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(12) Patent Application Publication (10) Pub. No.: US 2015/0320694 A1 GU Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2015/0320694 A1 GU Et Al US 2015 0320694A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0320694 A1 GU et al. (43) Pub. Date: Nov. 12, 2015 (54) MUCOADHESIVENANOPARTICLE Publication Classification DELIVERY SYSTEM (51) Int. Cl. A 6LX 9/5 (2006.01) (71) Applicants: Frank GU, Kitchener (CA); Lyndon A638/3 (2006.01) James William JONES. Waterloo (CA): A613 L/704 (2006.01) Shengyan (Sandy) LIU, Waterloo (CA) (52) U.S. Cl. CPC ............. A61K9/5 161 (2013.01); A61 K3I/704 (72) Inventors: Frank GU, Kitchener (CA); Lyndon (2013.01); A61 K9/5192 (2013.01); A61 K James WilliamO O JONES. Waterloo (CA): 9/5153 (2013.01);A6K9/523 A61K 38/13 (2013.01);(2013.O1 Shengyan (Sandy) LIU, Waterloo (CA) ( .01) (57) ABSTRACT (21) Appl. No.: 14/410,521 The present disclosure relates generally to a mucoadhesive nanoparticle delivery system. The nanoparticles are formed 1-1. from amphiphilic macromolecules conjugated to a mucosal (22) PCT Filed: Jun. 20, 2013 targeting moiety in Such a manner that the Surface of the nanoparticle is coated with the targeting moiety. The Surface (86). PCT No.: PCT/CA2O13/OSO475 density of the targeting moiety can be tuned for adjustable S371 (c)(1) targeting of the nanoparticles to a mucosal site without Sub A ri stantially compromising the stability of the particles. The (2) Date: Dec. 22, 2014 particles were found to have high loading efficiency and Sustained release properties at the mucosal site. The present O O disclosure also relates to polymers and macromolecules use Related U.S. Application Data ful in the preparation of the mucoadhesive nanoparticles, as (60) Provisional application No. 61/690,127, filed on Jun. well as compositions, methods, commercial packages, kits 20, 2012. and uses related thereto. Hydrophobic polymer * Hydrophilic polynner Targeting moiety Active ingredient Targeting moiety linked to a multinter Targeting moiety linked to the backie of a Eisner Targeting moiety linked to at branched ultiner Targeting city linked the side as fa. braich cri Tiitine Patent Application Publication Nov. 12, 2015 Sheet 1 of 19 US 2015/0320694 A1 Fragry gotri sogo.g 3. 3. 3.35. 32. Césis: 3; it fire fy rity-r ". "g gy"Ty"T my s: & 3. g 33. 3. 33. s g Cigariat Site gir. Ctesic: Stsi.gif represerpyriggs's spysysygressessessepsiegoersssssssseggeysergeysergeyesigrgeryggerers gigsgregarsyegressesseen s: 3. $3: 33 : 8: 33 f Sai 3. & 3. : sigg: Si: Ext: Fig. 1 Patent Application Publication Nov. 12, 2015 Sheet 2 of 19 US 2015/0320694 A1 Fig.2b Patent Application Publication Nov. 12, 2015 Sheet 3 of 19 US 2015/0320694 A1 Oc PC-ex O. s 60 M 2 50 EE$ 40 S 30 2 20 10 O O Frtial Doxoruitir feed wt.) b PA-ex 3- PLA20-Dex10 FPGA-PEG s s 10 w i took coss -- 3. Initial Doxorubicir feed (wt %) Patent Application Publication Nov. 12, 2015 Sheet 4 of 19 US 2015/0320694 A1 1OO a *--- PLA20-Dex6 -A-PLGA-PEG Fig. 4 Patent Application Publication Nov. 12, 2015 Sheet 5 of 19 US 2015/0320694 A1 LA20-Dex6 PLA 20-Dex 10 sus 2, Concentration of Polymer (mg/ml) Fig. 5 Tirne (hrs) Fig. 6 Patent Application Publication Nov. 12, 2015 Sheet 6 of 19 US 2015/0320694 A1 s ason lung Heart Kidney Spleen Liver Patent Application Publication Nov. 12, 2015 Sheet 7 of 19 US 2015/0320694 A1 PLA-Dex copolymer Active ingredient {X Targeting ligand Muco adhesive NP Lipid f witcois Layer Aqueous neinbrane layer Fig. 8 siatic acid icy , i.e. L., Dr. NP correal epithelius Fig. 9 Patent Application Publication Nov. 12, 2015 Sheet 8 of 19 US 2015/0320694 A1 a'', Hydrophobic polyfier rear. His is phili: polisher targeting poiety Active it gredigit rgeting Eliety linked t; 3. Lattir irgeting sity link: is a lackhic as: ising: as its ancies inked to graecil; if Targeting moiety inked is is: Si: ; is fa. F3ricicci Jutiser b O Dex-b-PLANPs Patent Application Publication Nov. 12, 2015 Sheet 9 of 19 US 2015/0320694 A1 PLA-Dex PBA arts: as s Fig. 12b Patent Application Publication Nov. 12, 2015 Sheet 10 of 19 US 2015/0320694 A1 || || f PLA-Dex CWSteamine - trary reperry-repertyarrer & & W X gyarrerargyey sergery reprogrgy grey-grgy 5. S. s 3. 3. y 8. 3. '' i Cyria, S. gr. Fig. 13 3 s . s s . e -° e ch e- er cer . e 38 x so S. sis SO th Patent Application Publication Nov. 12, 2015 Sheet 11 of 19 US 2015/0320694 A1 a) 2O Dex 18 Dex 40PBA s 16 Dex 32OPBA 3 14 12 C O 5. 