RS20110313A - Atorvastatin calcium in pharmaceutical form, composition thereof, and pharmaceutical formulation comprising atorvastation calcium - Google Patents

Atorvastatin calcium in pharmaceutical form, composition thereof, and pharmaceutical formulation comprising atorvastation calcium

Info

Publication number
RS20110313A
RS20110313A RS20110313A RSP20110313A RS20110313A RS 20110313 A RS20110313 A RS 20110313A RS 20110313 A RS20110313 A RS 20110313A RS P20110313 A RSP20110313 A RS P20110313A RS 20110313 A RS20110313 A RS 20110313A
Authority
RS
Serbia
Prior art keywords
atorvastatin
calcium
pharmaceutical
atorvastatin calcium
amorphous
Prior art date
Application number
RS20110313A
Other languages
English (en)
Inventor
Janez Kerc
Salobir Mateja
Sasa Bavec
Original Assignee
Lek Pharmaceutical And Chemical Company D.D.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=20432850&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RS20110313(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lek Pharmaceutical And Chemical Company D.D. filed Critical Lek Pharmaceutical And Chemical Company D.D.
Publication of RS20110313A publication Critical patent/RS20110313A/sr
Publication of RS55021B1 publication Critical patent/RS55021B1/sr

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
    • A61K9/16—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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Abstract

Atorvastatin kalcijum, supstanca, poznata po hemijskom imenu (R-(R*, R*))-2-(4-fluorofenil)-β,δ-dihidroksi-5-(1-metiletil)-3-fenil-((fenilamino) karbonil)-1H-pirol-1-heptanoična kiselina, hemi kalcijumova so, poznat je kao inhibitor HMG-CoA reduktaze i koristi se kao antihiper-holesterolemijski agens. Atorvastatin u farmaceutskimsmešama, raspoloživim na tržištu, uglavnom se priprema u vidu svoje kalcijumove soli, s obzirom na to da ona omogućava da atorvastatin bude pogodno formulisan u farmaceutskim formulacijama, na primer, u tabletama, kapsulama, praškovima i sličnim formulacijama za oralnu primenu. Atorvastatin kalcijum može postojati u amorfnom obliku ili u jednom od najmanje četiri poznata kristalna oblika (Oblik I, Oblik II, Oblik III i Oblik IV). Atorvastatin kalcijum je supstanca, koja je umereno slabo rastvorljiva u vodi, sa pKa 4,5, a utvrđeno je da su kristalni oblici manje rastvorljivi od amorfnog oblika, što može izazvati probleme u bioraspoloživosti atorvastatina u organizmu. Ovaj pronalazak razrešava problem obezbeđivanja terapeutske ekvivalentnosti farmaceutske formulacije atorvastatina, bez obzira na oblik (kristalni, amorfni ili smeša jednog i drugog) atorvastatin kalcijuma, koji se koristi za njenu izradu.
RS20110313A 2001-03-14 2002-03-13 Atorvastatin kalcijum u farmaceutskom obliku, njegovoj smeši i farmaceutskoj formulaciji, koja sadrži atorvastatin kalcijum RS55021B1 (sr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
SI200100069A SI20848A (sl) 2001-03-14 2001-03-14 Farmacevtska formulacija, ki vsebuje atorvastatin kalcij

Publications (2)

Publication Number Publication Date
RS20110313A true RS20110313A (en) 2011-10-31
RS55021B1 RS55021B1 (sr) 2016-11-30

Family

ID=20432850

Family Applications (2)

Application Number Title Priority Date Filing Date
RS20110313A RS55021B1 (sr) 2001-03-14 2002-03-13 Atorvastatin kalcijum u farmaceutskom obliku, njegovoj smeši i farmaceutskoj formulaciji, koja sadrži atorvastatin kalcijum
YU69603A RS51746B (sr) 2001-03-14 2002-03-13 Atorvastatin kalcijum u farmaceutskom obliku, njegovoj smeši i farmaceutskoj formulaciji, koja sadrži atorvastatin kalcijum

Family Applications After (1)

Application Number Title Priority Date Filing Date
YU69603A RS51746B (sr) 2001-03-14 2002-03-13 Atorvastatin kalcijum u farmaceutskom obliku, njegovoj smeši i farmaceutskoj formulaciji, koja sadrži atorvastatin kalcijum

Country Status (25)

Country Link
US (1) US7030151B2 (sr)
EP (2) EP2263655B1 (sr)
JP (1) JP4295988B2 (sr)
KR (1) KR100905730B1 (sr)
CN (1) CN1630510B (sr)
AT (1) ATE500818T1 (sr)
BG (1) BG66339B1 (sr)
BR (1) BR0207880A (sr)
CA (1) CA2440331C (sr)
CZ (1) CZ306128B6 (sr)
DE (1) DE60239425D1 (sr)
ES (2) ES2361609T3 (sr)
HR (1) HRP20030726B1 (sr)
HU (1) HU230213B1 (sr)
IL (2) IL157534A0 (sr)
ME (1) ME00517B (sr)
MX (1) MXPA03008340A (sr)
PL (2) PL211803B1 (sr)
RS (2) RS55021B1 (sr)
RU (1) RU2293555C2 (sr)
SI (2) SI20848A (sr)
SK (1) SK287925B6 (sr)
UA (1) UA78201C2 (sr)
WO (1) WO2002072073A2 (sr)
ZA (1) ZA200306575B (sr)

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