PE20150597A1 - Preparacion farmaceutica solida que contiene levotiroxina - Google Patents
Preparacion farmaceutica solida que contiene levotiroxinaInfo
- Publication number
- PE20150597A1 PE20150597A1 PE2015000222A PE2015000222A PE20150597A1 PE 20150597 A1 PE20150597 A1 PE 20150597A1 PE 2015000222 A PE2015000222 A PE 2015000222A PE 2015000222 A PE2015000222 A PE 2015000222A PE 20150597 A1 PE20150597 A1 PE 20150597A1
- Authority
- PE
- Peru
- Prior art keywords
- solid pharmaceutical
- pharmaceutical preparation
- levothyroxin
- preparation containing
- preparation
- Prior art date
Links
- XUIIKFGFIJCVMT-LBPRGKRZSA-N L-thyroxine Chemical compound IC1=CC(C[C@H]([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-LBPRGKRZSA-N 0.000 title abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title abstract 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract 3
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 abstract 2
- 229920002261 Corn starch Polymers 0.000 abstract 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 abstract 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 abstract 1
- 108010010803 Gelatin Proteins 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 230000003078 antioxidant effect Effects 0.000 abstract 1
- 239000008120 corn starch Substances 0.000 abstract 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 abstract 1
- 239000000945 filler Substances 0.000 abstract 1
- 239000008273 gelatin Substances 0.000 abstract 1
- 229920000159 gelatin Polymers 0.000 abstract 1
- 235000019322 gelatine Nutrition 0.000 abstract 1
- 235000011852 gelatine desserts Nutrition 0.000 abstract 1
- 229960003918 levothyroxine sodium Drugs 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000473 propyl gallate Substances 0.000 abstract 1
- 235000010388 propyl gallate Nutrition 0.000 abstract 1
- 229940075579 propyl gallate Drugs 0.000 abstract 1
- 239000000600 sorbitol Substances 0.000 abstract 1
- 235000010384 tocopherol Nutrition 0.000 abstract 1
- 229960001295 tocopherol Drugs 0.000 abstract 1
- 229930003799 tocopherol Natural products 0.000 abstract 1
- 239000011732 tocopherol Substances 0.000 abstract 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—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
- A61K9/1658—Proteins, e.g. albumin, gelatin
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Referida a una preparacion farmaceutica solida que comprende levotiroxina sodica, gelatina, acido citrico y un relleno tal como manitol, almidon de maiz, sorbitol, entre otros. Ademas puede comprender un antioxidante tal como tocoferol, galato de propilo, entre otros. Tambien esta referida a un proceso para la produccion de dicha preparacion
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12005960 | 2012-08-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20150597A1 true PE20150597A1 (es) | 2015-05-06 |
Family
ID=46832170
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2015000222A PE20150597A1 (es) | 2012-08-20 | 2013-08-01 | Preparacion farmaceutica solida que contiene levotiroxina |
Country Status (34)
| Country | Link |
|---|---|
| US (2) | US20150231101A1 (es) |
| EP (1) | EP2885005B1 (es) |
| JP (1) | JP6195424B2 (es) |
| KR (1) | KR102184254B1 (es) |
| CN (1) | CN104582731B (es) |
| AR (1) | AR092151A1 (es) |
| AU (1) | AU2013304795B2 (es) |
| BR (1) | BR112015003116B1 (es) |
| CA (1) | CA2882372A1 (es) |
| CL (1) | CL2015000390A1 (es) |
| CO (1) | CO7200278A2 (es) |
| DK (1) | DK2885005T3 (es) |
| EA (1) | EA027189B1 (es) |
| EC (1) | ECSP15010550A (es) |
| ES (1) | ES2654306T3 (es) |
| HK (1) | HK1204961A1 (es) |
| HR (1) | HRP20171784T1 (es) |
| HU (1) | HUE035222T2 (es) |
| IL (1) | IL237322A0 (es) |
| LT (1) | LT2885005T (es) |
| MX (1) | MX353618B (es) |
| MY (1) | MY184400A (es) |
| NO (1) | NO2885005T3 (es) |
| NZ (1) | NZ703038A (es) |
| PE (1) | PE20150597A1 (es) |
| PH (1) | PH12014502856A1 (es) |
| PL (1) | PL2885005T3 (es) |
| PT (1) | PT2885005T (es) |
| RS (1) | RS56745B1 (es) |
| SG (1) | SG11201501122WA (es) |
| SI (1) | SI2885005T1 (es) |
| TW (1) | TWI603730B (es) |
| UA (1) | UA115247C2 (es) |
| WO (1) | WO2014029464A1 (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267220B (zh) * | 2015-05-14 | 2019-06-28 | 北京科信必成医药科技发展有限公司 | 愈创甘油醚氢溴酸右美沙芬无水吞服掩味制剂 |
| EP3576795B1 (de) * | 2017-02-03 | 2021-04-07 | Berlin-Chemie AG | Orales schilddrüsentherapeutikum |
| IT201800003615A1 (it) * | 2018-03-15 | 2019-09-15 | Altergon Sa | Formulazioni altamente stabili di ormone tiroideo in capsule molli |
