DE19164145T1 - Schnellauflösungsformulierung einer calcium-rezeptor-aktivverbindung - Google Patents
Schnellauflösungsformulierung einer calcium-rezeptor-aktivverbindung Download PDFInfo
- Publication number
- DE19164145T1 DE19164145T1 DE19164145.5T DE19164145T DE19164145T1 DE 19164145 T1 DE19164145 T1 DE 19164145T1 DE 19164145 T DE19164145 T DE 19164145T DE 19164145 T1 DE19164145 T1 DE 19164145T1
- Authority
- DE
- Germany
- Prior art keywords
- tablet according
- weight
- tablet
- composition
- cinacalcet
- 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.)
- Pending
Links
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
- A61K31/00—Medicinal preparations containing organic active ingredients
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- 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
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
-
- 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
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Tablette, umfassend(a) von 10 Gew.-% bis 40 Gew.-% Cinacalcet HCl;(b) von 45 bis 85 Gew.-% mindestens eines Verdünnungsmittels, das aus Stärke, mikrokristalliner Cellulose, Dicalciumphosphat, Lactose, Sorbitol, Mannitol, Saccharose, Methyldextrinen und Mischungen davon ausgewählt wird; und(c) von 1 bis 5 Gew.-% mindestens eines Bindemittels; wobei der Gewichtsprozentsatz sich auf das Gesamtgewicht der Zusammensetzung bezieht; und wobei die Tablette ein Auflösungsprofil in 0,05 N HCl aufweist, das durch einen Auflösungstest bestimmt wird wird, der in einer USP 2-Apparatur bei einer Temperatur von 37°C und einer Rotationsgeschwindigkeit von 75 U/min durchgeführt wird, bei dem die Freisetzung von 50% bis 125% einer Zielmenge des Cinacalcets aus der Zusammensetzung nicht später als 30 Minuten nach Beginn des Tests erzielt wird.
Claims (13)
- Tablette, umfassend (a) von 10 Gew.-% bis 40 Gew.-% Cinacalcet HCl; (b) von 45 bis 85 Gew.-% mindestens eines Verdünnungsmittels, das aus Stärke, mikrokristalliner Cellulose, Dicalciumphosphat, Lactose, Sorbitol, Mannitol, Saccharose, Methyldextrinen und Mischungen davon ausgewählt wird; und (c) von 1 bis 5 Gew.-% mindestens eines Bindemittels; wobei der Gewichtsprozentsatz sich auf das Gesamtgewicht der Zusammensetzung bezieht; und wobei die Tablette ein Auflösungsprofil in 0,05 N HCl aufweist, das durch einen Auflösungstest bestimmt wird wird, der in einer USP 2-Apparatur bei einer Temperatur von 37°C und einer Rotationsgeschwindigkeit von 75 U/min durchgeführt wird, bei dem die Freisetzung von 50% bis 125% einer Zielmenge des Cinacalcets aus der Zusammensetzung nicht später als 30 Minuten nach Beginn des Tests erzielt wird.
