AR071366A1 - Composiciones que comprenden drogas debilmente basicas y formas de dosificacion de liberacion controlada. metodo de preparacion. - Google Patents
Composiciones que comprenden drogas debilmente basicas y formas de dosificacion de liberacion controlada. metodo de preparacion.Info
- Publication number
- AR071366A1 AR071366A1 ARP090101326A ARP090101326A AR071366A1 AR 071366 A1 AR071366 A1 AR 071366A1 AR P090101326 A ARP090101326 A AR P090101326A AR P090101326 A ARP090101326 A AR P090101326A AR 071366 A1 AR071366 A1 AR 071366A1
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical composition
- phosphate
- magnesium
- controlled release
- sodium
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 6
- 238000013270 controlled release Methods 0.000 title abstract 5
- 239000003814 drug Substances 0.000 title abstract 3
- 239000002552 dosage form Substances 0.000 title abstract 2
- 238000002360 preparation method Methods 0.000 title abstract 2
- 229940079593 drug Drugs 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 9
- 229910019142 PO4 Inorganic materials 0.000 abstract 4
- 239000010452 phosphate Substances 0.000 abstract 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 abstract 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 abstract 3
- 239000011248 coating agent Substances 0.000 abstract 3
- 238000000576 coating method Methods 0.000 abstract 3
- 239000006174 pH buffer Substances 0.000 abstract 3
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 abstract 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 abstract 2
- 239000011777 magnesium Substances 0.000 abstract 2
- 229910052749 magnesium Inorganic materials 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 235000021317 phosphate Nutrition 0.000 abstract 2
- 229920000642 polymer Polymers 0.000 abstract 2
- SCVFZCLFOSHCOH-UHFFFAOYSA-M potassium acetate Chemical compound [K+].CC([O-])=O SCVFZCLFOSHCOH-UHFFFAOYSA-M 0.000 abstract 2
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 abstract 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 abstract 2
- VEPAPKPPDFPLAX-UHFFFAOYSA-N 1-(butylamino)-1-phenoxypropan-1-ol Chemical compound CCCCNC(O)(CC)OC1=CC=CC=C1 VEPAPKPPDFPLAX-UHFFFAOYSA-N 0.000 abstract 1
- QEMPJKLBEHDRDW-UHFFFAOYSA-N 1-phenyl-1-(propan-2-ylamino)ethane-1,2-diol Chemical compound CC(C)NC(O)(CO)C1=CC=CC=C1 QEMPJKLBEHDRDW-UHFFFAOYSA-N 0.000 abstract 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 abstract 1
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical compound [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 abstract 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 abstract 1
- QPCVHQBVMYCJOM-UHFFFAOYSA-N Propiverine Chemical compound C=1C=CC=CC=1C(C=1C=CC=CC=1)(OCCC)C(=O)OC1CCN(C)CC1 QPCVHQBVMYCJOM-UHFFFAOYSA-N 0.000 abstract 1
- 229920001800 Shellac Polymers 0.000 abstract 1
- KEAYESYHFKHZAL-UHFFFAOYSA-N Sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 abstract 1
- 239000004115 Sodium Silicate Substances 0.000 abstract 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 abstract 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 abstract 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 abstract 1
- 229910052782 aluminium Inorganic materials 0.000 abstract 1
- -1 amino ethyl oxazole azepine Chemical compound 0.000 abstract 1
- 229940054053 antipsychotics butyrophenone derivative Drugs 0.000 abstract 1
- 239000011230 binding agent Substances 0.000 abstract 1
- FFSAXUULYPJSKH-UHFFFAOYSA-N butyrophenone Chemical class CCCC(=O)C1=CC=CC=C1 FFSAXUULYPJSKH-UHFFFAOYSA-N 0.000 abstract 1
- 239000000378 calcium silicate Substances 0.000 abstract 1
- 229910052918 calcium silicate Inorganic materials 0.000 abstract 1
- 235000012241 calcium silicate Nutrition 0.000 abstract 1
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 150000001720 carbohydrates Chemical class 0.000 abstract 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 abstract 1
- KCIDZIIHRGYJAE-YGFYJFDDSA-L dipotassium;[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl] phosphate Chemical compound [K+].[K+].OC[C@H]1O[C@H](OP([O-])([O-])=O)[C@H](O)[C@@H](O)[C@H]1O KCIDZIIHRGYJAE-YGFYJFDDSA-L 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 150000002148 esters Chemical class 0.000 abstract 1
- 239000008187 granular material Substances 0.000 abstract 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 abstract 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 abstract 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 abstract 1
- UEGPKNKPLBYCNK-UHFFFAOYSA-L magnesium acetate Chemical compound [Mg+2].CC([O-])=O.CC([O-])=O UEGPKNKPLBYCNK-UHFFFAOYSA-L 0.000 abstract 1
- 239000011654 magnesium acetate Substances 0.000 abstract 1