| JP7312751B2 (ja) * | 2018-07-30 | 2023-07-21 | 第一三共株式会社 | 安定化剤を含有する医薬品の固形製剤 |
| CN109364043A (zh) * | 2018-12-10 | 2019-02-22 | 唐熠达 | 一种治疗甲状腺功能异常的缓控释药物组合物 |
| CN110075305A (zh) * | 2019-05-22 | 2019-08-02 | 上海葆隆生物科技有限公司 | 一种含有左甲状腺素钠的药物组合物 |
| CN115737576B (zh) * | 2022-11-14 | 2024-05-07 | 山东创新药物研发有限公司 | 一种左甲状腺素钠片剂及其制备方法 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9401879D0 (en) * | 1994-02-01 | 1994-03-30 | Boots Co Plc | Therapeutic agents |
| GB9401892D0 (en) | 1994-02-01 | 1994-03-30 | Boots Co Plc | Therapeutic agents |
| DE19541128C2 (de) | 1995-10-27 | 1997-11-27 | Henning Berlin Gmbh & Co | Stabilisierte schilddrüsenhormonhaltige Arzneimittel |
| US6017958A (en) * | 1996-06-04 | 2000-01-25 | Octamer, Inc. | Method of treating malignant tumors with thyroxine analogues having no significant hormonal activity |
| US6649186B1 (en) | 1996-09-20 | 2003-11-18 | Ethypharm | Effervescent granules and methods for their preparation |
| WO1999022719A1 (fr) * | 1997-10-30 | 1999-05-14 | Morishita Jintan Co., Ltd. | Preparation de capsule contenant un acide gras insature ou un derive de celui-ci, et procede de fabrication |
| DE19821625C1 (de) * | 1998-05-15 | 2000-01-05 | Merck Patent Gmbh | Pharmazeutische Zubereitung |
| US20030099699A1 (en) * | 2001-11-13 | 2003-05-29 | Hanshew Dwight D. | Storage stable thyroxine active drug formulations and methods for their production |
| ATE465718T1 (de) * | 2003-05-02 | 2010-05-15 | Globopharm Pharmazeutische Pro | Feste pharmazeutische zubereitung enthaltend levothyroxin- und/oder liothyroninsalze |
| US8293272B2 (en) * | 2003-05-02 | 2012-10-23 | Globopharm Pharmazeutische Produktions-Und Handelsgesellschaft M.B.H. | Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts |
| IT1395454B1 (it) * | 2009-03-24 | 2012-09-21 | Altergon Sa | Composizioni e forme farmaceutiche per somministrazione orale di ormoni tiroidei in grado di contrastare l'azione di agenti sequestranti nel tratto gastrointestinale |
| US20110206775A1 (en) * | 2010-01-27 | 2011-08-25 | Groenewoud Pieter J | Preparation of inert pharmaceutical excipients for stabilizing unstable pharmaceutical ingredients |
-
2013
- 2013-08-01 US US14/422,546 patent/US20150231101A1/en not_active Abandoned
- 2013-08-01 KR KR1020157006959A patent/KR102184254B1/ko active IP Right Grant
- 2013-08-01 UA UAA201502393A patent/UA115247C2/uk unknown
- 2013-08-01 NO NO13747642A patent/NO2885005T3/no unknown
- 2013-08-01 RS RS20171340A patent/RS56745B1/sr unknown
- 2013-08-01 MY MYPI2015700450A patent/MY184400A/en unknown
- 2013-08-01 LT LTEP13747642.0T patent/LT2885005T/lt unknown
- 2013-08-01 CN CN201380042787.1A patent/CN104582731B/zh not_active Ceased
- 2013-08-01 ES ES13747642.0T patent/ES2654306T3/es active Active
- 2013-08-01 BR BR112015003116-1A patent/BR112015003116B1/pt active IP Right Grant
- 2013-08-01 SG SG11201501122WA patent/SG11201501122WA/en unknown
- 2013-08-01 EP EP13747642.0A patent/EP2885005B1/en active Active
- 2013-08-01 DK DK13747642.0T patent/DK2885005T3/en active
- 2013-08-01 SI SI201330892T patent/SI2885005T1/en unknown
- 2013-08-01 PL PL13747642T patent/PL2885005T3/pl unknown
- 2013-08-01 CA CA2882372A patent/CA2882372A1/en not_active Withdrawn
- 2013-08-01 EA EA201500245A patent/EA027189B1/ru not_active IP Right Cessation
- 2013-08-01 PE PE2015000222A patent/PE20150597A1/es active IP Right Grant
- 2013-08-01 NZ NZ703038A patent/NZ703038A/en unknown
- 2013-08-01 AU AU2013304795A patent/AU2013304795B2/en active Active
- 2013-08-01 HU HUE13747642A patent/HUE035222T2/hu unknown
- 2013-08-01 JP JP2015527806A patent/JP6195424B2/ja active Active
- 2013-08-01 MX MX2015001930A patent/MX353618B/es active IP Right Grant
- 2013-08-01 WO PCT/EP2013/002293 patent/WO2014029464A1/en active Application Filing
- 2013-08-01 PT PT137476420T patent/PT2885005T/pt unknown
- 2013-08-16 AR ARP130102913A patent/AR092151A1/es unknown
- 2013-08-19 TW TW102129710A patent/TWI603730B/zh active
-
2014
- 2014-12-22 PH PH12014502856A patent/PH12014502856A1/en unknown
-
2015
- 2015-02-18 CL CL2015000390A patent/CL2015000390A1/es unknown
- 2015-02-19 IL IL237322A patent/IL237322A0/en active IP Right Grant
- 2015-02-19 CO CO15036115A patent/CO7200278A2/es unknown
- 2015-03-19 EC ECIEPI201510550A patent/ECSP15010550A/es unknown
- 2015-06-16 HK HK15105713.8A patent/HK1204961A1/xx unknown
-
2017
- 2017-07-10 US US15/645,436 patent/US11298331B2/en active Active
- 2017-11-16 HR HRP20171784TT patent/HRP20171784T1/hr unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant, registration |