third of both opposite longitudinal edges.
5. The pharmaceutical dosage form according to claim 1, wherein one or both longitudinal edges are essentially straight over at least a major part of their length andor wherein one or both transversal edges are curved over a major part of their length.
6. The pharmaceutical dosage form according to claim 1, wherein the front side andor the back side comprise an essentially circumferential bulge at andor adjacent to the circumferential edge of the front side andor the back side of said pharmaceutical dosage form.
7. The pharmaceutical dosage form according to claim 1, wherein said pharmaceutical dosage form in its oblong form comprises at andor adjacent to major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge at andor adjacent to major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge at andor adjacent to the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge at andor adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
8. The pharmaceutical dosage form according to claim 7, wherein said pharmaceutical dosage form in its oblong form comprises at major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge at major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge at the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge at the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
9. The pharmaceutical dosage form according to claim 7, wherein said pharmaceutical dosage form in its oblong form comprises adjacent to major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge adjacent to major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge adjacent to the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
10. The pharmaceutical dosage form according to claim 7, wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
11. The pharmaceutical dosage form according to claim 1, wherein the front side andor the back side comprise, in addition to at least one bulge on the front side andor the back side, at least one indentation.
12. The pharmaceutical dosage form according to claim 11, wherein the front and the back side comprise at least one indentation.
13. The pharmaceutical dosage form according to claim 12, wherein the indentation(s) in the front side and the back side are at least once at least partially off-set.
14. The pharmaceutical dosage form according to claim 12, wherein all the indentations of the front side and all the indentations of the back side are at least partially off-set.
15. The pharmaceutical dosage form according to claim 12, wherein at least one indentation of the front side and at least one indentation of the back side are positioned in a congruent manner.
16. The pharmaceutical dosage form according to claim 15, wherein all indentations of the front side and all indentations of the back side are positioned in a congruent manner.
17. The pharmaceutical dosage form according to claim 11, wherein the indentations have a cylindrical or cube-like or cuboid-like shape or the shape of a half-sphere.
18. The pharmaceutical dosage form according to claim 1, comprising one or more hydrophilic polymers.
19. The pharmaceutical dosage form according to claim 18, wherein the one or more hydrophilic polymers are hydroxypropyl methyl cellulose andor hydroxypropyl cellulose.
20. The pharmaceutical dosage form according to claim 18, further comprising pregelatinized starch.
21. The pharmaceutical dosage form according to claim 1, wherein the longitudinal length of the pharmaceutical dosage form does not exceed 30 mm.
22. The pharmaceutical dosage form according to claim 1, having an average thickness over the basis areas of the front and the back side of about at least 1 mm.
23. The pharmaceutical dosage form according to claim 1, wherein the bulge extends perpendicular from the basis area of the front side andor from the basis area of the back side in average from about 0.5 mm to about 2 mm.
24. The pharmaceutical dosage form according to claim 1, having a length in the longitudinal direction in the range of about 5 mm to about 30 mm, a width in the range of about 5 mm to about 15 mm, and a thickness over the basis areas in the range of about 1 mm to about 6 mm.
25. The pharmaceutical dosage form according to claim 1, further comprising at least partially a coating.
26. Tamper-resistant pharmaceutical dosage form, which has a retarded release profile for pharmaceutical application as an oral dosage form, comprising at least one pharmaceutically active ingredient with potential for abuse, and having a shape comprising a longitudinal axis and two opposite longitudinal edges, a transversal axis perpendicular to the longitudinal axis and two opposite transversal edges, a front side, an opposite back side and a circumferential rim between said front and back side, wherein the front side andor the back side comprise a basis area and wherein the front side andor the back side comprise at least one bulge which extends above said basis area, said at least one bulge being present at andor adjacent to at least a section of one or both longitudinal edges andor at andor adjacent to at least a section of one or both transversal edges andor between both longitudinal edges and both transversal edges.
27. The pharmaceutical dosage form according to claim 26, which is a tablet having an oblong shape.
28. The pharmaceutical dosage form according to claim 26, wherein the front side and the back side each comprise at least one bulge at least along a section at andor adjacent to both longitudinal edges andor at least along a section at andor adjacent to both transversal edges.
29. The pharmaceutical dosage form according to claim 26, wherein said front side and said back side comprise an at least essentially continuous bulge at andor adjacent to at least two third of both opposite longitudinal edges.
30. The pharmaceutical dosage form according to claim 26, wherein one or both longitudinal edges are essentially straight over at least a major part of their length andor wherein one or both transversal edges are curved over a major part of their length.
