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WO2025170558A1 - Formulation pharmaceutique orale solide comprenant de l'avatrombopag - Google Patents

Formulation pharmaceutique orale solide comprenant de l'avatrombopag

Info

Publication number
WO2025170558A1
WO2025170558A1 PCT/TR2025/050083 TR2025050083W WO2025170558A1 WO 2025170558 A1 WO2025170558 A1 WO 2025170558A1 TR 2025050083 W TR2025050083 W TR 2025050083W WO 2025170558 A1 WO2025170558 A1 WO 2025170558A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
solid oral
sodium
oral pharmaceutical
formulation according
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
Application number
PCT/TR2025/050083
Other languages
English (en)
Inventor
Fatih Sunel
Fadime Bilgehan ATAK
Tolga GULER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
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 Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of WO2025170558A1 publication Critical patent/WO2025170558A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin

Definitions

  • the present invention relates to a solid oral pharmaceutical formulation comprising avatrombopag maleate or a pharmaceutically acceptable salt, amorphous or crystalline form thereof and at least one filler, wherein the filler is lactose anhydrous.
  • the present invention also relates to a simple, rapid, cost- effective, time-saving and industrially suitable process for preparing the solid oral pharmaceutical formulation.
  • Avatrombopag sold under the brand name Doptelet, is a medication that used for certain conditions that lead to thrombocytopenia (low platelets) such as thrombocytopenia associated with chronic liver disease in adults who are to undergo a planned medical or dental procedure.
  • the molecular formula of avatrombopag maleate is C29H34Cl2NgO3S2-C4H4O4, and its structural formula(l) is as follows:
  • Avatrombopag is a white to off white powder with a nonchiral structure.
  • the compound is practically insoluble in water and is nonhygroscopic.
  • avatrombopag maleate is almost insoluble in water and 0.1M hydrochloric acid and is almost insoluble in the pH range of all systems in the body.
  • the patent RU2769863C1 disclose the invention relates to the field of medicine, namely, to hematology, and is intended for treating thrombocytopenia.
  • the lubricant is magnesium stearate.
  • the solid oral pharmaceutical formulation is in the form of tablets, capsules, strips, powders, pastilles, sachets, effervescent compositions, pills, coated bead systems, granules, microspheres, dragees, films, orally administrable films, solids.
  • the solid oral pharmaceutical formulation is in the form of tablets or capsule.
  • the solid oral pharmaceutical formulation comprises;
  • a process for preparing the solid oral pharmaceutical formulation comprises the following steps;

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une formulation pharmaceutique orale solide comprenant du maléate d'avatrombopag ou un sel pharmaceutiquement acceptable, une forme amorphe ou cristalline de celui-ci et au moins une charge, la charge étant du lactose anhydre. La présente invention concerne également un procédé simple, rapide, économique, économe en temps et industriellement approprié pour préparer la formulation pharmaceutique orale solide.
PCT/TR2025/050083 2024-02-06 2025-02-04 Formulation pharmaceutique orale solide comprenant de l'avatrombopag Pending WO2025170558A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2024/001353 2024-02-06
TR2024/001353A TR2024001353A1 (tr) 2024-02-06 2024-02-06 Avatrombopag i̇çeren kati bi̇r oral farmasöti̇k formülasyon

Publications (1)

Publication Number Publication Date
WO2025170558A1 true WO2025170558A1 (fr) 2025-08-14

Family

ID=96700411

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2025/050083 Pending WO2025170558A1 (fr) 2024-02-06 2025-02-04 Formulation pharmaceutique orale solide comprenant de l'avatrombopag

Country Status (2)

Country Link
TR (1) TR2024001353A1 (fr)
WO (1) WO2025170558A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10568837B2 (en) * 2014-09-11 2020-02-25 Dejan Lamesic Particles of spherically agglomerated lactose for direct compression and method of preparation thereof
WO2020044364A1 (fr) * 2018-08-27 2020-03-05 Mylan Laboratories Limited Formes polymorphes de maléate d'avatrombopag
RU2769863C1 (ru) * 2020-10-08 2022-04-07 Нестерук Владимир Викторович Твердая лекарственная форма аватромбопага и способ ее получения
CN114377147A (zh) * 2020-10-16 2022-04-22 广东东阳光药业有限公司 一种阿伐曲泊帕包合物、组合物及其制备方法
CN114712359A (zh) * 2022-04-13 2022-07-08 上海复星医药产业发展有限公司 一种马来酸阿伐曲泊帕药物制剂及其制备方法和应用

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10568837B2 (en) * 2014-09-11 2020-02-25 Dejan Lamesic Particles of spherically agglomerated lactose for direct compression and method of preparation thereof
WO2020044364A1 (fr) * 2018-08-27 2020-03-05 Mylan Laboratories Limited Formes polymorphes de maléate d'avatrombopag
RU2769863C1 (ru) * 2020-10-08 2022-04-07 Нестерук Владимир Викторович Твердая лекарственная форма аватромбопага и способ ее получения
CN114377147A (zh) * 2020-10-16 2022-04-22 广东东阳光药业有限公司 一种阿伐曲泊帕包合物、组合物及其制备方法
CN114712359A (zh) * 2022-04-13 2022-07-08 上海复星医药产业发展有限公司 一种马来酸阿伐曲泊帕药物制剂及其制备方法和应用

Also Published As

Publication number Publication date
TR2024001353A1 (tr) 2025-08-21

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