JP2014513685A5 - - Google Patents
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- Publication number
- JP2014513685A5 JP2014513685A5 JP2014510273A JP2014510273A JP2014513685A5 JP 2014513685 A5 JP2014513685 A5 JP 2014513685A5 JP 2014510273 A JP2014510273 A JP 2014510273A JP 2014510273 A JP2014510273 A JP 2014510273A JP 2014513685 A5 JP2014513685 A5 JP 2014513685A5
- Authority
- JP
- Japan
- Prior art keywords
- coating
- core
- active ingredient
- drug delivery
- testosterone
- 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.)
- Granted
Links
- 239000011248 coating agent Substances 0.000 claims description 58
- 238000000576 coating method Methods 0.000 claims description 58
- 239000004480 active ingredient Substances 0.000 claims description 19
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 claims description 18
- 238000012377 drug delivery Methods 0.000 claims description 15
- 229920002678 cellulose Polymers 0.000 claims description 10
- 239000001913 cellulose Substances 0.000 claims description 10
- 230000009977 dual effect Effects 0.000 claims description 9
- 229960003604 testosterone Drugs 0.000 claims description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 7
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 6
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 6
- 229920001600 hydrophobic polymer Polymers 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 229920000858 Cyclodextrin Polymers 0.000 claims description 5
- 239000001856 Ethyl cellulose Substances 0.000 claims description 5
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 5
- 229920001249 ethyl cellulose Polymers 0.000 claims description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 5
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims description 5
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 5
- 102100022738 5-hydroxytryptamine receptor 1A Human genes 0.000 claims description 4
- 101710138638 5-hydroxytryptamine receptor 1A Proteins 0.000 claims description 4
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims description 4
- 229940123333 Phosphodiesterase 5 inhibitor Drugs 0.000 claims description 4
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims description 4
- 239000001506 calcium phosphate Substances 0.000 claims description 4
- 229960005168 croscarmellose Drugs 0.000 claims description 4
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims description 4
- 229940038472 dicalcium phosphate Drugs 0.000 claims description 4
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 239000002590 phosphodiesterase V inhibitor Substances 0.000 claims description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 239000000018 receptor agonist Substances 0.000 claims description 4
- 229940044601 receptor agonist Drugs 0.000 claims description 4
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims description 4
- QWCRAEMEVRGPNT-UHFFFAOYSA-N buspirone Chemical compound C1C(=O)N(CCCCN2CCN(CC2)C=2N=CC=CN=2)C(=O)CC21CCCC2 QWCRAEMEVRGPNT-UHFFFAOYSA-N 0.000 claims description 3
- 229920001688 coating polymer Polymers 0.000 claims description 3
- 239000007884 disintegrant Substances 0.000 claims description 3
- 239000002792 enkephalinase inhibitor Substances 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 3
- 208000010228 Erectile Dysfunction Diseases 0.000 claims description 2
- 206010057671 Female sexual dysfunction Diseases 0.000 claims description 2
- 206010057672 Male sexual dysfunction Diseases 0.000 claims description 2
- 229960001768 buspirone hydrochloride Drugs 0.000 claims description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 2
- 229940079593 drug Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 230000004064 dysfunction Effects 0.000 claims description 2
