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1032 Exhibit: Edman II et al, Microspheres as a nasal delivery system for peptide drugs, Journal of Controlled Release, Vol 21 1992 165 l72 Edman II

Document IPR2019-00450, No. 1032-48 Exhibit - Edman II et al, Microspheres as a nasal delivery system for peptide drugs, Journal of Controlled Release, Vol 21 1992 165 l72 Edman II (P.T.A.B. Jan. 29, 2...
Journal of Controlled Release, 2 0 1992 Elsevier Science Publishers B.V. All rights reserved 01%3659/92/$05.00 165 COREL 00753 Microspheres as a nasal delivery system for peptide drugs P. EdmanaTb, E. Bjiirka>b and L. RydCnb “Kabi Pharmacia Therapeutics, Uppsala, Sweden bCrppsala University, Department of Pharma~~t~cs, BMC, Uppsa~a, Sweden (Received 7 July 199 1; accepted in revised form 9 March 1992 ) Microspheres of starch and dextran, cross-linked with epichlorohydrine, function as an enhancer system for the absorption of insulin in rats.
A conceivable hypothesis with regard to the mech- anism of action of DSM can be that the epithelial mucosa is dehydrated, with a reversible “shrinkage” of the cells, thus giving a physical separation of the intercellular junctions.
Variations of pH [ 61, ionic strength f 71, and inhibition of proteolytic enzymes in the nose [ 8 ] are some ex- amples of parameters which can be varied in or- der to promote the nasal absorption of peptides.
This finding indicates that the mode of action of DSM on the epitheiial cell barrier, giving in- creased permeability of hydrophiIic compounds, is a temporary widening of the tight junctions, AQUESTIVE EXHIBIT 1032 page 0006
K. Morimoto, H. Yamaguchi, Y. Iwakura, K. Morisaka, Y. Ohashi and Y. Nakai, Effects of viscous hyaluronate- sodium solution on the nasal absorption of vasopressin and an analogue, Pharm. Res.
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1029 Exhibit: O¿¿¿Dell et al, School nurses¿¿¿ experience with administration of rectal diazepam gel for seizures, J Sch Nurs, June 2007, 233166 9 O¿¿¿Dell

Document IPR2019-00450, No. 1029-45 Exhibit - O¿¿¿Dell et al, School nurses¿¿¿ experience with administration of rectal diazepam gel for seizures, J Sch Nurs, June 2007, 233166 9 O¿¿¿Dell (P.T.A.B. Jan. 2...
Perceived Barriers to Diazepam Rectal Gel Administration in the School Perceived Barrier Number Privacy/setting Access/availability of nurse Legal/delegation issues Staff anxiety/fear Lack of training None Consent of ...
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1006 Exhibit: Provisional Patent Application No 61570,110, filed December 13, 2011 ¿¿¿110 Provisional

Document IPR2019-00450, No. 1006-14 Exhibit - Provisional Patent Application No 61570,110, filed December 13, 2011 ¿¿¿110 Provisional (P.T.A.B. Jan. 29, 2019)
... If Required, Foreign Filing License Granted: 12/27/2011 The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is US 61/570,110 Projected Publication Date: None ...
... If Required, Foreign Filing License Granted: 12/27/2011 The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is US 61/570,110 Projected Publication Date: None ...
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1004 Exhibit: Part 3 ¿¿¿ Pages 701 1050 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH

Document IPR2019-00450, No. 1004-7 Exhibit - Part 3 ¿¿¿ Pages 701 1050 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 29, 2019)
The reaction was worked up by partitioning between citric acid and ethyl acetate, drying the organic layer and solvent removal to give the crude product (1g).
Biochem., 99, procedure of Cawston and Barrett, 340-345, 1979), hereby incorporated by reference, 11. whereby a ImM solution of the inhibitor being tested or 12 dilutions thereof was incubated at 37° for 16 hours 13 with collagen and collagenase (buffered with 25mM 14 Hepes, pH 7.5 containing 5mM CaCly5, 0.05% Brij 35 and 0.02% NaN3).
J., 195, 159-165 1981), hereby incorporated by reference, whereby a 1mM solution of the inhibitor being tested or dilutions thereof was incubated at 37°C for 16 hours with stromelysin and 14, acetylate casein (buffered with 25mM Hepes, pH 7.5 containing 5mM CaCl5, 0.05% Brij 35 and 0.02% NaN3.
Armenia Austria Australia Barbados Belgium Burkina Faso Bulgaria Benin Brazil Belarus Canada Central African Republic Congo Switzerland Cite d'Ivoire Cameroon China Czechoslovakia Czech Republic Germany Denmark Estonia Spain Finland France Gabon Malawi Mexico Niger Netherlands Norway New Zealand Poland Portugal Romania Russian Federation Sudan Sweden Singapore Slovenia Slovakia Senegal Swaziland Chad Togo Tajikistan Trinidad and Tobago Ukraine Uganda United States of America Uzbekistan
The term "alkyl", as used herein, unless otherwise indicated, includes saturated monovalent hydrocarbon radicals having straight, branched or cyclic moieties or combinations thereof.
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1007 Exhibit: Part 1 ¿¿¿ Pages 1 400 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, No. 1007-15 Exhibit - Part 1 ¿¿¿ Pages 1 400 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019)
... Assignment For Published Patent Application HALE BIOPHARMA VENTURES, LLC, Encinitas, CA Powerof Attorney: None Domestic Priority data as claimed by applicant This appin claims benefit of 61/040,558 03/28/2008 Foreign ...
... PA; Andrew Loxley, Philadelphia, PA; Mark Mitchnick, East Hampton, NY; David F. Hale, San Diego, CA; Assignment For Published Patent Application HALE BIOPHARMA VENTURES, LLC, Encinitas, CA Powerof Attorney: None ...
It is preferable thatlittle or none of component c contains halogen substituted hydrocarbons since these tend to have ’ lower biocompatibility.
From Figure 4 (n=8) it appears that none of the investigated formulations has a severe burst effect.
... al Application No PCT/GB2005/002217 INTERNATIONAL SEARCH REPORT Patent document cited in search report WO 2005046642 US 5807573 A A 15-09-1998 date Patent family member(s) Publication date 26-05-2005 NONE ...
It is preferable thatlittle or none of component c contains halogen substituted hydrocarbons since these tend to have lower biocompatibility.
... SEARCH REPORT Information on patent family members Inter 1al application No PCT/GB2005/004746 Publication date Patent document cited in search report Publication date Patent family member(s) A 26-05-2005 NONE ...
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1021 Exhibit: Merkus, US Patent Application Publication No US 20050153956, Serial No 11034,474, published July 14, 2005 Merkus

Document IPR2019-00450, No. 1021-37 Exhibit - Merkus, US Patent Application Publication No US 20050153956, Serial No 11034,474, published July 14, 2005 Merkus (P.T.A.B. Jan. 29, 2019)
[0008] Nasal midaZolam at dosages of 0.2 mg/kg has been shoWn to have sedative and anXiolytic effects in children undergoing various diagnostic and minor surgical proce dures, and none of the children had clinical signs of respi ...
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1007 Exhibit: Part 4 ¿¿¿ Pages 1201 1600 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, No. 1007-18 Exhibit - Part 4 ¿¿¿ Pages 1201 1600 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019...
Noneofthese references describe nanoparticulate active agent compositions comprising a peptide surface stabilizer.
For compoundsofthe formula NR:RoR3Ry?: (i) none of R ...
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1050 Exhibit: Table of Various Diazepam Solutions Described in or Modified From Sonne¿¿¿s Example 11 ¿¿¿DS11¿¿¿

Document IPR2019-00450, No. 1050-68 Exhibit - Table of Various Diazepam Solutions Described in or Modified From Sonne¿¿¿s Example 11 ¿¿¿DS11¿¿¿ (P.T.A.B. Jan. 29, 2019)
**all % amounts are “about”**
(nasal spray) • 5% diazepam • 40% α-tocopherol • 55% ethanol and benzyl alcohol (combined)
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1004 Exhibit: Part 1 ¿¿¿ Pages 1 350 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH

Document IPR2019-00450, No. 1004-5 Exhibit - Part 1 ¿¿¿ Pages 1 350 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 29, 2019)
... will generate another Filing Receipt incorporating the requested corrections Applicant(s) Steve Cartt, Residence Not Provided; Assignment For Published Patent Application Hale BioPharma Ventures, LLC Powerof Attorney: None ...
... Assignment For Published Patent Application Hale BioPharma Ventures, LLC Powerof Attorney: None Domestic Priority data as claimed by applicant This application is a CIP of 12/413,439 03/27/2009 and claims benefit of 61/497,017 ...
) - None.
... the |IH-pyrrolo[2,3-d]pyrimidine-2,4(3H,7H)-diones exemplified by Compound Nos. 103, 111, 123, 129, and 131 of said Australian Patent Application, which havethe following substituents: 1,3,6-trimethyl; 1,3,6,7-tetramethyl: none; ...
... Stearic acid Zinc octoate (18% Zn) 2-8-(tetrahydropyranyl thioethylearboxylate) 100.0 parts 40.0 phr 5.0 phr 0.2 phr 0.05 phr 50 55 14 AQUESTIVE EXHIBIT 1004 AQUESTIVE EXHIBIT 1004 page 0284 page 0284 Control None ...
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1007 Exhibit: Part 3 ¿¿¿ Pages 801 1200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH

