Non-Cylindrical Buccal Implants for Sustained Drug Release
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Solution Overview
Problem
Existing implantable drug delivery devices face challenges in controlling drug release kinetics and maintaining a predictable release rate over extended periods, often leading to undesirable side effects and poor therapeutic outcomes due to rapid drug release and complications such as migration, inflammation, and fibrosis.
Innovation Solution
The development of buccal implant devices with non-cylindrical geometries and various design types (matrix, reservoir, hybrid) using thermoplastic polymers and elastomer materials for sustained drug delivery, optimized for placement in the oral mucosa to provide controlled and predictable drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If subdermal implants are used for sustained drug delivery, then dosing frequency is reduced and adherence improves, but device migration, infection, and fibrosis occur
Solution Approach 1:
The device is segmented into distinct functional components: a biocompatible body housing the drug reservoir, a separate delivery mechanism with controlled porosity, and an anchoring system. This segmentation allows each component to be optimized independently for its specific function while reducing overall complications.
Solution Approach 2:
A biocompatible intermediate layer or coating is introduced between the implant and surrounding tissue to reduce foreign body response, prevent fibrosis, and minimize migration. This intermediary layer acts as a barrier that maintains device stability while reducing harmful reactions.
2Speed
If drug is released rapidly from implant, then initial therapeutic effect is achieved, but cytotoxicity occurs at target site
Solution Approach 1:
The drug release rate parameters are precisely controlled by adjusting the porosity, surface area, and material composition of the delivery matrix. This allows optimization of release kinetics to achieve therapeutic levels without exceeding cytotoxic thresholds, maintaining a safe and effective concentration profile over time.
Solution Approach 2:
The device is designed to provide periodic or pulsed drug release rather than continuous or rapid release. This periodic action allows tissue recovery periods between drug exposures, preventing cumulative cytotoxicity while maintaining therapeutic efficacy through repeated dosing cycles.
3Reliability
If non-cylindrical geometry is used, then device stability and anchoring are improved, but manufacturing complexity increases
Solution Approach 1:
The device employs asymmetric or non-cylindrical geometric features such as irregular surface patterns, asymmetric anchoring protrusions, or non-uniform cross-sections. These asymmetric elements provide enhanced mechanical interlocking with surrounding tissue for improved stability while being manufacturable through modern molding or machining techniques.
4Object-generated harmful factors
If sustained release formulation is used, then side effects are reduced and therapeutic efficacy is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The device utilizes porous materials with controlled pore size, distribution, and connectivity to achieve sustained drug release. The porosity parameters are engineered to control drug diffusion rates, providing sustained release profiles that reduce side effects while using relatively simple material structures that are manufacturable through established porous material synthesis techniques.
Data Source
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AI summary
Disclosed herein are buccal implant devices comprising a body having a non-cylindrical geometry, the body adapted to be disposed within the oral cavity of a patient (e.g., the oral mucosa of a patient), and one or more pharmaceutically active ingredients. Also disclosed are methods of using the buccal implant devices in treating or preventing medical conditions.