What is Hot-Melt Extrusion?

 

Hot melt extrusion(HME) services have evolved as a unique processing technology in producing molecular dispersions of active pharmaceutical ingredients (APIs) into various polymer or/and lipid matrices, which has led to time-regulated, modified, extended, and targeted drug delivery. HME now allows us to use compounds to conceal the bitter taste of active drugs.

Since the industrial application of the extrusion process in the 1930s, proprietary hot melt extrusion has gotten a lot of attention from the pharmaceutical industry and academia for a variety of applications for pharmaceutical dosage forms like tablets, capsules, films, and implants for drug delivery via oral, transdermal, and transmucosal routes.

As a result, HME services are an ideal alternative to other commonly used processes such as roll spinning and spray drying which we make use of at Abbvie Contract Manufacturing. In addition to being a tried-and-true manufacturing process, meets the goal of the US Food and Drug Administration's (FDA) process analytical technology (PAT) scheme for designing, analysing, and controlling the manufacturing process through quality control measurements during the active extrusion process.

Advantages of Proprietary Hot Melt Extrusion

Proprietary hot melt extrusion has a number of benefits over currently used pharmaceutical processing methods, including

(a)  Increased solubility and bioavailability of water-insoluble compounds: 

This is because binder components of HME dissolve easily in water, yielding the free soluble API inside the drug delivery matrix.

(b) Solvent-free nonambient process:

HME is a solvent-free process that is capable of producing the active pharmaceutical ingredient in an ambient process.

(c) Automation:

HME allows for quick and simple processing and manufacturing of dosage forms, which translates into higher yields and a shorter time to market.

(d) More economical:

The economic process with reduced production time, fewer processing steps, and a continuous operation is an advantage of HME.

(e) Capabilities of sustained, modified, and targeted release:

HME allows for the extended, modified, and targeted release of drugs for more specific drug delivery.

(f)  Better content uniformity in extrudates:

HME has a superior variability to other conventional uses such as spray drying. This is a major benefit since it allows for a more uniform content of the active ingredient because of the uniformity in the flow rate of material and the consistency of pressure distribution during extrusion.

(g) No requirements for compressibility:

This is due to its low operating pressure, which does not require a high vacuum.

Disadvantages of Proprietary Hot Melt Extrusion

Like everything that has an advantage, HME has certain downsides as well.

1. The heating process (drug and polymer stability): Since HME is a process that derives its energy from heat, it cannot be controlled as easily as other extrusion processes such as heat treatment or freeze-drying. This means that the API and active ingredient cannot be added to the polymer matrix during the extrusion stage.

2. The use of a restricted number of polymers: HME cannot tolerate many additives like in other processing methods such as spray drying, so HME is limited to a few polymers.

3. The high flow characteristics of polymers: HME is a process that pulls in the polymer through the pump; hence a high flow rate of material is inevitable.

4. Requirement of excipients that are not suitable for relatively high heat sensitive molecules such as microbial species and proteins are the primary limitations of HME.

We at Abbvie Contract Manufacturing are the best among all manufacturers who offer Hot melt extrusion services. Our manufacturing is one of the best in the industry.