TR201807340T4 - Çan benzeri reseptör agonistleri içeren immünolojik kompozisyonların intradermal yoldan verilmesi. - Google Patents
Çan benzeri reseptör agonistleri içeren immünolojik kompozisyonların intradermal yoldan verilmesi. Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims abstract description 21
- 230000001900 immune effect Effects 0.000 title description 2
- 229940044601 receptor agonist Drugs 0.000 title description 2
- 239000000018 receptor agonist Substances 0.000 title description 2
- 230000002163 immunogen Effects 0.000 claims abstract description 23
- 239000000556 agonist Substances 0.000 claims abstract description 11
- 229940044616 toll-like receptor 7 agonist Drugs 0.000 claims description 11
- SWJXWSAKHXBQSY-UHFFFAOYSA-N benzo(c)cinnoline Chemical compound C1=CC=C2C3=CC=CC=C3N=NC2=C1 SWJXWSAKHXBQSY-UHFFFAOYSA-N 0.000 claims description 10
- 102000002689 Toll-like receptor Human genes 0.000 claims description 7
- 108020000411 Toll-like receptor Proteins 0.000 claims description 7
- 239000000427 antigen Substances 0.000 claims description 6
- 102000036639 antigens Human genes 0.000 claims description 6
- 108091007433 antigens Proteins 0.000 claims description 6
- 230000001580 bacterial effect Effects 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
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- 238000001035 drying Methods 0.000 claims description 2
- 125000001153 fluoro group Chemical group F* 0.000 claims 3
- 125000004178 (C1-C4) alkyl group Chemical group 0.000 claims 2
- 125000004169 (C1-C6) alkyl group Chemical group 0.000 claims 2
- 125000003161 (C1-C6) alkylene group Chemical group 0.000 claims 2
- 101000669447 Homo sapiens Toll-like receptor 4 Proteins 0.000 claims 2
- 102100039360 Toll-like receptor 4 Human genes 0.000 claims 2
- 125000000732 arylene group Chemical group 0.000 claims 2
- 125000005549 heteroarylene group Chemical group 0.000 claims 2
- 101000763579 Homo sapiens Toll-like receptor 1 Proteins 0.000 claims 1
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- 102100027010 Toll-like receptor 1 Human genes 0.000 claims 1
- 102100039387 Toll-like receptor 6 Human genes 0.000 claims 1
- 125000002947 alkylene group Chemical group 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- DAZSWUUAFHBCGE-KRWDZBQOSA-N n-[(2s)-3-methyl-1-oxo-1-pyrrolidin-1-ylbutan-2-yl]-3-phenylpropanamide Chemical compound N([C@@H](C(C)C)C(=O)N1CCCC1)C(=O)CCC1=CC=CC=C1 DAZSWUUAFHBCGE-KRWDZBQOSA-N 0.000 claims 1
- 229940044655 toll-like receptor 9 agonist Drugs 0.000 claims 1
- 241000283707 Capra Species 0.000 abstract 1
- 210000004207 dermis Anatomy 0.000 description 7
- 210000002615 epidermis Anatomy 0.000 description 6
- 238000007918 intramuscular administration Methods 0.000 description 4
- 229960005486 vaccine Drugs 0.000 description 4
- 238000010255 intramuscular injection Methods 0.000 description 3
- 239000007927 intramuscular injection Substances 0.000 description 3
- 210000003491 skin Anatomy 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 230000028993 immune response Effects 0.000 description 2
- 206010022000 influenza Diseases 0.000 description 2
- 239000010985 leather Substances 0.000 description 2
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- 102000005962 receptors Human genes 0.000 description 2
- 108020003175 receptors Proteins 0.000 description 2
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- 101000669402 Homo sapiens Toll-like receptor 7 Proteins 0.000 description 1
- 102100039390 Toll-like receptor 7 Human genes 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000003053 immunization Effects 0.000 description 1
- 238000002649 immunization Methods 0.000 description 1
- 239000003446 ligand Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
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- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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Abstract
Bir intradermal yoldan verme sistemi, bir TLR agonisti ve immünojen içeren bir immünojenik kompozisyon ve bir mikro-iğne ihtiva eder. İmmünojenik kompozisyon, bir yekpare biyo-degrade olabilir mikro-iğne veya bir yekpare kaplı mikro-iğneden oluşabilir. İntradermal yoldan verme sistemi, bir deri peçi halinde formüle edilebilir.
