EA003161B1 - Способ получения покрытых гранул со скрытым вкусом и немедленным высвобождением активного ингредиента - Google Patents
Способ получения покрытых гранул со скрытым вкусом и немедленным высвобождением активного ингредиента Download PDFInfo
- Publication number
- EA003161B1 EA003161B1 EA200200136A EA200200136A EA003161B1 EA 003161 B1 EA003161 B1 EA 003161B1 EA 200200136 A EA200200136 A EA 200200136A EA 200200136 A EA200200136 A EA 200200136A EA 003161 B1 EA003161 B1 EA 003161B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- mixture
- coating
- coated granules
- coated
- granules
- Prior art date
Links
- 239000007931 coated granule Substances 0.000 title claims abstract description 59
- 238000000034 method Methods 0.000 title claims abstract description 47
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 25
- 239000000203 mixture Substances 0.000 claims abstract description 72
- 239000011248 coating agent Substances 0.000 claims abstract description 59
- 238000000576 coating method Methods 0.000 claims abstract description 44
- 239000003826 tablet Substances 0.000 claims abstract description 39
- 239000008187 granular material Substances 0.000 claims abstract description 37
- 238000005469 granulation Methods 0.000 claims abstract description 34
- 230000003179 granulation Effects 0.000 claims abstract description 34
- 239000000725 suspension Substances 0.000 claims abstract description 29
- 239000002245 particle Substances 0.000 claims abstract description 27
- 229920000642 polymer Polymers 0.000 claims abstract description 25
- 235000003599 food sweetener Nutrition 0.000 claims abstract description 23
- 239000003765 sweetening agent Substances 0.000 claims abstract description 23
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 21
- 239000000843 powder Substances 0.000 claims abstract description 21
- 238000005507 spraying Methods 0.000 claims abstract description 21
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000011230 binding agent Substances 0.000 claims abstract description 15
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims abstract description 14
- 108010011485 Aspartame Proteins 0.000 claims abstract description 13
- 239000001856 Ethyl cellulose Substances 0.000 claims abstract description 13
- 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 abstract description 13
- 239000000605 aspartame Substances 0.000 claims abstract description 13
- 235000010357 aspartame Nutrition 0.000 claims abstract description 13
- 229960003438 aspartame Drugs 0.000 claims abstract description 13
- 239000007884 disintegrant Substances 0.000 claims abstract description 13
- 235000019325 ethyl cellulose Nutrition 0.000 claims abstract description 13
- 229920001249 ethyl cellulose Polymers 0.000 claims abstract description 13
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims abstract description 12
- 239000012528 membrane Substances 0.000 claims abstract description 12
- 229920000058 polyacrylate Polymers 0.000 claims abstract description 12
- 229960000913 crospovidone Drugs 0.000 claims abstract description 10
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims abstract description 10
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims abstract description 10
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 10
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 8
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- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 6
- 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 abstract description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 6
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- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 5
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- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 5
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 4
- 229920001577 copolymer Polymers 0.000 claims abstract description 4
- 239000007919 dispersible tablet Substances 0.000 claims abstract description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 4
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- 229940069328 povidone Drugs 0.000 claims abstract description 4
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims abstract description 3
- 238000001035 drying Methods 0.000 claims abstract description 3
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims abstract description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 3
- 125000005395 methacrylic acid group Chemical group 0.000 claims abstract 2
- ITVGXXMINPYUHD-CUVHLRMHSA-N neohesperidin dihydrochalcone Chemical compound C1=C(O)C(OC)=CC=C1CCC(=O)C(C(=C1)O)=C(O)C=C1O[C@H]1[C@H](O[C@H]2[C@@H]([C@H](O)[C@@H](O)[C@H](C)O2)O)[C@@H](O)[C@H](O)[C@@H](CO)O1 ITVGXXMINPYUHD-CUVHLRMHSA-N 0.000 claims abstract 2
- 239000003795 chemical substances by application Substances 0.000 claims description 57
- 239000004480 active ingredient Substances 0.000 claims description 54
- 239000000654 additive Substances 0.000 claims description 27
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- 239000007921 spray Substances 0.000 claims description 11
- 239000011247 coating layer Substances 0.000 claims description 5
- 230000006378 damage Effects 0.000 claims description 5
- -1 granulation Substances 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- ARGKVCXINMKCAZ-UHFFFAOYSA-N neohesperidine Natural products C1=C(O)C(OC)=CC=C1C1OC2=CC(OC3C(C(O)C(O)C(CO)O3)OC3C(C(O)C(O)C(C)O3)O)=CC(O)=C2C(=O)C1 ARGKVCXINMKCAZ-UHFFFAOYSA-N 0.000 claims 1
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical class [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 claims 1
- 235000011151 potassium sulphates Nutrition 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 230000008569 process Effects 0.000 abstract description 17
- 229920002678 cellulose Polymers 0.000 abstract description 4
- 239000001913 cellulose Substances 0.000 abstract description 4
- 235000010980 cellulose Nutrition 0.000 abstract description 4