31. The pharmaceutical dosage form according to claim 26, wherein the front side andor the back side comprise an essentially circumferential bulge at andor adjacent to the circumferential edge of the front side andor the back side of said pharmaceutical dosage form.
32. The pharmaceutical dosage form according to claim 26, wherein said pharmaceutical dosage form in its oblong form comprises at andor adjacent to major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge at andor adjacent to major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge at andor adjacent to the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge at andor adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
33. The pharmaceutical dosage form according to claim 32, wherein said pharmaceutical dosage form in its oblong form comprises at major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge at major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge at the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge at the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
34. The pharmaceutical dosage form according to claim 32, wherein said pharmaceutical dosage form in its oblong form comprises adjacent to major portions of both opposite longitudinal edges of the front side at least one bulge, or wherein said pharmaceutical dosage form in its oblong form comprises at least one bulge adjacent to major portions of both opposite longitudinal edges of both the front side and the back side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form comprises in its oblong form a circumferential bulge adjacent to the circumferential edge of the front side of said pharmaceutical dosage form, or wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
35. The pharmaceutical dosage form according to claim 32, wherein said pharmaceutical dosage form in its oblong form comprises a circumferential bulge adjacent to the circumferential edge of both the front side and the back side of said pharmaceutical dosage form.
36. The pharmaceutical dosage form according to claim 26, wherein the front side andor the back side comprise, in addition to at least one bulge on the front side andor the back side, at least one indentation.
37. The pharmaceutical dosage form according to claim 36, wherein the front and the back side comprise at least one indentation.
38. The pharmaceutical dosage form according to claim 37, wherein the indentation(s) in the front side and the back side are at least once at least partially off-set.
39. The pharmaceutical dosage form according to claim 37, wherein all the indentations of the front side and all the indentations of the back side are at least partially off-set.
40. The pharmaceutical dosage form according to claim 36, wherein at least one indentation of the front side and at least one indentation of the back side are positioned in a congruent manner.
41. The pharmaceutical dosage form according to claim 40, wherein all indentations of the front side and all indentations of the back side are positioned in a congruent manner.
42. The pharmaceutical dosage form according to claim 36, wherein the indentations have a cylindrical or cube-like or cuboid-like shape or the shape of a half-sphere.
43. The pharmaceutical dosage form according to claim 26, comprising a polyalkylene oxide.
44. The pharmaceutical dosage form according to claim 26, comprising at least one cellulose ether derivative.
45. The pharmaceutical dosage form according to claim 44, wherein the cellulose ether derivative is HPMC.
46. The pharmaceutical dosage form according to claim 43, wherein the polyalkylene oxide is polyethylene oxide.
47. The pharmaceutical dosage form according to claim 46, wherein the polyethylene oxide has a molecular weight in the range of about 2,000,000 to about 7,000,000.
48. The pharmaceutical dosage form according to claim 26, wherein the pharmaceutical dosage form further comprises a polyalkylene glycol.
49. The pharmaceutical dosage form according to claim 48, wherein the polyalkylene glycol is polyethylene glycol.
50. The pharmaceutical dosage form according to claim 26, wherein the pharmaceutically active ingredient with potential for abuse is a pain-killing drug.
51. The pharmaceutical dosage form according to claim 50, wherein the pharmaceutically active ingredient is tapentadol.
52. The pharmaceutical dosage form according to claim 26, comprising at least one pharmaceutically active ingredient with potential for abuse; at least one poly(alkylene oxide); at least one cellulose ether derivative; and at least one polyalkylene glycol; and optionally an additive.
53. The pharmaceutical dosage form according to claim 52, wherein the active ingredient with potential for abuse is present in an amount of at least 5 weight percent; poly(alkylene oxide) is present in an amount of at least 15 weight percent; cellulose ether derivative is present in an amount of at least 5 weight percent; and polyalkylene glycol is present in an amount of at least 5 weight percent.
54. The pharmaceutical dosage form according to claim 26, wherein the longitudinal length of the pharmaceutical dosage form does not exceed 30 mm.
55. The pharmaceutical dosage form according to claim 26, having an average thickness over the basis areas of the front and the back side of about at least 1 mm.
56. The pharmaceutical dosage form according to claim 26, wherein the bulge extends perpendicular from the basis area of the front side andor from the basis area of the back side in average from about 0.5 mm to about 2 mm.
57. The pharmaceutical dosage form according to claim 26, having a length in the longitudinal direction in the range of about 5 mm to about 30 mm, a width in the range of about 5 mm to about 15 mm, and a thickness over the basis areas in the range of about 1 mm to about 6 mm.
58. The pharmaceutical dosage form according to Claim 26, wherein said pharmaceutical dosage form is a monolith.
59. The pharmaceutical dosage form according to claim 26, which has been prepared via compression using a die and a punch from a monolithic mass obtained by melt extrusion.
