Emulsions and microemulsions have been used in drug delivery for several pharmaceutical-approved dosages. Manufacturing them at a production scale sounds simple but often times can prove to be challenging. Using state-of-the-art manufacturing systems, Ascendia Pharmaceutical Solutions is meeting these challenges.
Prepared by mixing an oil in water, results in emulsions and the mixing velocity can lead to breaking of larger droplets to smaller drops of microemulsions with heterogeneous particle size distributions ranging from nanometers and sub-microns. To overcome these challenges, and to achieve the homogeneous tiny droplets, microfluidics technology is used. It is a process that manipulates fluids to produce complex microemulsions at an unparalleled precision to achieve the desired particle size, composition, and encapsulation efficiency. These tiny droplets can also allow simultaneous encapsulation of multiple drugs requiring multi drug therapy (MDT). The result is reduced pill burden by improving the doses by controlled release.
In a recent publication, Yandrapalli (Pharmaceutics, 2024, 16, 707), describes the microfluidic technology for handling multiple drugs in a single droplet. Manipulating the small fluid volume with certain flow geometry, microfluidic system allows physical mixing of two liquids (organic and aqueous) under shear stress in a laminar flow to produce tiny spherical droplets with high uniformity and reproducibility.
T-junction Flow Geometry
For example, T-junction flow geometry leads to single emulsions (o/w) while generation of double or complex emulsions (w/o/w or o/w/o) can be accomplished if T-junction(s) are used in parallel. Unlike membrane emulsification or inverted emulsion method, a double emulsions microfluidic process produces small, homogeneous liposomes with narrow distribution range and with high encapsulation efficiency because of its precise controlled flow of fluid through microchannels. In addition to encapsulation of drugs, microfluidics can facilitate the surfactant tagging with the antibodies and proteins onto the surface of droplets for specific tissues targeting in gastro-intestinal tract, alleviating side effects by improving safety and enhancing delivery of molecules.
Drug release is governed by three distinct mechanisms, namely diffusion across the emulsions, degradation of polymers or matrices, and external environments, such as pH, temperature, enzymatic hydrolysis, osmotic or mechanical stress. Table 1 cites a few examples of mechanisms for triggering the drug release from double or complex emulsions. (Yandrapalli, 2024).
Table 1
Ascendia’s Microfluidic Systems
Ascendia employs its latest Cytiva’s microfluidic systems for generating polymeric and lipid nanoparticles. The state-of-the-art equipment, including NanoAssemblr™ Ignite™, NanoAssemblr™ Blaze™ and NanoAssemblr™ GMP systems can help drug development teams in need of early- and late-phase cGMP manufacturing of drugs encapsulated in liposomes, lipid nanoparticles (LNPs), polymeric micelles, and lipid-based emulsions and microemulsions. We have published a series of articles on polymeric and lipid nanoparticles:
Journal of Analytical and Pharmaceutical Research
American Pharmaceutical Review
American Pharmaceutical Review
American Pharmaceutical Review
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