Multidose Imiquimod Package with Airless Pump Metering
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current imiquimod cream formulations for treating actinic keratosis, basal cell carcinoma, and genital warts face challenges due to inconsistent dosing, potential microbial contamination, and degradation, especially when reused or exposed to air, leading to regulatory limitations and patient convenience issues.
Innovation Solution
A multidose package with a metered dosage system and airless pump technology that prevents microbial contamination and degradation, allowing for precise dosing and multiple uses without refrigeration, featuring a reservoir with a dispensing aperture, metered dosage means, and actuating mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If single-dose sachets are used to ensure preservative efficacy compliance, then microbial contamination is prevented, but patient convenience and ease of operation deteriorate due to refrigeration requirements and inability to reuse
Solution Approach 1:
The package is divided into separate functional components: a reservoir for the cream formulation, a metering mechanism for precise dosing, and a dispensing system. This segmentation allows the formulation to be protected in the sealed reservoir while providing controlled access through the metering system, eliminating the need for refrigeration and enabling multiple uses.
Solution Approach 2:
The package creates a protected environment for the cream formulation through the sealed reservoir and controlled dispensing system. This prevents exposure to air and microorganisms, maintaining preservative efficacy without requiring refrigeration, thus resolving the contradiction between reliability and ease of operation.
2Measurement precision
If multiple single-dose sachets are provided, then dosing precision is maintained, but loss of substance increases due to potential contamination and degradation when sachets are reused
Solution Approach 1:
The package provides continuous protection of the formulation throughout multiple uses. The sealed reservoir and controlled dispensing system maintain formulation integrity from first to last use, preventing degradation and contamination that would occur with repeated sachet handling and storage.
Solution Approach 2:
The metering mechanism is pre-configured to deliver precise doses automatically. This preliminary setup ensures accurate dosing without requiring patient intervention or judgment, while the sealed system prevents contamination before it can occur during use.
3Reliability
If patients refrigerate open sachets to prevent contamination, then microbial growth is inhibited, but device complexity and ease of operation worsen due to storage requirements and access issues
Solution Approach 1:
The sealed reservoir creates a protected environment that prevents microbial contamination without requiring external refrigeration. This eliminates the need for complex storage infrastructure, resolving the contradiction between contamination prevention and device complexity.
Solution Approach 2:
The package is self-sufficient with an integrated metering and dispensing system that automatically measures and delivers the correct dose. This eliminates the need for external refrigeration and complex storage arrangements, providing both contamination prevention and simplicity.
4Productivity
If larger amounts of cream are applied to cover extensive lesion areas, then treatment effectiveness improves, but harmful effects increase due to exceeding the recommended 20 cm2 treatment area
Solution Approach 1:
The mechanical judgment and measurement required by patients is replaced with an automated metering system. This system mechanically controls the cream output to deliver precise, predetermined doses, eliminating the risk of over-application while maintaining adequate coverage for the prescribed treatment area.
Solution Approach 2:
The metering mechanism provides inherent feedback control by measuring and limiting the cream output to predetermined amounts. This automatic feedback system prevents excessive application even when treating extensive areas, balancing productivity with safety by enforcing the 20 cm2 limit through mechanical means rather than patient judgment.
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 solution provides a convenient, hygienic, and effective treatment option by ensuring accurate dosing and maintaining the formulation's integrity, reducing the risk of contamination and degradation, thus enhancing patient compliance and convenience.
Implementation Method 1
a metered dosage means for measuring a predetermined dose of said formulation, said means comprising an inlet from said reservoir and an outlet to said dispensing aperture; and an actuating means for operating said dosage means such that the predetermined dose is delivered to said dispensing aperture
Data Source
AI summary
A multidose package containing an imiquimod formulation suitable for treating topical conditions includes: a) a dispensing aperture for dispensing the formulation from the package; b) a reservoir containing sufficient formulation to provide two or more doses; c) a metered dosage element for measuring a predetermined dose of the formulation, the element including an inlet from the reservoir and an outlet to the dispensing aperture; and d) an actuating element operating the dosage element so the predetermined dose is delivered to the dispensing aperture; wherein the dose is dispensed without microbial or other contamination or degradation of the formulation in reservoir. A corresponding course of treatment for various maladies includes providing a multidose package containing an imiquimod formulation suitable for the treatment. A corresponding method of treatment of diseases with multiple doses of an imiquimod formulation includes multiple doses provided by a multidose package.