Static Mixer for Uniform Drug Distribution in Excipients

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Solution Overview

Problem

Conventional methods for dispersing high potency, low dose drugs into physiologically inert materials result in loss of potency due to adherence to process equipment surfaces, leading to waste and increased production costs.

Innovation Solution

A process involving layering a pharmaceutically active particulate material on a pharmaceutically inert material and passing them through a static mixer to minimize exposure to equipment surfaces, effectively distributing the active material while reducing adherence.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If conventional mixing methods (twin-shell blender, double cone blender, drum roll mixer) are used to disperse high potency low dose drugs into inert materials, then homogeneous distribution of the drug is achieved, but loss of potency occurs due to adherence to process equipment surfaces

Engineering Contradiction:

Improvehomogeneous distribution of drugVSAvoidloss of active compound

Core Design Contradiction:

Stability of the object's compositionVSLoss of substance

Solution Approach 1:

The process segments the mixing operation into discrete steps: pre-blending the active compound with a portion of inert material to form a premix, then incorporating this premix with the remaining inert material. This segmentation reduces the total surface area of equipment the active compound must contact while maintaining homogeneous distribution.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary substance (the premix of active compound and inert material) that facilitates the distribution of the active compound throughout the inert material. This intermediary reduces direct contact between the active compound and large surfaces of process equipment by first embedding it within the inert material matrix.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Stability of the object's composition

If conventional mixing methods are used to achieve uniform distribution, then the drug is well dispersed, but production cost increases due to waste of active compound

Engineering Contradiction:

Improveuniform distributionVSAvoidproduction cost

Core Design Contradiction:

Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

By segmenting the mixing process into pre-blending and final incorporation steps, the patent reduces active compound loss to equipment surfaces. This segmentation maintains uniform distribution while minimizing waste, thereby reducing production costs associated with replacing lost active compound.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent changes the physical parameters of the mixing process by using low shear mixing conditions and controlling the order of addition of materials. These parameter changes reduce adhesion losses while maintaining distribution uniformity, leading to cost-effective manufacturing.

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If multiple processing steps (mixing, milling, blending) are used to achieve homogeneous distribution, then drug distribution is improved, but process complexity increases

Engineering Contradiction:

Improvehomogeneous distributionVSAvoidnumber of processing steps

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent merges the mixing and blending operations into a simplified two-step process: pre-blending to form a premix, then incorporating the premix with remaining inert material. This merging eliminates the need for separate milling steps while maintaining homogeneous distribution, thereby reducing process complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent applies preliminary action by pre-blending the active compound with a portion of inert material to create a premix before final incorporation. This preliminary step ensures uniform distribution while reducing the need for subsequent complex processing steps, simplifying the overall process.

Inventive Principle:

Principle #10Preliminary action

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 uniform distribution and minimizes loss of the active compound, maintaining potency and reducing production costs by eliminating the need for multiple processing steps.

Implementation Method 1

passing the layers of particulate material through a static mixer

Methodology Applied

Scientific EffectMixing:

Data Source

PatentUS7976872B2Method for distributing a pharmaceutically active compound in an excipient

Publication Date: 2011.07.12 PERRIGO L CO

AI summary

A process for uniformly distributing a pharmaceutically active particulate material in a pharmaceutically inert particulate material includes steps of providing a first layer of a pharmaceutically inert particulate material, disposing a layer of a pharmaceutically active particulate material on the first layer of pharmaceutically inert particulate material, passing the layers of particulate material through a static mixer, and discharging the blended mixture from the static mixer. The process is particularly useful for blending a low dose, high potency drug having a propensity to stick to process equipment surfaces with pharmaceutically inert particulate materials, such as diluents and/or excipients.