Intrathecal Baclofen Pre-filled Syringe System
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Solution Overview
Problem
Current methods for filling and refilling intrathecal infusion systems with baclofen are cumbersome, prone to contamination, and risk practitioner error due to the need to draw and filter the drug from ampoules, which compromises safety and efficiency.
Innovation Solution
A pre-filled syringe system with a sterilized solution of baclofen in sodium chloride and water, featuring a color coding system for concentration and size, minimal head space to prevent degradation, and instructions for use, eliminating the need for on-site drug preparation and filtering.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If baclofen is drawn and filtered from ampoules on-site, then the infusion system can be filled and refilled, but practitioner error and contamination risk increase
Solution Approach 1:
The syringes are pre-filled with sterile baclofen solution and pre-sterilized before use. This preliminary preparation eliminates the need for on-site drawing and filtering operations, thereby maintaining productivity while significantly improving reliability by removing practitioner error and contamination risks associated with manual preparation.
Solution Approach 2:
The system uses disposable pre-filled syringes that are single-use only. Each syringe is factory-prepared with the exact required dose of baclofen in a sterile state. This eliminates the need for reprocessing or sterilization steps by practitioners, improving both efficiency and safety through standardized, factory-controlled preparation.
2Ease of operation
If baclofen solution is exposed to air with head space in syringe, then filling is easier, but oxidation and degradation of baclofen occur
Solution Approach 1:
The syringes are pre-filled under controlled factory conditions with minimal or no head space, eliminating air exposure to the baclofen solution. This preliminary action preserves solution stability by preventing oxidation while maintaining ease of use through factory automation that doesn't require large head spaces for filling operations.
Solution Approach 2:
The baclofen solution is prepared and sealed in an inert or controlled atmosphere environment during manufacturing, preventing contact with oxygen that would cause oxidation. The minimal head space design further reduces air exposure, and the sterile seal maintains this protective environment until the moment of use.
3Quantity of substance
If baclofen is heated to high temperature for dissolution, then solubility increases, but thermal degradation occurs
Solution Approach 1:
The pH of the solution is adjusted to optimize baclofen solubility at lower temperatures. By controlling the chemical parameters of the solution (pH, ionic strength), the system achieves adequate solubility without requiring high temperature heating that would cause thermal degradation. This parameter optimization allows factory preparation of stable, concentrated solutions.
Solution Approach 2:
The system uses composite formulations combining baclofen with specific buffers, salts, and co-solvents that enhance solubility at controlled temperatures. This composite approach allows the drug to remain dissolved and stable without subjecting it to degrading high temperatures, while still achieving the required concentration for effective intrathecal administration.
4Quantity of substance
If multiple ampoules are used to fill large reservoirs, then adequate dosing is achieved, but contamination risk and practitioner error increase
Solution Approach 1:
The system segments the dosing into multiple pre-filled syringes, each containing a specific portion of the total required dose. Instead of opening multiple ampoules and manually combining them (which creates contamination risks), the practitioner simply connects multiple pre-sterilized syringes to the reservoir, maintaining sterility while achieving adequate total dosing.
Solution Approach 2:
The system employs multiple disposable pre-filled syringes rather than reusing or repurposing ampoules. Each syringe is factory-prepared with a specific volume and concentration, eliminating the need for practitioners to perform multiple transfer and mixing operations that increase contamination risk and potential for dosing errors.
Data Source
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AI summary
According to the subject invention, there is disclosed, a dosage and packaging configuration which includes the use of color-coded pre-filled syringes (10) and vials to fill and refill infusion systems with existing and new dosage forms of intrathecal baclofen.