Oral Polypeptide Formulations Using Carrier Co-Crystallization
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Solution Overview
Problem
The development of polypeptide formulations is burdened by the need for labor-intensive crystallization conditions specific to each polypeptide, making it inconvenient and inefficient.
Innovation Solution
Formulations of crystalline or amorphous polypeptides for oral administration, where a carrier polypeptide composition is embedded with an active polypeptide composition, allowing for systemic delivery via oral routes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If crystallization conditions are developed for each polypeptide, then the polypeptide can be delivered systemically, but the process becomes labor-intensive and inefficient
Solution Approach 1:
The patent employs a universal crystallization platform using carrier polypeptides (such as albumin or immunoglobulins) that can embed multiple different active polypeptides. This single crystallization methodology serves multiple functions across different polypeptide formulations, eliminating the need to develop separate crystallization conditions for each polypeptide while maintaining reliable systemic delivery through oral administration.
Solution Approach 2:
The patent introduces carrier polypeptides as intermediary substances that facilitate the crystallization and oral delivery of active polypeptides. The carrier polypeptide acts as a mediator that forms a crystalline structure embedding the active polypeptide, enabling systemic delivery without requiring direct crystallization of each active polypeptide individually, thus improving formulation development efficiency.
2Reliability
If intravenous or subcutaneous injection is used for polypeptide administration, then systemic delivery is achieved, but the route of administration is inconvenient
Solution Approach 1:
The patent replaces the mechanical injection system (needles, syringes, invasive procedures) with an oral administration system based on crystalline polypeptide formulations. The crystalline structure enables the polypeptide to survive gastrointestinal conditions and be absorbed systemically through the gut, substituting the invasive mechanical delivery method with a non-invasive oral route while maintaining systemic delivery effectiveness.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The formulations effectively deliver polypeptides to the bloodstream and lymphatic system, offering a new platform for polypeptide delivery with desirable pharmacokinetic properties and broad applicability to various polypeptides.
Implementation Method 1
during a process of crystallizing a carrier polypeptide composition, an active polypeptide composition can be embedded in such carrier polypeptide composition, thereby creating a composition comprising both a carrier polypeptide composition and an active polypeptide composition
Data Source
AI summary
The present disclosure provides, among other things, methods and compositions for the oral administration of polypeptides. Many polypeptides are typically administered in liquid solutions by intravenous or subcutaneous injection. The present disclosure provides methods and compositions that include a polypeptide formulation, e.g., truffle, tablet, globule, candy, capsule formulation suitable for oral administration, where the formulation includes an amorphous polypeptide composition or a crystallized polypeptide composition and a pharmaceutically acceptable carrier.