HRP20200642T1 - Čvrsti obrazac za doziranje koji sadrži mikronizirani citizin - Google Patents
Čvrsti obrazac za doziranje koji sadrži mikronizirani citizin Download PDFInfo
- Publication number
- HRP20200642T1 HRP20200642T1 HRP20200642TT HRP20200642T HRP20200642T1 HR P20200642 T1 HRP20200642 T1 HR P20200642T1 HR P20200642T T HRP20200642T T HR P20200642TT HR P20200642 T HRP20200642 T HR P20200642T HR P20200642 T1 HRP20200642 T1 HR P20200642T1
- Authority
- HR
- Croatia
- Prior art keywords
- microcrystalline cellulose
- phase
- micronized
- dosage form
- solid dosage
- Prior art date
Links
- 239000007909 solid dosage form Substances 0.000 title claims 3
- ANJTVLIZGCUXLD-BDAKNGLRSA-N (-)-Cytisine Natural products C1NC[C@@H]2CN3C(=O)C=CC=C3[C@H]1C2 ANJTVLIZGCUXLD-BDAKNGLRSA-N 0.000 title 1
- ANJTVLIZGCUXLD-DTWKUNHWSA-N cytisine Chemical compound C1NC[C@H]2CN3C(=O)C=CC=C3[C@@H]1C2 ANJTVLIZGCUXLD-DTWKUNHWSA-N 0.000 title 1
- 229940027564 cytisine Drugs 0.000 title 1
- 229930017327 cytisine Natural products 0.000 title 1
- ANJTVLIZGCUXLD-UHFFFAOYSA-N ent-cytisine Natural products C1NCC2CN3C(=O)C=CC=C3C1C2 ANJTVLIZGCUXLD-UHFFFAOYSA-N 0.000 title 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 5
- 238000000034 method Methods 0.000 claims 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims 2
- 239000007902 hard capsule Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- JMEVHYCNAPFOAB-UHFFFAOYSA-N 2-(3-hydroxy-5-sulfo-1H-indol-2-yl)-3-oxoindole-5-sulfonic acid Chemical compound Oc1c([nH]c2ccc(cc12)S(O)(=O)=O)C1=Nc2ccc(cc2C1=O)S(O)(=O)=O JMEVHYCNAPFOAB-UHFFFAOYSA-N 0.000 claims 1
- 229920002101 Chitin Polymers 0.000 claims 1
- 108091005960 Citrine Proteins 0.000 claims 1
- 229920002261 Corn starch Polymers 0.000 claims 1
- 241000016879 Cytinus hypocistis Species 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000011035 citrine Substances 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 239000008120 corn starch Substances 0.000 claims 1
- 238000005538 encapsulation Methods 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 235000012738 indigotine Nutrition 0.000 claims 1
- 239000004179 indigotine Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 235000012054 meals Nutrition 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 235000010215 titanium dioxide Nutrition 0.000 claims 1
- 239000004408 titanium dioxide Substances 0.000 claims 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Addiction (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (4)
1. Čvrsti oblik doziranja koji sadrži citin i pomoćne tvari, naznačen time, da sadrži od 0,1% do 5% mikronizirani citrin, gdje sve molekule imaju promjer manji od 10 mm, kukuruzni škrob od 40% do 60% pri čemu je 99,9% čestica veličine od 5 mm do 25 mm, mikrokristalna celuloza u količini od 40% do 60%, pri čemu veličina čestica je: 99% manja od 38 mm, pri čemu je maseni odnos aktivnog sastojka i pomoćnih tvari od 1:19 do 1: 999 i u obliku je tvrde kapsule.
2. Čvrsti oblik doziranja prema zahtjevu 1, naznačen time, da sadrži koloidni silicijev dioksid u količini od 0,4% kao i magnezijev stearat, a kapsula sadrži želatinu, titanov dioksid i indigotin
3. Postupak dobivanja tvrde kapsule koja sadrži citin, prema patentnom zahtjevu 1 ili 2, naznačen time, da obuhvaća:
a) miješanje mikroniziranog citinusa s porcijom, poželjno od 0,70% do 0,90%, mikrokristalne celuloze potreban za cijeli postupak,
b) miješanje nastale smjese iz faze a) sa obrokom, poželjno od 12% do 16% preostale količine mikrokristalne celuloze potrebne za cijeli postupak,
c) miješanje smjese iz faze b) s preostalom količinom mikrokristalne celuloze potrebne za cijeli postupak kao i preostale pomoćne tvari do homogenosti;
d) kapsulacija.