8 888 O 6 4 - 2 O aO Initial CycAfeed (wt %) Fig. 15 b) 1 OO 40 - 1 -0-PLA-Dex 40PBA -A-PLA-Dex 320PBA g - O 24 48 72 96 12O 144 168, 192 Time (hr) Fig. 16 Patent Application Publication Nov. 12, 2015 Sheet 12 of 19 US 2015/0320694 A1 112 O5O 5 OO 8O SO 40 20 6 12 18 24 3O 3S 42 8 Time (hr) Fig. 18 Patent Application Publication Nov. 12, 2015 Sheet 13 of 19 US 2015/0320694 A1 s 100 s 8O 2 SO E 40 i 2 N E in 48 96 44, 192 24, 288 Time (hr) Fig. 19 s CD 1OO f 3 8O 9. 6O E g 2 4O CD 2 A s 20 E O O O 24 48 72 96 12O Time (hr) Fig. 20 Patent Application Publication Nov. 12, 2015 Sheet 14 of 19 US 2015/0320694 A1 NP drug carriers Clearance Lipid layer Aqueous layer Mucous layer Epithelium Patent Application Publication Nov. 12, 2015 Sheet 15 of 19 US 2015/0320694 A1 1OO Patent Application Publication Nov. 12, 2015 Sheet 16 of 19 US 2015/0320694 A1 NP treated Control Cornea Bulbar Conjunctiva Tarsal Conjunctiva Fig. 24 4. - Conjunctival swelling are east 33 saxos Coro e 2 8 wk wk2 wk3 wk wk5 wks k wk8 wks wk ki wk2 4. Corneal opacification assas Treate ge 3 saxos Core e 2 3 wk wka wik3 wika wis' ' 'wks wik7 was wikg wk w1i i wiki: Fig. 25 Patent Application Publication Nov. 12, 2015 Sheet 17 of 19 US 2015/0320694 A1 fate arra NP reae: -s sover Contro O wk wk2 wk wkA wks RS y wk8 wks k wk k12 Disconfor arm ree a 3- weviews Contro I I I I I wks wka. wks wks wif wis' ' wis' ' wiki w w; 4. Conjunctival redness |-c-NP Treated a 3 sessor Core 9 2 3. 8 1 f wk wk2 wk WK4 wk5 wks wk 8 s wk k2 4. Lid Swelling -see NPrete f 3- season Citro 9 2 S 1 f I I I I I I wk wk2 wk wk. wks wks k wk wks k wk 1 wk2 4T Discharge al-NP reae a 3- seene Contro e c f I I i iwks' ' waI I wks'i 'i 'wis wif I i wis'i ' iwis' " wasI I wikii i w; Fig. 25 Cont'd Patent Application Publication Nov. 12, 2015 Sheet 18 of 19 US 2015/0320694 A1 4. Conjunctiva swelling are NPete 3 xssisirs Cot s S. 2 9 8 of sa i i I i Wik wk2 w wka 4. Corneal opacification area NP treate 3 assassis. Cotro s Se 2 8 of wk wk2 wk wk 4. filtrate as a NP tes 3 xsessions Coo r 9. 2 9. 1 8 (f) sta NP treated onio Control Conjunctiva redness are N tes wasnesia Co O Patent Application Publication Nov. 12, 2015 Sheet 19 of 19 US 2015/0320694 A1 lid swelling see NP treated 3- sailore Conto Discharge aro NP treated 3- across Coro Fig. 26 Cont'd US 2015/0320694 A1 Nov. 12, 2015 MUCOADHESIVENANOPARTICLE for example, in US. Pat. No. 2011/0300219. Amphiphilic DELIVERY SYSTEM compound assisted nanoparticles for targeted delivery have been disclosed, for example, in US. Pat. No. 2010/0203142. CROSS REFERENCE TO RELATED 0007 Targeting controlled release polymer systems (e.g., APPLICATIONS targeted to a particular tissue or cell type or targeted to a 0001. This application claims the benefit of priority of specific diseased tissue but not normal tissue) is desirable. It U.S. Provisional Patent Application No. 61/690,127, filed can enhance the drug effect at the target site and reduce the Jun. 20, 2012, which is incorporated herein by reference in its amount of a drug present in tissues of the body that are not entirety. targeted. Therefore, with effective drug targeting, it may be possible to reduce the amount of drug administered to treat a TECHNICAL FIELD particular disease or condition and undesirableside side effects may also be reduced. 0002 The present disclosure relates generally to a 0008 Various benefits can be obtained through delivery of mucoadhesive nanoparticle delivery system. The nanopar therapeutic agents through a mucosal tissue. For example, ticles can be tuned for controlled targeting and adhesion of the mucosal delivery is generally non-invasive, thereby avoiding nanoparticles at a mucosal site without Substantially compro uncomfortable aspects of intravenous, intramuscular, or Sub mising the stability of the particles. The present disclosure cutaneoud delivery means. Application of a therapeutic agent also relates to components useful in the preparation of the to a mucosal tissue can also reduce the effect of first-pass nanoparticles, as well as to compositions, methods, pro metabolism and clearance by circulating immune cells. How cesses, commercial packages, kits and uses related thereto. ever, given the tendency of natural bodily fluids to clear applied therapeutic agents from the site of administration, the BACKGROUND administration of therapeutic agents to mucosal sites, such as 0003.
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