CA2763676C - Systeme et procede de compression uniaxiale d'un article tel qu'une forme posologique a impression tridimensionnelle - Google Patents
Systeme et procede de compression uniaxiale d'un article tel qu'une forme posologique a impression tridimensionnelle Download PDFInfo
- Publication number
- CA2763676C CA2763676C CA2763676A CA2763676A CA2763676C CA 2763676 C CA2763676 C CA 2763676C CA 2763676 A CA2763676 A CA 2763676A CA 2763676 A CA2763676 A CA 2763676A CA 2763676 C CA2763676 C CA 2763676C
- Authority
- CA
- Canada
- Prior art keywords
- dosage form
- api
- ram
- compression
- lower die
- 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.)
- Expired - Lifetime
Links
- 239000002552 dosage form Substances 0.000 title claims abstract description 155
- 238000007906 compression Methods 0.000 title claims abstract description 113
- 230000006835 compression Effects 0.000 title claims abstract description 104
- 238000000034 method Methods 0.000 title claims description 71
- 239000008186 active pharmaceutical agent Substances 0.000 claims abstract description 132
- 239000011800 void material Substances 0.000 claims abstract description 69
- 239000000203 mixture Substances 0.000 claims abstract description 35
- 238000010146 3D printing Methods 0.000 claims abstract description 21
- 238000003825 pressing Methods 0.000 claims abstract description 21
- 239000000843 powder Substances 0.000 claims description 74
- 239000011230 binding agent Substances 0.000 claims description 72
- 239000007788 liquid Substances 0.000 claims description 62
- 239000000126 substance Substances 0.000 claims description 58
- 239000002245 particle Substances 0.000 claims description 35
- 238000007639 printing Methods 0.000 claims description 34
- 230000008569 process Effects 0.000 claims description 19
- 238000004519 manufacturing process Methods 0.000 claims description 17
- 239000006186 oral dosage form Substances 0.000 claims description 16
- 239000000463 material Substances 0.000 claims description 15
- 230000008707 rearrangement Effects 0.000 claims description 11
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000002775 capsule Substances 0.000 claims description 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 235000019589 hardness Nutrition 0.000 claims 4
- 230000000994 depressogenic effect Effects 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 238000009475 tablet pressing Methods 0.000 abstract description 2
- 239000003826 tablet Substances 0.000 description 33
- 239000007787 solid Substances 0.000 description 28
- 239000000546 pharmaceutical excipient Substances 0.000 description 13
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 9
- 238000013461 design Methods 0.000 description 9
- 238000002474 experimental method Methods 0.000 description 9
- 238000011068 loading method Methods 0.000 description 9
- 239000000243 solution Substances 0.000 description 9
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 7
- 238000009694 cold isostatic pressing Methods 0.000 description 7
- 229960001259 diclofenac Drugs 0.000 description 7
- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 description 7
- 229920003134 Eudragit® polymer Polymers 0.000 description 6
- 239000012530 fluid Substances 0.000 description 6
- 229940124531 pharmaceutical excipient Drugs 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 238000002835 absorbance Methods 0.000 description 5
- 229960001193 diclofenac sodium Drugs 0.000 description 5
- 238000012856 packing Methods 0.000 description 5
- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 239000007891 compressed tablet Substances 0.000 description 4
- 238000010410 dusting Methods 0.000 description 4
- 238000001704 evaporation Methods 0.000 description 4
- 230000008020 evaporation Effects 0.000 description 4
- 238000011049 filling Methods 0.000 description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 4
- 230000006872 improvement Effects 0.000 description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 3
- 238000005056 compaction Methods 0.000 description 3
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- 238000003306 harvesting Methods 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
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- 230000007935 neutral effect Effects 0.000 description 3
- 229940124641 pain reliever Drugs 0.000 description 3
- 239000002904 solvent Substances 0.000 description 3
- 229910001220 stainless steel Inorganic materials 0.000 description 3
- 239000010935 stainless steel Substances 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- GNBHRKFJIUUOQI-UHFFFAOYSA-N fluorescein Chemical class O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C=C1OC1=CC(O)=CC=C21 GNBHRKFJIUUOQI-UHFFFAOYSA-N 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 239000008108 microcrystalline cellulose Substances 0.000 description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 description 2
