US2012308658A1PendingUtilityA1

Methods and compositions to treat hemorrhagic conditions of the brain

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Assignee: MACDONALD R LOCHPriority: Jun 11, 2007Filed: Jul 13, 2012Published: Dec 6, 2012
Est. expiryJun 11, 2027(~0.9 yrs left)· nominal 20-yr term from priority
Inventors:R. Loch Macdonald
A61P 35/00A61P 9/10A61P 9/00A61P 7/04A61K 9/1647A61K 9/0085A61K 38/57A61K 9/5078A61P 25/00A61K 31/195A61K 31/198C12Y 304/21021A61K 45/00A61K 47/34A61K 38/4846A61K 31/122A61K 9/0002A61K 38/36A61K 31/197A61K 9/5153A61K 9/5031
45
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Claims

Abstract

The described invention provides a nonhuman animal model system for hemorrhagic brain conditions, methods for evaluating a substance for treating the hemorrhagic brain condition in a mammal, methods for treating hematoma expansion or recurrent rebleeding resulting from hemorrhagic brain conditions in a mammal, and pharmaceutical compositions for administration into or at a distance proximal to the hemorrhagic brain condition.

Claims

exact text as granted — not AI-modified
1 - 38 . (canceled) 
     
     
         39 . A flowable site-specific, sustained-release pharmaceutical composition for treating hematoma expansion or recurrent bleeding resulting from a hemorrhagic condition in brain, the pharmaceutical composition comprising:
 (a) a therapeutic amount of at least one hemostatic agent; and   (b) a pharmaceutically acceptable carrier, wherein the carrier comprises a plurality of microparticles, wherein the therapeutic agent is dispersed throughout each microparticle,   wherein the composition is formulated for administration locally in a cavity or space occupied by a hematoma or in a subdural space on the surface of the brain;   wherein the therapeutic amount is effective to reduce hematoma expansion or recurrent bleeding, when compared to a nontreated control, without entering systemic circulation in an amount to cause unwanted side effects.   
     
     
         40 . The pharmaceutical composition according to  claim 39 , wherein the hemorrhagic brain condition is rebleeding following traumatic brain injury. 
     
     
         41 . The pharmaceutical composition according to  claim 39 , wherein the hemorrhagic brain condition is a chronic subdural hematoma (SDH). 
     
     
         42 . The pharmaceutical composition according to  claim 39 , wherein the hemorrhagic brain condition is an intracerebral hematoma (ICH). 
     
     
         43 . The pharmaceutical composition according to  claim 42 , wherein the intracerebral hematoma is a spontaneous intracerebral hematoma (ICH). 
     
     
         44 . The pharmaceutical composition according to  claim 42 , wherein the intracerebral hematoma is a traumatic intracerebral hematoma (ICH). 
     
     
         45 . The pharmaceutical composition according to  claim 39 , wherein the hemorrhagic brain condition is bleeding following a craniotomy procedure. 
     
     
         46 . The pharmaceutical composition according to  claim 45 , wherein the craniotomy procedure is performed for treating a brain neoplasm. 
     
     
         47 . The pharmaceutical composition according to  claim 45 , wherein the craniotomy procedure is performed for treating a vascular malformation in brain. 
     
     
         48 . The composition according to  claim 45 , wherein the craniotomy procedure is performed for treating a brain aneurysm. 
     
     
         49 . The pharmaceutical composition according to  claim 39 , wherein the at least one hemostatic agent is at least one anti-fibrinolytic agent. 
     
     
         50 . The pharmaceutical composition according to  claim 39 , wherein the at least one hemostatic agent is Factor VII. 
     
     
         51 . The pharmaceutical composition according to  claim 50 , wherein the at least one hemostatic agent is a recombinant Factor VII. 
     
     
         52 - 53 . (canceled) 
     
     
         54 . The pharmaceutical composition according to  claim 39 , wherein the pharmaceutically acceptable carrier is a controlled-release carrier. 
     
     
         55 . The pharmaceutical composition according to  claim 39 , wherein the pharmaceutically acceptable carrier is a sustained-release carrier. 
     
