PL451295A1 - An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate - Google Patents

An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate

Info

Publication number
PL451295A1
PL451295A1 PL451295A PL45129525A PL451295A1 PL 451295 A1 PL451295 A1 PL 451295A1 PL 451295 A PL451295 A PL 451295A PL 45129525 A PL45129525 A PL 45129525A PL 451295 A1 PL451295 A1 PL 451295A1
Authority
PL
Poland
Prior art keywords
extrudate
amorphous form
pharmaceutically acceptable
acceptable salt
producing
Prior art date
Application number
PL451295A
Other languages
Polish (pl)
Inventor
Hanna Kierońska
Katarzyna Rogut
Anna Krause
Anna Pałubicka
Małgorzata Nawrocka
Original Assignee
Pikralida Spółka Z Ograniczoną Odpowiedzialnością
Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu
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 Pikralida Spółka Z Ograniczoną Odpowiedzialnością, Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu filed Critical Pikralida Spółka Z Ograniczoną Odpowiedzialnością
Priority to PL451295A priority Critical patent/PL451295A1/en
Publication of PL451295A1 publication Critical patent/PL451295A1/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

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

Abstract

Przedmiotem zgłoszenia jest ekstrudat charakteryzujący się tym, że zawiera naproksen w formie amorficznej, farmaceutycznie dopuszczalną sól drotaweryny w formie amorficznej, kopowidon i glicerynę. Kolejnym przedmiotem zgłoszenia jest sposób wytwarzania ekstrudatu charakteryzujący się tym, że sposób jest realizowany metodą ekstruzji na gorąco i obejmuje następujące etapy: a) dozowanie do ekstrudera mieszaniny zawierającej naproksen, farmaceutycznie dopuszczalną sól drotaweryny, kopowidon i glicerynę; b) transportowanie mieszaniny na śruby ekstrudera, gdzie jest mieszana, topiona i plastyfikowana, przy czym temperatura ekstruzji wynosi od 95°C do 105°C, a prędkość obrotów śrub ekstrudera wynosi od 90 do 110 obr./min; i c) wytłaczanie ekstrudatu powstałego w etapie b) przez dyszę.The subject of the application is an extrudate characterized in that it contains naproxen in amorphous form, a pharmaceutically acceptable salt of drotaverine in amorphous form, copovidone, and glycerin. Another subject of the application is a method for producing an extrudate characterized in that the method is carried out by hot extrusion and comprises the following steps: a) dosing a mixture comprising naproxen, a pharmaceutically acceptable salt of drotaverine, copovidone, and glycerin into an extruder; b) transporting the mixture to the extruder screws, where it is mixed, melted, and plasticized, wherein the extrusion temperature is from 95°C to 105°C and the rotation speed of the extruder screws is from 90 to 110 rpm; and c) extruding the extrudate formed in step b) through a nozzle.

PL451295A 2025-02-25 2025-02-25 An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate PL451295A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL451295A PL451295A1 (en) 2025-02-25 2025-02-25 An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PL451295A PL451295A1 (en) 2025-02-25 2025-02-25 An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate

Publications (1)

Publication Number Publication Date
PL451295A1 true PL451295A1 (en) 2026-04-13

Family

ID=99397024

Family Applications (1)

Application Number Title Priority Date Filing Date
PL451295A PL451295A1 (en) 2025-02-25 2025-02-25 An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate

Country Status (1)

Country Link
PL (1) PL451295A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA019805B1 (en) * 2010-09-16 2014-06-30 Закрытое Акционерное Общество "Афофарм" Paracetamol-based combined analgetic
WO2024189127A1 (en) * 2023-03-14 2024-09-19 Prolevi Bio Ab Compositions for sustained release of poorly soluble active ingredients

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA019805B1 (en) * 2010-09-16 2014-06-30 Закрытое Акционерное Общество "Афофарм" Paracetamol-based combined analgetic
WO2024189127A1 (en) * 2023-03-14 2024-09-19 Prolevi Bio Ab Compositions for sustained release of poorly soluble active ingredients

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DEDROOG S, HUYGENS C, VAN DEN MOOTER G: "Eur J Pharm Biopharm. 2019 Feb;135:1-12. doi: 10.1016/j.ejpb.2018.12.002", CHEMICALLY IDENTICAL BUT PHYSICALLY DIFFERENT: A COMPARISON OF SPRAY DRYING, HOT MELT EXTRUSION AND CRYO-MILLING FOR THE FORMULATION OF HIGH DRUG LOADED AMORPHOUS SOLID DISPERSIONS OF NAPROXEN *
LIU X, ZHOU L, ZHANG F: "Mol Pharm. 2017 Mar 6;14(3):658-673. doi: 10.1021/acs.molpharmaceut.6b00960", REACTIVE MELT EXTRUSION TO IMPROVE THE DISSOLUTION PERFORMANCE AND PHYSICAL STABILITY OF NAPROXEN AMORPHOUS SOLID DISPERSIONS *

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