Abstract: A method for controlling the encapsulation efficiency and burst release of water soluble molecules from nanoparticle and microparticle formulations produced by the inverted Flash NanoPrecipitation (iFNP) process and subsequent processing steps is presented. The processing steps and materials used can be adjusted to tune the encapsulation efficiency and burst release of the encapsulated water-soluble material. The encapsulation efficiency of the soluble agent in the particles and the burst release of the soluble agent from the particles can be controlled by: (1) the copolymers used in the assembly or coating process, (2) the degree of crosslinking of the nanoparticle core, (3) the incorporation of small molecule or polymeric additives, and/or (4) the processing and release conditions employed.

Abstract: Nanoparticles including a cellulosic polymer and a hydrophobic material and methods for forming them.

Abstract: A method for controlling the encapsulation efficiency and burst release of water soluble molecules from nanoparticle and microparticle formulations produced by the inverted Flash NanoPrecipitation (iFNP) process and subsequent processing steps is presented. The processing steps and materials used can be adjusted to tune the encapsulation efficiency and burst release of the encapsulated water-soluble material. The encapsulation efficiency of the soluble agent in the particles and the burst release of the soluble agent from the particles can be controlled by: (1) the copolymers used in the assembly or coating process, (2) the degree of crosslinking of the nanoparticle core, (3) the incorporation of small molecule or polymeric additives, and/or (4) the processing and release conditions employed.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described.

Abstract: A precipitation route to form nanoparticles with a hydrophilic core containing water soluble materials and a hydrophobic shell is described. The process requires a stabilizing polymer composed of more polar and more non-polar regions. These regions can be arranged as a linear block copolymer, or as a comb polymer with a linear or branched polar backbone and non-polar side chains or substituents. Nucleic acids, including DNA and RNA, as well as proteins, peptides, and polysaccharides or combinations can be encapsulated in the nanoparticle core. The encapsulation of nucleic acids can require partially or fully neutralizing the acid with a base to enhance the solubility of the nucleic acid in the process solvent stream. The core or the shell of the resulting nanoparticles can be crosslinked. The nanoparticles may be coated with additional polymer to bring them into water, or processed into microparticles or larger monoliths.

Abstract: Disclosed is a process to make nanoparticles highly loaded with water soluble actives, including biologics such as proteins and peptides, which are stabilized by random copolymers. The random copolymers used have all been approved by the FDA for oral formulations. The nanoparticles have a hydrophilic core and a hydrophobic corona and can be further processed through a number of different routes. The process to make these particles is highly scalable and could be used industrially.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described. The aggregation of these nanoparticles to form larger microparticles and monoliths provides a highly loaded construct (e.g., a depot) for the sustained and controlled release of actives.

Abstract: Hydrophilic molecules such as biologics, which can include peptides, proteins, and other biologically-derived materials, can be used as therapeutic agents in medical applications. They can face administration challenges because of poor membrane permeability and rapid clearance from the blood stream. Methods for the formation of a core-shell-brush nanoparticle from an A-B-C triblock copolymer are set forth. A hydrophilic core can contain the biologic and the C Block of the copolymer. The shell can be comprised of the precipitated B Block, and the A Block can form a stabilizing brush layer. The particles can be assembled by sequential precipitations under defined mixing conditions. Presented herein are methods to tune release based on process parameters during particle assembly and triblock characteristics.

Abstract: Nanoparticles including a cellulosic polymer and a hydrophobic material and methods for forming them.

Abstract: A method for controlling the encapsulation efficiency and burst release of water soluble molecules from nanoparticle and microparticle formulations produced by the inverted Flash NanoPrecipitation (iFNP) process and subsequent processing steps is presented. The processing steps and materials used can be adjusted to tune the encapsulation efficiency and burst release of the encapsulated water-soluble material. The encapsulation efficiency of the soluble agent in the particles and the burst release of the soluble agent from the particles can be controlled by: (1) the copolymers used in the assembly or coating process, (2) the degree of crosslinking of the nanoparticle core, (3) the incorporation of small molecule or polymeric additives, and/or (4) the processing and release conditions employed.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described. The aggregation of these nanoparticles to form larger microparticles and monoliths provides a highly loaded construct (e.g., a depot) for the sustained and controlled release of actives.

Abstract: An “inverse” precipitation route to precipitate aqueous soluble species with copolymers as nanoparticles having a hydrophilic, polar core and a less polar shell is described. A method of the invention for encapsulating water soluble molecules using rapid, controlled precipitation is presented. Water soluble molecules—including peptides, proteins, DNA, RNA, non-biologic therapeutics, polysaccharide-based therapeutics (e.g., tobramycin) and imaging agents—precipitate into nano articles that are protected by a copolymer stabilizing agent. These particles may be covalently or non-covalently stabilized. The particles may be coated with an amphiphilic polymer, or processed into microparticles or larger monoliths. Post processing on the final construct may be conducted.