Lactose Particle Classification for Pharmaceutical Formulations
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Solution Overview
Problem
Conventional processes for producing lactose for pharmaceutical formulations result in undesirable variations in particle size and morphology, leading to inconsistent bioavailability and stability issues due to excessive fine particle mass and surface roughness variations.
Innovation Solution
A process involving the classification and blending of lactose particles to achieve a predetermined particle size distribution, with a focus on reducing the volume average particle size to 70 microns or less, and separating into fine and coarse fractions to ensure consistent particle size and morphology, thereby improving the flow properties and stability of lactose in pharmaceutical formulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional spray drying or fine grinding is used to produce lactose, then lactose can be produced, but the particle size distribution and morphology show excessive variations leading to poor flow properties and inconsistent bioavailability
Solution Approach 1:
The patent divides the lactose production process into distinct stages: initial spray drying to create coarse crystals, followed by controlled milling to reduce particle size, and classification to separate fine and coarse fractions. This segmentation allows each stage to be optimized independently, achieving consistent particle size distribution while maintaining manageable process complexity
Solution Approach 2:
The patent applies preliminary classification before the final milling operation to remove excessively fine particles (less than 70 microns) from the feed material. This preliminary action ensures that only appropriately sized particles undergo milling, preventing over-grinding and ensuring consistent final particle size distribution and morphology
2Length of moving object
If fine grinding or milling is applied to produce fine lactose powder, then particle size is reduced, but flow properties deteriorate and surface roughness increases
Solution Approach 1:
The patent applies different processing intensities to different portions of the particle size distribution. Coarse crystals (greater than 70 microns) undergo full milling and classification to achieve fine particles, while already fine particles (less than 70 microns) are separated and used as-is. This local quality approach ensures that only necessary milling is applied, preserving flow properties while achieving desired particle size
Solution Approach 2:
The patent controls the milling parameters (intensity, duration, conditions) to achieve specific particle size reductions without excessive surface roughening. By optimizing these parameters and combining them with classification to remove the finest particles, the process achieves fine particle size while maintaining good flow properties and consistent surface morphology
3Quantity of substance
If conventional production methods are used, then lactose can be manufactured, but variations in particle size and morphology lead to excessive fine particle mass affecting bioavailability
Solution Approach 1:
The patent incorporates classification steps that continuously monitor and separate particles based on their size. The classification process provides feedback about the particle size distribution in real-time, allowing the system to adjust milling intensity and feed composition to maintain consistent particle size and controlled fine particle mass, thereby ensuring reliable bioavailability
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 achieves a more consistent particle size distribution and surface morphology, enhancing the bioavailability and stability of lactose in pharmaceutical formulations, ensuring effective delivery of therapeutic agents in inhalation therapy.
Implementation Method 1
classifying the plurality of milled lactose particles into at least two fractions comprising a fine fraction and a coarse fraction wherein the fine fraction has an average particle size, (D50), ranging from about 3 microns to about 50 microns, and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns
Implementation Method 2
milling the plurality of lactose particles to yield a plurality of milled lactose particles with an average particle size, (D50), ranging from about 50 microns to about 100 microns
Data Source
AI summary
A process for forming lactose suitable for use in a pharmaceutical formulation comprises providing a plurality of lactose particles containing no more than 10% w/w of lactose particles having a volume average particle size of about 70 microns or less; milling the plurality of lactose particles to yield a plurality of milled lactose particles with an average particle size, (D50), ranging from about 50 microns to about 100 microns; and classifying the plurality of milled lactose particles into at least two fractions comprising a fine fraction and a coarse fraction wherein the fine fraction has an average particle size, (D50), ranging from about 3 microns to about 50 microns, and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns.