As pharmaceutical companies face greater competitiveness, there is an industry-wide shift from batch to continuous processing using direct compression and other dry processing techniques such as hot-melt extrusion, dry-powder layering, roller compaction and dry granulation.
Dry powder processing involves less production steps than wet granulation, thus improving efficiency and reducing production costs. Furthermore, dry powder processing avoids the degradation of moisture-labile or heat-sensitive active pharmaceutical ingredients (APIs).
Direct compression is the ideal continuous processing option because all granulation steps are eliminated, further simplifying the manufacturing process. With direct compression, formulators can reduce waste, shorten development time, increase throughput, and lower total manufacturing costs by up to 60%.
Enabled by Dow’s patented Designed Particle Morphology (DPM) Technology, Dow engineered the METHOCEL™ DC2 product family to help formulators enjoy the benefits of dry powder processing techniques while maintaining a consistent modified release performance.
Furthermore, Dow’s ETHOCEL™ resins can be used as granulation binders to improve the flow and compaction characteristics of immediate and controlled release formulations made with dry processing techniques.
Solutions for Dry Processes
METHOCEL™ DC2 Polymers
METHOCEL™ DC2 excipients are engineered for improved flow with expected controlled release performance, facilitating greater tablet weight, excellent protection for heat and moisture sensitive APIs and content uniformity when used in dry powder processing techniques such as dry granulation/roller compaction and direct compression.
METHOCEL™ DC2 helps shorten development time and reduce manufacturing costs by up to 60% while achieving up to 15% higher press operation speeds.
ETHOCEL™ resins are excellent granulation binders for dry processing, offering versatility in drug release rates and producing hard tablets with low friability. In small, effective amounts ETHOCEL™ does not adversely affect tablet disintegration/dissolution rates. Fine Particle (FP) grades can also offer improved processing conditions.
In trials conducted by Dow, the use of ETHOCEL™ HP, a new high productivity ethylcellulose polymer for multi-particulate and taste masking applications, reduced overall coating times by 70% when compared to both aqueous and solvent spray systems. Such faster coating speeds could enable pharmaceutical companies to increase their productivity yields and decrease formulation development time.
ETHOCEL™ HP trials have also shown consistent 98-99% coating efficiency, providing pharmaceutical companies with opportunities for raw material cost savings and an easier clean-up step. All of these advantages, while still producing robust formulations, with excellent film strength and stable drug release.