A Quick Evaluation of the Hot Melt Extrusion Process

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proprietary-hot-melt-extrusion

Hot melt extrusion (HME) is the technique of heating polymeric materials far beyond their glass transition temperature (abbreviated Tg in pharmaceutical production circles) to achieve molecular level mixing of active compounds, polymers, and thermoplastic binders. HME is a mix of mechanical and melting energy that is used in a variety of sectors to improve continuous processing for dust reduction, online monitoring, and reproducible material analysis.

HME services are applied in pharmaceutical production to diffuse APIs in a matrix at the molecular level for the purpose of getting solid solutions. This allows for the development of drug delivery methods for poorly soluble medicines or specialty drug forms such as antidiabetic drugs and transdermal patch films.

Today, hot melt extrusion has an exalted position in pharmaceutical production and is used to make a variety of medication forms such as implants, granules, pellets, prolonged release tablets, and ophthalmic inserts. Polymers may be molded into a film by hot melt extrusion, eliminating the need for traditional solvent-casting procedures.

The pharmaceutical industry's focus on hot melt extrusion is primarily on the creation of bio-enhanced formulations, mass production of medications in the form of pellets, beads, and transdermal systems, and the formation of solid solutions from water soluble pharmaceuticals. This highlights hot melt extrusion as having advantages over more typical drug production procedures, but not without some cons.

Pros and Cons of HME Services

When it comes to pharmaceutical manufacturing, hot melt extrusion has several benefits over traditional drug manufacturing methods. Below are these pros and cons:

Pros

·       There are fewer procedures involved, along with the elimination of drying steps, which boosts productivity and saves time. The procedure is straightforward and may be carried out uninterruptedly and efficiently.


·       Because of the high temperatures and powerful mixing that ensue during the production process, active chemicals are more uniformly distributed in the polymer, resulting in higher bioavailability.


·       Hot melt extrusion allows for the production of a broad range of dosage forms, which is one of the main reasons why contract manufacturing pharma businesses are adopting the method on a larger scale.

·      When compared to traditional processes, the advantages clearly make this method of production enticing, but it is not without its problems.

Cons

·       Because it is a thermic process, there may be problems with the API/polymer stability. The flow characteristics of the polymer are critical in effective processing, and heat manufacturing can occasionally be a concern during the process.

·      The required number of polymers may be limited due to the fact that getting polymers that can be treated at low temperatures for this process can be difficult.

Looking For Quality Contract Pharma Services? AbbVie is here to meet those needs

AbbVie is a contract pharmaceutical manufacturer specializing in controlled release technologies such as fluid bed processing and hot melt extrusion (HME).

AbbVie Contract Manufacturing advances your science with proprietary hot melt extrusion technology and services.

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

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

• Expertise in bioavailability enhancement

• Solvent-free and continuous processing

• Support for good process control and scalability

• Abuse deterrent and taste masking capabilities.

Learn more about our processes here.


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