Description
TARIFNAME
CAN BENZERI RESEPTOR AGONISTLERI ICEREN
IMMUNOLOJIK KOMPOZISYONLARIN INTRADERMAL
YOLDAN VERILMESI
TEKNIK SAHA
Bu bulus, asi uygulama alaninda yer almaktadir.
GEÇMIS TEKNOLOJI
Çan benzeri reseptör (TLR) agonistleri içeren asi kompozisyonlari hali
hazirda elde edilebilir ve bu asilar, intramüsküler enjeksiyon yoluyla
uygulanir. Etkili olmakla birlikte intrami'isküler uygulama, agriya ve
lokal doku hasarina neden olabilir ve intramüsküler enjeksiyon
korkusu yaygindir. Intramüsküler enjeksiyonlar, tip alaninda egim
almis personel tarafindan uygulanmali, çabuk uygulama ve reçetesiz
satisin önüne geçilmelidir. Intramüsküler uygulama, uzun zaman
periyotlarinda stabilite kaybina ugrayabilen sivi formülasyonlarin
kullanilmasini gerektirir.
Weldon ve arkadaslari, 2012 (Effect of adjuvants on responses to skin
immunization by microneedles coated With influenza subunit vaccine.
PloS one, 7(7), e41501), influenza alt birim asisi ile birlikte bir TLR7
ligandi olan iinikiinodun mikro-igneyle verilmesinin, tek basina asiya
kiyasla gelismis immün tepkileri indükledigini buldu.
Bulusuii bir hedefi, TLR agoiiistleri içeren asilari uygulamada farkli
bir yöntem ve özellikle yukarida adi geçen sorunlardan muzdarip
olmayan daha uygun bir yol saglamaktir.
BULUSUN AÇIKLAMASI
Kasifler sasirtici bir sekilde bir Çan benzeri reseptör (TLR) agonisti
içeren immünojenik kompozisyonlarin, intrainüsküler yoldan çok
intradermal yolla verilirse daha iyi bir immün tepkisi
saglayabilecegini kesfetti. Kaslara kiyasla dermis ve epideriniste
TLRleri eksprese eden çok sayida hücre bulunabilir ve bu da, gelismis
tepki saglanmasini açiklayabilir. Ayrica özellikle intradermal yoldan
vermenin, bir cilt peçi gibi bir mikro-igne aygiti seklinde çoklu mikro-
igneler kullanilarak yapildigi durumda intraderinal yoldan verme,
intrainüsküler yoldan verineye göre anlainli sekilde daha az agriya
neden olabilir ve kompozisyonun kendi kendine uygulanmasina daha
kolay izin verebilir.
Bulus, bir yekpare biyo-degrade olabilir mikro-igne içeren bir
intradermal verme sisteini saglar; buradaki mikro-igne, bir
benzonaftiridin TLR7 agonisti ve bir immünojen içerir ve buradaki
immünojen, bir bakteriyel anti jen, örnegin bir Neisseria meningitidis
anti jenidir.
Bir düzenekte TLR7 agonisti, Tl formülüne sahiptir:
Bulus ayrica bir yekpare biyo-degrade olabilir mikro-igne içeren
bulusa ait bir intradermal verme sistemi hazirlanmasina yönelik bir
proses de saglar; buradaki mikro-igne, bir benzonaftiridin TLR7
agonisti ve bir bakteriyel immünojen içerir; buradaki yöntem, a)
immünojen ve benzonaftiridin TLR7 agonistinin karistirilmasiyla
immünojen konsantrasyonunun 10 mg/ml-SO mg/ml arasinda ve
benzonaftiridin TLR7 agonisti konsantrasyonunun 0.1 mg/ml-lO
mg/ml arasinda oldugu bir immünojenik kompozisyon olusturulmasi
ve b) immünojenik kompozisyonun kurutulmasiyla bir yekpare biyo-
degrade olabilir mikro-igne olusturulmasi adimlarini kapsar.
