AR121804A1 - SOLID PREPARATION AND METHOD FOR PRODUCING THE SAME - Google Patents

SOLID PREPARATION AND METHOD FOR PRODUCING THE SAME

Info

Publication number
AR121804A1
AR121804A1 ARP210100940A ARP210100940A AR121804A1 AR 121804 A1 AR121804 A1 AR 121804A1 AR P210100940 A ARP210100940 A AR P210100940A AR P210100940 A ARP210100940 A AR P210100940A AR 121804 A1 AR121804 A1 AR 121804A1
Authority
AR
Argentina
Prior art keywords
mass
parts
solid preparation
producing
granule
Prior art date
Application number
ARP210100940A
Other languages
Spanish (es)
Inventor
Rie Yamada
Hazuki Omagari
Toshinori Tanaka
Original Assignee
Nippon Shinyaku Co Ltd
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 Nippon Shinyaku Co Ltd filed Critical Nippon Shinyaku Co Ltd
Publication of AR121804A1 publication Critical patent/AR121804A1/en

Links

Classifications

    • 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
    • A61K31/4965—Non-condensed pyrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system

Abstract

La presente descripción proporciona una preparación sólida que contiene 2-{4-[N-(5,6-difenilpirazin-2-il)-N-isopropilamino]butiloxi}-N-(metilsulfonil)acetamida (nombre genérico; “selexipag”); y un método para producir la preparación sólida. La preparación sólida comprende un gránulo que contiene (A) selexipag, (B) almidón, y (C) al menos un aglutinante seleccionado del grupo que consiste en hidroxipropil celulosa e hipromelosa, en donde el componente (B) está presente en una cantidad de 20 partes en masa o más (excluyendo el rango de 30,2 a 30,4 partes en masa) por 100 partes en masa del gránulo, y el componente (C) está presente en una cantidad de 4 partes en masa o menos por 100 partes en masa del gránulo.The present disclosure provides a solid preparation containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide (generic name; selexipag) ; and a method for producing the solid preparation. The solid preparation comprises a granule containing (A) selexipag, (B) starch, and (C) at least one binder selected from the group consisting of hydroxypropyl cellulose and hypromellose, wherein component (B) is present in an amount of 20 parts by mass or more (excluding the range of 30.2 to 30.4 parts by mass) per 100 parts by mass of the granule, and component (C) is present in an amount of 4 parts by mass or less per 100 parts by mass of the granule.

ARP210100940A 2020-04-10 2021-04-09 SOLID PREPARATION AND METHOD FOR PRODUCING THE SAME AR121804A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2020071233 2020-04-10

Publications (1)

Publication Number Publication Date
AR121804A1 true AR121804A1 (en) 2022-07-13

Family

ID=78023633

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP210100940A AR121804A1 (en) 2020-04-10 2021-04-09 SOLID PREPARATION AND METHOD FOR PRODUCING THE SAME

Country Status (4)

Country Link
JP (2) JP6989064B1 (en)
AR (1) AR121804A1 (en)
TW (1) TW202203924A (en)
WO (1) WO2021206159A1 (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA124002C2 (en) * 2015-12-02 2021-07-07 Ніппон Сіняку Ко., Лтд. Pharmaceutical composition containing 2-{4-[n-(5,6- diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n- (methylsulfonyl)acetamide
US11382912B2 (en) * 2017-11-16 2022-07-12 Nippon Shinyaku Co., Ltd. Controlled-release preparation
CA3091584A1 (en) * 2018-02-21 2019-08-29 Nippon Shinyaku Co., Ltd. Granular composition, production method for granular composition, and dissolution property improvement method for granular composition

Also Published As

Publication number Publication date
JPWO2021206159A1 (en) 2021-10-14
JP2022016561A (en) 2022-01-21
TW202203924A (en) 2022-02-01
WO2021206159A1 (en) 2021-10-14
JP6989064B1 (en) 2022-01-05

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