JOP20210280A1 - توليفة ذات جرعة ثابتة مضادة لارتفاع ضغط الدم ومخفضة للكوليسترول وطريقة لتصنيعها - Google Patents

توليفة ذات جرعة ثابتة مضادة لارتفاع ضغط الدم ومخفضة للكوليسترول وطريقة لتصنيعها

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Publication number
JOP20210280A1
JOP20210280A1 JOP/2021/0280A JOP20210280A JOP20210280A1 JO P20210280 A1 JOP20210280 A1 JO P20210280A1 JO P20210280 A JOP20210280 A JO P20210280A JO P20210280 A1 JOP20210280 A1 JO P20210280A1
Authority
JO
Jordan
Prior art keywords
dose combination
cholesterol
fixed
hypertensive
lowering
Prior art date
Application number
JOP/2021/0280A
Other languages
English (en)
Inventor
Daniel Tyree Jr Gregory Dr
Stephan Dale Glenn Dr
P Hause David
A Stimits Roy
L Whittingham Wayne
Original Assignee
Cardiopharma Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Cardiopharma Inc filed Critical Cardiopharma Inc
Publication of JOP20210280A1 publication Critical patent/JOP20210280A1/ar

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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
    • A61K9/20—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • 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
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

يتعلق الاختراع الحالي بطريقة لتصنيع شكل جرعة صيدلانية من توليفة وعائية قلبية ذات جرعة ثابتة تشتمل على عامل فعال مضاد لارتفاع ضغط الدم، عامل فعال مخفض للكوليسترول واختيارياً مثبط للصفائح الدموية أو أسبرين مغلف معوياً. حيث يتم تحضير التوليفة ذات الجرعة الثابتة باستخدام اثنين على الأقل من محاليل التحبيب التي تخلو من حمض السيتريك وتعزز الذوبان المائي للعامل المخفض للكوليسترول في التوليفة ذات الجرعة الثابتة. ويكون للعوامل الفعالة في شكل الجرعة الناتج، الذي يكون أيضا خالياً من حمض الستريك، خصائص للقوة والاطلاق مماثلة لتلك لنفس العوامل الفعالة المحضرة كتركيبة مفردة. الشكل 5
JOP/2021/0280A 2019-04-17 2019-04-17 توليفة ذات جرعة ثابتة مضادة لارتفاع ضغط الدم ومخفضة للكوليسترول وطريقة لتصنيعها JOP20210280A1 (ar)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2019/027936 WO2020214163A1 (en) 2019-04-17 2019-04-17 Anti-hypertensive and cholesterol-lowering fixed-dose combination and method of manufacture

Publications (1)

Publication Number Publication Date
JOP20210280A1 true JOP20210280A1 (ar) 2023-01-30

Family

ID=72833469

Family Applications (1)

Application Number Title Priority Date Filing Date
JOP/2021/0280A JOP20210280A1 (ar) 2019-04-17 2019-04-17 توليفة ذات جرعة ثابتة مضادة لارتفاع ضغط الدم ومخفضة للكوليسترول وطريقة لتصنيعها

Country Status (10)

Country Link
US (1) US11737988B2 (ar)
EP (1) EP3955912A4 (ar)
AU (1) AU2019441241B2 (ar)
CA (2) CA3235781A1 (ar)
EA (1) EA202192854A1 (ar)
IL (1) IL287299A (ar)
JO (1) JOP20210280A1 (ar)
MX (1) MX2021012728A (ar)
WO (1) WO2020214163A1 (ar)
ZA (1) ZA202107873B (ar)

Family Cites Families (16)

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US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
US6669955B2 (en) 2001-08-28 2003-12-30 Longwood Pharmaceutical Research, Inc. Combination dosage form containing individual dosage units of a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, and aspirin
US6576256B2 (en) 2001-08-28 2003-06-10 The Brigham And Women's Hospital, Inc. Treatment of patients at elevated cardiovascular risk with a combination of a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, and aspirin
WO2003092729A1 (de) * 2002-05-03 2003-11-13 Hexal Ag Stabile pharmazeutische formulierung für eine kombination aus einem statin mit einem ace-hemmer
BRPI0412557A (pt) 2003-07-28 2006-09-19 Reddys Lab Inc Dr forma de dosagem farmacêutica de eventos cardiovasculares
US7838552B2 (en) * 2004-06-04 2010-11-23 Forest Laboratories Holdings Limited Compositions comprising nebivolol
WO2006085128A1 (en) * 2005-02-09 2006-08-17 Wockhardt Limited Cardiovascular therapeutic combinations
US20100310607A1 (en) * 2005-04-08 2010-12-09 Abbott Laboratories Pharmaceutical formulations
CN101590232A (zh) * 2008-05-29 2009-12-02 北京奥萨医药研究中心有限公司 血管紧张素转化酶抑制剂、他汀类降脂药和烟酸的药物组合物及其用途
CN101632673B (zh) * 2008-07-24 2011-08-10 鲁南制药集团股份有限公司 含有氯沙坦、吡格列酮和瑞舒伐他汀的药物组合物及其新用途
NZ595127A (en) * 2009-02-11 2013-08-30 Cadila Pharmaceuticals Ltd Stable pharmaceutical composition for atherosclerosis
MX357919B (es) * 2009-03-13 2018-07-25 Nucitec Sa De Cv Composición farmacéutica para el tratamiento de la hipercolesterolemia.
EP2424509A4 (en) 2009-04-30 2012-11-07 Reddys Lab Ltd Dr MEDICINAL COMBINATION FORMULATIONS WITH DETERMINED DOSAGE
KR101771766B1 (ko) * 2013-12-30 2017-08-28 알보젠코리아 주식회사 안지오텐신-Ⅱ 수용체 차단제 및 HMG-CoA 환원효소 저해제를 포함하는 약제학적 복합제제
CN111601590A (zh) * 2017-11-23 2020-08-28 浙江海正药业股份有限公司 一种海泽麦布片剂及其制备方法

Also Published As

Publication number Publication date
EP3955912A4 (en) 2022-12-14
IL287299A (en) 2022-07-01
EP3955912A1 (en) 2022-02-23
CA3235781A1 (en) 2020-10-22
US11737988B2 (en) 2023-08-29
US20200330391A1 (en) 2020-10-22
AU2019441241B2 (en) 2023-11-23
MX2021012728A (es) 2022-01-24
ZA202107873B (en) 2022-06-29
WO2020214163A1 (en) 2020-10-22
EA202192854A1 (ru) 2022-01-28
AU2019441241A1 (en) 2021-11-18
CA3136797A1 (en) 2020-10-22

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