Immünojen konsantrasyonu, lOmg/ml, lSmg/ml, 20mg/ml, 25mg/ml,
30mg/ml, 35mg/ml, 40mg/ml, 45mg/ml veya SOmg/ml olabilir ve
TLR agonisti konsantrasyonu, 0.1 mg/ml, 0.2mg/ml, 0.3mg/ml,
Smg/ml, 9mg/ml veya lOmg/ml olabilir.
Kullanilan anti jen-TLR agonisti orani, lO:l civarinda olabilir.
Intradermal yoldan vermeyi gerçeklestirmenin tercih edilen bir yolu,
bir deri peçidir (Örn., biyo-degrade olabilir bir mikro-igne veya kapli
bir mikro-igne yoluyla) ve bu yüzden bulus ayrica bir immünojenin
intradermal yoldan verilmesine yönelik olup, birçok biyo-degrade
olabilir mikro-igne içeren bir deri peçi ile de ilgilidir; buradaki mikro-
igneler, bir benzonaftiridin TLR7 agonisti ve bakteriyel inimi'inojen
Intradermal yoldan verilen immünojenik kompozisyon, standart
delikli intraderinal ignelerle verilen sivi kompozisyonlarin aksine
tercihen katidir. Kati immünojenik kompozisyonlar, deriye penetre
edebilen ve immünojenik kompozisyonlari intradermal yoldan
verebilen yekpare bir mikro-igne seklinde olabilir. Mikro-ignenin
kendisi, kati immünojenik kompozisyondan olusabilir (bakiniz
asagidaki yekpare biyo-bozunabilir mikro-igneler).
Intradermal yoldan verme
Bir kompozisyonun intradermal yoldan verilmesi islemi,
koinpozisyonun dermise verildigi ancak dermisten kasa geçmedigi
herhangi bir verme modu, örnegin kompozisyonun direkt olarak
dermise verildigi (örn., tami tamina epidermisten dermise geçen bir
igneyle) modlar ve kompozisyonun önce epiderinisin deliiimesiyle
epiderinise verildigi (örn., bir igneyle, burada kompozisyon daha
sonra epidermisten dermise hareket eder) inodlar kullanilarak
gerçeklestirilebilir. Intraderinal yoldan verme, verme sisteminin hem
epidermisten (insanlarda tipik olarak yaklasik lOOum kalinliginda)
hem de dermisten (insaiilarda tipik olarak yaklasik 0.6-3mm
kalinliginda) geçerek penetre ettigi ve kompozisyonun daha sonra
kasa verildigi önceki teknolojiye ait intramüsküler yoldan vermeye
Claims (7)
1. Bir yekpare biyo-degrade olabilir mikro-igne içeren bir intradermal yoldan verme sistemi; buradaki mikro-igne, bir benzonaftiridin TLR7 agonisti ve bir immünojen içerir ve buradaki immünojen, bir bakteriyel anti jendir.
2. Istein l”e göre intraderinal yoldan verine sistemi; buradaki bakteriyel anti jen, bir Neisseria meningitidis anti jenidir.
3. Istem 1 veya 2Sye göre intradermal yoldan verme sistemi; buradaki benzonaftiridin TLR7 agonisti, asagidaki T] formülüne sahiptir: R1, H, Ci-Cöalkil, -C(R5)20H,-L1R5,-L]R6, -L2R5, -LZRÖ, -OLZRS veya L1, -C(O)- veya -O-“dur; L2, Ci-Cöalkilen, Cz-Cöalkenilen, arilen, heteroarilen veya - ((CR4R4)po)q(CH2)p-“dir, burada L2”ye ait Ci-Cöalkilen ve C2- Cöalkenilen istege göre 1 ila 4 floro grubuyla ikame edilir; her bir L3 birbirinden bagimsiz olarak Ci-Cöalkilen ve - ((CR4R4)pO)q(CH2)p- arasindan seçilir; burada L3°e ait Cl-Cöalkilen istege göre 1 ila 4 floro grubu ile ikame edilir; L4, arilen veya heteroarilendir; R2, H veya Cl-Cöalkildir; ve - C(R5)20H arasindan seçilir; her bir R4 birbirinden bagimsiz olarak H ve floro arasindan seçilir; R5, -P(O)(OR9)2°dir, R6, -CF2P(O)(OR9)Z veya -C(O)ORl°”dur; R7, -CF2P(O)(OR9)2 veya -C(O)ORl°”dur; R8, H veya C1-C4alkildir; her bir R9 birbirinden bagimsiz olarak H ve C l-Cöalkil arasindan seçilir; RIO, H veya Ci-C4alkildir; her bir p birbirinden bagimsiz olarak 1, 2, 3, 4, 5 ve 6 arasindan seçilir q, 1, 2, 3 veya 4,tür.