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 abstract description 3
- 239000011591 potassium Substances 0.000 abstract description 3
- 229910052700 potassium Inorganic materials 0.000 abstract description 3
- ILRKKHJEINIICQ-OOFFSTKBSA-N Monoammonium glycyrrhizinate Chemical compound N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O ILRKKHJEINIICQ-OOFFSTKBSA-N 0.000 abstract description 2
- 229940117841 methacrylic acid copolymer Drugs 0.000 abstract description 2
- 229920003145 methacrylic acid copolymer Polymers 0.000 abstract description 2
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 abstract description 2
- 235000000346 sugar Nutrition 0.000 abstract description 2
- 150000008163 sugars Chemical class 0.000 abstract description 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 8
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- 239000000879 neohesperidine DC Substances 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 description 17
- 230000001066 destructive effect Effects 0.000 description 16
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 9
- 229960001680 ibuprofen Drugs 0.000 description 9
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 8
- 229960002472 eletriptan Drugs 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- OTLDLQZJRFYOJR-LJQANCHMSA-N eletriptan Chemical compound CN1CCC[C@@H]1CC1=CN=C2[C]1C=C(CCS(=O)(=O)C=1C=CC=CC=1)C=C2 OTLDLQZJRFYOJR-LJQANCHMSA-N 0.000 description 7
- 229960001233 pregabalin Drugs 0.000 description 7
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- AYXYPKUFHZROOJ-ZETCQYMHSA-N pregabalin Chemical compound CC(C)C[C@H](CN)CC(O)=O AYXYPKUFHZROOJ-ZETCQYMHSA-N 0.000 description 6
- 229920002785 Croscarmellose sodium Polymers 0.000 description 5
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- 235000019441 ethanol Nutrition 0.000 description 4
- 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 3
- 229930195725 Mannitol Natural products 0.000 description 3
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- 150000003839 salts Chemical class 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
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- 229920000178 Acrylic resin Polymers 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 240000004670 Glycyrrhiza echinata Species 0.000 description 1
- 235000001453 Glycyrrhiza echinata Nutrition 0.000 description 1
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- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
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- 230000002378 acidificating effect Effects 0.000 description 1
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- 235000013355 food flavoring agent Nutrition 0.000 description 1
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- 238000000265 homogenisation Methods 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
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- 229940039042 pregabalin 150 mg Drugs 0.000 description 1
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- 229910052623 talc Inorganic materials 0.000 description 1
- 239000006211 transdermal dosage form Substances 0.000 description 1
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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
- Y10T428/2991—Coated
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
- Y10T428/2991—Coated
- Y10T428/2998—Coated including synthetic resin or polymer
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Seasonings (AREA)
- General Preparation And Processing Of Foods (AREA)
- Formation And Processing Of Food Products (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9909047A FR2795962B1 (fr) | 1999-07-08 | 1999-07-08 | Procede de fabrication de granules enrobes a gout masque et liberation immediate du principe actif |
| PCT/FR2000/001855 WO2001003672A1 (fr) | 1999-07-08 | 2000-06-30 | Procede de fabrication de granules enrobes a gout masque et liberation immediate du principe actif |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA200200136A1 EA200200136A1 (ru) | 2002-06-27 |
| EA003161B1 true EA003161B1 (ru) | 2003-02-27 |
Family
ID=9548029
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA200200136A EA003161B1 (ru) | 1999-07-08 | 2000-06-30 | Способ получения покрытых гранул со скрытым вкусом и немедленным высвобождением активного ингредиента |
Country Status (31)
| Country | Link |
|---|---|
| US (1) | US6660382B2 (enExample) |
| EP (1) | EP1194125B1 (enExample) |
| JP (1) | JP4749639B2 (enExample) |
| KR (1) | KR100767928B1 (enExample) |
| CN (1) | CN1220485C (enExample) |
| AT (1) | ATE360412T1 (enExample) |
| AU (1) | AU760006B2 (enExample) |
| BG (1) | BG65615B1 (enExample) |
| BR (1) | BR0012250A (enExample) |
| CA (1) | CA2375600C (enExample) |
| CY (1) | CY1107695T1 (enExample) |
| CZ (1) | CZ300154B6 (enExample) |
| DE (1) | DE60034565T2 (enExample) |
| DK (1) | DK1194125T3 (enExample) |
| DZ (1) | DZ3257A1 (enExample) |
| EA (1) | EA003161B1 (enExample) |
| ES (1) | ES2284507T3 (enExample) |
| FR (1) | FR2795962B1 (enExample) |
| HK (1) | HK1049119B (enExample) |
| HU (1) | HU229568B1 (enExample) |
| IL (2) | IL147212A0 (enExample) |
| MA (1) | MA25426A1 (enExample) |
| MX (1) | MXPA01013354A (enExample) |
| NO (1) | NO331256B1 (enExample) |
| NZ (1) | NZ516594A (enExample) |
| PL (1) | PL201782B1 (enExample) |
| PT (1) | PT1194125E (enExample) |
| SK (1) | SK287322B6 (enExample) |
| TR (1) | TR200200013T2 (enExample) |
| WO (1) | WO2001003672A1 (enExample) |
| ZA (1) | ZA200200344B (enExample) |
Families Citing this family (60)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8071128B2 (en) | 1996-06-14 | 2011-12-06 | Kyowa Hakko Kirin Co., Ltd. | Intrabuccally rapidly disintegrating tablet and a production method of the tablets |
| US20030203036A1 (en) | 2000-03-17 | 2003-10-30 | Gordon Marc S. | Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients |
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1999
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