- 235000011285 magnesium acetate Nutrition 0.000 abstract 1
- 229940069446 magnesium acetate Drugs 0.000 abstract 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 abstract 1
- 239000001095 magnesium carbonate Substances 0.000 abstract 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 abstract 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 abstract 1
- 239000000347 magnesium hydroxide Substances 0.000 abstract 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 abstract 1
- GVALZJMUIHGIMD-UHFFFAOYSA-H magnesium phosphate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O GVALZJMUIHGIMD-UHFFFAOYSA-H 0.000 abstract 1
- 239000004137 magnesium phosphate Substances 0.000 abstract 1
- 229960002261 magnesium phosphate Drugs 0.000 abstract 1
- 229910000157 magnesium phosphate Inorganic materials 0.000 abstract 1
- 235000010994 magnesium phosphates Nutrition 0.000 abstract 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 abstract 1
- 239000011859 microparticle Substances 0.000 abstract 1
- MSROGRBMHWJLSB-UHFFFAOYSA-N n-phenoxypropan-1-amine Chemical compound CCCNOC1=CC=CC=C1 MSROGRBMHWJLSB-UHFFFAOYSA-N 0.000 abstract 1
- SACAEVOKRBNXPN-UHFFFAOYSA-N n-phenyl-4,5-dihydroimidazol-1-amine Chemical compound C1=NCCN1NC1=CC=CC=C1 SACAEVOKRBNXPN-UHFFFAOYSA-N 0.000 abstract 1
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 abstract 1
- 239000004014 plasticizer Substances 0.000 abstract 1
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 abstract 1
- 235000011056 potassium acetate Nutrition 0.000 abstract 1
- 239000011736 potassium bicarbonate Substances 0.000 abstract 1
- 235000015497 potassium bicarbonate Nutrition 0.000 abstract 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 abstract 1
- 229910000027 potassium carbonate Inorganic materials 0.000 abstract 1
- 235000011181 potassium carbonates Nutrition 0.000 abstract 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 abstract 1
- 229960003510 propiverine Drugs 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000004208 shellac Substances 0.000 abstract 1
- 229940113147 shellac Drugs 0.000 abstract 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 abstract 1
- 235000013874 shellac Nutrition 0.000 abstract 1
- 239000001632 sodium acetate Substances 0.000 abstract 1
- 235000017281 sodium acetate Nutrition 0.000 abstract 1
- 229910000029 sodium carbonate Inorganic materials 0.000 abstract 1
- 235000017550 sodium carbonate Nutrition 0.000 abstract 1
- 239000001488 sodium phosphate Substances 0.000 abstract 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 abstract 1
- 229910052911 sodium silicate Inorganic materials 0.000 abstract 1
- 239000012453 solvate Substances 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
- 229910000404 tripotassium phosphate Inorganic materials 0.000 abstract 1
- 235000019798 tripotassium phosphate Nutrition 0.000 abstract 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 abstract 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 abstract 1
- 235000019801 trisodium phosphate Nutrition 0.000 abstract 1
- 229920003169 water-soluble polymer Polymers 0.000 abstract 1
Classifications
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- 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
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
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- 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
Abstract
Composiciones farmacéuticas, y métodos para hacer dichas composiciones, que comprenden micropartículas que contienen un nucleo con droga débilmente básica, una capa de amortiguador de pH alcalino, y un recubrimiento de liberacion controlada. Formas de dosificacion farmacéutica, que incluyen tabletas de desintegracion oral, tabletas convencionales, y cápsulas, y métodos para su preparacion. Reivindicacion 4: La composicion farmacéutica de la reivindicacion 1, caracterizada porque dicha droga débilmente básica se selecciona entre el grupo que consiste en derivados de butirofenona que contienen una unidad nitrogeno, fenilamino imidazolina, dihidroxifenil isopropilamino etano, fenoxi butilamino propanol, fenoxi amino propano, amino etil oxazol azepina, propiverina, una sal, solvato, polimorfo, éster de los mismos farmacéuticamente aceptables, y mezclas de los mismos. Reivindicacion 11: La composicion farmacéutica de la reivindicacion 1, caracterizada porque dicho recubrimiento de liberacion controlada además comprende un plastificante. Reivindicacion 15: La composicion farmacéutica de la reivindicacion 1, caracterizada porque dicho amortiguador de pH alcalino se selecciona entre el grupo que consiste en hidroxido de sodio, fosfato diácido monosodico, fosfato monoácido disodico, fosfato trisodico, acetato de sodio, carbonato de sodio, bicarbonato