Methods and compositions for maintaining the conformation and structural integrity of biomolecules
Inventors
Sood, Paul R. • Patel, Alpeshkumar P. • Seifert, Jennifer • Zarzycki, Ryszard
Assignees
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Publication Number
US-12121560-B2
Publication Date
2024-10-22
Expiration Date
Abstract
A liquid ink composition includes a liquid phase and particles suspended in the liquid phase, the particles containing a target pharmaceutical or biological agent. The biological activity of the target pharmaceutical or biological agent is preserved upon suspension of the particles in the liquid phase. The liquid phase is capable of solidifying via a solidification process.
Core Innovation
The invention relates to maintaining conformation and structural integrity of a pharmaceutical or biological agent by forming particles from a solidifiable composition that includes a solution containing the pharmaceutical or biological agent and a substrate soluble in the solution. The substrate is solidified using vitrification, crystallization, physical cross-linking, chemical cross-linking, or combinations thereof, thereby forming particles containing the pharmaceutical or biological agent in a native configuration. During the forming of the particles, the biological activity of the pharmaceutical or biological agent is preserved.
A protection matrix is provided by solidified particles that are poorly swellable or non-swellable in a protecting organic solvent, while entrapping the pharmaceutical or biological agent. In the three-dimensional printing context, a liquid ink composition includes a polymer liquid phase and the particles suspended in the polymer liquid phase, where the liquid phase is configured to solidify to form a three dimensional structure. The biological activity of the pharmaceutical or biological agent is preserved upon solidification of the liquid phase.
The particle protection matrix is formed using physical or chemical cross-linking, gelation, vitrification, crystallization, dehydration, or lyophilization, depending on the substrate. Solidification is combined with selection of soluble substrate and surrounding components to obtain particles that remain suspendable and to control swellability in the protecting solvent; example systems include gelatin, collagen, fibrin proteins, sugars, and synthetic polymers, forming particles of sizes in the range of tens to thousands of nanometers.
Claims Coverage
The document includes two independent claims. The inventive features focus on a 3D-printing liquid ink composition with a polymer liquid phase and poorly swellable particles entrapping a pharmaceutical or biological agent in native configuration with preserved biological activity, and a method that forms such particles by solidifying a solution of the agent with a solidification-soluble substrate, then suspending the particles in a polymer liquid phase that solidifies while preserving biological activity.
Liquid ink composition for three-dimensional printing with poorly swellable agent-containing particles
A liquid ink composition configured for three-dimensional printing comprising a liquid phase comprising a polymer, and particles, poorly swellable in the liquid phase, suspended in the liquid phase, the particles containing an active pharmaceutical or biological agent in a native configuration with preserved biological activity; wherein the liquid phase is configured to solidify to form a three dimensional structure, and wherein the biological activity of the pharmaceutical or biological agent is preserved upon solidification of the liquid phase.
Method of forming a 3D-printing liquid composition via solidification into agent-containing particles and suspension in polymer phase
A method of forming a liquid composition configured for three-dimensional printing comprising preparing a solidifiable composition comprising a solution containing a pharmaceutical or biological agent having biological activity and a substrate soluble in the solution, the substrate comprising components capable of being solidified via vitrification, crystallization, physical cross-linking, chemical cross-linking, and combinations thereof; solidifying the solidifiable composition by means of the solidification process, thereby forming particles comprising the pharmaceutical or biological agent, wherein the biological activity of the pharmaceutical or biological agent is preserved during the forming of the particles; and suspending the particles in a liquid phase comprising a polymer, the liquid phase being configured to solidify, wherein the biological activity of the pharmaceutical or biological agent, comprised by the particles, is preserved upon forming the liquid composition, and upon solidification of the liquid phase.
Across the independent claims, the main inventive requirements are that the agent-containing particles are formed by solidifying a soluble-substrate composition using selected solidification processes, that the particles are poorly swellable in the polymer liquid phase, and that the agent’s biological activity is preserved both during particle formation and when the polymer liquid phase solidifies into a three-dimensional structure.
Stated Advantages
Biological activity of the pharmaceutical or biological agent is preserved upon forming the particles.
Biological activity is preserved upon solidification of the liquid polymer phase into a three-dimensional structure.
Documented Applications
Three-dimensional printing using a liquid ink composition configured for three-dimensional printing that solidifies into a three dimensional structure while preserving biological activity.
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