Methods and compositions for maintaining the conformation and structural integrity of biomolecules
Inventors
Nelson, Kevin D. • Crow, Brent B. • Griffin, Nickolas B. • Seifert, Jennifer • Sood, Paul R. • Patel, Alpeshkumar P. • Hubbard, Paul A.
Assignees
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Publication Number
US-10363281-B2
Publication Date
2019-07-30
Expiration Date
Abstract
A composition includes a target pharmaceutical or biological agent, a solution containing the target pharmaceutical or biological agent, and substrate that is soluble in the solution. The substrate is capable of being solidified via a solidification process and the solidification process causes the substrate to become physically or chemically cross-linked, vitrified, or crystallized. As a result of the solidification process, particles are formed. The target pharmaceutical or biological agent within the solution retains proper conformation to ultimately produce a desired effect.
Core Innovation
The invention provides a composition comprising a solution containing a target pharmaceutical or biological agent and a substrate that is soluble in the solution. Some components of the soluble substrate are capable of being solidified via a solidification process in which the substrate becomes physically or chemically cross-linked, vitrified, or crystallized to form particles. During or after the solidification process, the target pharmaceutical or biological agent within the resulting particles retains proper conformation to ultimately produce a desired effect.
The resulting particles are characterized as poorly swellable in a solvent from which protection is desired. The description emphasizes that the solidified substrate forms particles that maintain biomolecular conformation while providing poor swelling behavior in the protecting organic solvent. The invention further includes that particles are formed after or as a result of the solidification process.
The description also provides that the particles are incorporated into a polymer solution comprising a surfactant, stabilizer, or emulsifier, or that such a surfactant, stabilizer, or emulsifier is incorporated into the substrate prior to, during, or after solidification. The document further describes substrate material families and solidification approaches, including physically or chemically cross-linked, vitrified, or crystallized systems formed via temperature-induced phase change and/or lyophilization to yield protein-encapsulating particles.
Claims Coverage
The document contains two independent claims, each reciting substantially the same core composition: a solution with a target pharmaceutical or biological agent, a soluble substrate that is solidified into particles that preserve proper conformation and are poorly swellable in a solvent to be protected, with surfactant, stabilizer, or emulsifier incorporation as an additional defining feature.
Solidification into poorly swellable particles preserving proper conformation
A composition comprising a solution containing a target pharmaceutical or biological agent; a substrate that is soluble in the solution, wherein some components of said substrate are capable of being solidified via a solidification process, wherein the solidification process causes the substrate to become physically or chemically cross-linked, vitrified, or crystallized, and wherein particles are formed after or as a result of the solidification process, wherein the target pharmaceutical or biological agent within the resulting particles retains proper conformation to ultimately produce a desired effect, wherein the resulting particles are poorly swellable in a solvent from which protection is desired.
Incorporation into a polymer solution with surfactant, stabilizer, or emulsifier
The composition wherein the particles are incorporated into a polymer solution comprising a surfactant, stabilizer, or emulsifier.
Solidification with surfactant, stabilizer, or emulsifier incorporated into substrate at selectable timing
A composition wherein a surfactant, stabilizer, or emulsifier is incorporated into the substrate prior to, during, or after solidification.
Across the independent claims, the inventive focus is on forming poorly swellable particles from a soluble substrate by physical or chemical cross-linking, vitrification, or crystallization, while retaining proper conformation of a target pharmaceutical or biological agent for a desired effect. The independent claims additionally define incorporation of a surfactant, stabilizer, or emulsifier either into a polymer solution associated with the particles or into the substrate prior to, during, or after solidification.
Stated Advantages
Particles poorly swellable in a solvent from which protection is desired.
Target pharmaceutical or biological agent retains proper conformation to ultimately produce a desired effect.
Documented Applications
Protein-encapsulating particles protecting biomolecules against specific solvents described in the document (e.g., solvents contrasted by HFIP vs DCM).
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