Liposomal apparatus and manufacturing methods
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/127
A61K-047/44
A61K-031/7084
A61K-031/7088
A61K-047/10
A61K-047/24
출원번호
US-0684066
(2012-11-21)
등록번호
US-9492386
(2016-11-15)
발명자
/ 주소
MacLachlan, Ian
Jeffs, Lloyd
Palmer, Lorne R.
Giesbrecht, Cory
출원인 / 주소
PROTIVA BIOTHERAPEUTICS, INC.
대리인 / 주소
Kilpatrick Townsend & Stockton LLP
인용정보
피인용 횟수 :
9인용 특허 :
84
초록▼
The present invention provides apparatus and processes for producing liposomes. By providing a buffer solution in a first reservoir, and a lipid solution in a second reservoir, continuously diluting the lipid solution with the buffer solution in a mixing chamber produces a liposome. The lipid soluti
The present invention provides apparatus and processes for producing liposomes. By providing a buffer solution in a first reservoir, and a lipid solution in a second reservoir, continuously diluting the lipid solution with the buffer solution in a mixing chamber produces a liposome. The lipid solution preferably comprises an organic solvent, such as a lower alkanol.
대표청구항▼
1. A process for producing a lipid vesicle encapsulating one or more therapeutic agents within the lipid vesicle, said process comprising: providing an aqueous solution in a first reservoir;providing an organic lipid solution in a second reservoir, wherein the lipids present in said organic lipid so
1. A process for producing a lipid vesicle encapsulating one or more therapeutic agents within the lipid vesicle, said process comprising: providing an aqueous solution in a first reservoir;providing an organic lipid solution in a second reservoir, wherein the lipids present in said organic lipid solution are solubilized in a lower alkanol at a concentration of about 75% v/v to 100% v/v, wherein said aqueous solution and/or said organic lipid solution comprises one or more therapeutic agents, and wherein said one or more therapeutic agents is selected from the group consisting of a nucleic acid, a protein, an antigen, paclitaxel, protax III, taxol, and mixtures thereof; andmixing said organic lipid solution with said aqueous solution by introducing said organic lipid solution and said aqueous solution into a mixing environment at about equal flow rates;wherein said mixing instantaneously produces a lipid vesicle encapsulating said one or more therapeutic agents within the lipid vesicle by diluting said lower alkanol to a concentration of between 45% v/v to about 60% v/v; andwherein the mixing environment includes a mixing chamber, wherein said aqueous solution and said organic lipid solution are introduced into the mixing chamber at an angle of between about 27° and about 180° relative to each other and mixed within the mixing chamber. 2. The process of claim 1, further comprising diluting said lipid vesicle with a buffer solution wherein said lipid vesicle undergoes a continuous stepwise dilution to further stabilize the lipid vesicle. 3. The process of claim 1, wherein said nucleic acid is selected from the group consisting of a plasmid, an antisense polynucleotide, a ribozyme, mRNA, tRNA, snRNA, siRNA, pre-condensed DNA, and mixtures thereof. 4. The process of claim 1, wherein said aqueous solution comprises said nucleic acid, protein, antigen, or mixtures thereof. 5. The process of claim 1, wherein said organic lipid solution comprises said paclitaxel, protax III, taxol, or mixtures thereof. 6. The process of claim 1, wherein said angle is between about 27° and about 90° or between about 90° and about 180°. 7. The process of claim 1, wherein said lower alkanol is selected from the group consisting of methanol, ethanol, propanol, butanol, pentanol, isomers thereof, and mixtures thereof. 8. The process of claim 1, wherein the lipids present in said organic lipid solution are solubilized in said lower alkanol at a concentration of between about 80% v/v to about 90% v/v or 100% v/v. 9. The process of claim 1, wherein the lipids present in said organic lipid solution comprise a phospholipid, cholesterol, a PEG-lipid, and a cationic lipid. 10. The process of claim 2, further comprising concentrating said lipid vesicle by tangential flow ultrafiltration. 11. An apparatus for producing a lipid vesicle encapsulating one or more therapeutic agents within the lipid vesicle, said apparatus comprising: a first reservoir for holding an aqueous solution;a second reservoir for holding an organic lipid solution, wherein the lipids present in said organic lipid solution are solubilized in a lower alkanol at a concentration of about 75% v/v to 100% v/v, wherein said aqueous solution and/or said organic lipid solution comprises one or more therapeutic agents, and wherein said one or more therapeutic agents is selected from the group consisting of a nucleic acid, a protein, an antigen, paclitaxel, protax III, taxol, and mixtures thereof; anda pump mechanism configured to pump said aqueous solution and said organic lipid solution into a mixing environment at about equal flow rates;wherein said organic lipid solution mixes with said aqueous solution in the mixing environment to instantaneously produce a lipid vesicle encapsulating said one or more therapeutic agents within the lipid vesicle by diluting said lower alkanol to a concentration of between 45% v/v to about 60% v/v; andwherein the mixing environment includes a mixing chamber, wherein said aqueous solution and said organic lipid solution are introduced into the mixing chamber at an angle of between about 27° and about 180° relative to each other and mixed within the mixing chamber. 12. The apparatus of claim 11, wherein said nucleic acid is selected from the group consisting of a plasmid, an antisense polynucleotide, a ribozyme, mRNA, tRNA, snRNA, siRNA, pre-condensed DNA, and mixtures thereof. 13. The apparatus of claim 11, wherein said aqueous solution comprises said nucleic acid, protein, antigen, or mixtures thereof. 14. The apparatus of claim 11, wherein said organic lipid solution comprises said paclitaxel, protax III, taxol, or mixtures thereof. 15. The apparatus of claim 11, wherein said angle is between about 27° and about 90° or between about 90° and about 180°. 16. The apparatus of claim 11, wherein said lower alkanol is selected from the group consisting of methanol, ethanol, propanol, butanol, pentanol, isomers thereof, and mixtures thereof. 17. The apparatus of claim 11, wherein the lipids present in said organic lipid solution are solubilized in said lower alkanol at a concentration of between about 80% v/v to about 90% v/v or 100% v/v. 18. The apparatus of claim 11, wherein the lipids present in said organic lipid solution comprise a phospholipid, cholesterol, a PEG-lipid, and a cationic lipid. 19. The apparatus of claim 11, wherein the apparatus further comprises a tangential flow ultrafiltration system. 20. The apparatus of claim 11, wherein the pump mechanism comprises a peristaltic pump.
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