Hot Melt Extrusion
The versatile and sustainable plant-based polymer Hypromellose (HPMC) has a long history of safe and effective use as an excipient and controlled-delivery component in oral medications.
However, the application of HPMC into hot melt extrusion (HME) formulations has been successful but limited due to the narrow temperature range between thermal softening and discoloration, the high melt viscosity and the need to use plasticizers to broaden the processing range, which can be detrimental to the final product.
To address this challenge, Dow has designed the cellulosic polymer AFFINISOL™ HPMC HME, which maintains the crystallization inhibiting properties of traditional HPMC, but can be extruded over a wide temperature range without the use of plasticizers.
Other solutions for HME in Dow’s portfolio include ETHOCEL™, polymers which can help formulators to obtain specific release profiles, and POLYOX™ resins that can be used in HME formulations to enhance film-making properties (oral films) and dosage toughness (abuse deterrence).
Solutions for Hot Melt Extrusion
ETHOCEL™ possesses excellent thermoplasticity and softens between 135 °C to 160 °C. This softening point can be reduced by the incorporation of additives such as plasticizers, providing a wide temperature window in which to operate. ETHOCEL™ is a versatile and powerful tool in hot melt extrusion of pharmaceutical formulations, allowing researchers to obtain specific release profiles while producing a wide variety of final dosage forms including tablets, multiparticulates and core-sheath systems.
POLYOX™ resins extrude extremely well and can easily be used in other types of heat treatments. Many abuse deterrent technologies take advantage of this property. Easy to use in conventional equipment, POLYOX™ also offers good flow characteristics. POLYOX™ has great film-making properties and can be used at a wide range of temperatures (110°C to 180°C).
AFFINISOL™ HPMC HME Polymers
AFFINISOL™ HPMC HME is a cellulosic polymer designed to enhance solubilization and inhibit the recrystallization of APIs in (HME) formulations, providing drug formulators with new capabilities to formulate amorphous solid dispersions using extrusion processes.