WO2023281089A3 - Pharmaceutical composition comprising naproxen and paracetamol - Google Patents

Pharmaceutical composition comprising naproxen and paracetamol Download PDF

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Publication number
WO2023281089A3
WO2023281089A3 PCT/EP2022/069158 EP2022069158W WO2023281089A3 WO 2023281089 A3 WO2023281089 A3 WO 2023281089A3 EP 2022069158 W EP2022069158 W EP 2022069158W WO 2023281089 A3 WO2023281089 A3 WO 2023281089A3
Authority
WO
WIPO (PCT)
Prior art keywords
paracetamol
naproxen
layer
phase
extragranular
Prior art date
Application number
PCT/EP2022/069158
Other languages
French (fr)
Other versions
WO2023281089A4 (en
WO2023281089A2 (en
Inventor
Marko Benkovic
Kristina DEBELJAK SIMONCIC
Nastja BAŠELJ
Maja KINCL SKUBE
Klemen KORASA
Nina BRVAR
Original Assignee
Krka, D.D., Novo Mesto
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 Krka, D.D., Novo Mesto filed Critical Krka, D.D., Novo Mesto
Priority to EP22748316.1A priority Critical patent/EP4366707A2/en
Publication of WO2023281089A2 publication Critical patent/WO2023281089A2/en
Publication of WO2023281089A3 publication Critical patent/WO2023281089A3/en
Publication of WO2023281089A4 publication Critical patent/WO2023281089A4/en

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to a multilayer tablet comprising (i) a naproxen layer containing naproxen or a physiologically acceptable salt thereof and providing immediate release of the naproxen or the physio- logically acceptable salt thereof; and (ii) a paracetamol layer containing paracetamol and providing im- mediate release of the paracetamol. The multilayer tablet is preferably prepared by wet granulation such that the naproxen layer and the paracetamol layer both comprise an extragranular phase and an intragranular phase. Preferably, both extragranular phases contain microcrystalline cellulose. Preferably, the intragranular phase and the extragranular phase of the paracetamol layer both contain a disintegrant, whereas the naproxen layer does not contain disintegrant in any phase. The total content of excipients in both intragranular phases is particularly low.
PCT/EP2022/069158 2021-07-08 2022-07-08 Pharmaceutical composition comprising naproxen and paracetamol WO2023281089A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP22748316.1A EP4366707A2 (en) 2021-07-08 2022-07-08 Pharmaceutical composition comprising naproxen and paracetamol

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SIP-202100137 2021-07-08
SI202100137 2021-07-08

Publications (3)

Publication Number Publication Date
WO2023281089A2 WO2023281089A2 (en) 2023-01-12
WO2023281089A3 true WO2023281089A3 (en) 2023-03-16
WO2023281089A4 WO2023281089A4 (en) 2023-05-11

Family

ID=84802153

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/069158 WO2023281089A2 (en) 2021-07-08 2022-07-08 Pharmaceutical composition comprising naproxen and paracetamol

Country Status (1)

Country Link
WO (1) WO2023281089A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114796142A (en) * 2022-04-08 2022-07-29 黄山学院 Naproxen gastric floating tablet and preparation method thereof
WO2024097694A1 (en) * 2022-11-04 2024-05-10 Johnson & Johnson Consumer Inc. Acetaminophen and naproxen for treating pain

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010138441A1 (en) * 2009-05-28 2010-12-02 Aptapharma, Inc. Multilayer oral tablets containing a non-steroidal anti-inflammatory drug and/or acetaminophen
WO2021127546A1 (en) * 2019-12-19 2021-06-24 Bayer Healthcare Llc Oral tablets comprising roller-compacted granules of naproxen sodium, methods of preparing thereof, and methods of using thereof

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU528532B2 (en) 1978-12-18 1983-05-05 Mcniel Laboratories Acetaminophen analgesic potentiation
US20080275125A1 (en) 2004-07-07 2008-11-06 Aft Pharmaceuticals Limited Combination Composition
PL1799195T3 (en) 2004-08-12 2016-09-30 Granules comprising paracetamol, an nsaid and a sugar alcohol made by melt extrusion
US20080166407A1 (en) 2005-07-29 2008-07-10 Shalaby Shalaby W Solid oral formulations for combination therapy
GB0519350D0 (en) 2005-09-22 2005-11-02 Boots Healthcare Int Ltd Therapeutic agents
US8580855B2 (en) 2006-10-20 2013-11-12 Mcneil-Ppc, Inc. Acetaminophen / ibuprofen combinations and method for their use
US20090264530A1 (en) 2008-04-16 2009-10-22 Nickell Robert P Combined nsaid and acetaminophen formulation and method
PL2341900T3 (en) 2008-10-14 2019-08-30 Aft Pharmaceuticals Limited A medicinal product and treatment
MY164112A (en) 2010-07-07 2017-11-30 Aft Pharmaceuticals Ltd A combination composition comprising ibuprofen and paracetamol
MX2013005113A (en) 2010-11-04 2013-06-03 Aft Pharmaceuticals Ltd A combination composition.
MX2014008985A (en) 2014-07-24 2016-01-25 Liomont S A De C V Lab Pharmaceutical composition of sodic naproxene, paracetamol and pamabrom, for the treatment of pains related to dysmenorrhoea and/or premenstrual syndrome.
AU2016218950C1 (en) 2015-02-13 2022-11-03 Anlar Pty Ltd Analgesic formulation
CN110354111A (en) 2019-07-18 2019-10-22 上海臣邦医药科技股份有限公司 A kind of compound and its pharmaceutical composition and application

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010138441A1 (en) * 2009-05-28 2010-12-02 Aptapharma, Inc. Multilayer oral tablets containing a non-steroidal anti-inflammatory drug and/or acetaminophen
WO2021127546A1 (en) * 2019-12-19 2021-06-24 Bayer Healthcare Llc Oral tablets comprising roller-compacted granules of naproxen sodium, methods of preparing thereof, and methods of using thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Pharmaceutical Dosage Forms: Tablets", 1 January 1989, MARCEL DEKKER, US, ISBN: 978-0-8247-8044-9, article FRED J. BANDELIN: "Chapter 3 - Compressed Tablets by Wet Granulation", pages: 131 - 193, XP055370821 *
ABDUL S ET AL: "A flexible technology for modified release of drugs: multi layered tablets", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 97, no. 3, 7 July 2004 (2004-07-07), pages 393 - 405, XP004519504, ISSN: 0168-3659, DOI: 10.1016/J.JCONREL.2004.03.034 *

Also Published As

Publication number Publication date
WO2023281089A4 (en) 2023-05-11
WO2023281089A2 (en) 2023-01-12

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