AR101116A1 - Formas de dosificación farmacéuticas para administración oral - Google Patents
Formas de dosificación farmacéuticas para administración oralInfo
- Publication number
- AR101116A1 AR101116A1 ARP150102160A ARP150102160A AR101116A1 AR 101116 A1 AR101116 A1 AR 101116A1 AR P150102160 A ARP150102160 A AR P150102160A AR P150102160 A ARP150102160 A AR P150102160A AR 101116 A1 AR101116 A1 AR 101116A1
- Authority
- AR
- Argentina
- Prior art keywords
- weight
- pharmaceutical dosage
- dosage form
- drug
- microcrystalline cellulose
- Prior art date
Links
Classifications
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/45—Non condensed piperidines, e.g. piperocaine having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- A61K9/2036—Silicones; Polysiloxanes
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K9/2806—Coating materials
-
- 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
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/46—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of glucocorticosteroids
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Diabetes (AREA)
- Urology & Nephrology (AREA)
- Endocrinology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Reivindicación 1: Una forma de dosificación farmacéutica para administración oral que comprende (a) el fármaco 4-[(5R)-6,7-dihidro-5H-pirrolo[1,2-c]imidazol-5-il]-3-fluorobenzonitrilo como se define por la fórmula [1] o cualquier sal farmacéuticamente aceptable del mismo, y (b) al menos 30% por peso de celulosa microcristalina con base en el peso total de dicha forma de dosificación farmacéutica. Reivindicación 3: La forma de dosificación farmacéutica según cualquiera de las reivindicaciones anteriores, en donde dicho fármaco está presente como sal de fosfato, preferiblemente como sal de mono-fosfato. Reivindicación 11: La forma de dosificación farmacéutica según cualquiera de las reivindicaciones anteriores que comprende: (a) 4 ± 1%, calculado con base a su base libre, por peso del fármaco 4-[(5R)-6,7-dihidro-5H-pirrolo[1,2-c]imidazol-5-il]-3-fluorobenzonitrilo presente como sal de monofosfato, (b) 77 ± 7% por peso de la celulosa microcristalina, (c) 0.6 ± 0.2% por peso de dióxido de silicio coloidal, (b) 10 ± 2% por peso de manitol, y opcionalmente que comprende además: (e) 2 ± 0.5% por peso de un agente disgregante, preferiblemente croscarmelosa de sodio, y (f) 1.5 ± 0.5%, por peso de un lubricante, preferiblemente estearato de magnesio con base en el peso total de dicha forma de dosificación farmacéutica. Reivindicación 15: El proceso según las reivindicaciones 12 a 14 caracterizado además por los siguientes pasos del proceso: (1) mezclar el fármaco junto con la celulosa microcristalina y opcionalmente ingredientes adicionales tales como un agente deslizante, un agente disgregante. y un agente lubricante, para obtener una mezcla compactable por máquina, (2) compactar la mezcla compactable por máquina mediante granulación en seco, preferiblemente mediante compactación con rodillo, para obtener un material compactado, (3) mezclar el material compactado con dióxido de silicio coloidal, y opcionalmente con ingredientes adicionales tales como celulosa microcristalina, manitol, un agente disgregante, y un lubricante, para obtener una mezcla comprensible por máquina, (4) comprimir la mezcla comprensible por máquina mediante el uso de una máquina de formación de comprimidos para obtener los comprimidos. Reivindicación 17: El uso de celulosa microcristalina para transformar el fármaco 4-[(5R)-6,7-dihidro-5H-pirrolo[1,2-c]imidazol-5 il]-3-fluorobenzonitrilo en un material farmacéuticamente procesable. Reivindicación 18: Una forma de dosificación farmacéutica según cualquiera de las reivindicaciones 1 - 11 o la reivindicación 16 para uso en el tratamiento de la enfermedad de Cushing o síndrome de Cushing.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462021271P | 2014-07-07 | 2014-07-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR101116A1 true AR101116A1 (es) | 2016-11-23 |
Family
ID=53610933
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150102160A AR101116A1 (es) | 2014-07-07 | 2015-07-06 | Formas de dosificación farmacéuticas para administración oral |
Country Status (29)
| Country | Link |
|---|---|
| US (2) | US10143680B2 (es) |
| EP (2) | EP3166596B1 (es) |
| JP (2) | JP6731136B2 (es) |
| KR (1) | KR102468610B1 (es) |
| CN (1) | CN106470704B (es) |
| AR (1) | AR101116A1 (es) |