Document IPR2019-00450, No. 1007-17 Exhibit - Part 3 ¿¿¿ Pages 801 1200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 29, 2019)
... the |IH-pyrrolo[2,3-d]pyrimidine-2,4(3H,7H)-diones exemplified by Compound Nos. 103, 111, 123, 129, and 131 of said Australian Patent Application, which havethe following substituents: 1,3,6-trimethyl; 1,3,6,7-tetramethyl: none; ...
... were measured using a Hunter Labs Colorimeter (L, a, b) and the yellowness index was selected as the measurement for comparison in Table V. TABLE IV Example % sulfur|Amount (phr)Carboxylate 12.4 12 Hexanoate 1.6 Control None ...
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1028 Exhibit: Ivaturi et al, Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers, Acta Neurol Scand 2009 Nov1205353 7 doi 101111j1600 0404200901170x Epub 2009 May 14 Ivaturi

Document IPR2019-00450, No. 1028-44 Exhibit - Ivaturi et al, Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers, Acta Neurol Scand 2009 Nov1205353 7 d...
Nonetheless, some patients and caretakers would prefer the transient discomfort of the present in formulations to rectal administration of medica— tion in public settings.
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1019 Exhibit: Ueda et al, US Patent No 4,657,901, Pharmaceutical Composition, issued April 14, 1987 Ueda

Document IPR2019-00450, No. 1019-35 Exhibit - Ueda et al, US Patent No 4,657,901, Pharmaceutical Composition, issued April 14, 1987 Ueda (P.T.A.B. Jan. 29, 2019)
However, none of the commercially avail able preparations for the treatment of acne are com pletely free from a wide variety of defects.
... con symptom observed was rated on a scale divided into tains a gelling agent in an amount of 0.001 to about 20 five grades of intense (4), moderate (3), slight (2), little W/V 9% and an alcohol in an amount of 5 to 70 W/V 9%. (1) and none ...
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1015 Exhibit: Cartt et al, US Patent Application Publication No US 20080279784, Nasal Administration Of Benzodiazepines, Serial No 12116,842, published November 13, 2008 Cartt ¿¿¿784

Document IPR2019-00450, No. 1015-31 Exhibit - Cartt et al, US Patent Application Publication No US 20080279784, Nasal Administration Of Benzodiazepines, Serial No 12116,842, published November 1...
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, brotiZolam, chlordiaZepoxide, clobaZam, clon aZepam, cloraZepam, demoxaZepam, ?umaZenil, ?uraZepam, halaZepam, midaZolam, nordaZepam, medaZepam, diaZ AQUESTIVE EXHIBIT 1015 page 0006
In some embodiments, the nanoparticulate benZodi aZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, midaZolam, temaZepam and phar maceutically acceptable salts and combinations thereof.
In some embodiments, the benZodiaZepine particles comprise at least one member of the group consist ing of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, midaZolam, temaZepam and phar maceutically acceptable salts and combinations thereof.
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, mida Zolam, temaZepam and pharmaceutically acceptable salts and combinations thereof.
In some embodiments, the nanoparticulate benZodiaZepine particles comprise at least one member of the group consisting of alpraZolam, diaZepam, ?uraZepam, loraZepam, medaZepam, mexaZolam, mida Zolam, temaZepam and pharmaceutically acceptable salts and combinations thereof.
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1014 Exhibit: Gwozdz et al, WO 2009120933, Pharmaceutical Solutions And Metho...

Document IPR2019-00450, No. 1014-30 Exhibit - Gwozdz et al, WO 2009120933, Pharmaceutical Solutions And Method For Solubilizing Therapeutic Agents, published October 1, 2009, International Filing...

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1008 Exhibit: Provisional Patent Application No 61040,558, filed March 28, 2008 ¿¿¿...

Document IPR2019-00450, No. 1008-24 Exhibit - Provisional Patent Application No 61040,558, filed March 28, 2008 ¿¿¿558 Provisional (P.T.A.B. Jan. 29, 2019)

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