PL451291A1 - Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate - Google Patents

Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate

Info

Publication number
PL451291A1
PL451291A1 PL451291A PL45129125A PL451291A1 PL 451291 A1 PL451291 A1 PL 451291A1 PL 451291 A PL451291 A PL 451291A PL 45129125 A PL45129125 A PL 45129125A PL 451291 A1 PL451291 A1 PL 451291A1
Authority
PL
Poland
Prior art keywords
extrudate
naproxen
pharmaceutical composition
amorphous form
application
Prior art date
Application number
PL451291A
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 PL451291A priority Critical patent/PL451291A1/en
Publication of PL451291A1 publication Critical patent/PL451291A1/en

Links

Classifications

    • 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
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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

Landscapes

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

Abstract

Przedmiotem zgłoszenia jest ekstrudat charakteryzujący się tym, że zawiera naproksen w formie amorficznej i kopolimer szczepiony poliwinylokaprolaktamu, octanu poliwinylu i glikolu polietylenowego. 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 i kopolimer szczepiony poliwinylokaprolaktamu, octanu poliwinylu i glikolu polietylenowego; b) transportowanie mieszaniny na śruby ekstrudera, gdzie jest mieszana, topiona i plastyfikowana, przy czym temperatura ekstruzji wynosi od 125°C do 135°C, a prędkość obrotów śrub ekstrudera wynosi od 110 do 130 obr./min; i c) wytłaczanie ekstrudatu powstałego w etapie b) przez dyszę. Kolejnym przedmiotem zgłoszenia jest kompozycja farmaceutyczna charakteryzująca się tym, że zawiera ekstrudat oraz farmaceutycznie dopuszczalne substancje pomocnicze.The subject of the application is an extrudate characterized in that it contains naproxen in amorphous form and a graft copolymer of polyvinylcaprolactam, polyvinyl acetate, and polyethylene glycol. 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 and a graft copolymer of polyvinylcaprolactam, polyvinyl acetate, and polyethylene glycol into an extruder; b) transporting the mixture to the extruder screws, where it is mixed, melted, and plasticized, wherein the extrusion temperature is from 125°C to 135°C and the rotational speed of the extruder screws is from 110 to 130 rpm; and c) extruding the extrudate formed in step b) through a nozzle. Another subject of the application is a pharmaceutical composition characterized in that it contains an extrudate and pharmaceutically acceptable excipients.

PL451291A 2025-02-25 2025-02-25 Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate PL451291A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL451291A PL451291A1 (en) 2025-02-25 2025-02-25 Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PL451291A PL451291A1 (en) 2025-02-25 2025-02-25 Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate

Publications (1)

Publication Number Publication Date
PL451291A1 true PL451291A1 (en) 2026-04-13

Family

ID=99397022

Family Applications (1)

Application Number Title Priority Date Filing Date
PL451291A PL451291A1 (en) 2025-02-25 2025-02-25 Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate

Country Status (1)

Country Link
PL (1) PL451291A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013045365A1 (en) * 2011-09-26 2013-04-04 Abbott Gmbh & Co. Kg Formulations based on solid dispersions
US20210154172A1 (en) * 2014-09-19 2021-05-27 Board Of Regents, The University Of Texas System Methods of preparing extrudates

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013045365A1 (en) * 2011-09-26 2013-04-04 Abbott Gmbh & Co. Kg Formulations based on solid dispersions
US20210154172A1 (en) * 2014-09-19 2021-05-27 Board Of Regents, The University Of Texas System Methods of preparing extrudates

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KISSI EO, NILSSON R, NOGUEIRA LP, LARSSON A, THO I: "Molecules. 2021 Jul 26;26(15):4492. doi: 10.3390/molecules26154492", INFLUENCE OF DRUG LOAD ON THE PRINTABILITY AND SOLID-STATE PROPERTIES OF 3D-PRINTED NAPROXEN-BASED AMORPHOUS SOLID DISPERSION. *
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 *

Similar Documents

Publication Publication Date Title
CN1124129C (en) Solid foamed active substance preparations
WO2000032169A3 (en) Method for producing solid forms of administration by melt extrusion
EP1064935B1 (en) Solid controlled-release pharmaceutical compositions prepared by means of a thermoforming process
Verreck et al. Hot stage extrusion of p-amino salicylic acid with EC using CO2 as a temporary plasticizer
DK0864060T3 (en) Coextruded multilayer plastic pipes
WO2008062009A1 (en) Delivery system for risperidone
RU2010148536A (en) METHOD FOR CONTINUOUS PRODUCTION OF PHARMACEUTICAL COMPOSITIONS
CN1427765A (en) Method and device for blow molding polyvinyl alcohol capsules and blow molded polyvinyl alcohol capsules
RU2010131006A (en) Antiretroviral combination
CN102675786A (en) Preparation method for raw material used for bag film with two different water-soluble speeds on different parts
CN102597149A (en) Process for the continuous manufacture of polyisobutylene-based transdermal patches
JP2001504342A (en) Method for producing shaped or unshaped polyol material
PL451291A1 (en) Extrudate containing naproxen in amorphous form, method of preparation of the extrudate, and pharmaceutical composition containing the extrudate
EP1345594B1 (en) Thermoformable solid pharmaceutical composition for controlled release of ivabradine
PL451285A1 (en) Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate
PL451295A1 (en) An extrudate containing naproxen in amorphous form and a pharmaceutically acceptable salt of drotarverine in amorphous form and a method for producing the extrudate
JPH0216772B2 (en)
CN101717547B (en) Antistatic master batch for PP hollow plate and preparation method thereof
JP2022127843A5 (en)
CN107987407B (en) Thermoplastic dynamic vulcanization BIIR/PP composition and preparation method thereof
CN100537647C (en) Completely biodegradable plastic
KR20170016945A (en) Microcapillary polymer films for drug delivery
PL442419A1 (en) Method of producing a microporous film
JPH08281771A (en) Production of plastic film
JP3672418B2 (en) Breathable film production apparatus and breathable film production method using the same