| AU (1) | AU2015287336B2 (es) |
| BR (1) | BR112016030243B1 (es) |
| CA (1) | CA2954393C (es) |
| CL (1) | CL2017000026A1 (es) |
| CY (1) | CY1120749T1 (es) |
| DK (1) | DK3166596T3 (es) |
| EA (2) | EA201991359A1 (es) |
| EC (1) | ECSP17008187A (es) |
| ES (1) | ES2686704T3 (es) |
| HR (1) | HRP20181406T1 (es) |
| HU (1) | HUE039037T2 (es) |
| IL (1) | IL249374B (es) |
| LT (1) | LT3166596T (es) |
| MX (1) | MX2016017315A (es) |
| PE (1) | PE20170201A1 (es) |
| PH (1) | PH12016502540A1 (es) |
| PL (1) | PL3166596T3 (es) |
| PT (1) | PT3166596T (es) |
| SG (1) | SG11201610227TA (es) |
| SI (1) | SI3166596T1 (es) |
| TN (1) | TN2016000557A1 (es) |
| TW (1) | TWI707682B (es) |
| WO (1) | WO2016005880A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2020011471A (es) | 2018-05-03 | 2020-12-07 | Damian Pharma Ag | R-fadrozol para usar en el tratamiento de aldosteronismo. |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070191487A1 (en) | 2004-03-17 | 2007-08-16 | Rigassi-Dietrich Petra G | Galenic formulations of organic compounds |
| GT200600381A (es) * | 2005-08-25 | 2007-03-28 | Compuestos organicos | |
| TW200900094A (en) * | 2007-03-13 | 2009-01-01 | Takeda Pharmaceutical | Solid preparation |
| SG182393A1 (en) * | 2010-01-14 | 2012-08-30 | Novartis Ag | Use of an adrenal hormone-modifying agent |
| US20120064157A1 (en) * | 2010-08-27 | 2012-03-15 | Vertex Pharmaceuticals Incorporated | Pharmaceutical composition and administrations thereof |
| WO2013036563A1 (en) * | 2011-09-08 | 2013-03-14 | Novartis Ag | Pharmaceutical compositions comprising an aromatase inhibitor |
| JP5749410B2 (ja) | 2012-01-17 | 2015-07-15 | ノバルティス アーゲー | ジヒドロピロロ［１，２−ｃ］イミダゾリルアルドステロンシンターゼまたはアロマターゼ阻害薬の新たな形態および塩 |
| WO2013126326A1 (en) | 2012-02-21 | 2013-08-29 | Celgene Corporation | Solid forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, compositions and methods of use thereof |
| IN2014DN09240A (es) * | 2012-04-12 | 2015-07-10 | Novartis Ag | |
| EP2815749A1 (en) * | 2013-06-20 | 2014-12-24 | IP Gesellschaft für Management mbH | Solid form of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione having specified X-ray diffraction pattern |
-
2015
- 2015-07-06 US US15/323,991 patent/US10143680B2/en active Active
- 2015-07-06 DK DK15738484.3T patent/DK3166596T3/en active
- 2015-07-06 PE PE2016002812A patent/PE20170201A1/es not_active Application Discontinuation
- 2015-07-06 CN CN201580036746.0A patent/CN106470704B/zh active Active
- 2015-07-06 HU HUE15738484A patent/HUE039037T2/hu unknown
- 2015-07-06 AR ARP150102160A patent/AR101116A1/es not_active Application Discontinuation
- 2015-07-06 MX MX2016017315A patent/MX2016017315A/es active IP Right Grant
- 2015-07-06 WO PCT/IB2015/055098 patent/WO2016005880A1/en active Application Filing
- 2015-07-06 EP EP15738484.3A patent/EP3166596B1/en active Active
- 2015-07-06 EA EA201991359A patent/EA201991359A1/ru unknown
- 2015-07-06 AU AU2015287336A patent/AU2015287336B2/en active Active
- 2015-07-06 LT LTEP15738484.3T patent/LT3166596T/lt unknown
- 2015-07-06 CA CA2954393A patent/CA2954393C/en active Active
- 2015-07-06 PL PL15738484T patent/PL3166596T3/pl unknown
- 2015-07-06 TN TN2016000557A patent/TN2016000557A1/en unknown
- 2015-07-06 SI SI201530377T patent/SI3166596T1/sl unknown
- 2015-07-06 TW TW104121894A patent/TWI707682B/zh active
- 2015-07-06 PT PT15738484T patent/PT3166596T/pt unknown
- 2015-07-06 BR BR112016030243-5A patent/BR112016030243B1/pt active IP Right Grant
- 2015-07-06 KR KR1020177000218A patent/KR102468610B1/ko active IP Right Grant
- 2015-07-06 SG SG11201610227TA patent/SG11201610227TA/en unknown
- 2015-07-06 EA EA201790140A patent/EA033685B1/ru not_active IP Right Cessation
- 2015-07-06 ES ES15738484.3T patent/ES2686704T3/es active Active
- 2015-07-06 EP EP18176177.6A patent/EP3412278A1/en not_active Withdrawn
- 2015-07-06 JP JP2017500904A patent/JP6731136B2/ja active Active
-
2016
- 2016-12-04 IL IL249374A patent/IL249374B/en unknown
- 2016-12-19 PH PH12016502540A patent/PH12016502540A1/en unknown
-
2017
- 2017-01-06 CL CL2017000026A patent/CL2017000026A1/es unknown
- 2017-02-10 EC ECIEPI20178187A patent/ECSP17008187A/es unknown
-
2018
- 2018-08-30 HR HRP20181406TT patent/HRP20181406T1/hr unknown
- 2018-09-05 CY CY181100925T patent/CY1120749T1/el unknown
- 2018-10-30 US US16/175,082 patent/US10709691B2/en active Active
-
2019
- 2019-06-25 JP JP2019117118A patent/JP2019194221A/ja active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |