WO2020053658A2 - Solutions chimiothérapeutiques non aqueuses de dosage peroral - Google Patents

Solutions chimiothérapeutiques non aqueuses de dosage peroral Download PDF

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Publication number
WO2020053658A2
WO2020053658A2 PCT/IB2019/001012 IB2019001012W WO2020053658A2 WO 2020053658 A2 WO2020053658 A2 WO 2020053658A2 IB 2019001012 W IB2019001012 W IB 2019001012W WO 2020053658 A2 WO2020053658 A2 WO 2020053658A2
Authority
WO
WIPO (PCT)
Prior art keywords
oil
pharmaceutical composition
active pharmaceutical
enzalutamide
prostate cancer
Prior art date
Application number
PCT/IB2019/001012
Other languages
English (en)
Other versions
WO2020053658A3 (fr
Inventor
Malay Patel
Nilesh Patel
Manish UMRETHIA
Jayanta Mandal
Original Assignee
Ftf Pharma Private Limited
Lm Manufacturing 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 Ftf Pharma Private Limited, Lm Manufacturing Ltd. filed Critical Ftf Pharma Private Limited
Publication of WO2020053658A2 publication Critical patent/WO2020053658A2/fr
Publication of WO2020053658A3 publication Critical patent/WO2020053658A3/fr

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
    • A61K9/08—Solutions
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • beneficial or desired clinical results include, but are not limited to, improvement or alleviation of symptoms; diminishment of the extent of the condition, disorder or disease; stabilization (z.e., not worsening) of the state of the condition, disorder or disease; delay in onset or slowing of the progression of the condition, disorder or disease; amelioration of the condition, disorder or disease state; and remission (whether partial or total), whether detectable or undetectable, or enhancement or improvement of the condition, disorder or disease.
  • Treatment includes eliciting a clinically significant response without excessive levels of side effects. Treatment also includes prolonging survival as compared to expected survival if not receiving treatment.
  • the active pharmaceutical ingredient is in an amount of about 0.01% w/w to about 20% w/w. In some embodiments, the active pharmaceutical ingredient is in an amount of about 0.01% w/w to about 10% w/w. In some embodiments, the active pharmaceutical ingredient is in an amount of about 0.01% w/w to about 5% w/w. In some embodiments, the active pharmaceutical ingredient is in an amount of about 3% w/w.
  • the vehicle is an oil.
  • the vehicle may be a medium chain fatty acid.
  • the medium chain fatty acid may be any fatty acid having from 6 to 12 carbon atoms.
  • the medium chain fatty acid may be selected from caproic acid (C6), caprylic acid (C8), capric acid (C10), lauric acid (C12), coconut oilarachis oil, soya bean oil, castor oil, com oil, safflower oil, olive oil, apricot kernel oil, sesame oil, cotton seed oil, sunflower seed oil, palm oil, rapeseed oil, mineral oil, or a combination thereof.
  • the active pharmaceutical ingredient may be administered in combination with one or more additional active pharmaceutical ingredients.
  • the pharmaceutical composition of embodiments herein may include an additional active pharmaceutical ingredient.
  • the pharmaceutical composition of embodiments herein may be administered in conjunction with, either concurrently or sequentially, with the additional active pharmaceutical ingredient.
  • the liquid pharmaceutical compositions of embodiments herein comprising the active pharmaceutical ingredient or derivative thereof exhibit improved or comparable pharmacokinetic profiles as compared to marketed or known compositions of the same active pharmaceutical ingredient or derivative thereof.
  • the Cmax and/or AUC of the liquid pharmaceutical compositions of disclosed herein can be greater than or substantially equal to the Cmax and/or AUC for known or marketed compositions, e.g. solid formulations, administered at the same dose.
  • the Tmax of the liquid compositions of the present invention can be lower than or substantially equal to that obtained for a known or marketed compositions, administered at the same dose.
  • Example 2 Stability studies of the pharmaceutical composition prepared in Example 1

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques comprenant un véhicule, un agent de solubilisation et un tensioactif qui sont destinés à être utilisés conjointement avec des principes pharmaceutiques actifs chimiothérapeutiques qui sont solubles, ou insolubles, dans l'eau ou qui réagissent à l'eau, mais qui sont miscibles dans l'huile. Lesdits principes pharmaceutiques actifs chimiothérapeutiques peuvent comprendre de l'enzalutamide, du paclitaxel, de l'étoposide, de la camptothécine, de la sagopilone, du docétaxel, de la doxorubicine, du tamoxifène et de la cisplatine, du melphalan, un de leurs dérivés ou une de leurs combinaisons. Lesdites compositions pharmaceutiques peuvent être administrées en tant que solution perorale. D'autres modes de réalisation concernent des méthodes d'utilisation et des procédés de fabrication de telles formulations.
PCT/IB2019/001012 2018-09-13 2019-09-13 Solutions chimiothérapeutiques non aqueuses de dosage peroral WO2020053658A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821034588 2018-09-13
IN201821034588 2018-09-13

Publications (2)

Publication Number Publication Date
WO2020053658A2 true WO2020053658A2 (fr) 2020-03-19
WO2020053658A3 WO2020053658A3 (fr) 2020-07-30

Family

ID=68618173

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/001012 WO2020053658A2 (fr) 2018-09-13 2019-09-13 Solutions chimiothérapeutiques non aqueuses de dosage peroral

Country Status (1)

Country Link
WO (1) WO2020053658A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023053084A1 (fr) * 2021-10-01 2023-04-06 Ferring B.V. Compositions orales liquides à base d'enzalutamide

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3033085A1 (fr) * 2013-08-14 2016-06-22 ratiopharm GmbH Forme pharmaceutique comprenant de l'enzalutamide
WO2018037310A1 (fr) * 2016-08-20 2018-03-01 Ftf Pharma Private Limited Composition pharmaceutique comprenant un inhibiteur du récepteur des androgènes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023053084A1 (fr) * 2021-10-01 2023-04-06 Ferring B.V. Compositions orales liquides à base d'enzalutamide

Also Published As

Publication number Publication date
WO2020053658A3 (fr) 2020-07-30

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