Proprietary Hot Melt Extrusion in the Pharmaceutical Industry

Pharmaceutical companies are using twin-screw and conical extruders to blend drug molecules with bioactive polymers in cases where the ingredients are unstable or aren’t correctly soluble during processing. Extruders are also beneficial in preparing sustained release dosages and enteric dosages, creating forms like films, and in taste-masking.

HME Process

HME is the processing of polymeric materials that are above their glass transition temperature. This is done in order to effect molecular level blending of thermoplastic binders and active compounds and polymers.

Hot Melt Extrusions are used in various industries. It is a combination of mechanical energy and melting to improve continuous processing for reproducible analysis of online monitoring, dust reductions, and materials.

In pharmaceutical production, Active Pharmaceutical Ingredients is dispersed using hot melt extrusion in a medium at the molecular stage, thereby forming solid solutions. This allows drug delivery systems for specialized drugs or poorly soluble drug forms like films for transdermal patches.

HME Polymers

The choice of a sufficient polymer as a matrix to form stable solid solutions is essential in hot melt extrusion. Polymers with a high solubilization capacity are ideal because they can dissolve larger drug quantities. Polymers for HME experiments are based on diverse chemical structures and monomers, like solubilizers, amphiphilic copolymers, plasticizers, copolymers, and homopolymers.

Consideration for each of the materials must consider the solubility of the polymer in a solvent. This can vary from high hydrophilicity to high lipophilicity. An excellent solvent is required to be selected for the preparation of the solution. This is done by spray drying.

Hot melt extrusion polymers must show thermoplastic features and must be stable thermally at the proper extrusion temperature. The melting temperatures and glass transition are essential factors in manufacturing a hot melt extrusion drug system.

The extrudability of a polymer is chiefly determined by melt viscosity and Tm or Tg. Most polymers exhibit thixotropic behavior where the viscosity reduces as a function of increasing shear stress.

HME Technology

Modern drug discovery methodology brings about lipophilicity and increases the molecular size of candidate drugs. And this leads to poor permeability and solubility. Below ten percent of new drug candidates show both permeability and solubility. While about thirty to forty percent of the drugs that appear on the World Health Organization Essential Drugs List were reported to be lipophilic or poorly water-soluble. Proprietary hot melt extrusion disperses the drug in the matrix at a molecular level by forming a strong solution.

Hot melt extrusion is available for several applications, including novel cocrystallization, polymorph generation, Process Analytical Technology, porous polymeric systems, controlled release systems, and amorphous solid dispersion.

HME Process Parameters

In the HME process, the Active Pharmaceutical Ingredient and the excipients are fed into the extruder. The components are sheared, heated, plastified, blended, dispersed, and shaped. They are shaped by pressing them through a die opening.

Developing a hot melt extrusion manufacturing project entails the control of various handling strictures that has effects on residence time distribution. Also, specific mechanical energy consumption must be well-thought-out such as the pressure at the die, the temperature of the melt at the extrusion die, and the torque.

At AbbVie, we offer excellent HME services. Contact us today.