Subcutaneous Pump for Levodopa Delivery via Low-Viscosity Formulation
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Solution Overview
Problem
Current treatments for Parkinson’s disease, such as DUODOPA, are cumbersome and require frequent cassette replacements, with existing subcutaneously implanted devices hindered by low solubility and viscosity issues of levodopa and carbidopa formulations, limiting their use in small, patient-compatible devices for continuous gastrointestinal administration.
Innovation Solution
A subcutaneously implanted device with a pump and reservoir containing a low-viscosity, high-concentration formulation of levodopa and carbidopa, along with an intestinal absorbance enhancer, allowing for direct delivery to the GI tract, enabling prolonged and stable drug delivery without pump overwork or clogging, and facilitating refilling and maintenance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If high-concentration formulations of levodopa and carbidopa are used to reduce device size and extend refill intervals, then the device becomes more compact and patient-friendly, but the formulation viscosity increases causing pump overwork and clogging
Solution Approach 1:
The patent changes the physical-chemical parameters of the formulation by adjusting pH to 2.0-4.0 and using specific solvents (polyethylene glycol, propylene glycol, ethanol) to achieve high drug concentration (≥30% w/w) while maintaining low viscosity (<50 cP). This resolves the contradiction by modifying formulation parameters to simultaneously achieve high concentration and low viscosity.
Solution Approach 2:
The patent uses composite solvent systems combining multiple agents (polyethylene glycol, propylene glycol, ethanol, and water) to create a formulation that dissolves high concentrations of levodopa and carbidopa while maintaining fluidity. The composite material approach allows synergistic effects that reduce viscosity while preserving high drug content.
2Stability of the object's composition
If external infusion pumps like DUODOPA are used for continuous levodopa delivery, then dopamine level fluctuations are reduced, but the device size and complexity increase significantly causing patient inconvenience
Solution Approach 1:
By changing the formulation parameters (pH 2.0-4.0, specific solvent composition), the patent enables miniaturization of the delivery device. The optimized formulation allows use of smaller pumps and reservoirs while maintaining continuous delivery capability, thus reducing device complexity and size without sacrificing dopamine level stability.
Solution Approach 2:
The patent creates a simplified version of external infusion pumps by developing an implantable device that replicates the continuous delivery function. The high-concentration formulation enables a compact implantable design that copies the therapeutic effect of larger external devices.
3Stability of the object's composition
If frequent cassette replacements are required to maintain therapeutic levodopa levels, then dopamine level stability is maintained, but patient convenience and quality of life deteriorate
Solution Approach 1:
The patent prepares high-concentration formulations (≥30% w/w) in advance during manufacturing, allowing large volumes of medication to be stored in compact reservoirs. This preliminary concentration enables refill intervals of 1 week or longer, eliminating the need for frequent replacements and improving patient convenience while maintaining therapeutic stability.
Solution Approach 2:
By changing the concentration parameter of the formulation to ≥30% w/w, the patent extends the duration between refills. The high concentration allows sufficient drug quantity to be stored in a small volume, enabling weekly or monthly refill intervals instead of daily or weekly replacements.
4Object-generated harmful factors
If low-viscosity formulations are used to enable pump delivery, then pump overwork and clogging are prevented, but the concentration of levodopa and carbidopa must be reduced increasing device size
Solution Approach 1:
The patent simultaneously optimizes multiple parameters: pH (2.0-4.0), solvent composition (polyethylene glycol, propylene glycol, ethanol ratios), and drug concentration (≥30% w/w). These coordinated parameter changes achieve the counterintuitive result of high concentration with low viscosity (<50 cP), preventing pump clogging while maintaining high drug content.
Solution Approach 2:
The use of composite solvent systems with specific ratios of polyethylene glycol, propylene glycol, and ethanol creates a formulation matrix that maintains low viscosity while dissolving high concentrations of both levodopa and carbidopa. The composite material properties enable simultaneous achievement of high drug loading and pump-compatible fluidity.
Data Source
AI summary
A method includes using a subcutaneously-implanted pump to deliver to a portion of a gastrointestinal tract a formulation including a levodopa compound and a carbidopa compound which provides a treatment for a neurological disease, such as Parkinson’s disease.