     
         56 . The pharmaceutical composition according to  claim 55 , wherein the at least one hemostatic agent is embedded in the sustained-release carrier. 
     
     
         57 . The pharmaceutical composition according to  claim 55 , wherein the at least one hemostatic agent is coated on the sustained-release carrier. 
     
     
         58 . The pharmaceutical composition according to  claim 55 , wherein the sustained-release carrier is capable of releasing the hemostatic agent for at least 21 days post-administration. 
     
     
         59 . The pharmaceutical composition according to  claim 55 , wherein the sustained-release carrier is capable of releasing the hemostatic agent for about 3 to 5 days post-administration. 
     
     
         60 . (canceled) 
     
     
         61 . The pharmaceutical composition according to  claim 55 , wherein the sustained-release carrier comprises a nanoparticle. 
     
     
         62 . The pharmaceutical composition according to  claim 55 , wherein the sustained-release carrier comprises a biodegradable polymer. 
     
     
         63 . The pharmaceutical composition according to  claim 62 , wherein the biodegradable polymer is a synthetic polymer. 
     
     
         64 . The pharmaceutical composition according to  claim 62 , wherein the biodegradable polymer is a naturally occurring polymer. 
     
     
         65 . The pharmaceutical composition according to  claim 63 , wherein the synthetic polymer is selected from the group consisting of a polyester, a polyester polyethylene glycol polymer, a polyamino-derived biopolymer, a polyanhydride, a polyorthoester, a polyphosphazene, a sucrose acetate isobutyrate (SAIB), a photopolymerizable biopolymer, and a combination thereof. 
     
     
         66 . The pharmaceutical composition according to  claim 63 , wherein the synthetic polymer is polyglycolic acid (PGA). 
     
     
         67 . The pharmaceutical composition according to  claim 63 , wherein the synthetic polymer is a copolymer of polyglycolic acid formed with trimethylene carbonate, polylactic acid (PLA), or polycaprolactone. 
     
     
         68 . The pharmaceutical composition according to  claim 55 , wherein the sustained-release carrier is a hydrogel. 
     
     
         69 . The pharmaceutical composition according to  claim 64 , wherein the naturally occurring polymer is a protein polymer. 
     
     
         70 . The pharmaceutical composition according to  claim 69 , wherein the protein polymer is synthesized from self-assembling protein polymers. 
     
     
         71 . The pharmaceutical composition according to  claim 64 , wherein the naturally occurring polymer is a naturally occurring polysaccharide. 
     
     
         72 . The pharmaceutical composition according to  claim 64 , wherein the naturally occurring polymer comprises a hyaluronic acid. 
     
     
         73 . The pharmaceutical composition according to  claim 72 , wherein the naturally occurring polymer comprises less than 2.3% of hyaluronic acid. 
     
     
         74 . The pharmaceutical composition according to  claim 49 , wherein the at least one anti-fibrinolytic agent is ε-aminocaproic acid (AMICAR). 
     
     
         75 . The pharmaceutical composition according to  claim 49 , wherein the at least one anti-fibrinolytic agent is tranexamic acid. 
     
     
         76 . The pharmaceutical composition according to  claim 49 , wherein the at least one anti-fibrinolytic agent is aprotinin. 
     
     
         77 . The pharmaceutical composition according to  claim 49 , wherein the at least one anti-fibrinolytic agent is 4-aminomethylbenzoic acid. 
     
     
         78 . The pharmaceutical composition according to  claim 49 , wherein the at least one anti-fibrinolytic agent is 4 fibrin fragment D. 
     
     
         79 . The pharmaceutical composition according to  claim 39 , wherein the at least one hemostatic agent is antiplasmin. 
     
     
         80 . The pharmaceutical composition according to  claim 39 , wherein the at least one hemostatic agent is a vitamin K. 
     
     
         81 . The pharmaceutical composition according to  claim 80 , wherein the vitamin K is a vitamin K1. 
     
     
         82 . The pharmaceutical composition according to  claim 80 , wherein the vitamin K is a vitamin K2. 
     
     
         83 . The pharmaceutical composition according to  claim 80 , wherein the vitamin K is a vitamin K3.

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