60. The pharmaceutical dosage form according to claim 58, wherein said pharmaceutical dosage form has been obtained by compressing a melt extruded monolithic mass which exhibits ambient temperature.
61. The pharmaceutical dosage form according to claim 58, wherein the extruded monolithic mass has been cut prior to compression.
62. The pharmaceutical dosage form according to claim 58, wherein melt extrusion has been conducted with a twin-screw extruder.
63. The pharmaceutical dosage form according to claim 26, further comprising at least partially a coating.
64. A pharmaceutical dosage form with controlled release of a pharmacologically active compound (A) contained therein, the pharmaceutical dosage form having a breaking strength B1 of at least 500 N in direction of extension E1 and having a breaking strength B2 of less than 500 N in direction of extension E2.
65. The pharmaceutical dosage form according to claim 64, wherein E1 is orthogonal to E2.
66. The pharmaceutical dosage form according to claim 64, wherein E2 is the main direction of extension of the pharmaceutical dosage form.
67. The pharmaceutical dosage form according to claim 64, which provides fragments when exerting a force higher than B2 in direction of extension E2, said fragments in turn having a breaking strength of at least 500 N in any of their directions of extension.
68. The pharmaceutical dosage form according to claim 67, wherein the volume of each fragment is at least 5% of the volume of the pharmaceutical dosage form.
69. The pharmaceutical dosage form according to claim 64, wherein the total surface S of the pharmaceutical dosage form in mm2 satisfies the following requirement:
S\u2267A\xb7W23,
wherein
A is 4.5 and
W is the total weight of the pharmaceutical dosage form in mg.
70. The pharmaceutical dosage form according to claim 69, wherein A is 6.2.
71. The pharmaceutical dosage form according to claim 64, which is deformed when exerting a force in direction of extension E2 so that, when the amount of force reaches the breaking strength B2, deformation causes tractive forces that lead to disruption of the dosage form.
72. The pharmaceutical dosage form according to claim 64, which has released under in vitro conditions
after 0.5 h 1.0 to 35 wt.-%,
after 1 h 5.0 to 45 wt.-%,
after 2 h 10 to 60 wt.-%,
after 4 h at least 15 wt.-%,
after 6 h at least 20 wt.-%,
after 8 h at least 25 wt.-% and
after 12 h at least 30 wt.-%
of the pharmacologically active compound (A) that was originally contained in the pharmaceutical dosage form.
73. The pharmaceutical dosage form according to claim 64, which is not radial symmetric about its principal direction of extension.
74. The pharmaceutical dosage form according to claim 64, wherein the maximum extension of the dosage form orthogonal to the main area of extension of the dosage form is spaced from the centre of mass of the dosage form parallel to said main area of extension.
75. The pharmaceutical dosage form according to claim 64, wherein a portion of its surface is convex, another portion of its surface is concave.
76. The pharmaceutical dosage form according to claim 64, which contains a polymer (C) having a weight average molecular weight of at least 100.000 g mol\u22121.
77. The pharmaceutical dosage form according to claim 76, wherein the polymer (C) comprises a polyalkylene oxide.
78. The pharmaceutical dosage form according to claim 64, wherein
a portion of the surface of the pharmaceutical dosage form is convex, another portion of its surface is concave; and
the pharmacologically active compound (A) is a psychotropically acting substance; and
the content of the pharmacologically active compound (A) is at least 0.5 wt.-%, based on the total weight of the dosage form; and
polymer (C) is an polyalkylene oxide having a weight average molecular weight of at least 200,000 gmol; and
the content of polymer (C) is at least 15 wt.-%, based on the total weight of the dosage form; and
the pharmacologically active compound (A) is embedded in the polymer (C); and
the pharmaceutical dosage form is adapted for oral administration once daily or twice daily; and
the pharmaceutical dosage form is thermoformed.
79. (canceled)
80. (canceled)
81. A method of treating pain in a patient in need of such treatment, said method comprising administering to said patient an effective amount therefor of a pharmaceutical dosage form according to claim 1, wherein the pharmaceutically active ingredient is selected from the group consisting of analgesics.
82. A method of treating pain in a patient in need of such treatment, said method comprising administering to said patient an effective amount therefor of a pharmaceutical dosage form according to claim 26, wherein the pharmaceutically active ingredient with potential for abuse is selected from the group consisting of analgesics.
83. A method of treating pain in a patient in need of such treatment, said method comprising administering to said patient an effective amount therefor of a pharmaceutical dosage form according to claim 64, wherein the pharmacologically active compound (A) is selected from the group consisting of analgesics.