4. Postupak prema zahtjevu 3, naznačen time, da u fazi a) 0,79%, a u fazi b) 14,4% mikroniziranog mikrokristalna celuloza se miješa.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL401676A PL220354B1 (pl) | 2012-11-19 | 2012-11-19 | Stała postać dawkowania zawierająca zmikronizowaną cytyzynę oraz sposób jej otrzymywania |
| EP13826599.6A EP2919761B1 (en) | 2012-11-19 | 2013-11-19 | Solid dosage form comprising micronized cytisine |
| PCT/IB2013/060230 WO2014076680A1 (en) | 2012-11-19 | 2013-11-19 | Solid dosage form comprising micronized cytisine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200642T1 true HRP20200642T1 (hr) | 2020-09-04 |
Family
ID=50730669
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200642TT HRP20200642T1 (hr) | 2012-11-19 | 2020-04-15 | Čvrsti obrazac za doziranje koji sadrži mikronizirani citizin |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US9387172B2 (hr) |
| EP (1) | EP2919761B1 (hr) |
| AU (1) | AU2013346363B2 (hr) |
| CL (1) | CL2015001343A1 (hr) |
| CY (1) | CY1122947T1 (hr) |
| DK (1) | DK2919761T3 (hr) |
| ES (1) | ES2793527T3 (hr) |
| HR (1) | HRP20200642T1 (hr) |
| HU (1) | HUE048912T2 (hr) |
| LT (1) | LT2919761T (hr) |
| NZ (1) | NZ708199A (hr) |
| PL (1) | PL220354B1 (hr) |
| PT (1) | PT2919761T (hr) |
| RS (1) | RS60249B1 (hr) |
| SI (1) | SI2919761T1 (hr) |
| WO (1) | WO2014076680A1 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL408608A1 (pl) | 2014-06-18 | 2015-12-21 | Pharmacia Polonica Spółka Z Ograniczoną Odpowiedzialnością | Trwała stała kompozycja farmaceutyczna cytyzyny oraz sposób jej wytwarzania |
| GB201602145D0 (en) * | 2016-02-05 | 2016-03-23 | Achieve Pharma Uk Ltd | Salt |
| CN111278826A (zh) * | 2017-07-24 | 2020-06-12 | 英国雅琪制药有限公司 | 野靛碱盐 |
| EP3598968A1 (en) | 2018-07-23 | 2020-01-29 | Adamed Pharma S.A. | Solid pharmaceutical cytisine composition |
| BG67408B1 (bg) * | 2019-04-12 | 2022-01-17 | Софарма Ад | Перорален лекарствен състав с растителен алкалоид, за лечение на зависимости |
| PL444090A1 (pl) * | 2023-03-16 | 2024-09-23 | Uniwersytet Rzeszowski | Polimerowe kompozycje z cytyzyną oraz sposób ich wytwarzania |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BG65536B1 (bg) | 2004-04-16 | 2008-11-28 | "Софарма" Ад | Лекарствена форма, съдържаща цитизин |
| US20060211649A1 (en) | 2005-03-21 | 2006-09-21 | Eric Marchewitz | Use of cytisine for enhancing physical performance |
| AU2009303979A1 (en) | 2008-10-14 | 2010-04-22 | Mcneil Ab | Multi portion intra-oral dosage form and use thereof |
| EP2233134A1 (en) | 2009-03-27 | 2010-09-29 | McNeil AB | Multi-portion intra-oral dosage form with organoleptic properties |
-
2012
- 2012-11-19 PL PL401676A patent/PL220354B1/pl unknown
-
2013
- 2013-11-19 RS RS20200483A patent/RS60249B1/sr unknown
- 2013-11-19 DK DK13826599.6T patent/DK2919761T3/da active
- 2013-11-19 SI SI201331712T patent/SI2919761T1/sl unknown
- 2013-11-19 ES ES13826599T patent/ES2793527T3/es active Active
- 2013-11-19 HU HUE13826599A patent/HUE048912T2/hu unknown
- 2013-11-19 PT PT138265996T patent/PT2919761T/pt unknown
- 2013-11-19 US US14/443,584 patent/US9387172B2/en active Active
- 2013-11-19 LT LTEP13826599.6T patent/LT2919761T/lt unknown
- 2013-11-19 EP EP13826599.6A patent/EP2919761B1/en active Active
- 2013-11-19 AU AU2013346363A patent/AU2013346363B2/en active Active
- 2013-11-19 NZ NZ708199A patent/NZ708199A/en unknown
- 2013-11-19 WO PCT/IB2013/060230 patent/WO2014076680A1/en active Application Filing
-
2015
