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Lonza’s integrated product development and manufacturing model includes drug product intermediates. These intermediates consist of micronized compounds, spray-dried compounds or dispersions, hot-melt extrudates, and multiparticulates. Phase-appropriate processing equipment ensure that our drug product intermediates can be provided at any stage of the product development cycle – proof of concept studies, clinical trial material, and commercial quantities.

  • Micronized active ingredients are milled, often via jet milling, to precise particle size distributions required for the target product profile. These micronized intermediates can include excipient(s) to improve performance properties for further processing into finished dosage forms.  Micronization is routinely utilized for improving dissolution rate, enhancing palatability properties, meeting particle size distribution requirements for inhalation applications, and ensuring adequate absorption levels for transdermal products. Learn more about Micronization.

  • Spray-dried dispersions utilize a polymer matrix to form amorphous API-excipient dispersions for improved drug product bioavailability. Hot-melt extrusion (HME) is also utilized to produce amorphous solid dispersions for improved bioavailability. Dispersion carriers and functional excipients are utilized in HME processing and the resultant melt is typically milled. Learn more about Bioavailability Enhancement.

  • Spray dry processing is also utilized to achieve target particle size and distribution in dry powder inhaler applications. Spray dry processing is often utilized when conventional formulation strategies, such as lactose blend formulations utilizing micronized API, are unsuitable. Learn more about Inhalation Drug Delivery.

  • Multiparticulates are produced using a range of technologies. Active ingredients are either incorporated into the particulate and/or layered onto particulates using fluid bed processing. A range of excipients – both inert and functional – are typically utilized in the production of multiparticulates, with the choice dependent upon the API parameters, target product profile of the drug, and process technique utilized. For example, melt-spray-congeal, extrusion/spheronization, drug layering, or mini-tabletting. Learn more about Multiparticulates.

These drug product intermediates are produced at cGMP facilities in Bend, Oregon and Tampa, Florida USA (extruded/spheronized multiparticulates). Lonza’s Bend site is designed to support highly potent compounds, and accommodate the use of processes employing organic solvents, such as spray drying and fluid bed coating.

Learn more about our small molecule technologies employed to manufacture drug product intermediates: