Lyophilized Saccharide-Degrading Enzyme Unit Dose Formulation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Lyophilization of saccharide-degrading enzymes often results in significant reduction of enzyme titer, leading to wastage of expensive enzymes as only a portion is used for administration, while the remaining excess is discarded.
Innovation Solution
A pharmaceutical composition is developed as a unit dose formulation containing a lyophilized saccharide-degrading enzyme with a titer of not less than 0.3 unit/μg, and an amount of not less than 2 μg and not more than 8 μg, which is produced by lyophilizing a solution containing the enzyme in a container.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of energy
If lyophilization is used to prepare enzyme preparations, then distribution cost is reduced, but enzyme titer is significantly reduced
Solution Approach 1:
The patent applies parameter changes by optimizing the lyophilization process parameters (temperature, pressure, time) and formulation composition (protective agents, buffer systems) to minimize enzyme titer loss while maintaining the cost benefits of lyophilized preparation
Solution Approach 2:
The patent introduces protective agents and excipients as intermediaries during lyophilization to protect the enzyme from denaturation and aggregation, thereby preserving enzyme titer while still achieving the cost reduction benefits of frozen drying
2Ease of operation
If a lyophilized preparation in large excess is prepared first and then separated for single dose, then unit dose formulation is achieved, but large remaining amount of expensive enzyme is wasted
Solution Approach 1:
The patent applies segmentation by dividing the enzyme preparation into precise unit doses during the lyophilization process itself, rather than preparing large excess and separating later. This ensures each container receives exactly the required amount, eliminating waste from discarded excess enzyme while maintaining convenient unit dose formulation
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
This approach significantly suppresses the reduction in titer due to lyophilization and storage, allowing for a stable and effective enzyme dosage, while minimizing enzyme wastage.
Implementation Method 1
a step of putting a solution comprising not less than 2 μg and not more than 8 μg of a saccharide-degrading enzyme into the container, and a step of lyophilizing the solution
Implementation Method 2
lyophilizing the solution SO that a unit dose of the pharmaceutical composition can be provided
Data Source
AI summary
A pharmaceutical composition containing a lyophilized saccharide-degrading enzyme having excellent titer, and a package containing the pharmaceutical composition. The pharmaceutical composition is a unit dose formulation containing a lyophilized saccharide-degrading enzyme with a titer of not less than 0.3 unit/μg as an active ingredient, and contains the saccharide-degrading enzyme in an amount of not less than 2 μg and not more than 6 μg.