Polymer-Coated Hard Shell Capsule for Nucleic Acid Stability
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Solution Overview
Problem
Current methods for delivering nucleic acid-based drugs, particularly liquid nanoparticles, face challenges due to temperature sensitivity and degradation in gastric fluids, making oral delivery difficult and inefficient.
Innovation Solution
Development of a polymer-coated hard shell capsule with a functional coat and a top coat, optimized to limit gastric fluid influx and prevent drug release in the stomach, ensuring the integrity of nucleic acids during passage through the gastrointestinal tract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If hard shell capsules are coated after filling with nucleic acid-based drugs, then the coating process can be completed, but the temperature sensitivity of nucleic acids causes degradation and loss of activity
Solution Approach 1:
The capsule shell is pre-coated with the polymer coating before filling with the nucleic acid-based drug. This preliminary action ensures that the temperature-sensitive nucleic acids are not exposed to the heat and stress of the coating process, preventing degradation while still achieving the desired coating protection and controlled release functionality.
2Object-generated harmful factors
If conventional coatings are used to prevent drug release in gastric fluid, then release prevention is achieved, but gastric fluid influx into the capsule is not prevented, causing pepsin-mediated digestion
Solution Approach 1:
A polymer coating is applied to the capsule shell to create a flexible barrier that prevents gastric fluid influx while allowing the capsule to maintain its structural integrity. This thin film barrier effectively blocks pepsin and other gastric fluids from penetrating into the capsule, protecting the nucleic acid-based drug from digestion.
Solution Approach 2:
The invention uses a polymer coating composed of specific polymers (such as cellulose derivatives, acrylic polymers, or methacrylic polymers) that provide both mechanical barrier properties to prevent fluid influx and chemical properties to resist gastric enzymes. This composite approach combines multiple functional properties in a single coating system.
3Reliability
If nucleic acid-based drugs are administered via injection, then delivery is effective, but the complexity of production, storage, and handling increases due to temperature sensitivity
Solution Approach 1:
The polymer-coated capsule shell acts as an intermediary vehicle that protects the nucleic acid-based drug during oral passage through the gastrointestinal tract. This mediator enables the drug to be administered orally rather than by injection, simplifying the administration process while maintaining effectiveness.
Solution Approach 2:
The invention changes the administration route from parenteral (injection) to oral by modifying the drug delivery system with a protective polymer coating. This parameter change in administration route simplifies production, storage, and handling requirements while maintaining drug effectiveness through the use of stable polymer materials that protect the temperature-sensitive nucleic acids.
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 polymer-coated hard shell capsules effectively reduce gastric fluid influx, maintaining the stability and potency of nucleic acid-based drugs, enabling efficient oral delivery and sustained release.
Implementation Method 1
a polymer-coated hard shell capsule... comprising at least a functional coat and a top coat... to obtain the functional coat of the hard shell capsule... to obtain the top coat of the hard shell capsule
Data Source
AI summary
A process for preparing a polymer-coated hard shell capsule that has at least a functional coat and a top coat, suitable as container for pharmaceutical or nutraceutical biologically active ingredients can be performed. The hard shell capsule has a body and a cap, wherein in the closed state the cap overlaps the body either in a pre-locked state or in a final-locked state, wherein the hard shell capsule is provided in the pre-locked state and is coated with a first coating solution, suspension or dispersion that has at least one polymer; optionally at least one glidant; optionally at least one emulsifier; optionally at least one plasticizer; optionally at least one biologically active ingredient; and optionally at least one additive. The polymer-coated hard shell capsule obtained from the process according to the invention can be used for immediate, delayed or sustained release.