Compositions and methods of making sustained release liquid formulations
Inventors
Tengler, Mark • Taskey, Paul • Lockhart, Daniel • McMahen, Russell
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9522120-B2
Publication Date
2016-12-20
Expiration Date
Abstract
The present invention includes compositions and methods for the controlled release of active agents in a shelf-stable liquid formulation by blending one or more controlled release microbeads comprising one or more active agents, preparing a dense, thixotropic solution having a density that is at, or about, the density of the one or more microbeads comprising a thixotropic agent, water and one or more preservatives under conditions that reduce bubble formation and mixing the microbeads and the thixotropic solutions in a mixer that lacks scraping paddles.
Core Innovation
A liquid, controlled-release formulation comprising controlled release microbeads or controlled release beads comprising one or more active agents in coated drug-resin complexes and a dense, thixotropic solution having a density that is at or about the density of the one or more microbeads or beads is provided. The formulation is shelf-stable and has a uniform appearance with no visible lumps.
The formulation is made by obtaining one or more controlled release microbeads or beads comprising one or more active agents in coated drug-resin complexes. The dense, thixotropic solution is prepared under conditions that reduce bubble formation, and the microbeads or beads and the solution are mixed or blended under conditions that minimize the introduction of bubbles in the liquid and minimize air bubbles which cling to the beads.
In one form, the dense, thixotropic solution comprises a thixotropic agent, water and one or more preservatives. The approach maintains shelf-stability and a uniform appearance with no visible lumps.
Claims Coverage
Three independent claims are identified. The inventive coverage centers on a shelf-stable liquid controlled-release formulation using coated drug-resin complex microbeads or beads in a dense thixotropic solution, together with bubble-minimizing preparation and mixing or blending conditions.
Density-matched shelf-stable liquid with coated drug-resin complex microbeads
A liquid, controlled-release formulation comprising controlled release microbeads comprising one or more active agents in coated drug-resin complexes and a dense, thixotropic solution having a density that is at or about the density of the one or more microbeads, wherein the formulation is shelf-stable and has a uniform appearance with no visible lumps.
Preparing and mixing under conditions that minimize bubble formation
The formulation is made by preparing the dense, thixotropic solution having density at or about the density of the one or more microbeads under conditions that reduce bubble formation and mixing the microbeads and the solution under conditions that minimize the introduction of bubbles in the liquid.
Blending controlled release beads under conditions that minimize air bubbles clinging to beads
A liquid, controlled-release formulation comprising controlled release beads comprising one or more active agents in coated drug-resin complexes and a dense, thixotropic solution having a density that is at or about the density of the one or more beads, wherein blending is performed under conditions that minimize air bubbles which cling to said beads.
Dense thixotropic solution comprising thixotropic agent, water and preservatives
A liquid, controlled-release formulation comprising controlled release microbeads comprising one or more active agents in coated drug-resin complexes, a dense, thixotropic solution having a density that is at or about the density of the one or more microbeads, wherein the dense, thixotropic solution comprises a thixotropic agent, water and one or more preservatives.
The claims define a shelf-stable, uniform-appearance liquid controlled-release formulation that uses coated drug-resin complex microbeads or beads dispersed in a dense, thixotropic solution with density at or about the bead or microbead density, combined with preparation and mixing or blending conditions intended to reduce bubble formation and minimize air bubbles clinging to the beads.
Stated Advantages
Shelf-stable formulation.
Uniform appearance with no visible lumps.
Documented Applications
No documented applications found
Interested in licensing this patent?