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PE20211489A1 - Formas de dosificacion pediatricas de vitamina d, metodos de elaboracion y uso - Google Patents

Formas de dosificacion pediatricas de vitamina d, metodos de elaboracion y uso

Info

Publication number
PE20211489A1
PE20211489A1 PE2021000260A PE2021000260A PE20211489A1 PE 20211489 A1 PE20211489 A1 PE 20211489A1 PE 2021000260 A PE2021000260 A PE 2021000260A PE 2021000260 A PE2021000260 A PE 2021000260A PE 20211489 A1 PE20211489 A1 PE 20211489A1
Authority
PE
Peru
Prior art keywords
vitamin
dosage forms
preparation
methods
pediatric dosage
Prior art date
Application number
PE2021000260A
Other languages
English (en)
Inventor
Praful Balavant Deshpande
Stephen James Quinlan
Marta Golec
John Gerard O'brien
James Joseph Mcdonald
Reem Elamein Elsiddig
Ken O'shea
Original Assignee
Opko Ireland Global Holdings 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 Opko Ireland Global Holdings Ltd filed Critical Opko Ireland Global Holdings Ltd
Publication of PE20211489A1 publication Critical patent/PE20211489A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5929,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • A61P5/20Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Esta referido a formas de dosificacion de compuestos de vitamina D de liberacion prolongada, que comprenden un compuesto de vitamina D, opcionalmente 25-hidroxivitamina D o calcifediol, disperso en una composicion polimerica. Tambien se refiere a formulaciones de vitamina D de liberacion prolongada, incluyendo formulaciones adecuadas para el suministro a pacientes pediatricos que necesitan del tratamiento. Tales formulaciones pueden tambien ser utiles en el tratamiento de adultos que necesitan del tratamiento, por ejemplo, para insuficiencia de vitamina D y para hiperparatiroidismo secundario en CKD y otras enfermedades y afecciones relacionadas con vitamina D.
PE2021000260A 2018-08-31 2019-08-30 Formas de dosificacion pediatricas de vitamina d, metodos de elaboracion y uso PE20211489A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862725940P 2018-08-31 2018-08-31
PCT/IB2019/057360 WO2020044314A1 (en) 2018-08-31 2019-08-30 Vitamin d pediatric dosage forms, methods of making and using

Publications (1)

Publication Number Publication Date
PE20211489A1 true PE20211489A1 (es) 2021-08-11

Family

ID=68165642

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2021000260A PE20211489A1 (es) 2018-08-31 2019-08-30 Formas de dosificacion pediatricas de vitamina d, metodos de elaboracion y uso

Country Status (22)

Country Link
US (4) US11000480B2 (es)
EP (1) EP3843706A1 (es)
JP (2) JP7603000B2 (es)
KR (1) KR20210054539A (es)
CN (2) CN112912067B (es)
AU (4) AU2019329905B2 (es)
BR (1) BR112021003788A2 (es)
CA (1) CA3110020A1 (es)
CL (2) CL2021000493A1 (es)
CO (1) CO2021003805A2 (es)
CR (2) CR20210158A (es)
DE (1) DE202019005769U1 (es)
EA (1) EA202190633A1 (es)
EC (1) ECSP21021189A (es)
IL (2) IL322133A (es)
MX (1) MX2020011740A (es)
MY (1) MY210476A (es)
PE (1) PE20211489A1 (es)
PH (1) PH12021550413A1 (es)
SG (1) SG11202101905YA (es)
TW (1) TWI856972B (es)
WO (1) WO2020044314A1 (es)

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CN112912067B (zh) 2018-08-31 2025-04-04 欧普科爱尔兰环球控股有限公司 儿童剂型、制造和使用方法
TW202203936A (zh) 2020-04-06 2022-02-01 愛爾蘭商艾爾根製藥有限公司 啟動內源性抗菌藥物治療sars-cov-2感染
CN120694962A (zh) 2020-05-31 2025-09-26 艾尔金制药有限公司 硬胶囊剂型和其用途
WO2022103635A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN114176164A (zh) * 2021-12-17 2022-03-15 广东驱动力生物科技股份有限公司 反刍动物用水溶性抗应激助剂
WO2025094144A1 (en) 2023-11-02 2025-05-08 Eirgen Pharma Ltd. Controlling loss of kidney function

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CN112912067B (zh) 2018-08-31 2025-04-04 欧普科爱尔兰环球控股有限公司 儿童剂型、制造和使用方法

Also Published As

Publication number Publication date
CA3110020A1 (en) 2020-03-05
ECSP21021189A (es) 2021-04-29
KR20210054539A (ko) 2021-05-13
US20200338006A1 (en) 2020-10-29
WO2020044314A1 (en) 2020-03-05
JP2021535155A (ja) 2021-12-16
CL2023002539A1 (es) 2024-02-23
AU2019329905A1 (en) 2021-03-18
IL280937B1 (en) 2025-08-01
US20210401752A1 (en) 2021-12-30
AU2019329905B2 (en) 2024-02-01
MX2020011740A (es) 2021-04-19
EA202190633A1 (ru) 2021-07-12
TWI856972B (zh) 2024-10-01
DE202019005769U1 (de) 2022-01-13
JP2025060651A (ja) 2025-04-10
MY210476A (en) 2025-09-24
CN112912067A (zh) 2021-06-04
SG11202101905YA (en) 2021-03-30
US12433842B2 (en) 2025-10-07
IL322133A (en) 2025-09-01
US11000480B2 (en) 2021-05-11
AU2024202877A1 (en) 2024-05-23
IL280937B2 (en) 2025-12-01
CN112912067B (zh) 2025-04-04
US20220000783A1 (en) 2022-01-06
AU2021107174A4 (en) 2021-12-09
TW202034905A (zh) 2020-10-01
US12133917B2 (en) 2024-11-05
CL2021000493A1 (es) 2021-07-23
CO2021003805A2 (es) 2021-04-19
JP7603000B2 (ja) 2024-12-19
CR20210158A (es) 2021-05-21
EP3843706A1 (en) 2021-07-07
US20250025423A1 (en) 2025-01-23
PH12021550413A1 (en) 2021-09-27
CN120154576A (zh) 2025-06-17
CR20250081A (es) 2025-05-05
IL280937A (en) 2021-04-29
AU2021107168A4 (en) 2021-12-09
BR112021003788A2 (pt) 2021-06-08

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