ME02153B - Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida - Google Patents
Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioidaInfo
- Publication number
- ME02153B ME02153B MEP-2015-71A MEP201571A ME02153B ME 02153 B ME02153 B ME 02153B ME P201571 A MEP201571 A ME P201571A ME 02153 B ME02153 B ME 02153B
- Authority
- ME
- Montenegro
- Prior art keywords
- tablet
- tablet according
- buprenorphine
- particle
- mixing
- Prior art date
Links
- 208000026251 Opioid-Related disease Diseases 0.000 title 1
- 201000005040 opiate dependence Diseases 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000002245 particle Substances 0.000 claims 11
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 9
- 150000003839 salts Chemical class 0.000 claims 7
- 238000000034 method Methods 0.000 claims 6
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 claims 5
- 229960001736 buprenorphine Drugs 0.000 claims 5
- 239000011859 microparticle Substances 0.000 claims 4
- 238000002156 mixing Methods 0.000 claims 4
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims 3
- 229960004127 naloxone Drugs 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 206010012335 Dependence Diseases 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 238000007580 dry-mixing Methods 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 230000002452 interceptive effect Effects 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4748—Quinolines; Isoquinolines forming part of bridged ring systems
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A61K9/2095—Tabletting 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
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Addiction (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Emergency Medicine (AREA)
- Zoology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. Tableta pogodna za sublingvalnu administraciju koja sadrži:(a) mikročestice farmakološki efektivne količine buprenorfina ili njegove farmaceutski prihvatljive soli koje su u kontaktu su sa česticama koje sadrže limunsku kiselinu;(b) farmakološki efektivne količine naloksona ili njegove farmaceutski prihvatljive soli; i(c) dezintegrator izabran iz grupe natrijum karboksimetilceluloze, natrijum skrob glikolata, razgranatog polivinilpirolidona i njihove smeše
2. Tableta prema patentnom Zahtjevu 1, pri čemu mikročestice buprenorfina imaju maseni prečnik manji od oko 15 μm.
3. Tableta prema bilo kojem od prethodnih patentnih zahtjeva, koja je prisutna kao interaktivna smjesa i sadrži mikročestice buprenorfina ili njegove prihvatljive soli predstavljenim na površinama nosača čestica.
4. Tableta prema patentnom Zahtjevu 3, gde je nosač čestica veličine između oko 100 i 800 μm
5. Tableta prema patentnom Zahtjevu 3 ili Zahtjevu 4, pri čemu je nosač čestica rastvoran u vodi.
6. Tableta prema bilo kojem od patentnih Zahtjeva od 3 do 5, pri čemu nosač čestica sadrži manitol.
7. Tableta prema bilo kojem od patentnih Zahtjeva od 3 do 6, pri čemu su čestice limunske kiseline predstavljene i ponašaju se kao nosači čestica.
8. Tableta prema bilo kojem od prethodnih zahtjeva, pri čemu tableta sadrži čestice koje sadrže nalokson ili njegove soli i dezintegrator.
9. Proces za pripremu tablete definisane prema bilo kojem od prethodnih zahtjeva, gde mješanje uzima mesto između mikročestica buprenorfina ili njegove soli i čestice limunske kiseline, vraća ih u kontakt jedne s drugima.
10. Proces prema patentnom Zahtevu 9, gde mješanje sadrži prosto mješanje ili granulaciju.
11. Proces za pripremu tablete iz bilo kojeg od Zahtjeva od 3 do 8, što sadrži suvo mješanje nosača čestica sa buprenorfinom ili njegovom soli.
12. Proces za pripremu tablete prema patentnom Zahtjevu 8, koji sadrži proces prema patentnom Zahtjevu 11, praćen mješanjem sa česticama koji sadrže nalokson ili njegove soli i dezintegrator.
