Looking Into the Processes Involved in HME Services

HME is a solvent-free production method that improves the bioavailability of poorly soluble and powerful APIs. HME is less expensive than other formulation choices due to continuous processing and may be utilized for taste masking. This can result in a higher-quality, more marketable product consistent with your marketing strategy.

In this article, we will be looking at the polymers used, the technology involved, and the process parameters in HME services.

Polymers Used in Hot Melt Extrusion

In HME, selecting an appropriate polymer as a matrix to produce stable solid solutions is critical. Polymers with a high solubilization capacity are ideal because they can dissolve huge amounts of drugs. Polymers for HME experimentations are composed of various chemical structures and monomers, including copolymers, amphiphilic copolymers, homopolymers, and plasticizers and solubilizers.

The polymer's solubility in a solvent, ranging from high hydrophilicity to high lipophilicity, must be considered for each substance. For the manufacture of solid solutions by spray drying, a suitable solvent must be used, where polymer and medication must be dissolved in a volatile solvent.

Polymers for hot-melt extrusion must be thermoplastic and thermally stable at the appropriate extrusion temperature. Also, glass transition and melting temperatures are essential criteria in developing an HME medication system. Tg or Tm and melt viscosity are the primary determinants of a polymer's extrudability. Most polymers display thixotropic behavior, where viscosity decreases as shear force increases.

Pharmaceutical Extrusion Technology

The current drug development technique generates candidate medications with increasing lipophilicity and molecular size, resulting in poor permeability and solubility. Less than ten percent of novel drug candidates display both high solubility and permeability, while about thirty to forty per cent of medications on the World Health Organization Essential Drug List have been observed to be poorly water-soluble or lipophilic. HME diffuses the medication in the matrix at the molecular phase by producing a solid solution.

HME is used in a variety of applications such as controlled release systems, amorphous solid dispersion, innovative cocrystallization (solvent-free continuous cocrystallization), polymorph production, porous polymeric systems, and Process Analytical Technology (PAT).

Process Parameters for HME Processing

During the HME process, the active pharmaceutical ingredient and excipients are introduced into the extruder. All components are sheared, fired up, plastified, blended and distributed before being formed by squeezing them through a die aperture.

When developing an HME manufacturing project, controlling many processing factors that impact residence time distribution is required, and specific mechanical energy consumption (SMEC), such as melt temperature at the extruder die, pressure at the die, and torque must be considered.

Conclusion

AbbVie is a pharmaceutical contract manufacturing company offering proprietary hot melt extrusion services suitable to your specific product and marketing strategy.

AbbVie offers different kinds of proprietary hot melt extrusion services, such as:

• End-to-end manufacturing from extrudate to packaged drug products.

• Expertise in bioavailability enhancement

• Solvent-free and continuous processing

• Support for good process control and scalability

• Abuse deterrent and taste masking capabilities.

We advance your science with customized pharmaceutical hot melt extrusion technology and services.