Our breadth of solubilization technologies and depth of fundamental understanding facilitates the use of a creative, fit-for-purpose, drug development approach.


Hot-melt extrusion (HME) technology is an established solid dispersion technology for improving dissolution rate and solubility, and a component of our premier bioavailability enhancement services. HME has broad applicability across poorly soluble (BCS II and IV) compounds and the resultant extrudate can be readily formulated in either tablets or capsules.  We offer our customers flexible end-to-end solutions for bioavailability challenged compounds from concept to commercial, and from API to finished drug products.

Effective delivery of many BCS class II compounds with low solubility can be enabled with amorphous dispersions made by HME. HME manufacture of amorphous dispersion involves the melting of a drug substance with an appropriate polymeric excipient in a co-rotating twin-screw extruder. Functional excipients, such as surfactants, may be added to aid in the extrusion process or to improve dissolution performance upon administration. When cooled, the extrudate generally consists of a single-phase amorphous glassy matrix that can be milled to the desired particle size and incorporated into traditional tablet or capsule dosage forms.

Resultant extrudate is typically milled and directly filled into capsules, or formulated with excipients and compressed into tablet formats. We are fully equipped to produce the hot-melt extrudate and finished dosage form for feasibility assessments, clinical trials and commercial scale applications. 

Formulation & Process Development Flow Chart

LPB-T.26-HotMeltExtrusion-Formulation&ProcessDevelopmentFlowChart
We have more than 25 years' experience in addressing solubility challenges with amorphous solid dispersion technology.

hot-melt extrusion highlights


Our breadth of solubilization technologies and depth of fundamental understanding allows the use of a creative, fit-for-purpose, drug development approach. This means we may focus on low-risk, drug-sparing spray-dried dispersions in early development and transition to HME formulations when and where appropriate based on considerations such as drug properties, dose and cost of goods. The use of extrudates at a wide range of scales enables production of extrudates using current cGMP and development processes for use in clinical studies and at small commercial levels. HME capabilities are in place for  development or cGMP production of extrudate for use in clinical studies or small commercial levels.

Capability Highlights:

  • Rational selection of technology based on physicochemical properties of drug, development stage, and cost of goods implications
  • Extensive experience formulating solid dosage forms incorporating HME intermediates
  • Development and cGMP extrusion manufacturing capabilities (18-, 19- and 27mm twin-screw extruders) with a large selection of prefabricated dies
  • Full selection of ancillary feeding, cooling, pelletizing and milling equipment
  • Predictive model-based approach to performance evaluation, stability assessment and process definition to minimize development time and risk to clients’ programs.
Our expertise in addressing bioavailability challenges is based on the experience of advancing thousands of molecules across a myriad of compound parameters and target product profiles.

related content

Formulation & Product Development
We provide integrated preformulation, formulation and product development services to our biopharmaceutical customers using a broad range of enabling technologies to address formulation challenges.
Lipid and Liquid Based Formulations
Our lipid & liquid-based formulation services provide flexible, fit for purpose solutions to a wide range of formulation challenges including solubility / bioavailability improvement, addressing food effect, low dose applications, colonic delivery and abuse deterrence.
Micronization / Jet Milling
Particle size reduction is increasingly utilized to address a range of formulation issues facing oral solid and inhaled dosage forms. Stability, flowability, dissolution rate and bioavailability are critical performance parameters impacted by particle size distribution.
SimpliFiH™ Solutions
We can provide integrated drug substance and drug product services for preclinical studies and phase I clinical trials.
Spray Drying Technology
Pioneered for pharmaceutical applications by Lonza, spray drying has emerged as a primary technology for addressing poor dissolution rate, solubility and bioavailability.
Technology Selection
We have developed models, reference tools and methodologies to accelerate technology selection for BCS II compounds.