Polymeric compositions containing ambient-temperature stable biopharmaceuticals and methods for formulation thereof
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Publication Number
US-11260024-B2
Publication Date
2022-03-01
Expiration Date
Abstract
Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and a volatile organic solvent, yet the carbohydrate-glass particles are insoluble in the volatile organic solvent.
Core Innovation
The invention relates to ambient-temperature stable biopharmaceutical compositions in which vaccine agents and/or probiotics are encapsulated in carbohydrate-glass particles and embedded within an amorphous polymer substrate. The amorphous substrate includes a polymeric excipient and a plasticizer, forming a solid composition that incorporates the carbohydrate-encapsulated biopharmaceuticals within the amorphous matrix.
A key characterization is that the polymeric excipient is soluble in both water and an organic solvent, while the carbohydrate-encapsulated biopharmaceuticals are not soluble in the organic solvent. In this way, the carbohydrate-glass particles are insoluble in the volatile organic solvent used for compatibility with the polymeric excipient. The compositions are described as enabling delivery without reconstitution and without cold-chain storage.
The document describes use of carbohydrate-glass particles prepared as thermostable powders using PBV and related foam-drying approaches. Formulation examples include embedding carbohydrate-glass particles in an amorphous bi-soluble polymer substrate for syringeless needle-free administration, including dissolvable films and micro-needle patches.
Claims Coverage
The independent claims define three inventive features centered on carbohydrate-glass particles encapsulating vaccine agents and/or probiotics and being embedded in an amorphous polymer substrate with a defined solubility relationship.
Bi-soluble amorphous polymer substrate with insoluble carbohydrate-glass biopharmaceutical encapsulation
An amorphous substrate including a polymeric excipient and a plasticizer, wherein the polymeric excipient is soluble in both water and an organic solvent and the carbohydrate-encapsulated biopharmaceuticals are not soluble in said organic solvent, with the carbohydrate-encapsulated biopharmaceuticals encapsulated in carbohydrate-glass particles.
Hydroxypropyl cellulose/triacetin amorphous substrate with embedded carbohydrate-glass encapsulated biopharmaceuticals
An amorphous substrate comprising between 70 to 95 percent by weight hydroxypropyl cellulose and 5 to 30 percent by weight triacetin, with carbohydrate-encapsulated biopharmaceuticals embedded in said amorphous substrate, wherein the carbohydrate-encapsulated biopharmaceuticals are encapsulated in carbohydrate-glass particles.
Medical delivery device using carbohydrate-glass encapsulated biopharmaceuticals in an organic-solvent-insoluble embedding amorphous polymer substrate
A medical delivery device comprising a vaccine agent and/or a probiotic encapsulated in carbohydrate-glass particles, wherein said carbohydrate-glass particles are embedded in an amorphous polymer substrate that is soluble in both water and an organic solvent, and wherein said carbohydrate-glass particles are not soluble in the organic solvent.
Across the independent claims, the scope is anchored on carbohydrate-glass particles encapsulating vaccine agents and/or probiotics and being embedded in an amorphous polymer substrate with a defined solubility relationship. Additional scope is provided by specifying an amorphous substrate composition comprising hydroxypropyl cellulose and triacetin.
Stated Advantages
Ambient-temperature stable biopharmaceutical compositions.
Enables syringeless needle-free delivery.
Avoids reconstitution.
Avoids cold-chain storage.
Documented Applications
Medical delivery to a patient using syringeless needle-free administration, including dissolvable films and micro-needle patches.
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