JP2023036901A5 - - Google Patents
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- JP2023036901A5 JP2023036901A5 JP2022211549A JP2022211549A JP2023036901A5 JP 2023036901 A5 JP2023036901 A5 JP 2023036901A5 JP 2022211549 A JP2022211549 A JP 2022211549A JP 2022211549 A JP2022211549 A JP 2022211549A JP 2023036901 A5 JP2023036901 A5 JP 2023036901A5
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- JP
- Japan
- Prior art keywords
- coating
- sustained release
- antibody
- weight
- dosage form
- 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.)
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- 239000011248 coating agent Substances 0.000 claims 27
- 238000000576 coating method Methods 0.000 claims 27
- 238000000034 method Methods 0.000 claims 17
- 239000012634 fragment Substances 0.000 claims 15
- 238000013268 sustained release Methods 0.000 claims 14
- 239000012730 sustained-release form Substances 0.000 claims 14
- 239000007909 solid dosage form Substances 0.000 claims 10
- 239000000243 solution Substances 0.000 claims 10
- 239000013543 active substance Substances 0.000 claims 8
- 239000011230 binding agent Substances 0.000 claims 7
- 239000003814 drug Substances 0.000 claims 7
- 229940079593 drug Drugs 0.000 claims 7
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 6
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 claims 5
- 239000007788 liquid Substances 0.000 claims 5
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims 5
- 229920000642 polymer Polymers 0.000 claims 4
- 229920002845 Poly(methacrylic acid) Polymers 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 238000004581 coalescence Methods 0.000 claims 3
- 239000003623 enhancer Substances 0.000 claims 3
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- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- 102000013462 Interleukin-12 Human genes 0.000 claims 2
- 108010065805 Interleukin-12 Proteins 0.000 claims 2
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- 108090000176 Interleukin-13 Proteins 0.000 claims 2
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- 108010065637 Interleukin-23 Proteins 0.000 claims 2
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- 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 claims 2
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- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 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 claims 2
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 2
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- 229920000609 methyl cellulose Polymers 0.000 claims 2
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- FEBUJFMRSBAMES-UHFFFAOYSA-N 2-[(2-{[3,5-dihydroxy-2-(hydroxymethyl)-6-phosphanyloxan-4-yl]oxy}-3,5-dihydroxy-6-({[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}methyl)oxan-4-yl)oxy]-3,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl phosphinite Chemical compound OC1C(O)C(O)C(CO)OC1OCC1C(O)C(OC2C(C(OP)C(O)C(CO)O2)O)C(O)C(OC2C(C(CO)OC(P)C2O)O)O1 FEBUJFMRSBAMES-UHFFFAOYSA-N 0.000 claims 1
- SATHPVQTSSUFFW-UHFFFAOYSA-N 4-[6-[(3,5-dihydroxy-4-methoxyoxan-2-yl)oxymethyl]-3,5-dihydroxy-4-methoxyoxan-2-yl]oxy-2-(hydroxymethyl)-6-methyloxane-3,5-diol Chemical compound OC1C(OC)C(O)COC1OCC1C(O)C(OC)C(O)C(OC2C(C(CO)OC(C)C2O)O)O1 SATHPVQTSSUFFW-UHFFFAOYSA-N 0.000 claims 1
- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims 1
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 1
- 229920000945 Amylopectin Polymers 0.000 claims 1
- 229920000856 Amylose Polymers 0.000 claims 1
- 239000001904 Arabinogalactan Substances 0.000 claims 1
- 229920000189 Arabinogalactan Polymers 0.000 claims 1
- 102100022005 B-lymphocyte antigen CD20 Human genes 0.000 claims 1
- 241000894006 Bacteria Species 0.000 claims 1
- 101710098275 C-X-C motif chemokine 10 Proteins 0.000 claims 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 1
- 229920002101 Chitin Polymers 0.000 claims 1
- 229920001661 Chitosan Polymers 0.000 claims 1
