SG11201408318RA - Compositions and methods for transmucosal absorption - Google Patents
Compositions and methods for transmucosal absorptionInfo
- Publication number
- SG11201408318RA SG11201408318RA SG11201408318RA SG11201408318RA SG11201408318RA SG 11201408318R A SG11201408318R A SG 11201408318RA SG 11201408318R A SG11201408318R A SG 11201408318RA SG 11201408318R A SG11201408318R A SG 11201408318RA SG 11201408318R A SG11201408318R A SG 11201408318RA
- Authority
- SG
- Singapore
- Prior art keywords
- lllll
- new york
- international
- methods
- compositions
- 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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
-
- 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
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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
- A61P25/22—Anxiolytics
-
- 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
- A61P25/24—Antidepressants
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 19 December 2013 (19.12.2013) WIPOIPCT (10) International Publication Number WO 2013/188847 A1 (51) International Patent Classification: A61K31/135 (2006.01) A61K 9/00 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/US2013/046023 14 June 2013 (14.06.2013) English English (30) Priority Data: 61/660,593 15 June 2012 (15.06.2012) US 61/667,774 3 July 2012 (03.07.2012) US 61/725,402 12 November 2012 (12.11.2012) US 61/792,900 15 March 2013 (15.03.2013) US (71) Applicant (for all designated States except KM, US): TONIX PHARMACEUTICALS, INC. [US/US]; 509 Madison Avenue, Suite 306, New York, New York 10022 (US). (72) Inventors; and (71) Applicants (for US only): LEDERMAN, Seth [US/US]; 245 E. 93rd Street, Apt. 14E, New York, New York 10128 (US). REINER, Giorgio [IT/IT]; Via Rusconi 24, 1-22 100 Como (IT). (72) Inventor; and (71) Applicant : BRITTAIN, Harry [US/US]; 10 Charles Road, Milford, New Jersey 08848 (US). (74) Agents: HALEY, James F., Jr. et al.; Ropes & Gray LLP, 1211 Avenue of the Americas, New York, New York 10036-8704 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. [Continued on next page] (54) Title: COMPOSITIONS AND METHODS FOR TRANSMUCOSAL ABSORPTION l> 00 00 00 5000 • 4000 - 15) Q. 0\" .§ 3000 • Q. CD N 4.8 mg, sublingual 5 mg, oral 0 .o o o >> O ro £ tn _cp CL 2000 - 1000 - 0 - 0.0 0.5 1.0 1.5 Time, hr Figure 14b 2.0 2.5 (57) Abstract: The invention provides compositions and methods for adminis tering therapeutic compounds, specific ally cyclobenzaprine or amitryptyline, for transmucosal absorption, wherein the compositions contain a basifying agent in addition to the therapeutic agent. The compositions and methods have a number of surprising pharma cokinetic benefits over oral administra tion. Methods of treating fibromyalgia in human subject a are also provided. WO 2013/188847 A11 lllll llllllll II llllll III lllll lllll III III III lllll lllll lllll lllll llll lllll llll lllllll llll llll (84) Designated States (unless otherwise indicated, for every kind of regional protection available)'. ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, — TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h))
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261660593P | 2012-06-15 | 2012-06-15 | |
| US201261667774P | 2012-07-03 | 2012-07-03 | |
| US201261725402P | 2012-11-12 | 2012-11-12 | |
| US201361792900P | 2013-03-15 | 2013-03-15 | |
| PCT/US2013/046023 WO2013188847A1 (en) | 2012-06-15 | 2013-06-14 | Compositions and methods for transmucosal absorption |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201408318RA true SG11201408318RA (en) | 2015-01-29 |
Family
ID=49758769
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201408318RA SG11201408318RA (en) | 2012-06-15 | 2013-06-14 | Compositions and methods for transmucosal absorption |
| SG10201605407TA SG10201605407TA (en) | 2012-06-15 | 2013-06-14 | Compositions and methods for transmucosal absorption |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG10201605407TA SG10201605407TA (en) | 2012-06-15 | 2013-06-14 | Compositions and methods for transmucosal absorption |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US20140171515A1 (en) |
| EP (1) | EP2861223B1 (en) |
| JP (5) | JP6259452B2 (en) |
| CN (2) | CN111388430A (en) |
| AR (1) | AR092330A1 (en) |
| AU (2) | AU2013274003B2 (en) |
| BR (1) | BR112014031394B1 (en) |
| CA (2) | CA3118913A1 (en) |
| DK (1) | DK2861223T3 (en) |
