HRP20211361T1 - Kombinirana formulacija tezofenzina i metoprolola - Google Patents
Kombinirana formulacija tezofenzina i metoprolola Download PDFInfo
- Publication number
- HRP20211361T1 HRP20211361T1 HRP20211361TT HRP20211361T HRP20211361T1 HR P20211361 T1 HRP20211361 T1 HR P20211361T1 HR P20211361T T HRP20211361T T HR P20211361TT HR P20211361 T HRP20211361 T HR P20211361T HR P20211361 T1 HRP20211361 T1 HR P20211361T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- metoprolol
- api
- composition
- preparation according
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 15
- 229960002237 metoprolol Drugs 0.000 title claims 12
- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 title claims 12
- 238000009472 formulation Methods 0.000 title 1
- VCVWXKKWDOJNIT-ZOMKSWQUSA-N tesofensine Chemical compound C1([C@H]2C[C@@H]3CC[C@@H](N3C)[C@@H]2COCC)=CC=C(Cl)C(Cl)=C1 VCVWXKKWDOJNIT-ZOMKSWQUSA-N 0.000 title 1
- 229950009970 tesofensine Drugs 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 23
- 239000008186 active pharmaceutical agent Substances 0.000 claims 12
- 239000007888 film coating Substances 0.000 claims 6
- 238000009501 film coating Methods 0.000 claims 6
- 230000002209 hydrophobic effect Effects 0.000 claims 6
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 6
- 238000013265 extended release Methods 0.000 claims 5
- 239000008188 pellet Substances 0.000 claims 5
- 239000011248 coating agent Substances 0.000 claims 4
- 238000000576 coating method Methods 0.000 claims 4
- 238000013270 controlled release Methods 0.000 claims 4
- 239000002552 dosage form Substances 0.000 claims 4
- 208000008338 non-alcoholic fatty liver disease Diseases 0.000 claims 4
- 239000004014 plasticizer Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 208000008589 Obesity Diseases 0.000 claims 3
- 229920001688 coating polymer Polymers 0.000 claims 3
- 229940079593 drug Drugs 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 235000020824 obesity Nutrition 0.000 claims 3
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 claims 2
- RGHAZVBIOOEVQX-UHFFFAOYSA-N Metoprolol succinate Chemical compound OC(=O)CCC(O)=O.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 RGHAZVBIOOEVQX-UHFFFAOYSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 229920001577 copolymer Polymers 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 208000035475 disorder Diseases 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
- 229960000939 metoprolol succinate Drugs 0.000 claims 2
- 206010053219 non-alcoholic steatohepatitis Diseases 0.000 claims 2
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 201000001320 Atherosclerosis Diseases 0.000 claims 1
- 206010006550 Bulimia nervosa Diseases 0.000 claims 1
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims 1
- 208000032928 Dyslipidaemia Diseases 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 206010018429 Glucose tolerance impaired Diseases 0.000 claims 1
- 206010020710 Hyperphagia Diseases 0.000 claims 1
- 208000017170 Lipid metabolism disease Diseases 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 208000001280 Prediabetic State Diseases 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 208000014679 binge eating disease Diseases 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 150000001860 citric acid derivatives Chemical class 0.000 claims 1
- 239000002537 cosmetic Substances 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 230000008482 dysregulation Effects 0.000 claims 1
- 235000005686 eating Nutrition 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000012458 free base Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229960001300 metoprolol tartrate Drugs 0.000 claims 1
- 235000020830 overeating Nutrition 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 201000009104 prediabetes syndrome Diseases 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 238000013268 sustained release Methods 0.000 claims 1
- 239000012730 sustained-release form Substances 0.000 claims 1
- 150000003892 tartrate salts Chemical class 0.000 claims 1
- WUBVEMGCQRSBBT-UHFFFAOYSA-N tert-butyl 4-(trifluoromethylsulfonyloxy)-3,6-dihydro-2h-pyridine-1-carboxylate Chemical compound CC(C)(C)OC(=O)N1CCC(OS(=O)(=O)C(F)(F)F)=CC1 WUBVEMGCQRSBBT-UHFFFAOYSA-N 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/20—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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/167—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
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2072—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
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
- A61P3/04—Anorexiants; Antiobesity agents
-
- 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
- A61P3/06—Antihyperlipidemics
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Child & Adolescent Psychology (AREA)
- Cardiology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (17)
1. Farmaceutski pripravak, koji sadrži:
a. prvi pripravak, koji sadrži produljeno otpuštani (ER) pripravak aktivnog farmaceutskog sastojka (API), kojeg se bira između metoprolola i njegove farmaceutski prihvatljive soli,
b. drugi pripravak, koji sadrži aktivni farmaceutski sastojak (API), kojeg se bira između tezofenzina i njegove farmaceutski prihvatljive soli, te
c. treći pripravak, koji sadrži neposredno otpuštani (IR) pripravak aktivnog farmaceutskog sastojka (API), kojeg se bira između metoprolola i njegove farmaceutski prihvatljive soli.