- 229920001287 Chondroitin sulfate Polymers 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
- 229920003143 Eudragit® FS 30 D Polymers 0.000 claims 1
- 229920003139 Eudragit® L 100 Polymers 0.000 claims 1
- 229920003135 Eudragit® L 100-55 Polymers 0.000 claims 1
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 claims 1
- 229920003141 Eudragit® S 100 Polymers 0.000 claims 1
- 229920003142 Eudragit® S 12,5 Polymers 0.000 claims 1
- 229920003134 Eudragit® polymer Polymers 0.000 claims 1
- 208000018522 Gastrointestinal disease Diseases 0.000 claims 1
- 229920002907 Guar gum Polymers 0.000 claims 1
- 101000897405 Homo sapiens B-lymphocyte antigen CD20 Proteins 0.000 claims 1
- 101000858088 Homo sapiens C-X-C motif chemokine 10 Proteins 0.000 claims 1
- 229920001202 Inulin Polymers 0.000 claims 1
- 229920000161 Locust bean gum Polymers 0.000 claims 1
- 102000002067 Protein Subunits Human genes 0.000 claims 1
- 239000004373 Pullulan Substances 0.000 claims 1
- 229920001218 Pullulan Polymers 0.000 claims 1
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 claims 1
- 229920000294 Resistant starch Polymers 0.000 claims 1
- 229920002305 Schizophyllan Polymers 0.000 claims 1
- UQZIYBXSHAGNOE-USOSMYMVSA-N Stachyose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@H](CO[C@@H]2[C@@H](O)[C@@H](O)[C@@H](O)[C@H](CO)O2)O1 UQZIYBXSHAGNOE-USOSMYMVSA-N 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 claims 1
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims 1
- 229940072056 alginate Drugs 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000007900 aqueous suspension Substances 0.000 claims 1
- 235000019312 arabinogalactan Nutrition 0.000 claims 1
- 210000001815 ascending colon Anatomy 0.000 claims 1
- 235000010418 carrageenan Nutrition 0.000 claims 1
- 229920001525 carrageenan Polymers 0.000 claims 1
- 239000000679 carrageenan Substances 0.000 claims 1
- 229940113118 carrageenan Drugs 0.000 claims 1
- 229920002301 cellulose acetate Polymers 0.000 claims 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 1
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- 229940059329 chondroitin sulfate Drugs 0.000 claims 1
- 210000001731 descending colon Anatomy 0.000 claims 1
- 229960002086 dextran Drugs 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 229920000578 graft copolymer Polymers 0.000 claims 1
- 239000000665 guar gum Substances 0.000 claims 1
- 235000010417 guar gum Nutrition 0.000 claims 1
- 229960002154 guar gum Drugs 0.000 claims 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 1
- 210000003405 ileum Anatomy 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 102000006495 integrins Human genes 0.000 claims 1
- 108010044426 integrins Proteins 0.000 claims 1
- JYJIGFIDKWBXDU-MNNPPOADSA-N inulin Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)OC[C@]1(OC[C@]2(OC[C@]3(OC[C@]4(OC[C@]5(OC[C@]6(OC[C@]7(OC[C@]8(OC[C@]9(OC[C@]%10(OC[C@]%11(OC[C@]%12(OC[C@]%13(OC[C@]%14(OC[C@]%15(OC[C@]%16(OC[C@]%17(OC[C@]%18(OC[C@]%19(OC[C@]%20(OC[C@]%21(OC[C@]%22(OC[C@]%23(OC[C@]%24(OC[C@]%25(OC[C@]%26(OC[C@]%27(OC[C@]%28(OC[C@]%29(OC[C@]%30(OC[C@]%31(OC[C@]%32(OC[C@]%33(OC[C@]%34(OC[C@]%35(OC[C@]%36(O[C@@H]%37[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O%37)O)[C@H]([C@H](O)[C@@H](CO)O%36)O)[C@H]([C@H](O)[C@@H](CO)O%35)O)[C@H]([C@H](O)[C@@H](CO)O%34)O)[C@H]([C@H](O)[C@@H](CO)O%33)O)[C@H]([C@H](O)[C@@H](CO)O%32)O)[C@H]([C@H](O)[C@@H](CO)O%31)O)[C@H]([C@H](O)[C@@H](CO)O%30)O)[C@H]([C@H](O)[C@@H](CO)O%29)O)[C@H]([C@H](O)[C@@H](CO)O%28)O)[C@H]([C@H](O)[C@@H](CO)O%27)O)[C@H]([C@H](O)[C@@H](CO)O%26)O)[C@H]([C@H](O)[C@@H](CO)O%25)O)[C@H]([C@H](O)[C@@H](CO)O%24)O)[C@H]([C@H](O)[C@@H](CO)O%23)O)[C@H]([C@H](O)[C@@H](CO)O%22)O)[C@H]([C@H](O)[C@@H](CO)O%21)O)[C@H]([C@H](O)[C@@H](CO)O%20)O)[C@H]([C@H](O)[C@@H](CO)O%19)O)[C@H]([C@H](O)[C@@H](CO)O%18)O)[C@H]([C@H](O)[C@@H](CO)O%17)O)[C@H]([C@H](O)[C@@H](CO)O%16)O)[C@H]([C@H](O)[C@@H](CO)O%15)O)[C@H]([C@H](O)[C@@H](CO)O%14)O)[C@H]([C@H](O)[C@@H](CO)O%13)O)[C@H]([C@H](O)[C@@H](CO)O%12)O)[C@H]([C@H](O)[C@@H](CO)O%11)O)[C@H]([C@H](O)[C@@H](CO)O%10)O)[C@H]([C@H](O)[C@@H](CO)O9)O)[C@H]([C@H](O)[C@@H](CO)O8)O)[C@H]([C@H](O)[C@@H](CO)O7)O)[C@H]([C@H](O)[C@@H](CO)O6)O)[C@H]([C@H](O)[C@@H](CO)O5)O)[C@H]([C@H](O)[C@@H](CO)O4)O)[C@H]([C@H](O)[C@@H](CO)O3)O)[C@H]([C@H](O)[C@@H](CO)O2)O)[C@@H](O)[C@H](O)[C@@H](CO)O1 JYJIGFIDKWBXDU-MNNPPOADSA-N 0.000 claims 1
