PL451285A1 - Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate - Google Patents

Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate

Info

Publication number
PL451285A1
PL451285A1 PL451285A PL45128525A PL451285A1 PL 451285 A1 PL451285 A1 PL 451285A1 PL 451285 A PL451285 A PL 451285A PL 45128525 A PL45128525 A PL 45128525A PL 451285 A1 PL451285 A1 PL 451285A1
Authority
PL
Poland
Prior art keywords
extrudate
ramipril
producing
pharmaceutical composition
amorphous form
Prior art date
Application number
PL451285A
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 PL451285A priority Critical patent/PL451285A1/en
Publication of PL451285A1 publication Critical patent/PL451285A1/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
    • A61K31/33—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
    • 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
    • A61K47/30—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)

Abstract

Przedmiotem zgłoszenia jest ekstrudat charakteryzujący się tym, że zawiera ramipryl w formie amorficznej, poli(1-winylo-2-pirolidon) 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 ramipryl, poli(1-winylo-2-pirolidon) i glicerynę; b) transportowanie mieszaniny na śruby ekstrudera, gdzie jest mieszana, topiona i plastyfikowana, przy czym temperatura ekstruzji wynosi od 70°C do 90°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 dopuszczalny nośnik.The subject of the application is an extrudate characterized in that it contains ramipril in amorphous form, poly(1-vinyl-2-pyrrolidone), 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 containing ramipril, poly(1-vinyl-2-pyrrolidone), 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 70°C to 90°C and the rotation 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 comprises an extrudate and a pharmaceutically acceptable carrier.

PL451285A 2025-02-25 2025-02-25 Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate PL451285A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL451285A PL451285A1 (en) 2025-02-25 2025-02-25 Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PL451285A PL451285A1 (en) 2025-02-25 2025-02-25 Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate

Publications (1)

Publication Number Publication Date
PL451285A1 true PL451285A1 (en) 2026-04-13

Family

ID=99397017

Family Applications (1)

Application Number Title Priority Date Filing Date
PL451285A PL451285A1 (en) 2025-02-25 2025-02-25 Extrudate containing ramipril in amorphous form, method for producing the extrudate and pharmaceutical composition containing the extrudate

Country Status (1)

Country Link
PL (1) PL451285A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007001451A2 (en) * 2004-11-09 2007-01-04 Board Of Regents, The University Of Texas System Stabilized hme composition with small drug particles
EP2249808A2 (en) * 2008-01-11 2010-11-17 Cipla Limited Solid pharmaceutical dosage form

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007001451A2 (en) * 2004-11-09 2007-01-04 Board Of Regents, The University Of Texas System Stabilized hme composition with small drug particles
EP2249808A2 (en) * 2008-01-11 2010-11-17 Cipla Limited Solid pharmaceutical dosage form

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KOLLAMARAM G, FAUCHER A, CROKER DM, WALKER GM: "Pharm Res. 2018 Jul 27;35(9):181. doi: 10.1007/s11095-018-2465-7.", VALVEJET TECHNOLOGY FOR THE PRODUCTION OF A PERSONALISED FIXED DOSE COMBINATION OF RAMIPRIL AND GLIMEPIRIDE: AN INVESTIGATIVE STUDY ON THE STABILITY OF RAMIPRIL *
PARK, C., RENUKA, V. S., LEE, B. J., DE LA PEÑA, I., & PARK, J. B.: "Journal of Pharmaceutical Investigation, 55(3), 333-350. https://doi.org/10.1007/s40005-024-00684-9", ADVANCEMENTS OF HOT-MELT EXTRUSION TECHNOLOGY TO ADDRESS UNMET PATIENT NEEDS AND PHARMACEUTICAL QUALITY ASPECTS. *

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