Chemicals & raw materials
manufacturing techniques that enable the production of personalised medicines. Another market report, by BCC Research, says that organic excipients will come to dominate over the years ahead. That’s due to growing demand for natural, biocompatible materials in drug formulation.
Strategies for success
Excipients are vital components of drug formulations – often making up more than 50% of a dosage form, helping to enhance their solubility, bioavailability, and stability.
API delivery and bioavailability challenges. Its three new VitiPure excipients are suitable for many different API formulations and administration routes, including biologics. Two of these products have a high purity grade, ideal for more unstable APIs, while the other is suited to formulations that require especially high sterility.
“The excipients under the Polyglykols, VitiPure, and
VitiPure LEX brands are highly versatile,” says Barlas. “Excipients under the VitiPure Superior brand are specifically designed for APIs sensitive to impurities, ensuring enhanced purity and performance. Our products excel through consistent high quality across global production, enhanced purity profiles, comprehensive regulatory documentation, and versatility across different drug delivery systems.” With these additions to its portfolio, Clariant is tapping into the market trend for multi-purpose, multi-functional excipients that cater to many needs. Another company, Lubrizol, is doing something similar with its Carbopol polymers, which are suitable for a wide range of oral dosage forms. The company says these polymers can ‘impart patient-centric features to new drugs in several ways’. For instance, drugmakers may be able to reduce the size of the tablet and better control the release rate of the API.
Other excipient manufacturers have been working to formulate more specialised options, such as excipients designed for inhalation powders or those that work exclusively with lipid nanoparticles. Often, the development of the API and development of a novel excipient happen in tandem. According to a 2024 report by
Market.us Media, there are a number of emerging trends to look out for. These include coprocessed excipients (in which multiple functionalities are combined into a single component); nanotechnology in excipients (for example, nanocoatings that help control the release rate of the drug); and advanced
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So how do these next-gen excipients succeed in improving drug performance? To home in on stability as an example, the excipients would typically be mixed into formulations using water, binder, or dissolution solution. This would be followed by melting or solvent evaporation. Let’s say the drugmaker is trying to protect the API from moisture. According to a 2022 review paper, they could try using an amorphous or hydrophilic excipient. This excipient would absorb the moisture, safeguarding the API and improving its stability in storage. Or they could try a water- repellent excipient, which prevents moisture uptake throughout the product as a whole. As discussed, many manufacturers are also keen to improve their product’s water solubility. As discussed in a 2017 review paper, solubility- enhancing excipients can be polymer, surfactant or lipid-based, with the majority falling into the former category.
The authors use the example of hypromellose acetate succinate, which is used to create solid dispersions. Once in the gut, it swells and dissolves, releasing the API. Another example is mesoporous silica, which is also used in solid dispersions. Because it is very porous, the drug solution can be loaded into its pore structure. The API will stay in an amorphous (more water-soluble) form and doesn’t have much chance of recrystallising. As for Clariant, Barlas says the company uses “advanced PEG products with superior purity profiles, specialised poloxamer grades for various applications, high-performance polysorbates and castor oil derivatives, and pharmaceutical-grade Meglumine”. But it isn’t essential to know all the technical details to understand why excipients are so important. As pharma companies move away from small-molecule drugs, their formulation challenges become more pressing, and it will fall to excipient manufacturers to help them solve these problems. That, in turn, will highlight the need for safe, high- quality excipients, which are monitored under the right kind of regulatory frameworks.
“There is a growing focus on supply chain security and transparency. The importance of excipient manufacturer reliability is rising. Regulatory requirements are expanding globally,” says Barlas. This won’t always be straightforward for the industry. But the upshot will be more effective, sustainable, and patient-centric medications. ●
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
PowerUp/
shutterstock.com
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