- 239000008055 phosphate buffer solution Substances 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- 238000003892 spreading Methods 0.000 description 2
- 230000003746 surface roughness Effects 0.000 description 2
- 238000003826 uniaxial pressing Methods 0.000 description 2
- JKNCOURZONDCGV-UHFFFAOYSA-N 2-(dimethylamino)ethyl 2-methylprop-2-enoate Chemical compound CN(C)CCOC(=O)C(C)=C JKNCOURZONDCGV-UHFFFAOYSA-N 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 description 1
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
- 101100114828 Drosophila melanogaster Orai gene Proteins 0.000 description 1
- 239000004593 Epoxy Substances 0.000 description 1
- 229920003139 Eudragit® L 100 Polymers 0.000 description 1
- 239000005715 Fructose Substances 0.000 description 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 1
- 229930091371 Fructose Natural products 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 229920003094 Methocel™ K4M Polymers 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000018737 Parkinson disease Diseases 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- TYVWBCMQECJNSK-UHFFFAOYSA-N [2-methyl-3-(2-methylprop-2-enoyloxy)butan-2-yl]azanium;chloride Chemical compound [Cl-].CC([NH3+])(C)C(C)OC(=O)C(C)=C TYVWBCMQECJNSK-UHFFFAOYSA-N 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 229920006318 anionic polymer Polymers 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 208000015802 attention deficit-hyperactivity disease Diseases 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 125000002091 cationic group Chemical group 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000004148 curcumin Substances 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
- 229940038472 dicalcium phosphate Drugs 0.000 description 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 238000010252 digital analysis Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 125000004185 ester group Chemical group 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 229960002143 fluorescein Drugs 0.000 description 1
- 239000007850 fluorescent dye Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 230000002706 hydrostatic effect Effects 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 208000035231 inattentive type attention deficit hyperactivity disease Diseases 0.000 description 1
- 238000007641 inkjet printing Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 125000005397 methacrylic acid ester group Chemical group 0.000 description 1
- 210000003739 neck Anatomy 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000012805 post-processing Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 238000007790 scraping Methods 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- -1 sorbitoi Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 230000036962 time dependent Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Une forme posologique comprimée axialement fabriquée par impression tridimensionnelle préserve l'architecture interne prédéterminée de la forme posologique tout en produisant un fini de surface amélioré. La compression comprime la forme posologique et élimine au moins certains espaces vides qui restent à la fin de l'impression tridimensionnelle habituelle. Le fini de surface obtenu par le procédé de compression uniaxiale peut être essentiellement égal à celui obtenu de la compaction habituelle de comprimé. De plus, la structure interne ou la variation spatiale de la composition de la forme posologique est conservée pendant l'opération de compaction, où la compaction géométrique survient principalement dans la direction de l'axe de compaction. De plus, en conséquence de la compression, une plus grande quantité d'API peut être intégrée dans un volume final donné d'une forme posologique.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33992001P | 2001-10-29 | 2001-10-29 | |
| US60/339,920 | 2001-10-29 | ||
| CA2464478A CA2464478C (fr) | 2001-10-29 | 2002-10-29 | Systeme et procede de compression uniaxiale d'un article tel qu'une forme posologique a impression tridimensionnelle |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2464478A Division CA2464478C (fr) | 2001-10-29 | 2002-10-29 | Systeme et procede de compression uniaxiale d'un article tel qu'une forme posologique a impression tridimensionnelle |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2763676A1 CA2763676A1 (fr) | 2003-05-08 |
| CA2763676C true CA2763676C (fr) | 2015-01-27 |
Family
ID=45560131
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2763676A Expired - Lifetime CA2763676C (fr) | 2001-10-29 | 2002-10-29 | Systeme et procede de compression uniaxiale d'un article tel qu'une forme posologique a impression tridimensionnelle |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2763676C (fr) |
-
2002
- 2002-10-29 CA CA2763676A patent/CA2763676C/fr not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CA2763676A1 (fr) | 2003-05-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20221031 |