Large-scale manufacturing methods for aminoglycosides
AssigneeInsmed Incorporated
InventorRobert WORSHAM
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Abstract
Provided herein is a method for the large-scale manufacture of liposomal drug formulations containing an aminoglycoside such as amikacin having advantageous lipid/drag characteristics. The method utilizes a particular relative flow rate ratio of lipid to drug streams to obtain liposomes with a high aminoglycoside encapsulation efficiency. The resulting liposomal drug formulations advantageously comprise an overall lipid-to-drug weight ratio of less than 1:1.
Claims35
A large-scale method of preparing a liposomal aminoglycoside formulation comprising a lipid and an aminoglycoside, wherein the overall lipid-to-drug weight ratio is less than 1:1, the method comprising:
- (a) mixing a first stream comprising the lipid with a second stream comprising the aminoglycoside to form a combined lipid-aminoglycoside stream,
- (b) mixing the lipid-aminoglycoside stream of Step (a) with an aqueous saline solution in a reaction vessel, and
- (c) washing the product of Step (b) comprising the liposomal aminoglycoside formulation to remove unencapsulated aminoglycoside,
- wherein the relative flow rate ratio of the second stream to the first stream is about 1.5:1 to about 2:1.
Dependencies are inferred from the claim text.