Tabletization of peptide self-assemblies and methods of making and using the same
Inventors
Assignees
Publication Number
US-12290603-B2
Publication Date
2025-05-06
Expiration Date
2040-09-28
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Abstract
The present disclosure provides, in part, peptide self-assemblies that are made into tablet form and methods of making and using the same. In some embodiments, the disclosure provides methods and formulations for a tabletized form of a vaccine, particularly a vaccine comprising self-assembling peptide-polymer nanofibers, an excipient and an adjuvant. Methods of making and using the tablet formulation are also provided.
Core Innovation
The present disclosure addresses the need for heat-stable and easily deliverable vaccines, particularly to improve global vaccine coverage in regions facing challenges with cold-chain distribution and access to trained medical personnel. The invention introduces a first-of-its-kind dissolvable tablet formulation comprising peptide self-assemblies that function as a sublingual vaccine. This tablet includes self-assembling peptide-polymer nanofibers, an excipient for tablet porosity and integrity, and an adjuvant, all designed for sublingual administration.
The formulation overcomes limitations of traditional vaccines that require continuous cold-chain storage and injection, providing a solid dosage form that is heat stable and capable of rapid disintegration under the tongue. The invention details a method for formulating the tablet by dissolving the peptide in water, fibrilizing with buffer, adding cryoprotectant, excipients, and adjuvant, pipetting the solution into a tray, and then freezing and lyophilizing to produce the tablet. The resulting tablet is strong, porous, and readily dissolvable, suitable for sublingual use, and preserves the immunogenic nanofiber structure required for vaccine efficacy.
Through this approach, the invention enables a sublingual vaccine delivery platform that is heat stable for at least one week at 45°C and can elicit antibody and T cell immune responses upon sublingual administration. The tablet can contain peptide or protein antigens from bacterial, viral, or fungal sources and is adaptable to a variety of epitopes or antigens. This technology seeks to make vaccines more accessible by enabling self-administration, eliminating the need for needles, and improving storage and distribution logistics.
Claims Coverage
The patent contains several independent claims that define the subject matter coverage, focusing primarily on the composition of dissolvable tablets, their immunological function, and the methods for their formulation and use.
Dissolvable tablet formulation comprising peptide-polymer nanofibers with a peptide epitope or protein antigen and a mucus-inert domain, excipient, and adjuvant
- The tablet contains: - Self-assembling peptide-polymer nanofibers featuring: - A self-assembling domain (polypeptide) with C-terminal and N-terminal ends. - A peptide epitope or protein antigen linked to one end. - A mucus-inert domain linked to the opposite end. - An excipient. - An adjuvant.
Method of eliciting an immune response by sublingual administration of the dissolvable tablet
- Administering a therapeutically effective amount of the dissolvable tablet (as described in the composition claim) sublingually to a subject to elicit an immune response against a peptide or protein antigen.
Method of formulating a dissolvable sublingual tablet vaccine using self-assembling peptide-polymer nanofibers
- Steps include: 1. Combining a self-assembling peptide-polymer conjugate with a buffer to form peptide-polymer nanofibers. 2. Adding at least one excipient and an adjuvant to the peptide-polymer nanofiber to form a vaccine solution. 3. Placing the vaccine solution into a mold. 4. Removing the liquid from the vaccine solution to produce a tablet.
Vaccine formulated in tablet form produced by the specified method
- A vaccine in tablet form that is specifically produced according to the method of formulating a dissolvable sublingual tablet as disclosed in the patent.
In summary, the inventive features broadly cover the dissolved tablet formulation comprising peptide-polymer nanofibers with specific structural and functional arrangements, the elicitation of an immune response via sublingual administration, and the methods for manufacturing such vaccine tablets.
Stated Advantages
Provides a heat-stable, dissolvable tablet form suitable for sublingual vaccine administration, allowing for storage and shipping without reduction in vaccine efficacy.
Eliminates the need for needles and trained personnel for vaccination, enabling potential self-administration and pain-free delivery.
Improves accessibility and equity in global vaccine distribution, particularly in areas with unreliable cold-chain infrastructure.
Tablets rapidly disintegrate under the tongue, allowing for convenient use and efficient immunization.
Preserves nanofiber structure and immunogenicity of the peptide-polymer assemblies even after tabletization and heat exposure.
Documented Applications
Use as a sublingual vaccine to elicit antibody and T cell immune responses against peptide or protein antigens.
Application for vaccination against infectious diseases, including vaccines specific for bacteria (such as M. tuberculosis), viruses, and fungi.
Use of the vaccine tablet formulation for global health, particularly to address gaps in vaccine distribution where cold-chain and trained personnel are limiting.
Use in animal models (mice and rabbits) for immunization against specific bacterial and viral epitopes as demonstrated in experimental examples.
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