MEP48308A - Oralne formulacije opijatnog agonista otporne na mehaničke, termičke i/ili hemijske promjene fizičkih osobina doznog oblika - Google Patents
Oralne formulacije opijatnog agonista otporne na mehaničke, termičke i/ili hemijske promjene fizičkih osobina doznog oblikaInfo
- Publication number
- MEP48308A MEP48308A MEP-483/08A MEP48308A MEP48308A ME P48308 A MEP48308 A ME P48308A ME P48308 A MEP48308 A ME P48308A ME P48308 A MEP48308 A ME P48308A
- Authority
- ME
- Montenegro
- Prior art keywords
- dosage form
- antagonist
- tamper
- opioid agonist
- resistant oral
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
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- Biophysics (AREA)
- Molecular Biology (AREA)
- Otolaryngology (AREA)
- Addiction (AREA)
- Pain & Pain Management (AREA)
- Optics & Photonics (AREA)
- Nanotechnology (AREA)
- Physics & Mathematics (AREA)
- Inorganic Chemistry (AREA)
- Rheumatology (AREA)
- Psychiatry (AREA)
- Toxicology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Opisan je oralni oblik za doziranje koji sadrži (i) opijatni agonist u obliku iz koga može da se oslobađa, i (ii) izolovani antagonist, koji se ne oslobađa bitno ukoliko se oblik za doziranje ordinira nedirnut, tako da je odnos količine antagonista oslobođenog iz pomenutog oblika za doziranje nakon tamperovanja, tj. mehaničkog, termičkog ili hemijskog manipulisanja, prema količini pomenutog antagonista oslobođenog iz pomenutog nedirnutog oblika za doziranje oko 4:1 ili više, na osnovu rastvaranja in vitro pomenutog oblika za doziranje tokom 1 h u 900 ml simuliranog želudačnog fluida, koristeći aparaturu USP Type II (paddle) apparatus, pri 75 o/min, na 37° C, pri čemu su pomenuti agonist i antagonist međusobno dispergovani, a nisu izolovani jedan od drugog u dva različita sloja.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18136900P | 2000-02-08 | 2000-02-08 | |
PCT/US2001/004346 WO2001058451A1 (en) | 2000-02-08 | 2001-02-08 | Tamper-resistant oral opioid agonist formulations |
Publications (2)
Publication Number | Publication Date |
---|---|
ME00398B ME00398B (me) | 2011-05-10 |
MEP48308A true MEP48308A (bs) | 2011-05-10 |
Family
ID=22663996
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MEP-483/08A MEP48308A (bs) | 2000-02-08 | 2001-02-08 | Oralne formulacije opijatnog agonista otporne na mehaničke, termičke i/ili hemijske promjene fizičkih osobina doznog oblika |
Country Status (35)
Country | Link |
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US (15) | US6696088B2 (bs) |
EP (6) | EP3130338A1 (bs) |
JP (10) | JP2003522146A (bs) |
KR (2) | KR100552038B1 (bs) |
CN (3) | CN1423559A (bs) |
AP (1) | AP1665A (bs) |
AT (1) | ATE431145T1 (bs) |
AU (2) | AU776904B2 (bs) |
BG (1) | BG65828B1 (bs) |
BR (2) | BRPI0108380B8 (bs) |
CA (1) | CA2400567C (bs) |
CY (2) | CY1109270T1 (bs) |
CZ (1) | CZ299991B6 (bs) |
DE (1) | DE60138706D1 (bs) |
DK (5) | DK1299104T3 (bs) |
EA (1) | EA004876B1 (bs) |
EE (1) | EE05171B1 (bs) |
ES (5) | ES2415407T3 (bs) |
GE (1) | GEP20053614B (bs) |
HK (3) | HK1051487A1 (bs) |
HU (2) | HUP0204163A2 (bs) |
IL (5) | IL151057A0 (bs) |
ME (1) | MEP48308A (bs) |
MX (2) | MXPA02007690A (bs) |
NO (2) | NO324717B1 (bs) |
NZ (1) | NZ520554A (bs) |
OA (1) | OA12215A (bs) |
PL (1) | PL210845B1 (bs) |
PT (6) | PT2283842E (bs) |
RS (1) | RS50407B (bs) |
SI (5) | SI2283842T1 (bs) |
SK (1) | SK287107B6 (bs) |
TW (1) | TWI292317B (bs) |
UA (1) | UA79069C2 (bs) |
WO (2) | WO2001058447A1 (bs) |
Families Citing this family (330)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
HU1500214D0 (hu) | 1997-12-22 | 2002-03-28 | Euro Celtique Sa | Opioid agonista és antagonista hatóanyagot tartalmazó gyógyszerkészítmény |
JP2001526229A (ja) * | 1997-12-22 | 2001-12-18 | ユーロ−セルティーク,エス.エイ. | オピオイド投薬剤形の乱用を防止する方法 |
AU764453B2 (en) | 1999-10-29 | 2003-08-21 | Euro-Celtique S.A. | Controlled release hydrocodone formulations |
US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
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