- Tablette gemäß
Anspruch 1 , in der die Freisetzung von 70% bis 110% einer Zielmenge des Cinacalcets aus der Zusammensetzung nicht später als 30 Minuten nach Beginn des Tests erzielt wird. - Tablette gemäß
Anspruch 1 , in der das Bindemittel aus Povidon, Hydroxypropylmethylcellulose, Dihydroxypropylcellulose und Natriumcarboxylmethylcellulose ausgewählt wird. - Tablette gemäß
Anspruch 1 , die ferner von 0,05% bis 5% mindestens eines Additivs umfasst, das aus Gleitmitteln, Schmiermitteln und Haftmitteln ausgewählt wird, wobei sich der Gewichtsprozentsatz auf das Gesamtgewicht der Zusammensetzung bezieht. - Tablette gemäß
Anspruch 4 , in der das Gleitmittel aus einem oder mehreren von Magnesiumstearat, Calciumstearat, Stearinsäure, Glycerylbehenat, hydriertem Pflanzenöl, Glycerinfumarat ausgewählt wird. - Tablette gemäß
Anspruch 5 , in der das Gleitmittel Magnesiumstearat ist. - Tablette gemäß
Anspruch 6 , die ferner 0,05% bis 1,5% Magnesiumstearat enthält. - Tablette gemäß
Anspruch 1 , bei der das zur Herstellung der Tablette verwendete Cinacalcet HCl ein kristallines Pulver ist. - Tablette gemäß
Anspruch 1 , bei der die Teilchengröße D50 der Cinacalcet-HCl-Teilchen kleiner als oder gleich etwa 50µm ist. - Tablette gemäß
Anspruch 1 , wobei das Granulat D50 mittels Siebanalyse gemessen wird. - Tablette gemäß
Anspruch 1 , ferner umfassend 0,05 bis 1,5 Gew.-% kolloidales Siliciumdioxid, bezogen auf das Gesamtgewicht der Zusammensetzung. - Tablette gemäß
Anspruch 1 , in der das mindestens eine Sprengmittel aus Crospovidon, Natriumstärkeglycolat, Croscarmellose-Natrium und Mischungen der vorgenannten Stoffe ausgewählt wird. - Tablette gemäß
Anspruch 1 , die ferner ein Überzugsmaterial umfasst, das Hydroxypropylmethylcellulose umfasst.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US50221903P | 2003-09-12 | 2003-09-12 | |
US502219P | 2003-09-12 | ||
EP19164145.5A EP3578175B1 (de) | 2003-09-12 | 2004-09-10 | Schnellauflösungsformulierung einer calcium-rezeptor-aktivverbindung |
Publications (1)
Publication Number | Publication Date |
---|---|
DE19164145T1 true DE19164145T1 (de) | 2021-04-29 |
Family
ID=34434844
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE19164145.5T Pending DE19164145T1 (de) | 2003-09-12 | 2004-09-10 | Schnellauflösungsformulierung einer calcium-rezeptor-aktivverbindung |
Country Status (30)
Country | Link |
---|---|
US (7) | US7829595B2 (de) |
EP (8) | EP3395338B1 (de) |
JP (3) | JP5026077B2 (de) |
KR (1) | KR101332058B1 (de) |
CN (1) | CN1946382B (de) |
AR (1) | AR045637A1 (de) |
AU (1) | AU2004279318C1 (de) |
BR (2) | BR122018013029B1 (de) |
CA (1) | CA2536487C (de) |
CY (5) | CY1119609T1 (de) |
DE (1) | DE19164145T1 (de) |
DK (6) | DK3260117T3 (de) |
EA (1) | EA013425B1 (de) |
ES (7) | ES2735226T3 (de) |
HR (1) | HRP20130114T4 (de) |
HU (5) | HUE045411T2 (de) |
IL (1) | IL173737A (de) |
IS (1) | IS3027B (de) |
MX (1) | MXPA06002616A (de) |
MY (1) | MY142046A (de) |
NO (1) | NO335739B1 (de) |
NZ (1) | NZ545498A (de) |
PL (6) | PL1663182T5 (de) |
PT (6) | PT2821067T (de) |
SG (1) | SG146608A1 (de) |
SI (6) | SI3395340T1 (de) |
TR (4) | TR201910447T4 (de) |
TW (1) | TWI344363B (de) |
WO (1) | WO2005034928A1 (de) |
ZA (1) | ZA200602710B (de) |
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CN101006076B (zh) | 2004-06-24 | 2010-09-29 | 沃泰克斯药物股份有限公司 | Atp-结合弹夹转运蛋白的调控剂 |
ATE443038T1 (de) * | 2005-05-16 | 2009-10-15 | Teva Pharma | Verfahren zur herstellung von cinacalcet hydrochlorid |
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