June 6, 2023 PAO-05-23-CL-06
With respect to the pellets/spheres themselves, there are three main critical quality attributes (CQAs) that enable the effective drug loading and coating of the particles: particle size distribution, sphericity, and friability. The particle size distribution must be fairly narrow, and the pellets must be as spherical as possible and must be able to withstand the process conditions involved in manufacturing the final drug product. All three properties can impact the release profile of the API(s). As a result, close attention must be paid during production of the pellets/spheres to ensure that the desired CQAs are achieved. It is also critical that formulators pay close attention to CQAs to ensure that the products they create are high functioning and reproducible, because not all manufacturers produce spheres with suitable CQAs.
basic APIs, which otherwise can be quite challenging because they tend to exhibit poor dissolution in the gastrointestinal (GI) tract. The tartaric acid provides a local acidic environment that facilitates dissolution of weakly basic APIs in higher-pH regions of the GI tract, even in modified- and controlled-release products.
ACTILLETS® MCC Microcrystalline Cellulose Pellets and TAP® Tartaric Acid Pellets from SPI Pharma are used to create modified-release drugs and multi-unit particulate systems (MUPS) when used as starter cores for drug layering and coating. ACTILLETS® MCC pellets have low friability, high sphericity, and smooth surfaces for consistent coating. TAP® tartaric acid pellets can be used to improve the solubility of weakly basic pharmaceutical actives.
Both types of pellets are manufactured using a process designed to generate highly robust pellets of high sphericity and very low friability. Notably, the particle size distribution of ACTILLETS® pellets is tightly controlled, and they are available in various particle sizes for use with different APIs in a variety of applications. TAP® Tartaric Acid Pellets are ideal for use with APIs that exist in the bitartrate salt form.
distribution rights for CELLETS® MCC pellets and TAP® tartaric acid pellets for North America, Latin America, New Zealand, and Australia from Glatt. The MCC products will be distributed under the ACTILLETS™ brand name in these regions.
ACTILLETS™ MCC and TAP® products give SPI Pharma the ability to support the modified-release market with highly specialized, high-performing excipients.
ACTILLETS™ products rather than just reselling them allows SPI Pharma to combine this exciting solution for modified-release and multiparticulate formulations with our specialized formulation expertise and other advanced excipient technologies. Formulation is always the key barrier to adoption, no matter how compelling a technology might be. Multiparticulate and modified-release dosage forms are no exception.
SPI Pharma is always focused on the concerns and pain points of the customer and on developing solutions to address these challenges. In the process, we seek to form long-term relationships with our customers that go well beyond simply selling them the ingredients that they require. Of course, for those customers that have relevant in-house formulation expertise, SPI Pharma is happy to provide ACTILLETS™ MCC and TAP® products by themselves. For customers that lack the specialized expertise needed to use these sophisticated excipients, SPI provides assistance in addressing the challenges of preparing loaded pellets/spheres and then formulating them into final drug products. Preparing the modified release pellet is only the first step — those pellets must then be matched with the right delivery system to ensure that the pellets/spheres reach the right location within the body for the API’s action.
Unlike other excipient manufacturers, sellers, and distributors that focus solely on the material, SPI Pharma is a highly specialized excipient company that collaborates with customers to ensure that the excipients we sell are used optimally and cost-effectively. With SPI Pharma, drug developers get access not only to ACTILLETS™ technology but to a portfolio of other innovative excipients that can be used in combination to provide unique formulation solutions. In addition, through our partnership with Glatt, we can offer additional expertise in making these different dosage forms and the processing that is involved in realizing their full potential.
ACTILLETS™ Mannogem XL grades, specifically, offer higher compactability and faster disintegration times than standard spray-dried or granular grades. They can be used as the binder for coated pellets/spheres in multiparticulate tablet formulations to ensure robust tablet formation combined with the appropriate disintegration time that allows release of the pellets/spheres and ultimately release of the API. Such tablets are highly complementary to oral dispersible tablets, formulations for which SPI Pharma already provides extensive excipient technologies and expertise.
SPI Pharma’s ambition is global, multi-material, and application-focused.ACTILLETS™ MCC and TAP® products ACTILLETS™ technology and SPI’s knowledge will be developed for the regions covered in the agreement and shared with interested scientists, globally.
ACTILLETS™ pellets/spheres from anyone anywhere in the world, not just people located in regions covered by this recent agreement. We are looking to drive interest in the use of MCC and TAP cores for the formulation of modified-release drug products, regardless of where the purchase of those materials occurs. We are willing to engage with anyone and connect them with the authorized distributors for their markets.
ACTILLETS™ MCC and TAP® products, the agreement with Glatt includes distribution rights for Ibuprofen DC100, a 100% active granule from IPC produced without further excipients, enabling simpler, more cost-effective ibuprofen formulations. This specialty API expands SPI Pharma’s portfolio of APIs, which includes taste-masked ibuprofen and acetaminophen.
We are excited to explore various formulating opportunities with Ibuprofen DC100. Ibuprofen is one of the most widely prescribed APIs in the United States and Europe (with even greater nonprescription sales). It is a non-opioid pain reliever that is highly effective and is associated with relatively moderate liver toxicity. For these reasons, there are significant opportunities for growth in this market. Ibuprofen DC100 addresses some of the shortcomings of immediate-release ibuprofen, but SPI Pharma is looking to advance the technology even further.
Bill McCarthy joined SPI Pharma in 2018 as the Global Marketing Manager for the Excipients and Drug Delivery Systems business unit. He has been the Marketing Director for SPI since 2021. His background includes nearly 20 years in the excipient market with a focus on material science, new application development, and technical promotion. Bill has held roles in operations, technical service, and marketing in the medical device and specialty excipient fields. He brings an understanding of market structure and market-based insights on the value created by SPI Pharma’s product offerings. Bill holds an MBA (International Business) from Loyola University Maryland and a BS in chemical engineering from the University of Notre Dame.