BR112023005228A2 - Forma de dosagem oral de uma composição farmacêutica para controlar diabetes ou pré-diabetes em um indivíduo - Google Patents

Forma de dosagem oral de uma composição farmacêutica para controlar diabetes ou pré-diabetes em um indivíduo

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Publication number
BR112023005228A2
BR112023005228A2 BR112023005228A BR112023005228A BR112023005228A2 BR 112023005228 A2 BR112023005228 A2 BR 112023005228A2 BR 112023005228 A BR112023005228 A BR 112023005228A BR 112023005228 A BR112023005228 A BR 112023005228A BR 112023005228 A2 BR112023005228 A2 BR 112023005228A2
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BR
Brazil
Prior art keywords
dosage form
oral dosage
pharmaceutical composition
antidiabetic
individual
Prior art date
Application number
BR112023005228A
Other languages
English (en)
Inventor
Tian Wu
Wang Yan
Original Assignee
Elite Pharmaceutical Solution 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 Elite Pharmaceutical Solution Inc filed Critical Elite Pharmaceutical Solution Inc
Publication of BR112023005228A2 publication Critical patent/BR112023005228A2/pt

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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/166Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
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    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
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    • A61K31/403Heterocyclic 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
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    • A61K31/41Heterocyclic 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
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    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

FORMA DE DOSAGEM ORAL DE UMA COMPOSIÇÃO FARMACÊUTICA PARA CONTROLAR DIABETES OU PRÉ-DIABETES EM UM INDIVÍDUO. Uma forma de dosagem oral de uma composição farmacêutica antidiabética compreende uma porção de núcleo, uma porção externa e um filme de membrana controlado entre elas. As porções de núcleo e externa compreendem, respectivamente, um primeiro agente antidiabético e um segundo agente antidiabético, tal como HCl de metformina e fosfato de sitagliptina, cada um em uma quantidade terapeuticamente eficaz. O filme de membrana controlado encapsula a porção de núcleo e é fornecida com pelo menos uma passagem para permitir a liberação do primeiro agente antidiabético quando a forma de dosagem oral está em um ambiente aquoso, tal como no trato gastrointestinal (GI) de um sujeito. A forma de dosagem oral é configurada, após uma administração oral de dose única, para fornecer uma concentração plasmática máxima do primeiro agente antidiabético no sujeito de aproximadamente 7,5 a 15 horas após a administração. Um método para fabricar a forma de dosagem oral da composição farmacêutica antidiabética também é fornecido.
BR112023005228A 2020-09-22 2021-08-27 Forma de dosagem oral de uma composição farmacêutica para controlar diabetes ou pré-diabetes em um indivíduo BR112023005228A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/028,403 US11684596B2 (en) 2020-09-22 2020-09-22 Antidiabetic pharmaceutical compositions and preparation method thereof
PCT/US2021/048104 WO2022066363A1 (en) 2020-09-22 2021-08-27 Antidiabetic pharmaceutical compositions and preparation method thereof

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BR112023005228A2 true BR112023005228A2 (pt) 2023-04-25

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US (1) US11684596B2 (pt)
EP (1) EP4216942A1 (pt)
JP (1) JP2023541928A (pt)
KR (1) KR20230093255A (pt)
CN (1) CN114929210A (pt)
AU (1) AU2021349178A1 (pt)
BR (1) BR112023005228A2 (pt)
CA (1) CA3192584A1 (pt)
WO (1) WO2022066363A1 (pt)

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WO2024043358A1 (ko) * 2022-08-24 2024-02-29 동아에스티 주식회사 에보글립틴 및 메트포르민을 포함하는 경구용 복합제제 및 그의 제조방법

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Publication number Priority date Publication date Assignee Title
US4783337A (en) * 1983-05-11 1988-11-08 Alza Corporation Osmotic system comprising plurality of members for dispensing drug
US6342249B1 (en) * 1998-12-23 2002-01-29 Alza Corporation Controlled release liquid active agent formulation dosage forms
EP1663145B1 (en) * 2003-09-26 2011-04-06 ALZA Corporation Oros-push-stick for controlled delivery of active agents
JP2009510137A (ja) * 2005-10-07 2009-03-12 アディテック・ファルマ・アクチボラゲット フマル酸エステルを含む制御放出医薬組成物
EP2259676A4 (en) * 2008-03-04 2011-03-16 Merck Sharp & Dohme PHARMACEUTICAL COMPOSITIONS OF A COMBINATION OF METFORMIN AND A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
CN101940578B (zh) * 2010-08-25 2012-07-25 山东新华制药股份有限公司 一种用于治疗2型糖尿病的药物组合物及其制备方法
CN101984974B (zh) * 2010-11-15 2013-04-17 山东新华制药股份有限公司 一种用于治疗2型糖尿病的药物组合物的制备方法
CN105663130B (zh) * 2011-04-15 2019-08-09 江苏豪森药业集团有限公司 一种具有第一和第二活性药物的制剂
US9555001B2 (en) * 2012-03-07 2017-01-31 Boehringer Ingelheim International Gmbh Pharmaceutical composition and uses thereof
CN103285398B (zh) * 2013-06-28 2015-07-22 青岛黄海制药有限责任公司 含有dpp-ⅳ抑制剂和第二种糖尿病药物的复方制剂及其制备方法
CN103933031B (zh) * 2014-05-13 2017-01-18 中国药科大学 一种含有dpp‑4抑制剂和盐酸二甲双胍的复方制剂及其制备方法
CN105878256B (zh) * 2015-01-05 2019-10-22 合肥立方制药股份有限公司 含有盐酸二甲双胍和格列美脲的控释制剂及其制备方法
CN104940159B (zh) * 2015-07-15 2018-09-18 山东司邦得制药有限公司 一种盐酸二甲双胍控释片及其制备方法与应用
US10987311B2 (en) * 2017-06-16 2021-04-27 Kashiv Specialty Pharmaceuticals, Llc Extended release compositions comprising pyridostigmine
US20200289420A1 (en) * 2019-03-17 2020-09-17 Elite Pharmaceutical Solution Inc. Pharmaceutical compositions for treating diabetes and preparation method thereof

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