Granted Patent
B2
US 12,239,823 · App. 17/991,676 · Granted Mar 4, 2025
Drug mixing and delivery system and method
Inventors:
Brent A. Buchine (Austin, TX); Adam R. Standley (Cambridge, MA); Christopher J. Stepanian (Somerville, MA)
Assignee:
Windgap Medical, Inc.
A61M5/2448A61K9/0019A61K31/137A61K31/4045A61K38/26A61K45/06A61M5/1409A61M5/19A61M5/2046A61M5/284A61M5/3294A61M5/44A61K38/00A61M2205/364A61M2205/366
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Abstract
The present disclosure provides methods of preparing a medical solution. In some aspects, the medical solution can be prepared from mixing a first liquid with a second liquid or mixing a solid component with a liquid in an autoinjector. In some aspects, the heat released from the mixing can promote solubility of a dry medicament in the solution.
Claims (16)
1. An autoinjector comprising:
a dry chamber comprising a dry epinephrine composition; and
a wet chamber comprising a liquid acid composition, wherein the dry chamber is sealed from the wet chamber prior to activation,
wherein activation of the autoinjector results in mixing of the liquid acid composition from the wet chamber with the dry epinephrine composition from the dry chamber.
2. The autoinjector of claim 1 , wherein the liquid acid composition comprises HCl, phosphoric acid, or sulfuric acid.
3. The autoinjector of claim 1 , wherein the liquid acid is sterile.
4. The autoinjector of claim 1 , wherein the liquid acid comprises one solvent.
5. The autoinjector of claim 1 , wherein the liquid acid comprises water.
6. The autoinjector of claim 5 , wherein the liquid acid comprises water and an acid.
7. The autoinjector of claim 1 , wherein the liquid acid has a pH from 0.1 to 6.0.
8. The autoinjector of claim 1 , wherein the liquid acid has a pH from 0.5 to 5.0.
9. The autoinjector of claim 1 , wherein the dry epinephrine forms a readily solubilized salt upon mixing with the liquid acid.
10. The autoinjector of claim 1 , wherein the dry epinephrine is an epinephrine free base.
11. The autoinjector of claim 10 , wherein the epinephrine free base is L-epinephrine free base.
12. The autoinjector of claim 1 , wherein the dry epinephrine is an epinephrine salt.
13. The autoinjector of claim 12 , wherein the epinephrine salt is a maleate, malate, fumarate, tartrate, bitartrate, sulfate, hydrochloride, or borate salt of epinephrine.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 11, 2025
From: WINDGAP MEDICAL, INC.
To: WINDGAPLEGACYCO, LLC
Reel/Frame 071907/0607 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 21, 2023
From: BUCHINE, BRENT A.; STANDLEY, ADAM R.; STEPANIAN, CHRISTOPHER J.
To: WINDGAP MEDICAL, INC.
Reel/Frame 062752/0486 →
Continuity (4)
Provisional Application
62016260
· Jun 24, 2014
Provisional Application
61917925
· Dec 18, 2013
References Cited (110)
US 4147767A
· Yapel
· 1979
[cited by applicant]
US 4479794A
· Urquhart et al.
· 1984
[cited by applicant]
US 4511351A
· Theeuwes
· 1985
[cited by applicant]
US 4755169A
· Sarnoff et al.
· 1988
[cited by applicant]
US 4820286A
· van der Wal
· 1989
[cited by applicant]
US 6641561B1
· Hill et al.
· 2003
[cited by applicant]
US 6656150B2
· Hill et al.
· 2003
[cited by applicant]
US 6770052B2
· Hill et al.
· 2004
[cited by applicant]
US 6793646B1
· Giambattista et al.
· 2004
[cited by applicant]
US 6953455B2
· Cho et al.
· 2005
[cited by applicant]
US 7323477B2
· Chow et al.
· 2008
[cited by applicant]
US 7449012B2
· Young et al.
· 2008
[cited by applicant]
US 7544189B2
· Griffiths
· 2009
[cited by applicant]
US 7556614B2
· Griffiths et al.
· 2009
[cited by applicant]
US 7608055B2
· Griffiths et al.
· 2009
[cited by applicant]
US 7621887B2
· Griffiths et al.
· 2009
[cited by applicant]
US 7678073B2
· Griffiths et al.
· 2010
[cited by applicant]
US 7749190B2
· Griffiths et al.
· 2010
[cited by applicant]
US 7757370B2
· Griffiths
· 2010
[cited by applicant]
US 7776015B2
· Sadowski et al.
· 2010
[cited by applicant]
US 7794432B2
· Young et al.
· 2010
[cited by applicant]
US 7947742B2
· Batycky et al.
· 2011
[cited by applicant]
US 8048035B2
· Mesa et al.
· 2011
[cited by applicant]
US 8057427B2
· Griffiths et al.
· 2011
[cited by applicant]
US 8092420B2
· Bendek et al.
· 2012
[cited by applicant]
US 8123719B2
· Edwards et al.
· 2012
[cited by applicant]
US 8177758B2
· Brooks, Jr. et al.
· 2012
[cited by applicant]
US 8187220B2
· Griffiths et al.
· 2012
[cited by applicant]
US 8251947B2
· KraMer et al.
· 2012
[cited by applicant]
US 8313466B2
· Edwards et al.
· 2012
[cited by applicant]
US 8496619B2
· Kramer et al.
· 2013
[cited by applicant]
US 8506526B2
· Griffiths et al.
· 2013
[cited by applicant]
US 8568367B2
· Griffiths et al.
· 2013
[cited by applicant]
US 8613720B2
· Bendek et al.
