Low-Temperature Masterbatch Process for Drug Distribution
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Solution Overview
Problem
Current drug delivery compositions face challenges in achieving controlled and homogeneous drug distribution within polymer-based matrices, especially for thermosensitive or high molecular weight drugs, due to limitations in solvent use, heat sensitivity, and accuracy of drug dosage.
Innovation Solution
A process involving the creation of a masterbatch with a high drug concentration and a first polymer, heated to a temperature below 140°C, which is then incorporated into a polymer-based matrix, allowing for precise control of drug release correlated with polymer degradation, even for drugs with high molecular masses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If hot melt extrusion is used to disperse drug into polymer structure, then continuous process and absence of solvent are achieved, but thermal treatment may inactivate the drug
Solution Approach 1:
The patent changes the temperature parameter from conventional hot melt extrusion (typically 150-200°C) to a lower temperature range (below 140°C) that maintains drug activity while still enabling polymer melting and drug incorporation. This parameter modification resolves the contradiction between continuous processing and drug stability.
2Manufacturing precision
If high temperature is used to melt polymer for drug incorporation, then homogeneous distribution is achieved, but thermosensitive drugs are inactivated
Solution Approach 1:
The patent modifies the temperature parameter to below 140°C, which is sufficient to melt the polymer matrix for homogeneous drug distribution while remaining below the thermal inactivation threshold of thermosensitive drugs. This resolves the contradiction between achieving homogeneous distribution and preventing thermal damage.
3Adaptability or versatility
If solvent-based incorporation is used, then drugs soluble in solvent can be incorporated, but solvent traces must be removed and quality control is complex
Solution Approach 1:
The patent extracts and eliminates the solvent from the incorporation process, using direct thermal melting of polymer to achieve drug incorporation. This removes the need for solvent evaporation, drying, and extensive quality control for solvent residues, while maintaining versatility through the ability to incorporate various drugs by controlling temperature and polymer selection.
4Quantity of substance
If low quantity of drug is introduced by hot melt extrusion, then precise dosage is required, but accurate drug dosage is hardly achieved
Solution Approach 1:
The patent performs preliminary action by pre-mixing the drug with the polymer at below 140°C to create a homogeneous masterbatch before final extrusion. This preliminary homogeneous distribution ensures that even low quantities of drug are uniformly dispersed, enabling accurate dosage control that would be difficult to achieve through direct extrusion of low drug quantities.
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 process ensures the activity and homogeneous distribution of drugs within the matrix, enabling controlled release and increased drug content, suitable for long-term applications and thermosensitive compounds.
Implementation Method 1
heating the first polymer, wherein said first polymer has a melting temperature below 140°C
Implementation Method 2
introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition, wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, preferably by extrusion
Data Source
AI summary
The present invention relates to process for preparing a drug delivery composition comprising the steps of a) preparing a masterbatch comprising a drug and a first polymer by (i) extruding the first polymer, wherein said first polymer has a melting temperature below 140° C.; and (ii) introducing the drug during extrusion of the first polymer, with a drug content between 0.1% and 90%, based on the total weight of the masterbatch; and b) introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition, wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, and step b) is performed at a temperature at which both the first polymer and at least a polymer of the polymer-based matrix are in a partially or totally molten state.