- 201000001881 impotence Diseases 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 229960002639 sildenafil citrate Drugs 0.000 claims description 2
- DEIYFTQMQPDXOT-UHFFFAOYSA-N sildenafil citrate Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 DEIYFTQMQPDXOT-UHFFFAOYSA-N 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 2
- PASHVRUKOFIRIK-UHFFFAOYSA-L calcium sulfate dihydrate Chemical compound O.O.[Ca+2].[O-]S([O-])(=O)=O PASHVRUKOFIRIK-UHFFFAOYSA-L 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000000926 separation method Methods 0.000 description 5
- 229910017053 inorganic salt Inorganic materials 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 108010011485 Aspartame Proteins 0.000 description 2
- 239000000605 aspartame Substances 0.000 description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 2
- 229960003438 aspartame Drugs 0.000 description 2
- 235000010357 aspartame Nutrition 0.000 description 2
- 239000004067 bulking agent Substances 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000001525 mentha piperita l. herb oil Substances 0.000 description 2
- 235000019477 peppermint oil Nutrition 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- BNRNXUUZRGQAQC-UHFFFAOYSA-N sildenafil Chemical compound CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 description 2
- 241000167880 Hirundinidae Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229960002495 buspirone Drugs 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 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
- 229960003310 sildenafil Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11166091.6 | 2011-05-13 | ||
| EP11166091 | 2011-05-13 | ||
| EP11181165 | 2011-09-13 | ||
| EP11181165.9 | 2011-09-13 | ||
| EP11183732 | 2011-10-03 | ||
| EP11183732.4 | 2011-10-03 | ||
| PCT/NL2012/050336 WO2012158030A2 (en) | 2011-05-13 | 2012-05-14 | Drug delivery system |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014513685A JP2014513685A (ja) | 2014-06-05 |
| JP2014513685A5 true JP2014513685A5 (enExample) | 2015-07-16 |
| JP6121990B2 JP6121990B2 (ja) | 2017-04-26 |
Family
ID=46197660
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014510273A Active JP6121990B2 (ja) | 2011-05-13 | 2012-05-14 | 薬物送達システム |
Country Status (15)
| Country | Link |
|---|---|
| US (4) | US9763884B2 (enExample) |
| EP (1) | EP2709597A2 (enExample) |
| JP (1) | JP6121990B2 (enExample) |
| KR (2) | KR102158948B1 (enExample) |
| CN (2) | CN103648487B (enExample) |
| AU (1) | AU2012256501B2 (enExample) |
| BR (1) | BR112013029199B1 (enExample) |
| CA (1) | CA2835845C (enExample) |
| EA (1) | EA034288B1 (enExample) |
| IL (1) | IL229425B (enExample) |
| MX (1) | MX353623B (enExample) |
| PH (1) | PH12013502325A1 (enExample) |
| SG (2) | SG10201606751XA (enExample) |
| WO (1) | WO2012158030A2 (enExample) |
| ZA (1) | ZA201309156B (enExample) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160095818A1 (en) * | 2013-06-03 | 2016-04-07 | Mcneil Ab | Solid pharmaceutical dosage form for release of at least one active pharmaceutical ingredient in the oral cavity |
| US20160279146A1 (en) | 2013-11-11 | 2016-09-29 | Limoxifen B.V. | Methods and pharmaceutical formulations for treatment of selective estrogen-receptor modulator-induced adverse drug reactions |
| EP3248592A1 (en) * | 2016-05-25 | 2017-11-29 | EB IP Hybritabs B.V. | Process for the preparation of drug delivery systems having a testosterone compound present in an outer layer or part, as well as such drug delivery systems |
| AU2017445093B2 (en) * | 2017-12-29 | 2024-09-19 | Exentis Knowledge Gmbh | Drug delivery system |
| US20190381056A1 (en) | 2018-06-17 | 2019-12-19 | Axsome Therapeutics, Inc. | Compositions for delivery of reboxetine |
| US20200147093A1 (en) | 2018-10-15 | 2020-05-14 | Axsome Therapeutics, Inc. | Use of esreboxetine to treat nervous system disorders such as fibromyalgia |
