Tunable, controlled-release, urethane-containing elastomers and processes of forming the same

• Main Authors: Smoot, Carissa, D'Ottavio, John, Nicholson, Charles Brendan, Shull, Dennis, Gabriele, Peter D, Ely, Jared, Crumbling, Todd, Harris, Jeremy J, Reed, Stephanie
• Format: Patent
• Language: English
• Published: 09.08.2022
• Subjects: ADDITIVE MANUFACTURING TECHNOLOGY; ADDITIVE MANUFACTURING, i.e. MANUFACTURING OFTHREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVEAGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING,STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; HUMAN NECESSITIES; HYGIENE; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES; MEDICAL OR VETERINARY SCIENCE; METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL; PERFORMING OPERATIONS; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDEDFOR; SHAPING OR JOINING OF PLASTICS; TRANSPORTING; WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL

A process forms an implantable product including poly(glycerol sebacate) urethane (PGSU) loaded with an active pharmaceutical ingredient (API). The process includes homogeneously mixing a flowable poly(glycerol sebacate) (PGS) resin with the API and a catalyst to form a resin blend. The process also includes homogeneously combining the resin blend with an isocyanate to form a reaction mixture and injecting the reaction mixture to form the PGSU loaded with the API. An implantable product includes a PGSU loaded with an API. In some embodiments, the implantable product includes at least 40% w/w of the API, and the implantable product releases the API by surface degradation of the PGSU at a predetermined release rate for at least three months under physiological conditions. In some embodiments, the PGSU is formed from a PGS reacted with an isocyanate at an isocyanate-to-hydroxyl stoichiometric (crosslinking) ratio in the range of 1:0.25 to 1:1.25.