2. Pripravak u skladu s patentnim zahtjevom 1, pri čemu se farmaceutski prihvatljivu sol metoprolola bira između metoprolol-sukcinata i metoprolol-tartarata.
3. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu se tezofenzin bira između slobodne baze, citratne soli, te tartaratne soli.
4. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu je drugi pripravak prva obloga primijenjena na prvi pripravak, pri čemu je poželjno treći pripravak druga obloga primijenjena na prvu oblogu.
5. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, pri čemu prvi pripravak čini tabletna jezgra pokrivena oblogom koja sadrži drugi i treći pripravak.
6. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu prvi pripravak sadrži pelete, koji sadrže:
a. inertnu peletnu jezgru;
b. lijek sloj, koji sadrži aktivni farmaceutski sastojak, gdje taj sloj pokriva inertnu peletnu jezgru; i
c. sloj za kontrolirano otpuštanje na sebi.
7. Pripravak u skladu s patentnim zahtjevom 6, pri čemu inertna jezgra peleta sadrži šećerne sfere, obložene plastificiranom filmskom podoblogom od polimera hidrofobne filmske obloge plastificiranog hidrofilnim i hidrofobnim plastifikatorom; sloj s lijekom sadrži API i vezivo; sloj za kontrolirano otpuštanje sadrži plastificiranu filmsku oblogu od polimera hidrofobne filmske obloge plastificiranog hidrofilnim i hidrofobnim plastifikatorom, te pri čemu su peleti pomiješani s konačnom tabletnom smjesom koja sadrži praškastu mješavinu jednog ili više punila, sredstava za raspadanje, sredstava za kliženje i/ili maziva.
8. Pripravak u skladu s patentnim zahtjevom 7, pri čemu polimer hidrofobne filmske obloge sadrži etilcelulozu, hidrofilni plastifikator sadrži polietilen-glikol, hidrofobni plastifikator sadrži dibutil-sebakat, API je metoprolol-sukcinat, vezivo sadrži povidon, a praškasta mješavina sadrži StarLac, Syloid, umreženi povidon i magnezijev stearat.
9. Pripravak u skladu s patentnim zahtjevom 1, pri čemu prvi pripravak sadrži sloj za kontrolirano otpuštanje, koji sadrži mješavinu sljedećih komponenata:
a. etil-akrilat/metil-metakrilatnog kopolimera,
b. tenzida, te
c. natrijevog stearil-fumarata,
pri čemu je sloj za kontrolirano otpuštanje nataložen iz tekućine koja sadrži vodu, a količina etil-akrilat/metil-metakrilatnog kopolimera u filmskoj oblozi je u rasponu od 80-99.5 % (tež./tež.).
10. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu je pripravak u obliku farmaceutskog oblika doziranja, poput tablete ili kapsule, pri čemu poželjno tableta sadrži vanjsku kozmetičku filmsku oblogu.
11. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu jedan oblik doziranja sadrži količinu prvog pripravka od 25-200 mg API, poželjno 50-150, primjerice 75-125, primjerice otprilike 80 mg ili otprilike 100 mg.
12. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu jedan oblik doziranja sadrži količinu drugog pripravka od 0.1-1 mg API, poželjno 0.2-0.8 mg, primjerice 0.25-0.75 mg, primjerice 0.4-0.6 mg, primjerice otprilike 0.25 mg, 0.5 mg ili 0.75 mg.
13. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu jedan oblik doziranja sadrži količinu trećeg pripravka od 5-100 mg API, poželjno 10-75 mg, poput 10-50 mg, poput 20-30 mg ili 10-20 mg, primjerice otprilike 10 mg, otprilike 15 mg, ili otprilike 25 mg.
14. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu je omjer između produljeno otpuštanog metoprolola i neposredno otpuštanog metoprolola 75-95:25-5, primjerice 75:25, 80:20, 90:10, 100:10.
15. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, koji sadrži 25-200 mg ER metoprolola, 5-50 mg IR metoprolola, te 0.1-1.5 mg tezofenzina, primjerice 50-125 mg ER metoprolola, 10-25 mg IR metoprolola, te 0.25-0.75 mg tezofenzina, primjerice 75-80 mg ER metoprolola, 10-15 mg IR metoprolola, te 0.25-0.75 mg tezofenzina.
16. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, namijenjen uporabi u liječenju pretilosti, poremećaja povezanog s pretilosti, dijabetesa, uključujući dijabetes tip 2 i preddijabetes, metaboličkog sindroma, dislipidemije, ateroskleroze, pretilosti uzrokovane lijekovima, poremećaja prejedanja, bulimije nervoze, poremećaja neumjerenog jedenja, kompulzivnog prejedanja, poremećaja reguliranja teka, bolesti nealkoholne masne jetre (NAFLD), odnosno nealkoholnog steatohepatitisa (NASH).
17. Pripravak namijenjen uporabi u skladu s patentnim zahtjevom 16, pri čemu se pripravak primjenjuje jednom dnevno.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA201570117 | 2015-03-03 | ||
DKPA201570644 | 2015-10-09 | ||
EP16711521.1A EP3265126B1 (en) | 2015-03-03 | 2016-03-02 | Tesofensine and metoprolol combination formulation |
PCT/DK2016/050058 WO2016138908A1 (en) | 2015-03-03 | 2016-03-02 | Tesofensine, beta blocker combination formulation |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211361T1 true HRP20211361T1 (hr) | 2021-11-26 |
Family
ID=55589632
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211361TT HRP20211361T1 (hr) | 2015-03-03 | 2021-08-26 | Kombinirana formulacija tezofenzina i metoprolola |
Country Status (33)
Country | Link |
---|---|
US (6) | US10231951B2 (hr) |
EP (1) | EP3265126B1 (hr) |
JP (1) | JP6772430B2 (hr) |
KR (1) | KR101999463B1 (hr) |
CN (1) | CN107666913B (hr) |
AU (1) | AU2016228002B2 (hr) |
CA (1) | CA2977415A1 (hr) |
CL (1) | CL2017002214A1 (hr) |
CO (1) | CO2017009930A2 (hr) |
CR (1) | CR20170447A (hr) |
DK (1) | DK3265126T3 (hr) |
DO (1) | DOP2017000219A (hr) |
EA (1) | EA033298B1 (hr) |
EC (1) | ECSP17059323A (hr) |
ES (1) | ES2885437T3 (hr) |
GT (1) | GT201700194A (hr) |
HK (1) | HK1247127A1 (hr) |
HR (1) | HRP20211361T1 (hr) |
HU (1) | HUE055974T2 (hr) |
IL (1) | IL254179B (hr) |
LT (1) | LT3265126T (hr) |
MA (1) | MA41634B1 (hr) |
MX (1) | MX2017011257A (hr) |
PE (1) | PE20180187A1 (hr) |
PH (1) | PH12017501509B1 (hr) |
PL (1) | PL3265126T3 (hr) |
PT (1) | PT3265126T (hr) |
RS (1) | RS62275B1 (hr) |
SA (1) | SA517382209B1 (hr) |
SG (1) | SG11201706899VA (hr) |
SI (1) | SI3265126T1 (hr) |
UA (1) | UA122224C2 (hr) |
WO (1) | WO2016138908A1 (hr) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2704987T3 (es) * | 2012-02-16 | 2019-03-21 | Saniona As | Composiciones farmacéuticas para terapia de combinación |
US20190060301A1 (en) * | 2016-01-15 | 2019-02-28 | Saniona A/S | Tesofensine and metoprolol for treatment of hypertension |
JP6612004B1 (ja) * | 2018-07-31 | 2019-11-27 | 株式会社親広産業 | グルコース消費促進剤および解糖系促進剤 |
WO2020026471A1 (ja) * | 2018-07-31 | 2020-02-06 | 株式会社親広産業 | グルコース消費促進剤および解糖系促進剤 |
BR112021013463A2 (pt) * | 2019-01-07 | 2021-09-14 | Saniona A/S | Tesofensina para redução do peso corporal em pacientes com prader-willi |
JP2023523738A (ja) | 2020-04-22 | 2023-06-07 | サニオナ エー/エス | 視床下部性肥満症の処置 |
