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PE20231844A1 - DECONGESTANT AND BILASTINE DRUG DELIVERY SYSTEM - Google Patents

DECONGESTANT AND BILASTINE DRUG DELIVERY SYSTEM

Info

Publication number
PE20231844A1
PE20231844A1 PE2023000151A PE2023000151A PE20231844A1 PE 20231844 A1 PE20231844 A1 PE 20231844A1 PE 2023000151 A PE2023000151 A PE 2023000151A PE 2023000151 A PE2023000151 A PE 2023000151A PE 20231844 A1 PE20231844 A1 PE 20231844A1
Authority
PE
Peru
Prior art keywords
bilastine
decongestant
weight
core
present
Prior art date
Application number
PE2023000151A
Other languages
Spanish (es)
Inventor
Herrero Gonzalo Hernandez
Azpitarte Ignacio Ortega
Moreno Patricia Marcianes
Cerdeiras Paloma Tato
Negre Jose Maria Sune
Pujo Francisco Gual
Carreras Manuel Roig
Original Assignee
Faes Farma Sa
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 Faes Farma Sa filed Critical Faes Farma Sa
Publication of PE20231844A1 publication Critical patent/PE20231844A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/14Decongestants or antiallergics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Immunology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Referido a una composicion farmaceutica oral multicapa que comprende: un nucleo matricial, que comprende un descongestivo seleccionado de pseudoefedrina, fenilefrina y sales farmaceuticas de las mismas, y una combinacion de al menos dos derivados de celulosa seleccionados de alquilcelulosas C1-6, hidroxialquilcelulosas C1-6, carboxialquilcelulosas C1-3 y celulosa microcristalina, en la que al menos hay presente hidroxipropilmetilcelulosa entre 15 y 40% en peso de hidroxipropilmetilcelulosa y hay presente celulosa microcristalina en una cantidad entre 20 y 50% en peso; y una primera capa que cubre dicho nucleo, que comprende un derivado de celulosa seleccionado de alquilcelulosas C1-6, hidroxialquilcelulosas C1-6, carboxialquilcelulosas C1-3 y celulosa microcristalina, en la que hay presente etilcelulosa. Ademas, una segunda capa que cubre la primera capa, de liberacion inmediata, que comprende de 1 a 20 % en peso de bilastina con respecto al peso total del nucleo. Este sistema de liberacion controlada de farmacos descongestivos y bilastina se usa para tratar signos y sintomas asociados a estados alergicos y/o infamatorios de la piel o de las vias respiratorias altas y bajas.Referring to a multilayer oral pharmaceutical composition comprising: a matrix core, comprising a decongestant selected from pseudoephedrine, phenylephrine and pharmaceutical salts thereof, and a combination of at least two cellulose derivatives selected from C1-6 alkylcelluloses, C1-6 hydroxyalkylcelluloses, C1-3 carboxyalkylcelluloses and microcrystalline cellulose, wherein at least hydroxypropylmethylcellulose is present between 15 and 40% by weight of hydroxypropylmethylcellulose and microcrystalline cellulose is present in an amount between 20 and 50% by weight; and a first layer covering said core, comprising a cellulose derivative selected from C1-6 alkylcelluloses, C1-6 hydroxyalkylcelluloses, C1-3 carboxyalkylcelluloses and microcrystalline cellulose, in which ethylcellulose is present. In addition, a second layer covering the first layer, of immediate release, comprising 1 to 20% by weight of bilastine with respect to the total weight of the core. This controlled release system of decongestant drugs and bilastine is used to treat signs and symptoms associated with allergic and/or inflammatory conditions of the skin or upper and lower respiratory tract.

PE2023000151A 2020-07-30 2021-07-29 DECONGESTANT AND BILASTINE DRUG DELIVERY SYSTEM PE20231844A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20382701 2020-07-30
PCT/EP2021/071244 WO2022023463A1 (en) 2020-07-30 2021-07-29 Decongestant drug delivery system

Publications (1)

Publication Number Publication Date
PE20231844A1 true PE20231844A1 (en) 2023-11-21

Family

ID=72039495

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2023000151A PE20231844A1 (en) 2020-07-30 2021-07-29 DECONGESTANT AND BILASTINE DRUG DELIVERY SYSTEM

Country Status (8)

Country Link
EP (1) EP4188339A1 (en)
CL (1) CL2023000262A1 (en)
CO (1) CO2023002166A2 (en)
CR (1) CR20230109A (en)
DO (1) DOP2023000017A (en)
EC (1) ECSP23010160A (en)
PE (1) PE20231844A1 (en)
WO (1) WO2022023463A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230248667A1 (en) * 2022-02-04 2023-08-10 Aurobindo Pharma Ltd Extended release compositions of pseudoephedrine or its pharmaceutically acceptable salt thereof

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4990535A (en) 1989-05-03 1991-02-05 Schering Corporation Pharmaceutical composition comprising loratadine, ibuprofen and pseudoephedrine
ES2048109B1 (en) 1992-07-20 1994-12-16 Espanola Prod Quimicos PROCEDURE FOR THE PREPARATION OF NEW PIPERIDIC DERIVATIVES OF BENCIMIDAZOLE.
US5314697A (en) 1992-10-23 1994-05-24 Schering Corporation Stable extended release oral dosage composition comprising loratadine and pseudoephedrine
ES2124167B1 (en) 1996-06-04 1999-09-16 Espanola Prod Quimicos NEW DERIVATIVES OF BENZMIDAZOLE WITH ANTIHISTAMINE ACTIVITY.
AU2277101A (en) 1999-12-20 2001-07-03 Schering Corporation Stable extended release oral dosage composition
NZ539915A (en) * 2002-12-11 2007-09-28 Pfizer Prod Inc Controlled-release of an active substance into a high fat environment
US20070014855A1 (en) * 2005-07-12 2007-01-18 Rahul Gawande S Stable desloratadine compositions
NZ573174A (en) * 2006-06-01 2012-01-12 Msd Consumer Care Inc Sustained release pharmaceutical dosage form containing phenylephrine
MX2011005899A (en) 2011-06-03 2013-01-10 Senosiain S A De C V Lab Pharmaceutical composition with non-sedative antihistamine and combinations thereof.
CN104000822A (en) * 2014-06-10 2014-08-27 合肥医工医药有限公司 Compound cold medicinal composition containing bilastine
MX2015003937A (en) * 2015-03-26 2016-09-26 Alparis Sa De Cv Pharmaceutical composition including a non-sedating antihistaminic and an anti-inflammatory immunosuppressant.

Also Published As

Publication number Publication date
EP4188339A1 (en) 2023-06-07
CL2023000262A1 (en) 2023-10-06
WO2022023463A1 (en) 2022-02-03
CR20230109A (en) 2023-05-11
ECSP23010160A (en) 2023-03-31
DOP2023000017A (en) 2023-02-28
CO2023002166A2 (en) 2023-06-09

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