DK4005555T3 - Fremgangsmåder til at sikre resuspension af paliperidonpalmitat-formuleringer - Google Patents

Fremgangsmåder til at sikre resuspension af paliperidonpalmitat-formuleringer Download PDF

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Publication number
DK4005555T3
DK4005555T3 DK21210307.1T DK21210307T DK4005555T3 DK 4005555 T3 DK4005555 T3 DK 4005555T3 DK 21210307 T DK21210307 T DK 21210307T DK 4005555 T3 DK4005555 T3 DK 4005555T3
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DK
Denmark
Prior art keywords
resuspension
ensuring
methods
paliperidone palmitate
formulations
Prior art date
Application number
DK21210307.1T
Other languages
English (en)
Inventor
Peter D'hoore
Ignace Wallaert
Jimmy Nguyen
Frank Meeussen
Srihari Gopal
Original Assignee
Janssen Pharmaceutica Nv
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Publication date
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Application granted granted Critical
Publication of DK4005555T3 publication Critical patent/DK4005555T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/0007Special media to be introduced, removed or treated introduced into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/21General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/06Packaging for specific medical equipment

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
DK21210307.1T 2020-11-30 2021-11-24 Fremgangsmåder til at sikre resuspension af paliperidonpalmitat-formuleringer DK4005555T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063119305P 2020-11-30 2020-11-30
US202163237883P 2021-08-27 2021-08-27

Publications (1)

Publication Number Publication Date
DK4005555T3 true DK4005555T3 (da) 2024-05-27

Family

ID=78789763

Family Applications (1)

Application Number Title Priority Date Filing Date
DK21210307.1T DK4005555T3 (da) 2020-11-30 2021-11-24 Fremgangsmåder til at sikre resuspension af paliperidonpalmitat-formuleringer

Country Status (14)

Country Link
US (2) US11666697B2 (da)
EP (1) EP4005555B1 (da)
JP (1) JP2023551007A (da)
KR (1) KR20230116008A (da)
AU (1) AU2021388842A1 (da)
CA (1) CA3203567A1 (da)
DK (1) DK4005555T3 (da)
FI (1) FI4005555T3 (da)
IL (1) IL303254A (da)
LT (1) LT4005555T (da)
MX (1) MX2023006369A (da)
PT (1) PT4005555T (da)
RS (1) RS65612B1 (da)
WO (1) WO2022112367A1 (da)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3203015A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5254556A (en) 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
TW487572B (en) 1996-05-20 2002-05-21 Janssen Pharmaceutica Nv Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
UA72189C2 (uk) 1997-11-17 2005-02-15 Янссен Фармацевтика Н.В. Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот
LT2234617T (lt) 2007-12-19 2021-05-25 Janssen Pharmaceutica Nv Dozės režimai, susiję su ilgo veikimo injekuojamais paliperidono esteriais
PL3280416T3 (pl) 2015-04-07 2020-12-14 Janssen Pharmaceuticals, Inc. Reżim dawkowania dla pominiętych dawek dla długo działających wstrzykiwalnych estrów paliperydonu
WO2016199170A2 (en) * 2015-06-10 2016-12-15 Cipla Limited Paliperidone palmitate particles and compositions thereof
JP6668387B2 (ja) * 2015-06-19 2020-03-18 ヤンセン ファーマシューティカ エヌ.ベー. 薬物の投与及び混合のための装置及び方法、並びにそのための適切な技法のトレーニング
US20220062557A1 (en) 2020-09-02 2022-03-03 Janssen Pharmaceutica Nv Pre-filled syringe with optimized stopper placement
CA3203448A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
CA3203015A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
EP4356966A3 (en) 2020-11-30 2024-07-17 JANSSEN Pharmaceutica NV Dosing regimens associated with extended release paliperidone injectable formulations

Also Published As

Publication number Publication date
LT4005555T (lt) 2024-06-25
IL303254A (en) 2023-07-01
US20230241304A1 (en) 2023-08-03
CA3203567A1 (en) 2022-06-02
KR20230116008A (ko) 2023-08-03
AU2021388842A1 (en) 2023-07-13
MX2023006369A (es) 2023-08-09
PT4005555T (pt) 2024-05-23
US11666697B2 (en) 2023-06-06
FI4005555T3 (fi) 2024-06-18
US20220168497A1 (en) 2022-06-02
RS65612B1 (sr) 2024-07-31
EP4005555A1 (en) 2022-06-01
WO2022112367A1 (en) 2022-06-02
EP4005555B1 (en) 2024-05-15
JP2023551007A (ja) 2023-12-06

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