- 2015-05-18 CL CL2015001343A patent/CL2015001343A1/es unknown
-
2020
- 2020-04-15 HR HRP20200642TT patent/HRP20200642T1/hr unknown
- 2020-04-15 CY CY20201100355T patent/CY1122947T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014076680A1 (en) | 2014-05-22 |
| DK2919761T3 (da) | 2020-11-02 |
| EP2919761B1 (en) | 2020-01-15 |
| SI2919761T1 (sl) | 2020-08-31 |
| AU2013346363A1 (en) | 2015-06-11 |
| EP2919761A1 (en) | 2015-09-23 |
| AU2013346363B2 (en) | 2018-08-09 |
| RS60249B1 (sr) | 2020-06-30 |
| PT2919761T (pt) | 2020-05-18 |
| PL220354B1 (pl) | 2015-10-30 |
| US20150342884A1 (en) | 2015-12-03 |
| NZ708199A (en) | 2018-10-26 |
| LT2919761T (lt) | 2020-05-25 |
| CY1122947T1 (el) | 2021-10-29 |
| PL401676A1 (pl) | 2014-05-26 |
| HUE048912T2 (hu) | 2020-08-28 |
| ES2793527T3 (es) | 2020-11-16 |
| US9387172B2 (en) | 2016-07-12 |
| CL2015001343A1 (es) | 2015-10-23 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| HRP20200642T1 (hr) | Čvrsti obrazac za doziranje koji sadrži mikronizirani citizin | |
| BR112015023629A2 (pt) | formulação de acetato de abiraterona | |
| MX349106B (es) | Forma de dosificacion solida oral que contiene nanoparticulas y proceso para su formulacion utilizando gelatina de pescado. | |
| FI3482771T3 (fi) | Maapähkinäformulaatioiden valmistaminen oraaliseen siedätyshoitoon | |
| EA201692388A1 (ru) | Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы | |
| TN2015000395A1 (en) | Respirable agglomerates of porous carrier particles and micronized drug | |
| WO2013132457A3 (en) | Nanocrystalline solid dispersion compositions and process of preparation thereof | |
| NZ602442A (en) | A fast dissolving pharmaceutical composition | |
| WO2012053785A3 (ko) | 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛 | |
| JP2012236834A5 (hr) | ||
| HRP20171266T1 (hr) | Čvrsti dozni oblik koji sadrži hidroksialkilcelulozu niskog viskoziteta | |
| MX2018000546A (es) | Composiciones farmaceuticas que contienen celecoxib y tramadol. | |
| HRP20161624T1 (hr) | Produkt ko-mikronizacije koji sadrži ulipristal acetat | |
| MX2017013636A (es) | Combinacion de dosis fija resistente a la manipulacion que proporciona una liberacion rapida de dos farmacos desde diferentes particulas. | |
| TR201001417A1 (tr) | Geliştirilmiş çözünme hızına sahip sefdinir formülasyonu | |
| TW201129386A (en) | Microcrystalline cellulose and calcium phosphate compositions useful as pharmaceutical excipients | |
| EA201700182A1 (ru) | Состав для повышения стабильности лекарственного препарата, содержащий по меньшей мере один сухой порошок, полученный распылительной сушкой | |
| JP2014166994A (ja) | 新規な漢方エキス製剤 | |
| WO2015024577A3 (fr) | Composition a base de safranal | |
| MX2017013633A (es) | Combinacion de dosis fija resistente a la manipulacion que proporciona una liberacion rapida de dos farmacos desde particulas. | |
| HRP20192328T1 (hr) | Farmaceutski pripravci koji sadrže niske doze lijekova | |
| CL2016000183A1 (es) | Composición farmacéutica anti-tuberculosis estable en una forma de un comprimido redispersable que comprende gránulos de isoniazid y gránulos de rifapentina y su proceso de preparación | |
| RS53835B1 (en) | PHARMACEUTICAL COMPOSITION WITH ANTIMICROBIC ACTION AND FOR ACCELERATED HEALING, FOR EXTERNAL ADMINISTRATION, PROCESSES FOR ITS ACQUISITION | |
| JP2015120758A5 (hr) | ||
| MX2017013643A (es) | Combinacion de dosis fija resistente a la manipulacion que proporciona una liberacion rapida de dos farmacos desde particulas y una matriz. |