1. What in your opinion is currently the single largest trend with respect to lactose excipients?
For over a century, lactose has been one of the most widely used diluents or binders in solid dosage form manufacturing. For the past couple decades, lactose has become an important ingredient in dry powder inhalation drug delivery. Most recently, lactose has found its way into parenterals, where it acts as a drug stabilizer and prevents proteins from denaturing.
2. How in your mind has the landscape of lactose excipients shifted in the past few years?
The lactose industry, like the pharmaceutical industry, has experienced consolidation in recent years. Where there were once six global pharmaceutical lactose producers and various domestic producers, there are now three pharmaceutical lactose producers left that can manage with the regulatory requirements and possess proper regional representation around the globe. In addition, customers require a secure supply chain and that has led to MEGGLE’s decision to build a second production site in the US, expanding our current capabilities in Germany.
3. How do co-processed excipients work as ideal fillers/binders?
While a formulation can be developed at bench scale, scale-up and full-scale product manufacture can be problematic. The more excipients and process steps used during development, the greater the design of experiments’ complexity and the higher the probability of failure during operations. Co-processed excipients provide a pathway to simplifying a formulation and curtailing a complex manufacturing process. Well-designed co-processed excipients should offer superior and more predictable functional performance over a simple physical blend or traditional granulation process. Therefore, co-processed excipients should not only result in more robust formulations but also in economic benefits through higher throughput, greater yields, reduced in-process testing and streamlined inventory management.
4. What are the technological advantages of direct compression (DC) compared to wet granulation?
Traditionally, excipients for direct compression have been designed to enhance flow and compressibility of a formulation with the goal of decreasing the number of manufacturing steps. Overall, DC offers a simplified, faster, and more economical production process, which is less labor, energy and equipment intensive. Because APIs are not exposed to heat and moisture in direct compression, API stability is not compromise and may even be enhanced. Co-processed excipients offer additional advantages in direct compression, such as improved blending with reduced segregation tendency, increased compaction, and improved tablet disintegration time.
5. MEGGLE opened their first production site in the US last September. How has this affected manufacturing?
The two sites give us more flexibility in our production planning and reduce the pressures in times of high demand. We can react faster to customers’ requirements, reduce the lead-time dramatically, and offer a secure supply chain, which unfortunately is still not on everyone’s agenda. Furthermore, building a second production site in the US with our partner Davisco International Foods Inc. helped us to review every step of our production process in Germany and to understand how the smallest factors could influence the final process.
6. How will MEGGLE expand its portfolio in terms of products and services over the next year?
We have observed that more and more excipient manufacturers are trying to become a one-stop-shop for their customers. From our perspective, this will not benefit the pharmaceutical industry. The industry already can choose from a broad range of similar products and does not need additional me-too excipients. MEGGLE would rather focus on value-added products, like coprocessed excipients, that have unique benefits and make the development of formulations more predictable and less costly. In addition, MEGGLE has a long contract manufacturing history for various excipient manufactures. MEGGLE wants to leverage this experience to enter into partnerships with pharmaceutical companies and develop excipients that will solve formulation development and manufacturing problems.
7. What can we expect from MEGGLE at CPhI this year?
MEGGLE is always working on new developments and we have currently two projects that are near completion and ready for introduction to the pharmaceutical industry. But since I do not want to spoil any surprises that we might have in store for the industry, I would only like to say: Come and see us at the CPhI.
8. How has MEGGLE confronted recent regulatory initiatives involving excipients?
By attending industry, academic, and regulatory sponsored conferences and seminars, MEGGLE continues to remain quality focused and abreast of changes in the regulatory landscape. And as an IPEC member, MEGGLE is taking a proactive approach on regulatory changes and issues.
9. Lastly, what recent innovations or advances regarding excipients have made the biggest impact?
The industry is finally seeing excipients as functional and not just as inactive ingredients and is amenable to new, innovative, highly functional excipients. The FDA has facilitated that development by approving new drug products that contain co-processed excipients. Additional support has come from USP in its endeavors to include co-processed excipient monographs in NF as well as soliciting monograph drafts for other co-processed excipients. We see this as a validation of the innovations created by the excipient industry, and the excipient industry needs innovation as much as the pharmaceutical industry!