In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.
There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.
Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.
As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated. With OSD manufacturing, a number of processes are taking place under one roof, from granulation of dry and wet substances to milling and blending, tablet press and coater processes, and encapsulation. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders.
Containment solutions for OSD manufacturing
ILC Dover provides containment solutions specifically designed for different stages of OSD manufacturing, ensuring that the risk of cross contamination is mitigated. These include extraction support systems, single-use liquid bags, ArmorFlex Films, continuous liners, contained powder transfer systems, bag in/bag out systems, and drum liners. It also supplies equipment such as the JetBreaker for breaking up organic powder clumps, the JetMixer for fast and uniform organic powder mixing, as well as dosing-weighing equipment, and contained pack-off systems.
ILC Dover’s flexible enclosures and isolators are made using ArmorFlex Films, which deliver permanent static dissipative properties, with ArmorFlex 113 offering superior visual clarity. These single-use technologies allow pharmaceutical companies to achieve continuous manufacturing, which significantly reduces the risk of cross-contamination without the need for extensive cleaning and disinfecting.
In addition to providing single-use technology for OSD manufacturing and containment, ILC Dover can support facilities in developing Standard Operating Procedures (SOP). Developing a good SOP entails understanding all the application requirements at every manufacturing stage, and providing operators with procedures that they can follow. By working with OSD manufacturers to assess their requirements, ILC Dover has helped facilities to streamline production efficiency, and potentially even expand capacity. Effective supply chain management is essential for OSD manufacturers that are operating in such a competitive market.
The company’s single-use powder handling solutions are also considerably more cost-effective that stainless-steel solutions, as it cuts down on cleaning time and expenditure, whilst still protecting operators from exposure and contamination.
As world-leading experts in the design and production of engineered flexible solutions for the pharmaceutical and biopharmaceutical industries, ILC Dover offers a range of containment equipment suitable for eliminating product variants and mitigating risk. Download the whitepaper below to find out more about ILC Dover’s flexible solutions for protecting the entire supply chain.