de sodio, fosfato diácido monopotásico, fosfato monoácido dipotásico, fosfato tripotásico, acetato de potasio, carbonato de potasio, bicarbonato de potasio, fosfato de magnesio, acetato de magnesio, silicato de calcio, metasilicatos complejos de magnesio y aluminio, carbonato de magnesio, oxido de magnesio, hidroxido de magnesio, silicato de sodio, y mezclas de los mismos. Reivindicacion 17: La composicion farmacéutica de la reivindicacion 1, caracterizada porque el recubrimiento de liberacion controlada además comprende un polímero soluble en agua. Reivindicacion 20: La composicion farmacéutica de la reivindicacion 1 caracterizada porque dicha capa de liberacion controlada además comprende un polímero entérico. Reivindicacion 21: La composicion farmacéutica de la reivindicacion 20, caracterizada porque dicho polímero entérico se selecciona entre el grupo que consiste en ftalato de hidroxipropil metilcelulosa, ftalato acetato de celulosa, acetato succinato de hidroxipropil metilcelulosa, ftalato de acetato de polivinilo, copolímeros de ácido metacrílico-metacrilato de metilo sensibles al pH, Shellac, y mezclas de los mismos. Reivindicacion 33: La composicion farmacéutica de la reivindicacion 1, caracterizada porque dicha capa amortiguadora de pH alcalina además comprende un aglutinante polimérico. Reivindicacion 35: La composicion farmacéutica de la reivindicacion 1, caracterizada porque dicha composicion además comprende gránulos de desintegracion rápida que comprenden un sacárido y/o azucar alcohol en combinacion con un desintegrante.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| US4517008P | 2008-04-15 | 2008-04-15 |
Publications (1)
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| AR071366A1 true AR071366A1 (es) | 2010-06-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| ARP090101326A AR071366A1 (es) | 2008-04-15 | 2009-04-15 | Composiciones que comprenden drogas debilmente basicas y formas de dosificacion de liberacion controlada. metodo de preparacion. |
Country Status (19)
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| US (1) | US20090258066A1 (es) |
| EP (1) | EP2276472B1 (es) |
| JP (2) | JP5808670B2 (es) |
| KR (1) | KR20110008036A (es) |
| CN (2) | CN106389340A (es) |
| AR (1) | AR071366A1 (es) |
| AU (1) | AU2009236271B2 (es) |
| CA (1) | CA2721083A1 (es) |
| CL (1) | CL2009000903A1 (es) |
| CO (1) | CO6300931A2 (es) |
| CR (1) | CR11740A (es) |
| IL (1) | IL208774A0 (es) |
| MX (1) | MX2010011381A (es) |
| NZ (1) | NZ588499A (es) |
| RU (1) | RU2548748C2 (es) |
| SA (1) | SA109300226B1 (es) |
| TW (1) | TWI519322B (es) |
| WO (1) | WO2009129282A1 (es) |
| ZA (1) | ZA201007294B (es) |
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- 2009-04-15 US US12/424,201 patent/US20090258066A1/en not_active Abandoned
- 2009-04-15 CN CN201610244474.XA patent/CN106389340A/zh active Pending
- 2009-04-15 EP EP09732469.3A patent/EP2276472B1/en not_active Not-in-force
- 2009-04-15 SA SA109300226A patent/SA109300226B1/ar unknown
- 2009-04-15 JP JP2011505155A patent/JP5808670B2/ja not_active Expired - Fee Related
- 2009-04-15 KR KR1020107022990A patent/KR20110008036A/ko not_active Application Discontinuation
- 2009-04-15 CA CA2721083A patent/CA2721083A1/en not_active Abandoned
- 2009-04-15 AR ARP090101326A patent/AR071366A1/es unknown
- 2009-04-15 MX MX2010011381A patent/MX2010011381A/es active IP Right Grant
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- 2009-04-15 AU AU2009236271A patent/AU2009236271B2/en not_active Ceased
- 2009-04-15 NZ NZ588499A patent/NZ588499A/xx not_active IP Right Cessation
- 2009-04-15 RU RU2010146173/15A patent/RU2548748C2/ru not_active IP Right Cessation
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Also Published As
| Publication number | Publication date |
|---|---|
| CN102006862A (zh) | 2011-04-06 |
| AU2009236271B2 (en) | 2013-10-17 |
| US20090258066A1 (en) | 2009-10-15 |
| NZ588499A (en) | 2013-01-25 |
| CL2009000903A1 (es) | 2010-03-12 |
| CR11740A (es) | 2011-01-21 |
| IL208774A0 (en) | 2010-12-30 |
| CA2721083A1 (en) | 2009-10-22 |
| RU2010146173A (ru) | 2012-05-20 |
| EP2276472B1 (en) | 2018-11-21 |
| CO6300931A2 (es) | 2011-07-21 |
| JP5808670B2 (ja) | 2015-11-10 |
| SA109300226B1 (ar) | 2014-09-02 |
| EP2276472A4 (en) | 2013-05-08 |
| ZA201007294B (en) | 2011-12-28 |
| JP2015098477A (ja) | 2015-05-28 |
| CN106389340A (zh) | 2017-02-15 |
| EP2276472A1 (en) | 2011-01-26 |
| JP2011516611A (ja) | 2011-05-26 |
| AU2009236271A1 (en) | 2009-10-22 |
| MX2010011381A (es) | 2011-03-02 |
| TWI519322B (zh) | 2016-02-01 |
| RU2548748C2 (ru) | 2015-04-20 |
| WO2009129282A1 (en) | 2009-10-22 |
| KR20110008036A (ko) | 2011-01-25 |
| TW201006509A (en) | 2010-02-16 |
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