| ES (1) | ES2929133T3 (en) |
| HK (1) | HK1209361A1 (en) |
| HR (1) | HRP20221325T1 (en) |
| HU (1) | HUE060175T2 (en) |
| IL (1) | IL236268B (en) |
| LT (1) | LT2861223T (en) |
| MX (2) | MX2021005317A (en) |
| MY (1) | MY194495A (en) |
| NZ (2) | NZ726488A (en) |
| PL (1) | PL2861223T3 (en) |
| PT (1) | PT2861223T (en) |
| RS (1) | RS63822B1 (en) |
| SG (2) | SG11201408318RA (en) |
| SI (1) | SI2861223T1 (en) |
| TW (3) | TWI590820B (en) |
| WO (1) | WO2013188847A1 (en) |
| ZA (1) | ZA201500288B (en) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NO2501234T3 (en) | 2009-11-20 | 2018-02-10 | ||
| US20110319389A1 (en) | 2010-06-24 | 2011-12-29 | Tonix Pharmaceuticals, Inc. | Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine |
| US10117936B2 (en) | 2013-03-15 | 2018-11-06 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride |
| CN107072968B (en) * | 2014-09-18 | 2021-01-12 | 通尼克斯制药控股有限公司 | Eutectic formulation of cyclobenzaprine hydrochloride |
| EP3322412B1 (en) * | 2015-07-15 | 2021-04-07 | Theranexus | Use of amitriptyline for blocking brain hemichannels and method for potentiating its effect in vivo |
| WO2018045367A1 (en) * | 2016-09-02 | 2018-03-08 | Nova Southeastern University | Atropine sulfate rapidly-disintegrating sublingual tablets for treatment of acute organophosphate toxicity |
| CN110996932A (en) * | 2017-07-13 | 2020-04-10 | 托尼克斯医药控股公司 | Cyclobenzaprine and amitriptyline analogs |
| CN107519142B (en) * | 2017-08-24 | 2021-02-26 | 正大制药（青岛）有限公司 | Cyclobenzaprine hydrochloride sublingual tablet and preparation method thereof |
| CN107496355B (en) * | 2017-08-24 | 2021-04-30 | 正大制药（青岛）有限公司 | Cyclobenzaprine hydrochloride sublingual spray and preparation method thereof |
| ES2930376T3 (en) * | 2017-12-08 | 2022-12-09 | Hoffmann La Roche | pharmaceutical formulation |
| WO2019116091A1 (en) | 2017-12-11 | 2019-06-20 | Tonix Pharma Holdings Limited | Cyclobenzaprine treatment for agitation, psychosis and cognitive decline in dementia and neurodegenerative conditions |
| CN108721240A (en) * | 2018-06-08 | 2018-11-02 | 华益药业科技(安徽)有限公司 | A kind of 25mg amitriptylines film coating tablet recipe and technological procedure |
| BR112021003107A2 (en) * | 2018-08-20 | 2021-05-11 | Tonix Pharma Holdings Limited | Acute stress disorder and post-traumatic stress disorder treatment methods |
| CA3156118A1 (en) * | 2019-09-30 | 2021-04-08 | Cadila Healthcare Limited | Intranasal pharmaceutical compositions of cyclobenzaprine |
| CA3179754A1 (en) * | 2020-04-08 | 2021-10-14 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for sexual dysfunction |
| JP2023554597A (en) | 2020-11-20 | 2023-12-28 | トニックス ファーマシューティカルズ ホールディング コーポレイション | Cyclobenzaprine treatment for alcohol use disorder |
| CA3204202A1 (en) | 2020-12-07 | 2022-06-16 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for fibromyalgia |
| WO2022170107A2 (en) | 2021-02-04 | 2022-08-11 | Tonix Pharmaceuticals Holding Corp. | An improved method of assessing clinical response in the treatment of ptsd symptoms |
| WO2023059728A1 (en) | 2021-10-06 | 2023-04-13 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine for treatment or prevention of sexual dysfunction associated with mental health conditions in female patients |
| WO2023250036A1 (en) | 2022-06-21 | 2023-12-28 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for post-acute sequelae of (sars)-cov-2 infection (pasc) |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4968507A (en) * | 1984-06-20 | 1990-11-06 | Merck & Co., Inc. | Controlled porosity osmotic pump |
| US20030077227A1 (en) | 1997-10-01 | 2003-04-24 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system |
| WO1999018937A1 (en) * | 1997-10-16 | 1999-04-22 | Merck & Co., Inc. | New cyclobenzaprine composition |
| AU3885799A (en) * | 1998-05-14 | 1999-11-29 | Alza Corporation | Antidepressant therapy |
| US6395788B1 (en) | 1999-08-13 | 2002-05-28 | Vela Pharmaceuticals, Inc. | Methods and compositions for treating or preventing sleep disturbances and associated illnesses using very low doses of cyclobenzaprine |
| ES2212737B1 (en) | 1999-08-13 | 2005-10-01 | Vela Pharmaceuticals Inc. | CYCLLOBENZAPRINE TO TREAT DISORDERS OF GENERAL ANXIETY AND COMPOSITIONS OF THE SAME. |
| WO2001089476A1 (en) * | 2000-05-19 | 2001-11-29 | Npd Llc | Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements |
| WO2002094229A1 (en) * | 2001-05-24 | 2002-11-28 | Alexza Molecular Delivery Corporation | Delivery of muscle relaxants through an inhalation route |