CN117045610B (zh) * | 2023-08-24 | 2024-04-30 | 杭州沐源生物医药科技有限公司 | 一种溶出高稳定性的盐酸拉贝洛尔组合物及其制备方法 |
Family Cites Families (42)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0677291A3 (en) | 1991-03-18 | 1996-08-07 | Sepracor Inc | Composition and method containing optically pure S-metoprolol. |
AU720358B2 (en) | 1996-02-22 | 2000-06-01 | Neurosearch A/S | Tropane-derivatives, their preparation and use |
US5885616A (en) * | 1997-08-18 | 1999-03-23 | Impax Pharmaceuticals, Inc. | Sustained release drug delivery system suitable for oral administration |
US6638937B2 (en) | 1998-07-06 | 2003-10-28 | Bristol-Myers Squibb Co. | Biphenyl sulfonamides as dual angiotensin endothelin receptor antagonists |
SE0100200D0 (sv) * | 2001-01-24 | 2001-01-24 | Astrazeneca Ab | New film coating |
DE10129725A1 (de) | 2001-06-20 | 2003-01-02 | Bayer Ag | Kombinationstherapie substituierter Oxazolidinone |
US8101209B2 (en) | 2001-10-09 | 2012-01-24 | Flamel Technologies | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles |
HUP0200849A2 (hu) | 2002-03-06 | 2004-08-30 | Sanofi-Synthelabo | N-aminoacetil-2-ciano-pirrolidin-származékok, e vegyületeket tartalmazó gyógyszerkészítmények és eljárás előállításukra |
WO2004069234A1 (en) | 2003-02-05 | 2004-08-19 | Ipca Laboratories Limited | Pharmaceutical compositions and process of production thereof |
WO2004096810A1 (en) | 2003-04-29 | 2004-11-11 | Pfizer Limited | 5,7-diaminopyrazolo`4,3-d!pyrimidines useful in the treatment of hypertension |
US7314640B2 (en) * | 2003-07-11 | 2008-01-01 | Mongkol Sriwongjanya | Formulation and process for drug loaded cores |
CA2553649A1 (en) | 2004-01-22 | 2005-08-04 | Neurosearch A/S | Compounds for the sustained reduction of body weight |
DE102005034351A1 (de) | 2005-07-22 | 2007-01-25 | Sension, Biologische Detektions- Und Schnelltestsysteme Gmbh | Farb-Umschlag-Indikator zur Statusanzeige von RFID-Tickets und -Etiketten |
US20070053983A1 (en) | 2005-09-06 | 2007-03-08 | Girish Jain | Extended release compositions of metoprolol succinate |
US20070092573A1 (en) | 2005-10-24 | 2007-04-26 | Laxminarayan Joshi | Stabilized extended release pharmaceutical compositions comprising a beta-adrenoreceptor antagonist |
PL1842534T3 (pl) | 2006-02-24 | 2012-05-31 | Teva Pharma | Tabletki bursztynianu metoprololu o przedłużonym uwalnianiu oraz sposoby ich wytwarzania |
US20090068260A1 (en) * | 2006-02-24 | 2009-03-12 | Tomer Gold | Beta-1-selective adrenoceptor blocking agent compositions and methods for their preparation |
US8815285B2 (en) | 2006-03-28 | 2014-08-26 | Wockhardt Ltd. | Extended release dosage forms of metoprolol |
DE102006020604A1 (de) | 2006-05-02 | 2007-11-08 | Bayer Healthcare Ag | Flüssige Arzneimittelformulierung |
BRPI0714586A2 (pt) | 2006-07-28 | 2013-05-07 | Farmaprojects S A | formulaÇço farmacÊutica de liberaÇço prolongada de metropolol e processo para a sua preparaÇço |
WO2009065845A1 (en) | 2007-11-20 | 2009-05-28 | Neurosearch A/S | A method for treating over-eating disorders |
WO2009080691A2 (en) | 2007-12-20 | 2009-07-02 | Neurosearch A/S | Pharmaceutical composition comprising tesofensine or its analogue and an anti-obesity compound |
WO2009080693A2 (en) | 2007-12-20 | 2009-07-02 | Neurosearch A/S | Pharmaceutical composition comprising tesofensine or its analogue and a beta blocker |
