Enhance your drug's dissolution rate and solubility efficiently with hot melt extrusion
This flexible end-to-end process offers a cost-effective solution for developing life-changing drug formulations, from concept to commercial, or from API to finished drug products.
HME enables effective delivery of many BCS class II compounds with low solubility, which has an endless amount of benefits, such as:
- Improved therapeutic outcomes
- Reduced food-effect
- Improvements to overall bioavailability of the drug
Proven hot-melt extrusion technology
Our HME technology allows you to create amorphous solid dispersions by melting or dissolving the drug substance in a dispersion carrier. This mixture is then thoroughly mixed to stabilize the amorphous form of the drug. We can also incorporate functional excipients, like surfactants, to aid in the extrusion process or enhance dissolution performance when the medication is administered.
Once cooled, the resulting extrudate (products produced by HME) forms a uniform amorphous glassy matrix. This material can be finely milled to achieve the desired particle size and then added to traditional tablet or capsule formulations.
The extrudate can be processed further by milling and directly filled into capsules. Alternatively, it can be mixed with excipients and compressed into tablet form for ease of administration.
Presentation: Rapid and Material-Sparing Feasibility Screening for Hot Melt Extrusion
This presentation will demonstrate a screening process to quickly assess HME feasibility. Compared to traditional approaches, this protocol yields more accurate predictions for both API loading and degradation while saving material and time.
Creative fit-for-purpose hot melt extrusion process
Using a creative fit-for-purpose HME process, we deliver the best outcomes for both the drug and your business. We prioritize 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).
Reliable, scalable process
Extrudates are manufactured at various scales. Our HME process manufactures extrudates following current Good Manufacturing Practices (cGMP) and development processes to ensure formulations are suitable for small-scale clinical trials through to commercial production. Our HME process is reliable and enables you to scale-up manufacturing with ease.
Our hot melt extrusion capabilities
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Tech selection
- Formulating, development and cGMP manufacturing
- Feeding
- Cooling
- Pelletizing
- Milling