| US11020402B2 (en) | 2018-10-15 | 2021-06-01 | Axsome Therapeutics, Inc. | Use of reboxetine to treat narcolepsy |
| KR102084602B1 (ko) * | 2018-11-08 | 2020-03-04 | 주식회사 서흥 | 발포성 및 안정성이 향상된 구강 세정용 발포정 |
| WO2024253526A1 (en) | 2023-06-06 | 2024-12-12 | Van Rooij Kim | Compositions for treating a subject from sexual dysfunction |
| US20250073171A1 (en) * | 2023-09-05 | 2025-03-06 | Freya Pharma Solutions Holding B.V. | Drug delivery system for the treatment of female sexual interest and arousal disorder |
Family Cites Families (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4596795A (en) * | 1984-04-25 | 1986-06-24 | The United States Of America As Represented By The Secretary, Dept. Of Health & Human Services | Administration of sex hormones in the form of hydrophilic cyclodextrin derivatives |
| US4877774A (en) * | 1987-09-09 | 1989-10-31 | The United States Of America As Represented By The Department Of Health And Human Services | Administration of steroid hormones |
| US5120720A (en) * | 1990-09-20 | 1992-06-09 | The United States Of America As Represented By The Secretary Of The Department Of Health & Human Services | Preparation of lipophile:hydroxypropylcyclodextrin complexes by a method using co-solubilizers |
| US5162117A (en) | 1991-11-22 | 1992-11-10 | Schering Corporation | Controlled release flutamide composition |
| AU3949093A (en) | 1992-03-31 | 1993-11-08 | Benzon Pharma A/S | A pharmaceutical formulation |
| US5260069A (en) | 1992-11-27 | 1993-11-09 | Anda Sr Pharmaceuticals Inc. | Pulsatile particles drug delivery system |
| US5547948A (en) * | 1995-01-17 | 1996-08-20 | American Home Products Corporation | Controlled release of steroids from sugar coatings |
| US5698560A (en) | 1995-03-01 | 1997-12-16 | Kyowa Hakko Kogyo Co., Ltd. | Imidazoquinazoline derivatives |
| US5840332A (en) | 1996-01-18 | 1998-11-24 | Perio Products Ltd. | Gastrointestinal drug delivery system |
| JP3134187B2 (ja) * | 1996-03-07 | 2001-02-13 | 武田薬品工業株式会社 | 放出制御組成物 |
| US6245351B1 (en) | 1996-03-07 | 2001-06-12 | Takeda Chemical Industries, Ltd. | Controlled-release composition |
| AU5310898A (en) * | 1996-12-20 | 1998-07-17 | Dumex-Alpharma A/S | Release-controlled coated tablets |
| US5788987A (en) | 1997-01-29 | 1998-08-04 | Poli Industria Chimica Spa | Methods for treating early morning pathologies |
| US5840329A (en) | 1997-05-15 | 1998-11-24 | Bioadvances Llc | Pulsatile drug delivery system |
| WO1999018938A1 (en) | 1997-10-09 | 1999-04-22 | Perio Products Ltd. | Delayed total release gastrointestinal drug delivery system |
| IL141762A0 (en) * | 1998-10-01 | 2002-03-10 | Novartis Ag | New oral formulations |
| US6977083B1 (en) * | 1998-10-02 | 2005-12-20 | Jenapharm Gmbh & Co. Kg | Bioadhesive tablet containing testosterone/testosterone ester mixtures and method for producing a predetermined testosterone time-release profile with same |
| UA67802C2 (uk) | 1998-10-23 | 2004-07-15 | Пфайзер Рісьоч Енд Дівелепмент Компані, Н.В./С.А. | Фармацевтична композиція з контрольованим вивільненням інгібітора цгмф фде-5 (варіанти), спосіб її одержання та спосіб лікування еректильної дисфункції |
| US6632451B2 (en) * | 1999-06-04 | 2003-10-14 | Dexcel Pharma Technologies Ltd. | Delayed total release two pulse gastrointestinal drug delivery system |
| SE9902386D0 (sv) * | 1999-06-22 | 1999-06-22 | Astra Ab | New formulation |
| US20030027804A1 (en) * | 2001-06-27 | 2003-02-06 | Van Der Hoop Roland Gerritsen | Therapeutic combinations for the treatment of hormone deficiencies |
| CA2463687A1 (en) * | 2001-10-18 | 2003-04-24 | Decode Genetics Ehf | Cyclodextrin complexes |
| AR045068A1 (es) * | 2003-07-23 | 2005-10-12 | Univ Missouri | Formulacion de liberacion inmediata de composiciones farmaceuticas |