AU2008342250A1 (en) | 2007-12-27 | 2009-07-09 | Bayer Animal Health Gmbh | Treatment of heart disease using beta-blockers |
PT2406253E (pt) | 2009-03-11 | 2013-09-11 | Pfizer | Derivados de benzofuranilo utilizados como inibidores de glucocinase |
SG175995A1 (en) | 2009-06-05 | 2011-12-29 | Pfizer | L- ( piperidin-4-yl) -pyrazole derivatives as gpr 119 modulators |
JP5827952B2 (ja) * | 2009-10-09 | 2015-12-02 | ユンジン・ファーム・カンパニー・リミテッドYungjin Pharm. Co. Ltd. | 速効性と持続性を同時に有する薬剤学的組成物 |
JP5696156B2 (ja) | 2009-11-02 | 2015-04-08 | ファイザー・インク | ジオキサ−ビシクロ[3.2.1]オクタン−2,3,4−トリオール誘導体 |
CN102145000A (zh) * | 2010-02-06 | 2011-08-10 | 赤峰维康生化制药有限公司 | 一种坎地沙坦酯和美托洛尔复方制剂 |
WO2011100659A2 (en) | 2010-02-12 | 2011-08-18 | Kitov Pharmaceutical Ltd. | Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs |
CN102198112A (zh) * | 2010-03-26 | 2011-09-28 | 北京天衡药物研究院 | 一种渗透泵型控释片及其制备方法 |
US8235632B2 (en) | 2010-05-14 | 2012-08-07 | Illinois Tool Works Inc. | Cargo bag valve deflector |
WO2011144975A1 (en) * | 2010-05-15 | 2011-11-24 | Jubilant Life Sciences Limited | Multi-unit compositions |
WO2012052834A2 (en) | 2010-10-21 | 2012-04-26 | Inventia Healthcare Private Limited | Multiple unit particulate system comprising metoprolol succinate |
EP2704697B1 (en) | 2011-05-06 | 2018-09-12 | GlaxoSmithKline Consumer Healthcare (UK) IP Limited | Sustained release paracetamol formulations |
EP2726062A1 (en) * | 2011-06-29 | 2014-05-07 | Ranbaxy Laboratories Limited | Multilayered dosage form |
EP2747757A1 (en) | 2011-08-26 | 2014-07-02 | Wockhardt Limited | Methods for treating cardiovascular disorders |
JP5911969B2 (ja) | 2011-12-09 | 2016-04-27 | ウォックハート リミテッド | 心臓血管障害の治療方法 |
ES2704987T3 (es) * | 2012-02-16 | 2019-03-21 | Saniona As | Composiciones farmacéuticas para terapia de combinación |
IN2012DE00826A (hr) | 2012-03-21 | 2015-08-21 | Ranbaxy Lab Ltd | |
CN102626396B (zh) * | 2012-04-28 | 2014-05-07 | 海南华益泰康药业有限公司 | 一种美托洛尔缓释片剂及其制备方法 |
US20160143864A1 (en) | 2013-07-09 | 2016-05-26 | Sun Pharmaceutical Industries Limited | Extended-release pharmaceutical compositions of metoprolol |
-
2016
- 2016-03-02 JP JP2017546732A patent/JP6772430B2/ja active Active
- 2016-03-02 PT PT167115211T patent/PT3265126T/pt unknown
- 2016-03-02 UA UAA201709503A patent/UA122224C2/uk unknown
- 2016-03-02 WO PCT/DK2016/050058 patent/WO2016138908A1/en active Application Filing
- 2016-03-02 DK DK16711521.1T patent/DK3265126T3/da active
- 2016-03-02 EA EA201791875A patent/EA033298B1/ru unknown
- 2016-03-02 ES ES16711521T patent/ES2885437T3/es active Active
- 2016-03-02 MX MX2017011257A patent/MX2017011257A/es active IP Right Grant
- 2016-03-02 HU HUE16711521A patent/HUE055974T2/hu unknown
- 2016-03-02 SI SI201631317T patent/SI3265126T1/sl unknown
- 2016-03-02 MA MA41634A patent/MA41634B1/fr unknown
- 2016-03-02 KR KR1020177026895A patent/KR101999463B1/ko active IP Right Grant
- 2016-03-02 US US15/554,449 patent/US10231951B2/en active Active
- 2016-03-02 US US15/058,533 patent/US9579288B2/en active Active
- 2016-03-02 AU AU2016228002A patent/AU2016228002B2/en active Active
- 2016-03-02 SG SG11201706899VA patent/SG11201706899VA/en unknown
- 2016-03-02 CA CA2977415A patent/CA2977415A1/en active Pending
- 2016-03-02 PL PL16711521T patent/PL3265126T3/pl unknown
