Ranibizumab Dose Segmentation via Decapping and Sterile Extraction
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Solution Overview
Problem
The existing method of using a single-dose vial of ranibizumab results in significant drug wastage due to dead space in the syringe, leading to inefficiency and increased treatment costs for wet age-related macular degeneration.
Innovation Solution
A method is developed to extract multiple sterile and stable doses of ranibizumab from a single-dose vial by minimizing dead space using a 31G needle and decapping the vial, allowing for up to four 0.5 mg/0.05 ml doses, which are then stored in sterile bags for refrigeration, reducing wastage and improving patient comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a single-dose vial with tuberculin syringe is used to extract ranibizumab, then the extraction process is simple and quick, but significant drug wastage occurs due to dead space in the syringe
Solution Approach 1:
The single-dose vial is decapped to allow multiple extractions, effectively segmenting the single dose into multiple usable portions. The vial is divided into multiple 0.05ml doses through repeated extraction cycles, reducing the impact of dead space on overall drug utilization
Solution Approach 2:
The extraction process uses a smaller volume (0.05ml) than the total vial capacity, allowing multiple partial extractions. By extracting only the required dose amount each time rather than attempting to extract the entire vial content in one go, dead space losses are minimized across multiple extraction cycles
2Loss of substance
If multiple doses are extracted from a single-dose vial, then drug cost is reduced, but sterility and stability of extracted doses become compromised
Solution Approach 1:
The extraction and storage process is conducted in a sterile environment, and extracted doses are immediately transferred to sterile storage containers. The sterile barrier is maintained throughout the process to prevent contamination, ensuring that multiple extracted doses remain sterile and stable for future use
Solution Approach 2:
Proper sterilization and preparation steps are performed before extraction begins. The vial is decapped aseptically, and all extraction equipment is sterilized in advance. Doses are prepared and stored in sterile conditions before use, ensuring sterility and stability are maintained throughout the extended usage period
3Ease of manufacture
If a 30G needle is used for extraction, then the manufacturer's protocol is followed, but patient pain and discomfort increase
Solution Approach 1:
The needle gauge is changed from 30G to 31G, a subtle but meaningful parameter change that reduces needle diameter and consequently decreases patient pain and discomfort during injection. This parameter modification maintains clinical effectiveness while improving patient comfort
Data Source
AI summary
A method of preparing multiple doses of a pharmaceutical solution, such as ranibizumab, from a single-dose container, includes providing a sterile enclosed area with a plurality of unused sterile syringes, a decapper, and a plurality of sterile bags, opening a single-use container of a pharmaceutical solution in the enclosed area, withdrawing a first portion of the pharmaceutical solution using one of the sterile syringes, withdrawing a second portion of the pharmaceutical solution using a second of the sterile syringes, repeating the previous step for the remaining pharmaceutical solution using the remaining sterile syringes, and placing the sterile syringes containing portions of the pharmaceutical solution individually in the sterile bags.