| EP1596824A4 (en) * | 2003-02-04 | 2011-11-23 | Chrysalis Tech Inc | Aerosol formulations and aerosol delivery of buspirone, buprenorphine, triazolam, cyclobenzaprine and zolpidem |
| WO2006105205A1 (en) * | 2005-03-29 | 2006-10-05 | University Of Kentucky Research Foundation | Sublingual spray for the treatment of pain |
| US20090148532A1 (en) * | 2007-12-06 | 2009-06-11 | Venkatesh Gopi M | Preparation of controlled release skeletal muscle relaxant dosage forms |
| JP2009079060A (en) * | 2008-10-15 | 2009-04-16 | Novadel Pharma Inc | Polar or non-polar buccal spray or capsule |
| US20100266682A1 (en) * | 2008-12-10 | 2010-10-21 | Nipun Davar | Polyethylene glycol-coated sodium carbonate as a pharmaceutical excipient and compositions produced from the same |
| US20100247586A1 (en) * | 2009-03-27 | 2010-09-30 | Andreas Hugerth | Multi-Portion Intra-Oral Dosage Form With Organoleptic Properties |
| NO2501234T3 (en) * | 2009-11-20 | 2018-02-10 | ||
| US20110319389A1 (en) * | 2010-06-24 | 2011-12-29 | Tonix Pharmaceuticals, Inc. | Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine |
| ITMI20110558A1 (en) * | 2011-04-06 | 2012-10-07 | Campiglio Consulting Srl | PHARMACEUTICAL COMPOSITION CONTAINING CYCLOBENZAPRINE SUITABLE FOR ENDONASAL ADMINISTRATION |
| US10117936B2 (en) * | 2013-03-15 | 2018-11-06 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride |
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2013
- 2013-06-14 EP EP13804115.7A patent/EP2861223B1/en active Active
- 2013-06-14 HU HUE13804115A patent/HUE060175T2/en unknown
- 2013-06-14 SG SG11201408318RA patent/SG11201408318RA/en unknown
- 2013-06-14 SI SI201332010T patent/SI2861223T1/en unknown
- 2013-06-14 MY MYPI2014703784A patent/MY194495A/en unknown
- 2013-06-14 ES ES13804115T patent/ES2929133T3/en active Active
- 2013-06-14 BR BR112014031394-6A patent/BR112014031394B1/en active IP Right Grant
- 2013-06-14 RS RS20221005A patent/RS63822B1/en unknown
- 2013-06-14 PT PT138041157T patent/PT2861223T/en unknown
- 2013-06-14 TW TW102121267A patent/TWI590820B/en active
- 2013-06-14 TW TW106117185A patent/TWI642429B/en active
- 2013-06-14 PL PL13804115.7T patent/PL2861223T3/en unknown
- 2013-06-14 LT LTEPPCT/US2013/046023T patent/LT2861223T/en unknown
- 2013-06-14 CA CA3118913A patent/CA3118913A1/en active Granted
- 2013-06-14 JP JP2015517469A patent/JP6259452B2/en active Active
- 2013-06-14 NZ NZ726488A patent/NZ726488A/en unknown
- 2013-06-14 SG SG10201605407TA patent/SG10201605407TA/en unknown
- 2013-06-14 WO PCT/US2013/046023 patent/WO2013188847A1/en active Application Filing
- 2013-06-14 NZ NZ631144A patent/NZ631144A/en unknown
- 2013-06-14 MX MX2021005317A patent/MX2021005317A/en unknown
- 2013-06-14 CA CA2876902A patent/CA2876902C/en active Active
- 2013-06-14 MX MX2014015436A patent/MX2014015436A/en unknown
- 2013-06-14 DK DK13804115.7T patent/DK2861223T3/en active
- 2013-06-14 TW TW107117266A patent/TWI683660B/en active
- 2013-06-14 HR HRP20221325TT patent/HRP20221325T1/en unknown
- 2013-06-14 US US13/918,692 patent/US20140171515A1/en active Pending
- 2013-06-14 CN CN202010024102.2A patent/CN111388430A/en active Pending
- 2013-06-14 AR ARP130102101A patent/AR092330A1/en not_active Application Discontinuation
- 2013-06-14 CN CN201380039522.6A patent/CN104684550A/en active Pending
- 2013-06-14 AU AU2013274003A patent/AU2013274003B2/en active Active
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2014
- 2014-12-15 IL IL236268A patent/IL236268B/en unknown
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2015
- 2015-01-15 ZA ZA2015/00288A patent/ZA201500288B/en unknown
- 2015-10-16 HK HK15110186.6A patent/HK1209361A1/en unknown
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2017
- 2017-10-02 JP JP2017192713A patent/JP2017222726A/en not_active Withdrawn
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2018
- 2018-10-04 AU AU2018241128A patent/AU2018241128B2/en active Active
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2019
- 2019-05-14 JP JP2019091262A patent/JP2019123757A/en not_active Withdrawn
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2021
- 2021-06-16 JP JP2021100154A patent/JP2021138765A/en not_active Withdrawn
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2024
- 2024-02-02 JP JP2024014696A patent/JP2024032964A/en active Pending
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