- 2016-03-02 LT LTEPPCT/DK2016/050058T patent/LT3265126T/lt unknown
- 2016-03-02 CN CN201680024189.5A patent/CN107666913B/zh active Active
- 2016-03-02 EP EP16711521.1A patent/EP3265126B1/en active Active
- 2016-03-02 CR CR20170447A patent/CR20170447A/es unknown
- 2016-03-02 RS RS20211078A patent/RS62275B1/sr unknown
- 2016-03-02 PE PE2017001487A patent/PE20180187A1/es unknown
-
2017
- 2017-08-18 PH PH12017501509A patent/PH12017501509B1/en unknown
- 2017-08-28 IL IL254179A patent/IL254179B/en active IP Right Grant
- 2017-08-29 SA SA517382209A patent/SA517382209B1/ar unknown
- 2017-09-01 GT GT201700194A patent/GT201700194A/es unknown
- 2017-09-01 CL CL2017002214A patent/CL2017002214A1/es unknown
- 2017-09-07 EC ECIEPI201759323A patent/ECSP17059323A/es unknown
- 2017-09-20 DO DO2017000219A patent/DOP2017000219A/es unknown
- 2017-09-28 CO CONC2017/0009930A patent/CO2017009930A2/es unknown
-
2018
- 2018-05-25 HK HK18106872.0A patent/HK1247127A1/zh unknown
- 2018-08-27 US US16/113,574 patent/US10537551B2/en active Active
-
2019
- 2019-12-06 US US16/705,370 patent/US10828278B2/en active Active
-
2020
- 2020-10-09 US US17/066,843 patent/US11426383B2/en active Active
-
2021
- 2021-08-26 HR HRP20211361TT patent/HRP20211361T1/hr unknown
-
2022
- 2022-08-24 US US17/821,905 patent/US20230092397A1/en active Pending
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
HRP20211361T1 (hr) | Kombinirana formulacija tezofenzina i metoprolola | |
JP6453380B2 (ja) | ヒドロコドン放出制御製剤 | |
JP4790415B2 (ja) | 医薬組成物 | |
AU665733B2 (en) | Delayed, sustained-release pharmaceutical preparation | |
KR101573889B1 (ko) | 속효성과 지속성을 동시에 갖는 약제학적 조성물 | |
US9629915B2 (en) | Sustained release dosage form | |
TWI617307B (zh) | 包含抑制癌細胞之生長的醯胺衍生物及非金屬鹽潤滑劑之藥學組成物 | |
JP2018507875A5 (hr) | ||
KR101317592B1 (ko) | 프레가발린, 폴리에틸렌옥사이드 및 폴리비닐알코올-폴리에틸렌글리콜 그라프트 공중합체를 함유하는 위체류형 서방성 제제 | |
WO1999061005A1 (en) | Controlled release oral dosage form | |
EP1476139A4 (en) | DOSAGE FORMS WITH CONTROLLED RELEASE | |
EP1385486A1 (en) | A novel coating for a sustained release pharmaceutical composition | |
HU184366B (en) | Process for producing petarde pharmaceutical compositions containing 2,6-bis-bracket-diethanol-mino-bracket-4,8-dipiperidine-py-pyrimido-square bracket-5,4-d-square bracket closed-pyrimidine | |
KR100678421B1 (ko) | 염산 탐스로신 함유 방출조절 제제 | |
RU2372893C2 (ru) | Содержащий фармацевтический агент состав с покрытием | |
JP5667113B2 (ja) | 時限放出製剤用コーティング用組成物、これによりコーティングされた時限放出固形製剤及び時限放出固形製剤の製造方法 | |
JP6099638B2 (ja) | エタノールの影響に耐性のある胃液抵抗性の医薬又は栄養補助組成物 | |
FI3324948T3 (fi) | Monikerroksisia farmaseuttisesti aktiivista yhdistettä vapauttavia mikropartikkeleita nestemäisessä annosmuodossa | |
RU2017141029A (ru) | Фармацевтическая пероральная композиция изотретиноина для применения один раз в сутки | |
WO2009069089A9 (en) | Levetiracetam controlled release composition | |
US20160074333A1 (en) | Pharmaceutical compositions of tamsulosin or salts thereof | |
CN109152772A (zh) | 烟酰胺的口服药物组合物 | |
WO2016203018A1 (en) | Pharmaceutical compositions of prasugrel hydrobromide | |
BG65878B1 (bg) | Многосъставна лекарствена форма, съдържаща най-малко две различни покрити пелетни форми | |
US20180333362A1 (en) | Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems |