EP4021411A4 - Liquid pharmaceutical compositions of melatonin for oral and parenteral administration - Google Patents

Liquid pharmaceutical compositions of melatonin for oral and parenteral administration Download PDF

Info

Publication number
EP4021411A4
EP4021411A4 EP20859314.5A EP20859314A EP4021411A4 EP 4021411 A4 EP4021411 A4 EP 4021411A4 EP 20859314 A EP20859314 A EP 20859314A EP 4021411 A4 EP4021411 A4 EP 4021411A4
Authority
EP
European Patent Office
Prior art keywords
melatonin
oral
pharmaceutical compositions
parenteral administration
liquid pharmaceutical
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
EP20859314.5A
Other languages
German (de)
French (fr)
Other versions
EP4021411A1 (en
Inventor
Ritesh Anil Chavan
Poonam Sanjay BHATJIRE
Shweta V REDASANI
Vijayendrakumar Virendrakumarji Redasani
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP4021411A1 publication Critical patent/EP4021411A1/en
Publication of EP4021411A4 publication Critical patent/EP4021411A4/en
Pending legal-status Critical Current

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP20859314.5A 2019-08-30 2020-08-31 Liquid pharmaceutical compositions of melatonin for oral and parenteral administration Pending EP4021411A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201921035140 2019-08-30
PCT/IN2020/050759 WO2021038601A1 (en) 2019-08-30 2020-08-31 Liquid pharmaceutical compositions of melatonin for oral and parenteral administration

Publications (2)

Publication Number Publication Date
EP4021411A1 EP4021411A1 (en) 2022-07-06
EP4021411A4 true EP4021411A4 (en) 2023-08-09

Family

ID=74685384

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20859314.5A Pending EP4021411A4 (en) 2019-08-30 2020-08-31 Liquid pharmaceutical compositions of melatonin for oral and parenteral administration

Country Status (3)

Country Link
EP (1) EP4021411A4 (en)
AU (1) AU2020339867A1 (en)
WO (1) WO2021038601A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113072479A (en) * 2021-03-26 2021-07-06 罗田县新普生药业有限公司 Method for extracting melatonin from melatonin crystallization mother liquor
EP4186504B1 (en) 2021-11-25 2024-05-29 Alissa Healthcare Research Limited Oral pharmaceutical aqueous solutions comprising melatonin and use thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999047175A1 (en) * 1998-03-13 1999-09-23 Recordati S.A. Chemical And Pharmaceutical Company Pharmaceutical compositions containing melatonin inclusion complexes
WO2010062153A1 (en) * 2008-11-27 2010-06-03 GARCÍA PÉREZ, Miguel, Ángel Pharmaceutical compositions containing melatonin for treatment of internal tissue and organ burns caused by corrosive substances
WO2012156565A1 (en) * 2011-05-17 2012-11-22 Universidad De Granada Injectable preparation of melatonin
US9468626B2 (en) * 2014-03-13 2016-10-18 Chiesi Farmaceutici S.P.A. Melatonin-based formulations for parenteral administration
US20170112810A1 (en) * 2014-03-27 2017-04-27 Servicio Andaluz De Salud Durable preparation of an injectable of melatonin exhibiting long-term stability
WO2018167162A1 (en) * 2017-03-17 2018-09-20 Chiesi Farmaceutici S.P.A. Therapeutic dosage and regimen for melatonin
US20180264013A1 (en) * 2010-07-08 2018-09-20 Wellesley Pharmaceuticals, Llc Composition and methods for treating sleep disorders

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20112042A1 (en) 2011-11-10 2013-05-11 Eratech S R L POWDER TO RECONSTITUTE BEFORE INCLUDING MELATONIN AND INJECTABLE PREPARATION OBTAINABLE FROM SUCH POWDER.
US10342779B2 (en) 2014-10-13 2019-07-09 Worphmed Srl Anhydrous liquid melatonin composition
EP3265058A1 (en) 2015-03-04 2018-01-10 Industria Farmaceutica Galenica Senese S.r.l. A pharmaceutical composition for the parenteral administration of melatonin, and a process for its preparation
US10307398B2 (en) 2016-09-20 2019-06-04 Regents Of The University Of Minnesota Resuscitation composition and methods of making and using

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999047175A1 (en) * 1998-03-13 1999-09-23 Recordati S.A. Chemical And Pharmaceutical Company Pharmaceutical compositions containing melatonin inclusion complexes
WO2010062153A1 (en) * 2008-11-27 2010-06-03 GARCÍA PÉREZ, Miguel, Ángel Pharmaceutical compositions containing melatonin for treatment of internal tissue and organ burns caused by corrosive substances
US20180264013A1 (en) * 2010-07-08 2018-09-20 Wellesley Pharmaceuticals, Llc Composition and methods for treating sleep disorders
WO2012156565A1 (en) * 2011-05-17 2012-11-22 Universidad De Granada Injectable preparation of melatonin
US9468626B2 (en) * 2014-03-13 2016-10-18 Chiesi Farmaceutici S.P.A. Melatonin-based formulations for parenteral administration
US20170112810A1 (en) * 2014-03-27 2017-04-27 Servicio Andaluz De Salud Durable preparation of an injectable of melatonin exhibiting long-term stability
WO2018167162A1 (en) * 2017-03-17 2018-09-20 Chiesi Farmaceutici S.P.A. Therapeutic dosage and regimen for melatonin

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JASPRICA I ET AL: "Determination of meglumine in pharmaceutical formulations using high performance liquid chromatography", PHARMAZIE, vol. 66, no. 12, 1 December 2011 (2011-12-01), DE, pages 916 - 919, XP093058870, ISSN: 0031-7144, Retrieved from the Internet <URL:https://www.ingentaconnect.com/content/govi/pharmaz/2011/00000066/00000012/art00002?crawler=true> DOI: 10.1691/ph.2011.1059 *
LI HAIYING ET AL: "A simple and effective method to improve bioavailability of glimepiride by utilizing hydrotropy technique", EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 77, 1 September 2015 (2015-09-01), NL, pages 154 - 160, XP055794588, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2015.06.016 *
See also references of WO2021038601A1 *

Also Published As

Publication number Publication date
AU2020339867A1 (en) 2022-04-14
EP4021411A1 (en) 2022-07-06
WO2021038601A1 (en) 2021-03-04

Similar Documents

Publication Publication Date Title
EP3813853A4 (en) Compositions for drug delivery and methods of use thereof
EP3947353A4 (en) Pharmaceutical compositions and combinations comprising inhibitors of the androgen receptor and uses thereof
EP3914252A4 (en) Pharmaceutical compositions of nilotinib
AU2018231044A8 (en) Pharmaceutical formulations of phloroglucinol and trimethylphloroglucinol
EP3946547A4 (en) Devices and methods for delivering pharmaceutical compositions
EP4073071A4 (en) Use and pharmaceutical composition of phenylisoxazolyl methylene-naphthalene-ether derivatives
EP3969054A4 (en) Oil-soluble drug containing compositions and methods of use thereof
EP4021411A4 (en) Liquid pharmaceutical compositions of melatonin for oral and parenteral administration
EP3600259A4 (en) Novel pharmaceutical formulations containing indirubin and derivatives thereof and methods of making and using the same
EP3784214A4 (en) Liquid oral pharmaceutical dosage form
EP3684371A4 (en) Abiraterone-cyclic oligomer pharmaceutical formulations and methods of formation and administration thereof
EP3921420A4 (en) Drug delivery compositions for ocular administration of therapeutics and methods of use thereof
EP4043014A4 (en) Pharmaceutical drug containing heterocyclidene acetamide derivative
EP3972691A4 (en) Methods and pharmaceutical compositions to treat drug overdose
EP3982942A4 (en) Drug delivery methods and compositions
EP3890778A4 (en) Pharmaceutical compositions comprising anti-191p4d12 antibody drug conjugates and methods of use thereof
EP4041309A4 (en) Micronized drug resinate-based pharmaceutical compositions and methods of preparation thereof
EP4122483A4 (en) Oral pharmaceutical composition
EP4023638A4 (en) Indole carboxamide derivative and pharmaceutical composition containing same
EP4015001A4 (en) Oral pharmaceutical composition
EP3952924A4 (en) Compositions and methods for administration of therapeutics
EP4042999A4 (en) Drug accommodating device of solid oral formulation, and oral administration and delivery apparatus comprising same
GB201910294D0 (en) Liquid pharmaceutical composition for oral administration comprising paracetamol and codeine phosphate
EP3897654A4 (en) Treatment of hypercoagulopathy in cushing&#39;s syndrome by administration of glucocorticoid receptor modulators
EP3801539A4 (en) Solid oral pharmaceutical compositions of linagliptin

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20220328

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20230710

RIC1 Information provided on ipc code assigned before grant

Ipc: A61P 9/00 20060101ALI20230704BHEP

Ipc: A61P 1/00 20060101ALI20230704BHEP

Ipc: A61P 29/00 20060101ALI20230704BHEP

Ipc: A61K 31/4045 20060101ALI20230704BHEP

Ipc: A61K 47/32 20060101ALI20230704BHEP

Ipc: A61K 47/26 20060101ALI20230704BHEP

Ipc: A61K 47/22 20060101ALI20230704BHEP

Ipc: A61K 47/10 20170101ALI20230704BHEP

Ipc: A61K 9/20 20060101ALI20230704BHEP

Ipc: A61K 9/00 20060101AFI20230704BHEP