Coprocessed Silica-Coated Polymer Excipient Flow
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Solution Overview
Problem
Excipient powders, particularly vinyl lactam derived polymers, exhibit poor flow and compaction behavior, leading to inconsistencies in tablet weight and active ingredient distribution, and existing methods like granulation and drying are time-consuming and costly.
Innovation Solution
A coprocessed excipient composition comprising vinyl lactam derived polymer and a deagglomerated coprocessing agent, such as fumed silica, is prepared using a continuous high-shear process, enhancing flow properties and compactability through increased bulk density and reduced interparticle cohesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If fine particles of vinyl lactam derived polymer are used as excipient, then the polymer can be processed into tablets, but the poor flow properties lead to consolidation of powder bed and inconsistency in tablet weight
Solution Approach 1:
A coprocessing agent is introduced as an intermediary substance to modify the surface properties of the vinyl lactam derived polymer particles. This agent acts as a mediator that reduces interparticle cohesion and improves flow characteristics without altering the fundamental properties of the polymer excipient, thereby enabling consistent tablet weight while maintaining the use of fine particles.
Solution Approach 2:
The surface parameters of the polymer particles are changed through coprocessing with a coprocessing agent. This modification alters the interparticle forces and surface characteristics, transforming the poor flow properties into improved flow behavior, allowing the material to be processed effectively into tablets with consistent weight.
2Ease of operation
If traditional granulation and drying processes are used to improve flow and compaction behavior, then the excipient properties are enhanced, but the process becomes time-consuming and costly
Solution Approach 1:
The invention extracts and eliminates the time-consuming drying step from the traditional granulation process. By using a coprocessing approach that does not require subsequent drying, the method achieves improved flow and compaction behavior while significantly reducing processing time and operational complexity.
Solution Approach 2:
The coprocessing method enables a continuous process where the coprocessing agent is incorporated during the granulation step itself, eliminating the need for separate drying and post-processing steps. This continuous action achieves the desired excipient properties more efficiently, reducing both time and cost.
3Ease of operation
If specialized instruments such as spray drying, mechanofusion, or magnetic assisted impaction are used, then flow properties are improved, but the equipment complexity and cost increase
Solution Approach 1:
The invention replaces complex, expensive specialized instruments with a simpler, more accessible coprocessing approach using conventional equipment. The method achieves improved flow properties through the use of a coprocessing agent in a standard granulation process, eliminating the need for sophisticated instruments like spray dryers or mechanofusion devices.
Solution Approach 2:
Complex mechanical systems such as spray drying, mechanofusion, and magnetic assisted impaction are replaced with a chemical/coprocessing-based approach. The coprocessing agent modifies particle properties through chemical interaction rather than complex mechanical processing, simplifying the equipment requirements while achieving the desired flow properties.
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 process improves flowability by 1.1 to 5.0 fold, achieves a Brookfield cohesion of less than 0.12 kPa, and maintains a bulk density of at least 0.249 g/ml, reducing processing time and costs while ensuring uniformity and scalability in pharmaceutical and industrial applications.
Implementation Method 1
A coprocessed excipient comprising vinyl lactam derived polymer or a blend and a deagglomerated coprocessing agent... prepared in a continuous process... using high shear
Implementation Method 2
enhancing flow properties and compactability through increased bulk density... maintains a bulk density of at least 0.249 g/ml
Data Source
AI summary
The present invention provides a coprocessed excipient composition and a method of producing the same. The coprocessed excipient comprises vinyl lactam derived polymer and a deagglomerated coprocessing agent. The coprocessing agent is fumed silica, colloidal silica or silicon dioxide. The coprocessed excipient is prepared by a continuous process and has a Brookfield cohesion of less than 0.12 kPa, a bulk density of at least 0.249 gram/milliliter and a flow property as measured by Johanson flow rate number increase from 1.1 to 5.0 fold.