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US 12,576,037 B2Granted
Polymer-encapsulated drug particles
AssigneeTonic Medical, Inc.
InventorsLixiao Wang, Peter Barnett
Life of this patent
Estimating the term…
Abstract
Various embodiments disclosed relate to polymer-encapsulated drug particles and a drug-releasing coating including the same, as well as drug-coated balloon catheters for treating, preventing, or reducing the recurrence of strictures in body lumens and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes the polymer-encapsulated drug particles; or a drug-releasing coating including the polymer-encapsulated drug particles; or a therapeutic agent and a first and/or second additive; or a combination thereof.
Claims31
Polymer-encapsulated drug particles comprising:
- a therapeutic agent;
- one or more polymers that encapsulate the therapeutic agent;
- and
- a first ionic or zwitterionic additive in the polymer-encapsulated drug particles;
- wherein
- the one or more polymers are less than or equal to 80 wt % of the polymer-encapsulated drug particles,
- the first ionic or zwitterionic additive is 0.5 wt % to 20 wt % of the polymer-encapsulated drug particles, and a total amount of lipids in the polymer-encapsulated drug particles is 0.5 wt % to 20 wt % of the polymer-encapsulated drug particles,
- the polymer-encapsulated drug particles have a weight ratio of the first ionic or zwitterionic additive to the one or more polymers of 1:3 to 1:60, and a weight ratio of the total amount of lipids in the polymer-encapsulated drug particles to the one or more polymers of 1:3 to 1:60,
- the first ionic or zwitterionic additive comprises a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof,
- two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or a combination thereof, and
- wherein the polymer-encapsulated drug particles are on a balloon of a balloon catheter such that a concentration density of the therapeutic agent on the balloon catheter is 1 μg/mm2 to 20 μg/mm2 as measured with the balloon at nominal diameter.
8 more elements
Polymer-encapsulated drug particles comprising:
- a therapeutic agent;
- one or more polymers that encapsulate the therapeutic agent;
- and
- a first ionic or zwitterionic additive in the polymer-encapsulated drug particles;
- wherein
- the one or more polymers are less than or equal to 80 wt % of the polymer-encapsulated drug particles,
- the first ionic or zwitterionic additive is less than or equal to 20 wt % of the polymer-encapsulated drug particles, and a total amount of lipids in the polymer-encapsulated drug particles is less than or equal to 20 wt % of the polymer-encapsulated drug particles,
- the polymer-encapsulated drug particles have a weight ratio of the first ionic or zwitterionic additive to the one or more polymers of 1:3 to 1:60, and a weight ratio of the total amount of lipids in the polymer-encapsulated drug particles to the one or more polymers of 1:3 to 1:60,
- the first ionic or zwitterionic additive comprises a mismatched charged lipid and/or phospholipid, 1,2-dihexanoyl-sn-glycero-3-phosphocholine, 1,2-diheptanoyl-sn-glycero-3-phosphocholine, 1,2-dioctanoyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphocholine, 1,2-dinonanoyl-sn-glycero-3-phosphocholine, 1,2-didecanoyl-sn-glycero-3-phosphocholine, 1,2-diundecanoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), or a combination thereof,
- two acyl groups of the mismatched charged lipid or phospholipid comprise mis-matched acyl groups, wherein the mis-matched acyl groups differ by length, degree of saturation, substituents thereon, substitution patterns thereon, or a combination thereof, and
- wherein the polymer-encapsulated drug particles are on a balloon of a balloon catheter such that a concentration density of the therapeutic agent on the balloon catheter is 1 μg/mm2 to 20 μg/mm2 as measured with the balloon at nominal diameter.
8 more elements
Dependencies are inferred from the claim text.