13. Tableta prema bilo kojem od Zahtjeva od 1 do 8, za upotrebu u metodu tretmana potrebe i/ili zavisnosti od opioida.
14. Tableta prema bilo kojem od patentnih Zahtjeva od 1 do 8, za upotrebu u metodu tretmana bola.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161536180P | 2011-09-19 | 2011-09-19 | |
| EP12775283.0A EP2706986B1 (en) | 2011-09-19 | 2012-09-18 | New abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
| PCT/GB2012/052303 WO2013041851A1 (en) | 2011-09-19 | 2012-09-18 | New abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02153B true ME02153B (me) | 2015-10-20 |
Family
ID=47046639
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2015-71A ME02153B (me) | 2011-09-19 | 2012-09-18 | Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida |
Country Status (31)
| Country | Link |
|---|---|
| US (16) | US20130071477A1 (me) |
| EP (3) | EP2915525B1 (me) |
| JP (2) | JP6210988B2 (me) |
| KR (1) | KR102078044B1 (me) |
| CN (1) | CN103813785B (me) |
| AU (1) | AU2012311293B2 (me) |
| BR (1) | BR112014006356B1 (me) |
| CA (1) | CA2834327C (me) |
| CL (1) | CL2014000575A1 (me) |
| CO (1) | CO6960541A2 (me) |
| CY (2) | CY1116270T1 (me) |
| DK (2) | DK2915525T3 (me) |
| EA (1) | EA029507B1 (me) |
| ES (2) | ES2887104T3 (me) |
| HR (2) | HRP20211539T1 (me) |
| HU (1) | HUE056309T2 (me) |
| IL (1) | IL230528B (me) |
| LT (1) | LT2915525T (me) |
| ME (1) | ME02153B (me) |
| MX (1) | MX361757B (me) |
| MY (1) | MY185284A (me) |
| PE (1) | PE20141198A1 (me) |
| PH (1) | PH12014500316B1 (me) |
| PL (2) | PL2706986T3 (me) |
| PT (2) | PT2706986E (me) |
| RS (2) | RS62505B1 (me) |
| SG (1) | SG2014009401A (me) |
| SI (2) | SI2706986T1 (me) |
| SM (2) | SMT202100546T1 (me) |
| WO (1) | WO2013041851A1 (me) |
| ZA (1) | ZA201400501B (me) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2915525B1 (en) | 2011-09-19 | 2021-08-11 | Orexo AB | Sublingual abuse-resistant tablets comprising buprenorphine and naloxone |
| US20140280531A1 (en) * | 2013-03-13 | 2014-09-18 | Xin Liu | Object ranking and recommendations within a social network |
| EP2983668A4 (en) * | 2013-04-08 | 2017-01-11 | Virginia Commonwealth University | Compositions to alleviate presystemic metabolism of opioids |
| EP2886103A1 (en) * | 2013-12-23 | 2015-06-24 | Hexal AG | Pharmaceutical orodispersible film comprising buprenorphine particles with a particular size |
| US10617686B2 (en) * | 2014-07-08 | 2020-04-14 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| US10722510B2 (en) | 2014-07-08 | 2020-07-28 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| US11135155B2 (en) | 2014-07-08 | 2021-10-05 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| WO2016007245A1 (en) * | 2014-07-08 | 2016-01-14 | Insys Pharma, Inc. | Sublingual naloxone spray |
| CA2965895C (en) | 2014-11-07 | 2019-08-06 | Indivior Uk Limited | The use of sustained-release buprenorphine formulations for the treatment of pain or opioid use disorders |
| CN109922805A (zh) * | 2016-08-17 | 2019-06-21 | 因塞斯发展股份有限公司 | 液体纳洛酮喷雾 |
| JP7076171B2 (ja) * | 2016-12-26 | 2022-05-27 | 塩野義製薬株式会社 | 含量均一性を改善した製剤の製造方法 |
| US10646484B2 (en) | 2017-06-16 | 2020-05-12 | Indivior Uk Limited | Methods to treat opioid use disorder |
| WO2019064026A1 (en) | 2017-09-29 | 2019-04-04 | Orexo Ab | NEW PHARMACEUTICAL COMPOSITIONS |
| CA3077627A1 (en) * | 2017-10-20 | 2019-04-25 | Chiesi Farmaceutici S.P.A. | Pharmaceutical formulations comprising opioid receptor agonist as active ingredients, methods of manufacture and therapeutic uses thereof |
| AU2018370000B2 (en) * | 2017-11-15 | 2024-07-25 | The Regents Of The University Of California | Treatment of opioid use disorder, opioid withdrawal symptoms, and chronic pain |
| WO2019175100A1 (en) | 2018-03-11 | 2019-09-19 | Nanologica Ab | Porous silica particles for use in compressed pharmaceutical dosage form |
| GB201904767D0 (en) | 2019-04-04 | 2019-05-22 | Orexo Ab | New pharmaceutical compositions |
| KR20220003541A (ko) * | 2019-04-18 | 2022-01-10 | 키에시 파르마슈티시 엣스. 피. 에이. | 신생아 오피오이드 금단 증후군 치료를 위한 방법 |
| US11571414B2 (en) | 2019-09-06 | 2023-02-07 | Eric Dwayne Ford | Methods of treating respiratory illnesses, alleviating inflammation and visceral pain, and alleviating opioid addiction while suppressing withdrawal symptoms |
| MX2022010800A (es) * | 2020-03-11 | 2022-09-27 | Purdue Pharma Lp | Composiciones y metodos para la administracion de naloxona. |
| US20250144015A1 (en) * | 2023-11-06 | 2025-05-08 | Extrovis Ag | Pharmaceutical Compositions |
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