| US20050031688A1 (en) * | 2003-08-04 | 2005-02-10 | Ayala William J. | Positive wakeup pharmaceutical sleep system with compatible pre-bedtime administration |
| US20060003002A1 (en) * | 2003-11-03 | 2006-01-05 | Lipocine, Inc. | Pharmaceutical compositions with synchronized solubilizer release |
| CN1946376A (zh) * | 2004-03-25 | 2007-04-11 | 布里斯托尔-迈尔斯·斯奎布公司 | 包衣片剂组合物及其制法 |
| RS52945B (sr) | 2004-05-11 | 2014-02-28 | Emotional Brain B.V. | Farmaceutske formulacije i njihova primena u lečenju ženske seksualne disfunkcije |
| WO2006027680A1 (en) | 2004-09-10 | 2006-03-16 | Pfizer Limited | 3-(1-carbamoylcyclohexyl) propionic acid derivatives as inhibitors of neutral endopeptidase enzyme |
| CN101146521A (zh) * | 2005-03-14 | 2008-03-19 | 太阳医药高级研究有限公司 | 提供包含纤维素和甲基丙烯酸衍生物包衣的口服药物输送系统 |
| FR2883179B1 (fr) * | 2005-03-18 | 2009-04-17 | Ethypharm Sa | Comprime enrobe |
| WO2007002823A2 (en) * | 2005-06-29 | 2007-01-04 | Wyeth | Formulations of conjugated estrogens and bazedoxifene |
| AR057882A1 (es) | 2005-11-09 | 2007-12-26 | Novartis Ag | Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra |
| CN100551373C (zh) | 2005-12-01 | 2009-10-21 | 北京华素制药股份有限公司 | 盐酸丁螺环酮缓/控释微丸 |
| WO2007106708A2 (en) | 2006-03-10 | 2007-09-20 | Novartis Ag | Combinations of the angiotensin ii antagonist valsartan and the nep inhibitor daglutril |
| GB0606562D0 (en) | 2006-03-31 | 2006-05-10 | Novartis Ag | Organic compounds |
| TW200806282A (en) * | 2006-05-05 | 2008-02-01 | Wyeth Corp | Solid dosage formulations |
| EP2457563B1 (en) | 2006-05-09 | 2017-03-22 | Mallinckrodt LLC | Zero-order modified release solid dosage forms |
| WO2008008434A1 (en) * | 2006-07-11 | 2008-01-17 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations |
| KR20090042967A (ko) * | 2006-08-14 | 2009-05-04 | 베링거 인겔하임 인터내셔날 게엠베하 | 플리반세린 제형 및 이의 제조방법 |
| EP1925307A1 (en) * | 2006-11-03 | 2008-05-28 | Emotional Brain B.V. | Use of 3-alpha-androstanediol in the treatment of sexual dysfunction |
| WO2009098697A1 (en) | 2008-02-08 | 2009-08-13 | Dexxon Ltd. | Modafinil and sildenafil dosage forms |
| JP5777273B2 (ja) | 2008-07-10 | 2015-09-09 | 大正製薬株式会社 | 不快な呈味を有する薬物を含有する製剤粒子 |
| US9005661B2 (en) | 2009-09-15 | 2015-04-14 | Beijing Team Hospital Management Co., Ltd. | Osmotic pump controlled release tablet and preparation method thereof |
-
2012
- 2012-05-14 CN CN201280034770.7A patent/CN103648487B/zh active Active
- 2012-05-14 KR KR1020197018829A patent/KR102158948B1/ko active Active
- 2012-05-14 EA EA201391689A patent/EA034288B1/ru not_active IP Right Cessation
- 2012-05-14 SG SG10201606751XA patent/SG10201606751XA/en unknown
- 2012-05-14 JP JP2014510273A patent/JP6121990B2/ja active Active
- 2012-05-14 EP EP12724767.4A patent/EP2709597A2/en active Pending
- 2012-05-14 MX MX2013013204A patent/MX353623B/es active IP Right Grant
- 2012-05-14 CN CN201910244873.XA patent/CN109908099B/zh active Active
- 2012-05-14 CA CA2835845A patent/CA2835845C/en active Active
- 2012-05-14 AU AU2012256501A patent/AU2012256501B2/en active Active
- 2012-05-14 BR BR112013029199-0A patent/BR112013029199B1/pt active IP Right Grant
- 2012-05-14 WO PCT/NL2012/050336 patent/WO2012158030A2/en not_active Ceased
- 2012-05-14 SG SG2013084132A patent/SG194943A1/en unknown
- 2012-05-14 KR KR1020137033031A patent/KR20140048882A/ko not_active Ceased
- 2012-05-14 PH PH1/2013/502325A patent/PH12013502325A1/en unknown
- 2012-05-14 US US14/117,619 patent/US9763884B2/en active Active
-
2013
- 2013-11-13 IL IL229425A patent/IL229425B/en active IP Right Grant
- 2013-12-05 ZA ZA2013/09156A patent/ZA201309156B/en unknown
-
2017
- 2017-08-25 US US15/687,303 patent/US10966933B2/en active Active
-
2021
- 2021-04-06 US US17/223,124 patent/US20210290551A1/en not_active Abandoned
-
2024
- 2024-01-18 US US18/416,774 patent/US20240165032A1/en active Pending
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