4. lstem 3”e ait intradermal yoldan verme sistemi; burada benzonaftiridin TLR7 agonisti, sunlar arasindan seçilir
5. 1 ila 4 isteinlerinden birine ait intradermal yoldan verme sistemi; 21) bir TLR4 agonisti; b) bir TLRS agoriisti; e) bir TLRl agonisti; d) bir TLR6 agonisti; veya 6) bir TLR9 agonisti. olan bir TLR agonisti de içerir.
6. Istem 5°e ait intradermal vemie sistemi; buradaki TLR4 agonisti, MPL”dir.
7. 1 ila 6 arasi istemlerderi birine göre bir intradermal yoldan verme sistemi hazirlanmasina yönelik bir proses; buradaki yöntem, a) immünojen ve benzonaftiridin TLR7 agonistinin karistirilmasiyla immünojen konsantrasyonunun lOmg/ml-SOmg/ml ve benzonaftiridin TLR7 agonisti konsantrasyonunun 0.1mg/m1-10mg/ml oldugu bir immünojenik kompozisyon olusturulmasi ve b) immünojenik kompozisyonun kurutulmasiyla bir yekpare biyo-degrade olabilir mikro-igne olusturulmasi adimlarini kapsar.
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| US201361759751P | 2013-02-01 | 2013-02-01 | |
| EP13169596 | 2013-05-28 |
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| JP2018513218A (ja) * | 2015-04-16 | 2018-05-24 | インベントプライズ リミテッド ライアビリティ カンパニー | 百日咳菌免疫原性ワクチン組成物 |
| AR111760A1 (es) | 2017-05-19 | 2019-08-14 | Novartis Ag | Compuestos y composiciones para el tratamiento de tumores sólidos mediante administración intratumoral |
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| US112509A (en) | 1871-03-07 | Improvement in medical compounds for treating fever and ague | ||
| US4057685A (en) | 1972-02-02 | 1977-11-08 | Abbott Laboratories | Chemically modified endotoxin immunizing agent |
| US4356170A (en) | 1981-05-27 | 1982-10-26 | Canadian Patents & Development Ltd. | Immunogenic polysaccharide-protein conjugates |
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-
2014
- 2014-01-30 WO PCT/EP2014/051860 patent/WO2014118305A1/en active Application Filing
- 2014-01-30 CA CA2899787A patent/CA2899787A1/en not_active Abandoned
- 2014-01-30 JP JP2015555711A patent/JP6411378B2/ja active Active
- 2014-01-30 CN CN201480007165.XA patent/CN105188747A/zh active Pending
- 2014-01-30 BR BR112015018014A patent/BR112015018014A2/pt not_active Application Discontinuation
- 2014-01-30 ES ES14704537.1T patent/ES2670863T3/es active Active
- 2014-01-30 US US14/764,997 patent/US9827190B2/en active Active
- 2014-01-30 TR TR2018/07340T patent/TR201807340T4/tr unknown
- 2014-01-30 EP EP14704537.1A patent/EP2950819B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| ES2670863T3 (es) | 2018-06-01 |
| WO2014118305A1 (en) | 2014-08-07 |
| EP2950819B1 (en) | 2018-03-28 |
| CN105188747A (zh) | 2015-12-23 |
| US9827190B2 (en) | 2017-11-28 |
| CA2899787A1 (en) | 2014-08-07 |
| US20150366796A1 (en) | 2015-12-24 |
| JP6411378B2 (ja) | 2018-10-24 |
| EP2950819A1 (en) | 2015-12-09 |
| JP2016508494A (ja) | 2016-03-22 |
| BR112015018014A2 (pt) | 2017-07-11 |
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