An Interview With...
Dr. Egmont G. Pfeifer1
and Dr. Albrecht Krämer2
1MEGGLE Group Wasserburg, Managing Director of Business Group Excipients & Technology 2MEGGLE Group Wasserburg, Head of Sales & Marketing, Business Group Excipients & Technology
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Meggle Excipients: A maximum of functionality by an optimized and broad product portfolio
What are the most important features of a “successful excipient”?
Many factors play into the success of an excipient. Besides the chemistry fulfilling pharmacological pre-requisites, presence in most frequently used dosage forms, considerable sales volumes, and existing in multiple grades within broad applications, a “successful excipient” is responsible for safe and efficacious drug delivery, regardless of route of administration. A long tradition in pharmaceutical practice often stands for profound material characteristic and process knowledge, and high and versatile functionality may implicate a superior potential of innovation. In addition to cellulosics, DCP, starches, and modified polyols, Lactose fits perfectly into this scheme.
What qualities make Lactose a well-known and versatile excipient?
Lactose serves a vivid palette of applications, functional categories, and material properties. In addition to utilization in solid oral dosage forms prepared through various granulation processes and direct compression, lactose is used in intravenous parenteral preparations and as a dry powder inhalation carrier. Lactose may be applied as lyophilization aid, tonicity agent, tablet binder, tablet and capsule diluent, or in coating solutions. It may occur in hydrous and anhydrous forms and different steric conformations. Lactose is applicable to many important pharmaceutical and non- pharmaceutical industrial processes.
68 | | May/June 2016
MEGGLE is an established Lactose-based excipient manufacturer with history a long history in the industry. What has changed over the years?
As the pharmaceutical industry changed over the years, so has MEGGLE. The whole story began in the 1950s when MEGGLE was more than willing to adapt the criteria of the former Deutsches Arzneibuch (German Pharmacopoeia). To fulfill the pharmaceutical development and manufacture standards at those times, lactose had to conform solely to effectual compendial attributes. This has changed dramatically. Today, pharmacopoeial requirement compliance represents, singularly, the admission ticket to the pharmaceutical sector. With increased criticality of excipient/API interaction(s) in finished products, new paradigms in understanding excipient complexity, as well as a changed regulatory and economical environment, found its way into daily formulation practice. From a manufacturer’s perspective, a new role of collaboration has been well accepted, where excipient sourcing has become an issue of Quality and R&D.
What joint efforts are made meeting the pharmaceutical industry’s needs?
On the technical side, MEGGLE followed several approaches: besides ensuring consistent and reliable excipient performance for a broad product range, as well phrased in USP ‹1059›, there is great demand to stream-line processes. MEGGLE’s agglomerated lactose grades followed this trend very early by economizing the individual,
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