· 2013
[cited by applicant]
US 8632504B2
· Young
· 2014
[cited by applicant]
US 8696618B2
· Kramer et al.
· 2014
[cited by applicant]
US 8770827B2
· Steinmuller et al.
· 2014
[cited by applicant]
US 8945053B2
· Vogt et al.
· 2015
[cited by applicant]
US 9364610B2
· KraMer et al.
· 2016
[cited by applicant]
US 9364611B2
· KraMer et al.
· 2016
[cited by applicant]
US 9586010B2
· Mesa et al.
· 2017
[cited by applicant]
US 20030187388A1
· Sharon et al.
· 2003
[cited by applicant]
US 20040110781A1
· Harmon et al.
· 2004
[cited by applicant]
US 20060257488A1
· Hubbard
· 2006
[cited by applicant]
US 20070203247A1
· Phillips et al.
· 2007
[cited by applicant]
US 20080269347A1
· Bruss et al.
· 2008
[cited by applicant]
US 20110092906A1
· Bottger et al.
· 2011
[cited by applicant]
US 20120016296A1
· Charles
· 2012
[cited by applicant]
US 20120046225A1
· Prestrelski et al.
· 2012
[cited by applicant]
US 20140276430A1
· Baker et al.
· 2014
[cited by applicant]
US 20150231334A1
· Buchine et al.
· 2015
[cited by applicant]
CN 1634002A
· 2005
[cited by applicant]
CN 1827109A
· 2006
[cited by applicant]
CN 101674812A
· 2010
[cited by applicant]
CN 102389403A
· 2012
[cited by applicant]
CN 102497882A
· 2012
[cited by applicant]
CN 102802668A
· 2012
[cited by applicant]
CN 103442695A
· 2013
[cited by applicant]
CN 106061253A
· 2016
[cited by applicant]
FR 2741810A1
· 1997
[cited by applicant]
JP 2010526039A
· 2010
[cited by applicant]
JP 2012528830A
· 2012
[cited by applicant]
JP 2013500952A
· 2013
[cited by applicant]
JP 5531075B2
· 2014
[cited by applicant]
JP 2014523296A
· 2014
[cited by applicant]
WO WO200048662A1
· 2000
[cited by applicant]
WO WO200066214A1
· 2000
[cited by applicant]
WO WO200241830A2
· 2002
[cited by applicant]
WO WO2003047663A2
· 2003
[cited by applicant]
WO WO2007057717A2
· 2007
[cited by applicant]
WO WO2008132224A1
· 2008
[cited by applicant]
WO WO2010139751A2
· 2010
[cited by applicant]
WO WO2010139752A2
· 2010
[cited by applicant]
WO WO2011012719A1
· 2011
[cited by applicant]
WO WO2012122535A2
· 2012
[cited by applicant]
WO WO2012177948A2
· 2012
[cited by applicant]
WO WO2014026694A1
· 2014
[cited by applicant]
WO WO2014059444A2
· 2014
[cited by applicant]
WO WO2014060563A2
· 2014
[cited by applicant]
WO WO2014066731A1
· 2014
[cited by applicant]
WO WO2014146060A1
· 2014
[cited by applicant]
WO WO2014205463A1
· 2014
[cited by applicant]
WO WO2015095624A2
· 2015
[cited by applicant]
WO WO2019011069A1
· 2019
[cited by applicant]
Supplementary European Search Report for European Patent Application No. EP 14 872 735.7 mailed on Aug. 23, 2017.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US14/71324 mailed Sep. 2, 2015.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US14/71324 mailed Jun. 30, 2016.
[cited by applicant]
Supplementary European Search Report for European Patent Application No. EP 15 871 257.0 mailed on Jul. 11, 2018.
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2015/066940 mailed Feb. 25, 2016.
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US2015/066940 mailed on Jun. 29, 2017.
[cited by applicant]
[No Author Listed], Addrenalin (epinephrine injection) 1 mg/mL (1:1000). JHP Pharmaceuticals, LLC. Dec. 2012. <URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf> [retrieved from internet o…
[cited by applicant]
[No Author Listed], Epinephrine Injection USP, Material Data Sheet. Luitpold Pharmaceuticals, Inc. Jan. 10, 2009. <URL: https://marketing.msdsonline.com/library/ioj/ioj708.pdf > retrieved from internet on Feb. 11, 2021]…
[cited by applicant]
Kerddonfak et al., The stability and sterility of epinephrine prefilled syringe. Asian Pac J Allergy Immunol. Mar. 2010;28(1):53-7.
[cited by applicant]
Alvarez-Perea et al., Advancements in Anaphylaxis Management. Curr Pharm Des. 2023;29(3):185-195. doi: 10.2174/1381612829666221021150946.
[cited by applicant]
Bansal, Product Development Issues of Powders for Injection. Mar. 2002. Last accessed on Feb. 27, 2017 from https://www.researchgate.net/profile/Arvind_Bansal/publication/228912123_Product_development_issues_of_powder_f…
[cited by applicant]
Landy et al., An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. Jan. 2013;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub N…
[cited by applicant]
Parish et al., A systematic review of epinephrine degradation with exposure to excessive heat or cold. Ann Allergy Asthma Immunol. Jul. 2016; 117(1):79-87. doi: 10.1016/j.anai.2016.04.006. Epub May 21, 2016.
[cited by applicant]
Shaker et al., An update on the impact of food allergy on anxiety and quality of life. Curr Opin Pediatr. Aug. 2017;29(4):497-502. doi: 10.1097/MOP.0000000000000509.
[cited by applicant]