Steroid Dimer Sustained Release Without Excipients
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Solution Overview
Problem
Current sustained drug release systems face challenges such as drug degradation, lack of controlled release, low encapsulation efficiency, and complexity in formulation, especially when delivering multiple drugs simultaneously, which complicates achieving a predetermined release profile.
Innovation Solution
A multi-component system comprising a steroid dimer and a biologically active agent, where the steroid dimer is formulated without controlled release excipients, allowing for a homogeneous or heterogeneous mixture that provides a controlled release of the therapeutic agent, either as a sustained, immediate, or delayed release, without relying on degradable matrices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If controlled release excipients or degradable matrices are used to achieve sustained drug release, then the duration of action is extended, but the formulation complexity and potential harmful factors from carriers increase
Solution Approach 1:
The patent removes controlled release excipients and degradable matrices from the formulation entirely. The steroid dimer itself serves as the active ingredient without requiring separate carrier materials, thereby eliminating formulation complexity while maintaining sustained release capability through the dimer's inherent properties
Solution Approach 2:
The steroid dimer provides its own controlled release mechanism without needing external carriers or matrices. The dimer structure inherently controls the release rate of the active ingredient, making the system self-sufficient and eliminating the need for additional formulation components
2Reliability
If multiple drugs are delivered simultaneously in combination therapy, then the therapeutic effectiveness is enhanced, but the manufacturing precision and formulation complexity increase
Solution Approach 1:
The patent combines multiple therapeutic agents into a single steroid dimer molecule through covalent bonding. This merging approach allows simultaneous delivery of multiple drugs with predetermined release profiles while simplifying the formulation to a single molecular entity, thereby maintaining manufacturing precision
Solution Approach 2:
The steroid dimer acts as a composite molecular structure where different therapeutic moieties are chemically linked together. This composite approach enables controlled release of multiple agents while maintaining a simple, well-defined formulation without requiring complex multi-component systems
3Ease of manufacture
If diffusion or bulk erosion mechanisms are used for drug release, then the formulation simplicity is maintained, but the release control is poor with unwanted burst or incomplete release
Solution Approach 1:
The patent changes the fundamental release mechanism from diffusion or bulk erosion to a controlled hydrolysis process. The steroid dimer is designed with specific chemical bonds that hydrolyze at predictable rates, providing precise release profile control while maintaining formulation simplicity through the use of a single active ingredient
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
This approach enables a controlled and sustained release of drugs over an extended period, minimizing side effects associated with carriers or matrices, and achieving desired therapeutic concentrations for days to weeks or even years, with the ability to deliver multiple drugs simultaneously.
Implementation Method 1
the article releases the first component (e.g., or at least a portion thereof, such as, for example, a monomer (e.g., in its free form) of a steroid dimer)
Data Source
AI summary
The present invention is directed towards articles comprising a steroid material comprising a steroid dimer and at least one therapeutic agent distributed throughout the steroid material and the use of such articles in sustained release delivery systems. Said article may be fibers, fiber meshes, woven fabrics, non-woven fabrics, films, pellets, cylinders, microparticles, nanoparticles, shaped articles or coatings on a substrate (such as an implant). Control of the release profile of the at least one therapeutic agent can be achieved via selection of the steroids within the steroid dimer, the linker conjugating the steroids within the dimer, the linkage groups between the steroids and the linker, the surface area of the article, the location of the at least one therapeutic agent within the article and the amount of the at least one therapeutic agent within the article.