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AR133232A1 - Composición farmacéutica orodispersable de clonazepam - Google Patents

Composición farmacéutica orodispersable de clonazepam

Info

Publication number
AR133232A1
AR133232A1 ARP240101807A ARP240101807A AR133232A1 AR 133232 A1 AR133232 A1 AR 133232A1 AR P240101807 A ARP240101807 A AR P240101807A AR P240101807 A ARP240101807 A AR P240101807A AR 133232 A1 AR133232 A1 AR 133232A1
Authority
AR
Argentina
Prior art keywords
agent
concentration
mixture
clonazepam
hydrophilic
Prior art date
Application number
ARP240101807A
Other languages
English (en)
Inventor
Rojas Marisol Alarid
Gallardo Rodrigo Alejandro Hernndez
Vargas Miriam Villa
Hernndez Omar Crespo
Original Assignee
Posi Visionary Solutions Llp
Productos Cientificos S A De C V
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 Posi Visionary Solutions Llp, Productos Cientificos S A De C V filed Critical Posi Visionary Solutions Llp
Publication of AR133232A1 publication Critical patent/AR133232A1/es

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
    • A61K31/16—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
    • A61K31/33—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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q90/00—Cosmetics or similar toiletry preparations for specific uses not provided for in other groups of this subclass

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención refiere a nuevas composiciones sólidas de desintegración oral que presentan un perfil de liberación de clonazepam sustancialmente similar o igual al que presenta una composición líquida de clonazepam de liberación inmediata, que además presenta una rápida desintegración, baja friabilidad y propiedades organolépticas agradables para el paciente. Además, las nuevas composiciones sólidas de desintegración oral de la presente invención son útiles para el tratamiento de trastornos neurológicos que incluyen el tratamiento de epilepsia, tanto crónica generalizada (ausencias, pequeño mal) como crónica parcial (crisis focales y complejas). Reivindicación 1: Una composición farmacéutica sólida orodispersable, caracterizada porque comprende clonazepam en una concentración de entre 0.1 y 1% (p/p); por lo menos un agente diluente hidrofílico en una concentración de entre 80 y 98% (p/p); por lo menos un agente deslizante en una concentración de entre 0.2 y 1.0% (p/p); por lo menos un agente desintegrante en una concentración de entre 1.0 y 3.0% (p/p); por lo menos un agente edulcorante y/o enmascarante en una concentración de entre 0.4 y 2.0% (p/p); y por lo menos un agente lubricante hidrofílico en una concentración de entre 0.3 y 2.5% (p/p). Reivindicación 17: Un método para la obtención de una composición farmacéutica sólida orodispersable de conformidad con la reivindicación 1, caracterizado porque comprende las etapas de: (i) mezclar por lo menos un agente diluente hidrofílico, por lo menos un agente deslizante, por lo menos un agente desintegrante y por lo menos un agente edulcorante y/o enmascarante; (ii) homogenizar la mezcla; (iii) adicionar a la mezcla el principio activo y homogenizar; (iv) dispersar la mezcla; (v) lubricar la mezcla con por lo menos un agente lubricante hidrofílico; y (vi) comprimir la mezcla para obtener tabletas.
ARP240101807A 2023-07-13 2024-07-12 Composición farmacéutica orodispersable de clonazepam AR133232A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2023008370A MX2023008370A (es) 2023-07-13 2023-07-13 Composicion farmaceutica orodispersable de clonazepam

Publications (1)

Publication Number Publication Date
AR133232A1 true AR133232A1 (es) 2025-09-10

Family

ID=89507668

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP240101807A AR133232A1 (es) 2023-07-13 2024-07-12 Composición farmacéutica orodispersable de clonazepam

Country Status (7)

Country Link
AR (1) AR133232A1 (es)
CL (1) CL2023002058A1 (es)
CO (1) CO2024002677A1 (es)
MX (1) MX2023008370A (es)
PE (1) PE20250418A1 (es)
UY (1) UY40818A (es)
WO (1) WO2025012877A1 (es)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2834889B1 (fr) * 2002-01-18 2004-04-02 Roquette Freres Forme pharmaceutique solide orodispersible
US20070196494A1 (en) * 2006-02-17 2007-08-23 Arnaud Grenier Low-friability, patient-friendly orally disintegrating formulations
JP5535616B2 (ja) * 2006-03-31 2014-07-02 ルビコン リサーチ プライベート リミテッド 口腔内崩壊錠剤のための直接圧縮性複合材

Also Published As

Publication number Publication date
WO2025012877A1 (es) 2025-01-16
PE20250418A1 (es) 2025-02-14
CO2024002677A1 (es) 2024-05-30
UY40818A (es) 2024-08-30
MX2023008370A (es) 2025-02-10
CL2023002058A1 (es) 2023-12-29

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