BR112017027688A2 - Composições orais que contêm éster de 17- hidroxiprogesterona e métodos relacionados - Google Patents

Composições orais que contêm éster de 17- hidroxiprogesterona e métodos relacionados

Info

Publication number
BR112017027688A2
BR112017027688A2 BR112017027688A BR112017027688A BR112017027688A2 BR 112017027688 A2 BR112017027688 A2 BR 112017027688A2 BR 112017027688 A BR112017027688 A BR 112017027688A BR 112017027688 A BR112017027688 A BR 112017027688A BR 112017027688 A2 BR112017027688 A2 BR 112017027688A2
Authority
BR
Brazil
Prior art keywords
oral dosage
pharmaceutically acceptable
hydroxyprogesterone
related methods
hydroxyprogesterone ester
Prior art date
Application number
BR112017027688A
Other languages
English (en)
Inventor
V Patel Mahesh
Chidambaram Nachiappan
K Nachaegari Satish
Original Assignee
Lipocine 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 Lipocine Inc filed Critical Lipocine Inc
Publication of BR112017027688A2 publication Critical patent/BR112017027688A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/06Antiabortive agents; Labour repressants
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nutrition Science (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

trata-se de formas de dosagem orais biodisponíveis que contêm ésteres de 17-hidroxiprogesterona assim como métodos relacionados. as formas de dosagem orais podem ser formuladas para apoio durante gravidez e podem incluir uma quantidade terapeuticamente eficaz de um éster de 17-hidroxiprogesterona e um carreador farmaceuticamente aceitável. em outra modalidade, é fornecida uma forma de dosagem oral farmaceuticamente aceitável para apoio durante a gestação. a dosagem oral farmaceuticamente aceitável pode incluir uma quantidade terapeuticamente eficaz de um éster de 17-hidroxiprogesterona e um carreador farmaceuticamente aceitável. a forma de dosagem oral pode, quando medida com o uso de um aparelho de dissolução usp tipo ii em 900 ml de água deionizada com 0,5 (p/v) de lauril sulfato de sódio a 50 rpm a 37 oc, liberar pelo menos 20% em peso da dose do éster de 17-hidroxiprogesterona após 60 minuto ou, alternativamente, liberar pelo menos mais 20% em peso após 60 minutos do que uma forma de dosagem oral dosada equivalentemente sem o carreador.
BR112017027688A 2015-06-22 2016-06-22 Composições orais que contêm éster de 17- hidroxiprogesterona e métodos relacionados BR112017027688A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562183031P 2015-06-22 2015-06-22
US201662295951P 2016-02-16 2016-02-16
PCT/US2016/038822 WO2016210003A2 (en) 2015-06-22 2016-06-22 17-hydroxyprogesterone ester-containing oral compositions and related methods

Publications (1)

Publication Number Publication Date
BR112017027688A2 true BR112017027688A2 (pt) 2018-09-04

Family

ID=57586205

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017027688A BR112017027688A2 (pt) 2015-06-22 2016-06-22 Composições orais que contêm éster de 17- hidroxiprogesterona e métodos relacionados

Country Status (11)

Country Link
US (3) US20170035781A1 (pt)
EP (1) EP3310359A4 (pt)
JP (1) JP2018522854A (pt)
CN (1) CN107847506A (pt)
AU (1) AU2016284459B2 (pt)
BR (1) BR112017027688A2 (pt)
IL (1) IL256493A (pt)
MX (1) MX2017016823A (pt)
PH (1) PH12017502416A1 (pt)
WO (1) WO2016210003A2 (pt)
ZA (1) ZA201801692B (pt)

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CN111135153A (zh) * 2020-01-21 2020-05-12 安士制药(中山)有限公司 一种熊去氧胆酸胶囊及其制备方法
CN113616660A (zh) * 2020-05-07 2021-11-09 深圳埃格林医药有限公司 孕激素制剂及其用途
US20230101470A1 (en) * 2020-10-27 2023-03-30 Lipocine Inc. Hydroxyprogesterone Caproate Compositions and Methods of Use in Preventing Preterm Birth
US11370811B1 (en) 2020-11-20 2022-06-28 Lipocine Inc. (17-)-3-oxoandrost-4-en-17-yl dodecanoate compositions and methods of preparation and use
CN116077416A (zh) * 2021-11-05 2023-05-09 深圳埃格林医药有限公司 一种包含孕激素的新型口服制剂及制备方法和应用
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Also Published As

Publication number Publication date
US20170035781A1 (en) 2017-02-09
PH12017502416A1 (en) 2018-07-02
AU2016284459B2 (en) 2021-12-23
WO2016210003A3 (en) 2017-02-09
JP2018522854A (ja) 2018-08-16
AU2016284459A1 (en) 2018-02-15
EP3310359A2 (en) 2018-04-25
US20190275060A1 (en) 2019-09-12
US20210169900A1 (en) 2021-06-10
EP3310359A4 (en) 2019-04-03
WO2016210003A2 (en) 2016-12-29
MX2017016823A (es) 2018-03-12
US11590147B2 (en) 2023-02-28
IL256493A (en) 2018-02-28
ZA201801692B (en) 2019-09-25
CN107847506A (zh) 2018-03-27

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Free format text: PERDA DA PRIORIDADE US 62/295,951 REIVINDICADA NO PPCT/US2016/038822, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 16 7O E ART 2O DA RESOLUCAO INPI 179 DE 21/02/2017. ESTA PERDA SE DEU PELO FATO DE O DEPOSITANTE CONSTANTE DA PETICAO DE REQUERIMENTO DO PEDIDO PCT (LIPOCINE INC.) SER DISTINTO DAQUELES QUE DEPOSITARAM A PRIORIDADE REIVINDICADA E NAO APRESENTOU DOCUMENTO COMPROBATORIO DE CESSAO DENTRO DO PRAZO DE 60 DIAS A CONTAR DA DATA DA ENTRADA DA FASE NACIONAL, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 16 6O, E NO ART. 28 DA RESOLUCAO INPI-PR 77/2013.

B12F Other appeals [chapter 12.6 patent gazette]
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Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI N? 10196/2001, QUE MODIFICOU A LEI N? 9279/96, A CONCESS?O DA PATENTE EST? CONDICIONADA ? ANU?NCIA PR?VIA DA ANVISA. CONSIDERANDO A APROVA??O DOS TERMOS DO PARECER N? 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL N? 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVID?NCIAS CAB?VEIS.

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