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.

A method for depositing a coating comprising a polymer and pharmaceutical agent on a substrate, comprising the following steps: discharging at least one pharmaceutical agent in a therapeutically desirable morphology in dry powder form through a first orifice; discharging at least one polymer in dry powder form through a second orifice; depositing the polymer and/or pharmaceutical particles onto said substrate, wherein an electrical potential is maintained between the substrate and the pharmaceutical and/or polymer particles, thereby forming said coating; and sintering said coating under conditions that do not substantially modify the morphology of said pharmaceutical agent.

A method of reducing the risk of embolization of peripheral blood vessels by providing a medical device having an expandable member having a drug coating layer which has a crystalline morphological form including a plurality of crystal particles of a water-insoluble drug regularly arranged and uniformly sized on the surface of the medical device, inserting the medical device in peripheral blood vessels, expanding the expandable member, pressing the drug coating layer to a blood vessel wall such that at least part of the plurality of crystal particles are transferred to the blood vessel wall, and deflating the expandable member such that the generation of microparticulates having a size that causes embolization of peripheral blood vessels is suppressed.

A method of inhibiting thickening of vascular intima by providing a medical device having an expandable member having a drug coating layer which has a crystalline morphological form including a plurality of crystal particles of a water-insoluble drug regularly arranged and uniformly sized on the surface of the medical device, inserting the medical device in peripheral blood vessels, expanding the expandable member, pressing the drug coating layer to a blood vessel wall such that at least part of the plurality of crystals are transferred to the blood vessel wall, and deflating the expandable member such that a vascular intima thickening is inhibited uniformly in an entire treated lesion of stenosis to uniformly cause patency of the lesion.

Articles-of-manufacturing comprising an object having a surface and at least a first layer of a first therapeutically active agent being deposited onto at least a continuous portion of the surface, wherein at least 50 weight percents of the first layer is the first therapeutically active agent in a crystalline form are disclosed. Methods utilizing such articles-of-manufacturing for treating medical conditions are also disclosed. Processes of preparing the articles-of-manufacturing by contacting a surface of the object with a solution containing the therapeutically active agent, without cooling the surface to a temperature below a temperature of the solution, are also disclosed.

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.

A medical device may be coated with a therapeutic composition that includes everolimus. Everolimus crystals may be coated with a mixture of excipients to form encapsulated everolimus crystals suspended in a coating composition. The medical device may be contacted with the coating composition in order to form a coating on the medical device. Coating the everolimus crystals with a mixture of excipients to form encapsulated everolimus crystals suspended in a coating composition may include suspending everolimus crystals in a first solution that includes acetyl tri-butyl citrate (ATBC) and adding a second solution to the first solution, the second solution including ethyl cellulose (EC), the EC mixing with the ATBC and coating the everolimus crystals, thereby forming a coating suspension including coated everolimus crystals in the suspension.

Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.

The present invention relates to a drug-eluting medical device, in particular a balloon for angioplasty catheters with drug elution to prevent the restenosis of the vessel subjected to angioplasty. More particularly, the present invention relates to a catheter balloon completely or partially coated with paclitaxel in hydrated crystalline form or in hydrated solvated crystalline form, having an immediate release and bioavailability of a therapeutically effective amount of paclitaxel at the site of intervention. The balloon can be made of a polyether-polyamide block copolymer, or a polyester amide, or polyamide-12.

Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, a drug delivery coating is included herein having a base polymeric layer, the base polymeric layer including a hydrophilic polyether block amide copolymer and having a hydrophilic surface. The drug delivery coating can further include a therapeutic agent layer forming an exterior surface the drug delivery coating, the therapeutic agent layer contacting the hydrophilic surface of the base polymeric layer and having a composition different than the base polymeric layer, the therapeutic agent layer including a particulate hydrophobic therapeutic agent and a cationic agent. Other embodiments are also included herein.