By MEGGLE Excipients
MEGGLE releases bulletin on lactose advantages for continuous manufacturing
Wasserburg, Germany: – Pharmaceutical lactose specialist MEGGLE has produced a technical presentation showing how its lactose-based excipients directly support the Continuous Manufacturing (CM) processes that are rapidly gaining ground in pharma manufacturing.
CM, the continuous manufacturing of a pharmaceutical product as an entire and uninterrupted process on a single production line, is expected to play an increasingly significant role in the pharmaceutical industry over the coming years, both for its superior efficiency and also quality control advantages.
Ensuring CM success
MEGGLE has developed an extensive portfolio of CM-ready excipients that can be combined with its technical expertise in production processes, regulatory affairs and packaging options to ensure the success of new continuous manufacturing projects.
The presentation DC lactoses: Cornerstones for reliable continuous manufacturing processes is available for PDF download or as a video webinar on request (see Resources).
Case study
The bulletin gives an overview on Continuous Manufacturing in general and the particular role of excipient properties in enabling CM processes. It covers aspects such as definitions of continuous manufacturing, CM advantages and challenges and key excipient requirements in these processes.
It also features a case study featuring performance of MEGGLE excipients in a continuous manufacturing setting for the production of Vitamin B2 tablets.
Continuous manufacturing advantages
The presentation shows how continuous manufacturing is supplanting batch production for manufacturing pharmaceutical products, partly driven by opinion on the part of the U.S. Food and Drug Administration(FDA) that CM enables improved product quality, increases efficiency, and can be a powerful factor in reducing medicine shortage. Other regulatory bodies also support CM as being more consistent with the quality-by-design (QbD) approach that increasingly guides development of pharma products.
Key advantages include lower unit manufacturing costs, enhanced quality, radically reduced production times, reduced risks of human error and greater propensity for automation. In general CM processes are both more flexible and scalable.
About MEGGLE
Bavarian-based MEGGLE is one of the world’s experts in co-processing and powder technology. From its roots as a dairy operation in the late 1880’s, MEGGLE has become one of the world’s leading manufacturers of pharmaceutical lactose, supplying the pharma market segment with a broad-based and unique lactose product portfolio.
MEGGLE Business Unit Excipients has harnessed outstanding product quality and intelligent innovation to become a global leader in the manufacture of lactose-based excipients, focusing on products for direct tableting and dry powder inhalation.
A multidisciplinary team of committed and highly qualified people allows MEGGLE clients to benefit from pioneering experience and innovative drive in industrial milk and whey processing. The company constantly strives to develop high-tech, functional products for solid dosage forms and DPI applications, where they can deliver maximum performance.
The company has introduced several pioneering products, notably Tablettose®, the world’s first agglomerated lactose for direct tableting, Cellactose® 80, a pioneering co-processed excipient based on cellulose-lactose for outstanding compression and flow properties and RetaLac®, the first direct compression co-processed excipient using a hypromellose-lactose base for sustained release formulations.
To learn more, visit: https://www.meggle-pharma.com/en/home.html
Resources
Click on DC lactoses: Cornerstones for reliable continuous manufacturing processes for contact form and free download.
Click on MEGGLE’s MEGGLE lactose portfolio for Direct Compression for further information.