This week, Sunil Kumar Nataraj, technical manager at DFE Pharma, USA and Canada, shares some of the company’s recent innovations in the world of excipients with SpeakPharma. These innovations improve the drug delivery system, thereby improving adherence of drugs by patients. Nataraj also talks about DFE’s eStore in the US, and how with the launch of this new e-commerce channel, drug companies will be able to order small quantities of GMP materials, that will be delivered to their doorstep. Excerpts: Tell us about DFE Pharma’s history and its activities? DFE Pharma has more than 100 years of experience in developing and co-developing excipients for the pharmaceutical industry. In time, some dairy producers transformed into modern suppliers of lactose excipients. Our pharmaceutical grade lactose production started in 1960 and today the lactose products offered by DFE Pharma are suited for overcoming various manufacturing challenges. For example, the micro-crystals in our SuperTab® 21AN product offers excellent compaction. The granular nature of our SuperTab® 24AN increases the compaction further with high drug loading possibilities. DFE has also pushed the boundary with the launch of SuperTab® 40LL, a co-processed anhydrous lactose-lactitol product offering compaction levels similar to silicified microcrystalline cellulose (a widely-used excipient, with high compact-ability) Since 1985, we have been providing advanced excipient solutions like inhalation grade lactose. Inhalation grade lactose is a common and frequently used carrier in dry powder inhalation formulations. It is popularly used in pulmonary drug delivery, since it minimizes dose variability. Being a global player, we operate in over 100 countries and have our own sales offices in Germany, the United States, Singapore, Japan and India. The geographical spread of our production plants enables us to guarantee security of supply, as we offer dual sourcing to our customers thereby lowering our customers’ supply chain risks. Our heritage, along with our geographical footprint, allows us to support accelerated drug product launches so that our customers get the necessary market advantage. As patient adherence to drugs continues to be a major challenge, how are you working towards overcoming this? Can you share some of the new developments underway at DFE Pharma? What has been the market response to these developments? There are various innovations underway to provide better drug delivery systems to improve patient adherence. For example, mini-tablets provide an advanced and convenient drug delivery method which is much easier to administer than conventional tablets. Mini tablets also overcome obstacles such as impaired swallowing and polypharmacy (use of multiple medicines) therapy, besides offering therapeutic benefits such as dose flexibility and combined release patterns. Mini-tablets can also be formulated as ODMT’s (orally disintegrating mini-tablets). These offer a more comfortable means to consume unpalatable drugs and many times there is also no requirement of water, as they dissolve in the mouth. Such tablets are a preferred means of drug delivery in pediatric and geriatric patients, and certain other targeted populations. However, the manufacturing of mini tablets is especially challenging due to constant die fill in tablet presses that is needed to achieve constant tablet weight and in-turn achieve good content uniformity. The efficiency of the die filling process is influenced by powder properties, such as flowability, cohesion, particle size and morphology, as well as the process conditions. SuperTab® 40LL is especially designed to produce mini-tablets with good content and blend uniformity. In addition, customers have successfully resolved high dose tableting with superior compact-ability of SuperTab® 40LL. In view of the increasing precision needed to formulate these innovative drug delivery systems, how does DFE Pharma assure quality and consistency? Since most excipients are powders and the size of the particles vary, this creates the need for enormous variation in the manufacturing processes. DFE offers excipients that operate at the centre of specifications and are supported by tools like in-house multivariate (MVA) and principal component analysis (PCA). This, in turn, helps customers in their Quality by Design (QbD) endeavor. DFE Pharma provides annual product consistency documents that summarize the production knowledge space, which reflects actual variability/consistency. This approach helps customers understand DFE’s excipient consistency and is a significant upgrade over the usual practice of testing three batch samples or reviewing 10 batch certificates of analysis (COA), which is usually followed by most customers. Our approach has been highly commended by customers and regulatory agencies globally. What are some of the new initiatives being undertaken at DFE? With DFE Pharma’s mission to lead in excipient expertise, we are the only excipient company offering two widely used and preferred excipients — lactose and microcrystalline cellulose (MCC). There have been recent innovations which have been undertaken in the area of lactose with the introduction of SuperTab® 50 ODT, where all required functionalities are combined into one single high functional excipient with desired pleasant mouthfeel. In June 2019, we announced the US launch of our excipient eStore. This new e-commerce channel will enable biotech, pharmaceutical and nutraceutical companies to order small quantities of GMP materials, delivered fast to their doorstep. On our website, we also encourage formulators to post formulation questions under the ‘Ask an Expert’ section. This service drives one of our formulation experts to revert with a response within three business days to drive accelerated drug development for our customers.