AU2008220573A1 - Improved medicinal compositions comprising buprenorphine and naloxone - Google Patents
Improved medicinal compositions comprising buprenorphine and naloxone Download PDFInfo
- Publication number
- AU2008220573A1 AU2008220573A1 AU2008220573A AU2008220573A AU2008220573A1 AU 2008220573 A1 AU2008220573 A1 AU 2008220573A1 AU 2008220573 A AU2008220573 A AU 2008220573A AU 2008220573 A AU2008220573 A AU 2008220573A AU 2008220573 A1 AU2008220573 A1 AU 2008220573A1
- Authority
- AU
- Australia
- Prior art keywords
- buprenorphine
- naloxone
- composition
- administration
- pain
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- 239000000203 mixture Substances 0.000 title claims description 36
- SFNLWIKOKQVFPB-KZCPYJDTSA-N bunavail Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C.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 SFNLWIKOKQVFPB-KZCPYJDTSA-N 0.000 title claims description 21
- 229960001736 buprenorphine Drugs 0.000 claims description 44
- 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 description 44
- 229960004127 naloxone Drugs 0.000 claims description 37
- 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 description 37
- 208000002193 Pain Diseases 0.000 claims description 18
- 230000036407 pain Effects 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 17
- 239000003814 drug Substances 0.000 claims description 12
- 230000036592 analgesia Effects 0.000 claims description 7
- 239000002552 dosage form Substances 0.000 claims description 7
- 230000037396 body weight Effects 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 210000003928 nasal cavity Anatomy 0.000 claims 1
- 230000000202 analgesic effect Effects 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- 230000000694 effects Effects 0.000 description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- 230000002411 adverse Effects 0.000 description 7
- 230000003389 potentiating effect Effects 0.000 description 6
- 239000003826 tablet Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 210000004877 mucosa Anatomy 0.000 description 4
- 230000037325 pain tolerance Effects 0.000 description 4
- 150000003839 salts Chemical class 0.000 description 4
- 208000004756 Respiratory Insufficiency Diseases 0.000 description 3
- 206010038678 Respiratory depression Diseases 0.000 description 3
- 230000003502 anti-nociceptive effect Effects 0.000 description 3
- 230000036772 blood pressure Effects 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 150000003840 hydrochlorides Chemical class 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000003402 opiate agonist Substances 0.000 description 3
- 239000003401 opiate antagonist Substances 0.000 description 3
- 229940005483 opioid analgesics Drugs 0.000 description 3
- 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 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- 206010028813 Nausea Diseases 0.000 description 2
- 241000700159 Rattus Species 0.000 description 2
- 239000000556 agonist Substances 0.000 description 2
- 229940035676 analgesics Drugs 0.000 description 2
- 239000005557 antagonist Substances 0.000 description 2
- 239000000730 antalgic agent Substances 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 210000000245 forearm Anatomy 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000007654 immersion Methods 0.000 description 2
- 239000002050 international nonproprietary name Substances 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000007937 lozenge Substances 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 239000003887 narcotic antagonist Substances 0.000 description 2
- 230000008693 nausea Effects 0.000 description 2
- 230000003040 nociceptive effect Effects 0.000 description 2
- 229940127240 opiate Drugs 0.000 description 2
- 239000006201 parenteral dosage form Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 229940069328 povidone Drugs 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 235000019759 Maize starch Nutrition 0.000 description 1
