Injectable Calcium Phosphate Rods for Osteogenic Protein Delivery
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Solution Overview
Problem
Current methods for treating osteoporosis and related fractures are ineffective in promoting bone repair and reducing the incidence of osteoporotic fractures, as they lack a reliable and precise delivery mechanism for osteogenic proteins.
Innovation Solution
The development of injectable compositions comprising osteogenic proteins, such as BMP-2, combined with a calcium phosphate material and optional bone resorption inhibitors, formulated as solid rods or hardenable pastes for localized delivery to induce bone formation and maintain bone density.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If liquid or gel formulations are used for delivery of osteogenic proteins, then ease of injection is improved, but risk of embolism and displacement increases
Solution Approach 1:
The patent changes the physical state parameter of the formulation from liquid/gel to solid rod form. This parameter change allows the composition to be delivered in a controlled manner that eliminates embolism risk while maintaining ease of injection through specialized delivery devices designed for solid rod insertion.
Solution Approach 2:
The solid rod formulation is designed as a single-use, disposable delivery system. The rod is inserted and left in place to provide sustained release, eliminating the need for retrieval or adjustment and preventing displacement issues associated with liquid/gel formulations that may migrate from the injection site.
2Object-affected harmful factors
If solid rod formulation is used for delivery of osteogenic proteins, then risk of embolism and displacement is reduced, but ease of injection deteriorates
Solution Approach 1:
The patent introduces a specialized delivery device as an intermediary between the solid rod formulation and the injection site. This device is specifically designed to facilitate the insertion of solid rods into bone defects, overcoming the challenge of delivering solid material while maintaining the safety advantages of the solid rod formulation.
3Reliability
If osteogenic proteins are delivered locally, then bone formation induction is improved, but manufacturing complexity increases
Solution Approach 1:
The patent merges the osteogenic protein drug substance with the solid rod carrier material into a single integrated formulation. This combining of drug and delivery system simplifies manufacturing by eliminating the need for separate drug loading steps and ensures precise local delivery, improving bone formation induction while managing manufacturing complexity through streamlined processing.
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
These compositions provide a sustained release of osteogenic proteins, reducing the risk of fractures and promoting bone growth by maintaining bone strength and density, while minimizing the risk of embolism and displacement associated with liquid or gel forms.
Implementation Method 1
The calcium phosphate solid rods and hardenable pastes of the present invention are suitable for intraosseous delivery of osteogenic proteins. Through the use of the present inventive methods and compositions, the severity of osteoporosis or the incidence of osteoporotic lesions can be advantageously lessened, ultimately lessening the incidence of bone fractures.
Implementation Method 2
These compositions provide a sustained release of osteogenic proteins, reducing the risk of fractures and promoting bone growth by maintaining bone strength and density
Data Source
AI summary
Osteogenic proteins are delivered via an injectable solid rod or hardenable paste. The formulation comprises a calcium phosphate material, an osteogenic protein, and optional additives and active ingredients such as a bone resorption inhibitor. Methods of making injectable pharmaceutical compositions and methods of using the osteogenic compositions to treat bone defects are also disclosed.