Dry Octreotide Implants With Hydrophilic Polymer Release
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Solution Overview
Problem
There is a need for a controlled-release treatment method for octreotide to avoid the complications of frequent injections in patients with hormonal disorders like acromegaly, as current formulations require multiple periodic injections.
Innovation Solution
A controlled-release formulation using an implantable device encased in a hydrophilic polymer, which delivers octreotide at a controlled rate over an extended period without requiring hydration prior to implantation, providing a zero-order release profile for at least six months.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If current octreotide formulations are used, then the drug can be administered to treat hormonal disorders, but frequent periodic injections are required which cause complications and reduce patient compliance
Solution Approach 1:
The octreotide formulation is segmented into multiple microspheres of different sizes (e.g., 30-70 μm and 70-150 μm) that are co-administered. These microspheres release the drug at different rates, creating a sustained release effect that extends the duration of action and reduces the frequency of injections required.
Solution Approach 2:
The invention uses a biphasic release mechanism where one population of microspheres provides an initial burst release of octreotide, followed by a second phase of sustained release from another population of microspheres. This periodic action pattern maintains therapeutic levels while extending the dosing interval.
2Duration of action of moving object
If controlled-release formulations are developed, then injection frequency can be reduced, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
Instead of using complex implantable devices that require surgery for insertion and removal, the invention employs disposable injectable microspheres that are administered via simple injection. The microspheres are designed to be biocompatible and biodegradable, eliminating the need for device retrieval and reducing overall system complexity.
Solution Approach 2:
The microsphere formulation self-regulates the drug release through its physical and chemical properties. The different sizes and compositions of microspheres automatically create the desired release profile without requiring external control mechanisms, sensors, or power sources, thereby minimizing device complexity.
3Ease of operation
If dry formulations are used for implantable devices, then hydration step prior to implantation can be eliminated, but the reliability of drug release may be affected
Solution Approach 1:
The invention changes the physical state parameter of the formulation from hydrated to dry state for storage and administration. The dry microspheres are designed to maintain their structural integrity and drug loading without requiring hydration before implantation, simplifying the administration procedure while ensuring reliable drug release upon contact with bodily fluids at the implantation site.
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 formulation maintains therapeutically effective octreotide serum levels for up to two years, reducing the frequency of injections and minimizing side effects, while effectively treating conditions such as acromegaly and other hormonal disorders.
Implementation Method 1
The formulation comprises octreotide in a hydrophilic polymer effective to permit in vitro release of no more than about 20% of said octreotide from the formulation after about 6 weeks
Implementation Method 2
provides a substantially linear release rate of from about 10 μg to about 1000 μg per day over an extended period of time
Data Source
AI summary
Methods and devices are described for delivering octreotide to a patient, comprising implanting a controlled release composition for delivering octreotide, wherein the composition does not require hydration prior to implantation, and wherein the composition optionally comprises a release agent.