Improving flowability and reducing storage agglomeration of metformin hydrochloride through QESD crystallization

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Metformin hydrochloride, a key type 2 diabetes medication, suffers from poor flowability and storage agglomeration.
• Conventional processing requires intermediate steps like granulation, adding complexity and cost to tablet manufacturing.

Purpose of the Study:

• To develop a simple quasi-emulsion solvent-diffusion crystallization method for metformin hydrochloride.
• To enable direct compression of metformin hydrochloride by improving its physical properties.
• To investigate the impact of surfactants and system parameters on particle characteristics.

Main Methods:

• A quasi-emulsion solvent-diffusion crystallization technique was employed.
• Various surfactants (HPMC, polysorbate 80, sorbitane monooleate) were tested to stabilize the emulsion.
• System parameters were varied to analyze their effect on particle morphology and flowability.

Main Results:

• Hollow, spherical metformin agglomerates with significantly improved flowability were successfully produced.
• Reduced storage agglomeration was observed in the manufactured particles.
• The study analyzed the influence of different surfactants and process parameters on particle properties.

Conclusions:

• The developed spherical crystallization method is effective for producing metformin hydrochloride with enhanced flowability.
• This technique offers a viable route for direct compression, simplifying the manufacturing process.
• The findings provide insights into optimizing surfactant selection and process parameters for metformin particle engineering.