- 229940127450 Opioid Agonists Drugs 0.000 description 1
- 208000000114 Pain Threshold Diseases 0.000 description 1
- 206010039897 Sedation Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000003042 antagnostic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 238000011260 co-administration Methods 0.000 description 1
- 239000013066 combination product Substances 0.000 description 1
- 229940127555 combination product Drugs 0.000 description 1
- 210000004207 dermis Anatomy 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 230000003205 diastolic effect Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 210000003414 extremity Anatomy 0.000 description 1
- 239000010408 film Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 239000011812 mixed powder Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- PFBSOANQDDTNGJ-YNHQPCIGSA-N morphinone Chemical compound O([C@H]1C(C=C[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O PFBSOANQDDTNGJ-YNHQPCIGSA-N 0.000 description 1
- 229960004088 naloxone hydrochloride dihydrate Drugs 0.000 description 1
- 230000003533 narcotic effect Effects 0.000 description 1
- 229940121367 non-opioid analgesics Drugs 0.000 description 1
- 231100000862 numbness Toxicity 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 230000037040 pain threshold Effects 0.000 description 1
- 239000004031 partial agonist Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 230000002385 psychotomimetic effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000036280 sedation Effects 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 229940098466 sublingual tablet Drugs 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
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
- A61K31/33—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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2014201779A AU2014201779A1 (en) | 2007-03-01 | 2014-03-25 | Improved medicinal compositions comprising buprenorphine and naloxone |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0703967A GB2447015A (en) | 2007-03-01 | 2007-03-01 | Analgesic composition comprising a specific ratio of buprenorphine and naltrexone |
| GB0703967.0 | 2007-03-01 | ||
| PCT/GB2008/000523 WO2008104737A1 (en) | 2007-03-01 | 2008-02-15 | Improved medicinal compositions comprising buprenorphine and naloxone |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2014201779A Division AU2014201779A1 (en) | 2007-03-01 | 2014-03-25 | Improved medicinal compositions comprising buprenorphine and naloxone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2008220573A1 true AU2008220573A1 (en) | 2008-09-04 |
Family
ID=37965734
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2008220573A Abandoned AU2008220573A1 (en) | 2007-03-01 | 2008-02-15 | Improved medicinal compositions comprising buprenorphine and naloxone |
Country Status (16)
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2054031B1 (en) | 2006-07-21 | 2016-04-06 | BioDelivery Sciences International, Inc. | Transmucosal delivery devices with enhanced uptake |
| US20110189259A1 (en) * | 2008-06-23 | 2011-08-04 | Biodelivery Sciences International, Inc. | Multidirectional mucosal delivery devices and methods of use |
| US8475832B2 (en) * | 2009-08-07 | 2013-07-02 | Rb Pharmaceuticals Limited | Sublingual and buccal film compositions |
| WO2013026064A1 (en) | 2011-08-18 | 2013-02-21 | Biodelivery Sciences International, Inc. | Abuse-resistant mucoadhesive devices for delivery of buprenorphine |
| PL2915525T3 (pl) * | 2011-09-19 | 2022-01-17 | Orexo Ab | Tabletki podjęzykowe niepodatne na nadużywanie zawierające buprenorfinę i nalokson |
| US9901539B2 (en) | 2011-12-21 | 2018-02-27 | Biodelivery Sciences International, Inc. | Transmucosal drug delivery devices for use in chronic pain relief |
| US20140275148A1 (en) * | 2013-03-15 | 2014-09-18 | Novus Pharma LLC | Orally administrable, self-supporting dissolving film dosage forms |
| WO2015095644A1 (en) | 2013-12-20 | 2015-06-25 | AntiOP, Inc. | Intranasal naloxone compositions and methods of making and using same |
| US9480644B2 (en) | 2014-03-14 | 2016-11-01 | Opiant Pharmaceuticals, Inc. | Nasal drug products and methods of their use |
| US10085937B2 (en) | 2014-03-14 | 2018-10-02 | Adapt Pharma Limited | Nasal drug products and methods of their use |
| EP3777838A1 (en) | 2014-03-14 | 2021-02-17 | Opiant Pharmaceuticals, Inc. | Nasal drug products and methods of their use |
| US9561177B2 (en) | 2014-03-14 | 2017-02-07 | Adapt Pharma Limited | Nasal drug products and methods of their use |
| EP4548911A1 (en) | 2023-11-06 | 2025-05-07 | Extrovis AG | Pharmaceutical compositions |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4457933A (en) * | 1980-01-24 | 1984-07-03 | Bristol-Myers Company | Prevention of analgesic abuse |
| GB8332556D0 (en) * | 1983-12-06 | 1984-01-11 | Reckitt & Colmann Prod Ltd | Analgesic compositions |
| IL136805A0 (en) * | 1997-12-22 | 2001-11-25 | Euro Celtique Sa | A method of preventing abuse of opioid dosage forms |
| AR031682A1 (es) | 1999-11-19 | 2003-10-01 | Reckitt Benckiser Helthcare Uk | Composiciones farmaceuticas |
| US20050191340A1 (en) * | 2002-08-09 | 2005-09-01 | Gruenenthal Gmbh | Opioid-receptor antagonists in transdermal systems having buprenorphine |
| PT1526848E (pt) * | 2002-08-09 | 2007-08-08 | Gruenenthal Gmbh | Antagonistas dos receptores de opióides em sistemas transdérmicos contendo buprenorfina |
| EP1584335A3 (en) * | 2004-04-05 | 2006-02-22 | Laboratorios Del Dr. Esteve, S.A. | Active substance combination comprising a carbinol composition and an opioid |
| WO2008109779A2 (en) * | 2007-03-07 | 2008-09-12 | The Johns Hopkins University | Use of follistatin-like related gene (flrg) to increase muscle mass |
-
2007
- 2007-03-01 GB GB0703967A patent/GB2447015A/en not_active Withdrawn
-
2008
- 2008-02-15 EP EP08709414A patent/EP2114453A1/en not_active Withdrawn
- 2008-02-15 MX MX2009009133A patent/MX2009009133A/es unknown
- 2008-02-15 CA CA002678675A patent/CA2678675A1/en not_active Abandoned
- 2008-02-15 CN CN2012101207560A patent/CN102670610A/zh active Pending
- 2008-02-15 BR BRPI0807905-6A2A patent/BRPI0807905A2/pt not_active IP Right Cessation
- 2008-02-15 US US12/529,309 patent/US20100168147A1/en not_active Abandoned
- 2008-02-15 JP JP2009551255A patent/JP2010520185A/ja not_active Ceased
- 2008-02-15 CN CN200880006847A patent/CN101622013A/zh active Pending
- 2008-02-15 WO PCT/GB2008/000523 patent/WO2008104737A1/en not_active Ceased
- 2008-02-15 KR KR1020097018324A patent/KR20090115863A/ko not_active Ceased
- 2008-02-15 AU AU2008220573A patent/AU2008220573A1/en not_active Abandoned
- 2008-02-27 TW TW097106772A patent/TW200836738A/zh unknown
- 2008-02-28 CL CL200800610A patent/CL2008000610A1/es unknown
- 2008-02-29 PE PE2008000412A patent/PE20081874A1/es not_active Application Discontinuation
- 2008-02-29 AR ARP080100882A patent/AR065581A1/es not_active Application Discontinuation
-
2009
- 2009-08-17 ZA ZA200905691A patent/ZA200905691B/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AR065581A1 (es) | 2009-06-17 |
| US20100168147A1 (en) | 2010-07-01 |
| TW200836738A (en) | 2008-09-16 |
| GB2447015A (en) | 2008-09-03 |
| WO2008104737A1 (en) | 2008-09-04 |
| GB0703967D0 (en) | 2007-04-11 |
| CL2008000610A1 (es) | 2008-09-05 |
| EP2114453A1 (en) | 2009-11-11 |
| PE20081874A1 (es) | 2009-01-26 |
| MX2009009133A (es) | 2009-09-03 |
| BRPI0807905A2 (pt) | 2014-06-17 |
| ZA200905691B (en) | 2010-10-27 |
| CN102670610A (zh) | 2012-09-19 |
| CN101622013A (zh) | 2010-01-06 |
| JP2010520185A (ja) | 2010-06-10 |
| KR20090115863A (ko) | 2009-11-09 |
| CA2678675A1 (en) | 2008-09-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC1 | Assignment before grant (sect. 113) |
Owner name: RB PHARMACEUTICALS LIMITED Free format text: FORMER APPLICANT(S): RECKITT BENCKISER HEALTHCARE (UK) LIMITED |
|
| MK5 | Application lapsed section 142(2)(e) - patent request and compl. specification not accepted |