- 229940029339 inulin Drugs 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- JCQLYHFGKNRPGE-FCVZTGTOSA-N lactulose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 JCQLYHFGKNRPGE-FCVZTGTOSA-N 0.000 claims 1
- 229960000511 lactulose Drugs 0.000 claims 1
- PFCRQPBOOFTZGQ-UHFFFAOYSA-N lactulose keto form Natural products OCC(=O)C(O)C(C(O)CO)OC1OC(CO)C(O)C(O)C1O PFCRQPBOOFTZGQ-UHFFFAOYSA-N 0.000 claims 1
- AIHDCSAXVMAMJH-GFBKWZILSA-N levan Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)OC[C@@H]1[C@@H](O)[C@H](O)[C@](CO)(CO[C@@H]2[C@H]([C@H](O)[C@@](O)(CO)O2)O)O1 AIHDCSAXVMAMJH-GFBKWZILSA-N 0.000 claims 1
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- 229940100467 polyvinyl acetate phthalate Drugs 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 235000019423 pullulan Nutrition 0.000 claims 1
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 235000021254 resistant starch Nutrition 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 1
- 239000007921 spray Substances 0.000 claims 1
- UQZIYBXSHAGNOE-XNSRJBNMSA-N stachyose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@@H]3[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O3)O)O2)O)O1 UQZIYBXSHAGNOE-XNSRJBNMSA-N 0.000 claims 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17192260.2A EP3459528B1 (en) | 2017-09-20 | 2017-09-20 | Preparation of solid dosage forms comprising antibodies by solution/suspension layering |
| EP17192260.2 | 2017-09-20 | ||
| JP2020515749A JP7204743B2 (ja) | 2017-09-20 | 2018-09-11 | 溶液／懸濁液層状化による抗体を含む固形剤形の調製 |
| PCT/EP2018/074520 WO2019057562A1 (en) | 2017-09-20 | 2018-09-11 | PREPARATION OF SOLID GALENIC SHAPES COMPRISING ANTIBODIES BY SOLUTION / SUSPENSION STRATIFICATION |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020515749A Division JP7204743B2 (ja) | 2017-09-20 | 2018-09-11 | 溶液／懸濁液層状化による抗体を含む固形剤形の調製 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023036901A JP2023036901A (ja) | 2023-03-14 |
| JP2023036901A5 true JP2023036901A5 (enExample) | 2023-04-03 |
Family
ID=59923358
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020515749A Active JP7204743B2 (ja) | 2017-09-20 | 2018-09-11 | 溶液／懸濁液層状化による抗体を含む固形剤形の調製 |
| JP2022211549A Pending JP2023036901A (ja) | 2017-09-20 | 2022-12-28 | 溶液／懸濁液層状化による抗体を含む固形剤形の調製 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020515749A Active JP7204743B2 (ja) | 2017-09-20 | 2018-09-11 | 溶液／懸濁液層状化による抗体を含む固形剤形の調製 |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US11826470B2 (enExample) |
| EP (2) | EP3459528B1 (enExample) |
| JP (2) | JP7204743B2 (enExample) |
| KR (2) | KR20200055711A (enExample) |
| CN (1) | CN111093635A (enExample) |
| AR (1) | AR112901A1 (enExample) |
| AU (2) | AU2018337493B2 (enExample) |
| BR (1) | BR112020005460A8 (enExample) |
| CA (1) | CA3075862A1 (enExample) |
| CL (1) | CL2020000735A1 (enExample) |
| CO (1) | CO2020003070A2 (enExample) |
| CR (2) | CR20210203A (enExample) |
| EA (1) | EA202090640A8 (enExample) |
| ES (1) | ES2938609T3 (enExample) |
| GE (2) | GEP20227351B (enExample) |
| IL (2) | IL272933B2 (enExample) |
| JO (1) | JOP20200064A1 (enExample) |
| MA (1) | MA50157A (enExample) |
| MX (1) | MX2020003032A (enExample) |
| MY (1) | MY209948A (enExample) |
| PH (1) | PH12020500353A1 (enExample) |
| SA (1) | SA520411573B1 (enExample) |
| SG (1) | SG11202002203YA (enExample) |
| TW (1) | TWI802592B (enExample) |
| UA (1) | UA129148C2 (enExample) |
| WO (1) | WO2019057562A1 (enExample) |
| ZA (2) | ZA202001752B (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3459528B1 (en) * | 2017-09-20 | 2022-11-23 | Tillotts Pharma Ag | Preparation of solid dosage forms comprising antibodies by solution/suspension layering |
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