Method for producing a lyophilisate from microspheres
The method stabilizes microspheres using HEPES, Triton X-100, and trehalose with hermetic sealing to address storage issues and toxic residues, enhancing stability and safety for clinical applications.
WO2026150337A1PCT designated stage Publication Date: 2026-07-16CHIRACON GMBH
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- CHIRACON GMBH
- Filing Date
- 2026-01-09
- Publication Date
- 2026-07-16
AI Technical Summary
Technical Problem
Existing methods for producing microspheres for molecular imaging face challenges in maintaining stability during storage, leading to aggregation and inefficiency, and often leave toxic residues that compromise patient safety.
Method used
A method involving the use of specific concentrations of HEPES, Triton X-100, trehalose, and optional DMSO, along with hermetic sealing, to stabilize microspheres during freeze-drying and reconstitution, minimizing toxic residues and maintaining functional integrity.
Benefits of technology
The method ensures high stability and effective targeting of microspheres, reducing toxic residues and improving imaging accuracy and safety for clinical use.
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Abstract
The invention relates to a method for producing a lyophilisate from microspheres, the method comprising the steps of: providing microspheres having a polymer shell made of poly(n-butyl cyanoacrylate) (PBCA), the polymer shell being modified with a peptide sequence that binds specifically to a target, for example integrin ανβ3 (alpha nu beta 3); and suspending the microspheres in a solution. According to the invention: the suspension is frozen in individual containers by directly exposing the containers, for example glass vials, to liquid nitrogen; and the frozen individual containers are freeze-dried at a pressure of ≤ 0.5 mbar, the freeze-drying being completed by hermetically sealing the individual containers in a freeze-drying chamber. The solution contains HEPES (4-(2-hydroxyethyl)piperazine-1-ethanesulphonic acid) at a concentration of from 1.5 to 3.5 g / L, preferably in the range of from 2.0 to 2.5 g / L, Triton X-100 at a concentration of from 50 mg / L to 150 mg / L, preferably in the range of from 80 mg / L to 120 mg / L, and trehalose at a concentration of from 12 wt.% to 21 wt.%, preferably from 15 wt.% to 18 wt.%.
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