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.
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,formulation-based granulation step on large scale. Subsequently, co-processing two or more compendial ingredients was recognized as a powerful tool, enhancing the performance of its parent components. MEGGLE was able to offer a remarkable portfolio of lactose-based combinations, expanding e.g. the functional purposes from immediate to modified release, and is certainly aware of the role of Co-processed Excipients (CPEs) in pharmaceutical innovation. MEGGLE’s humble contribution to these modern strategies is focused on the design of functional synergies, the reduction of unwanted variability in performance, which represents a core principle of QbD; it is concentrated on perfomance and efficiency, as well as cost in use. Practical advantages are seen e.g. in the reduction of raw material control procedures, warehousing, and providing valuable manufacturing processes.
Recently, there have been emerging tendencies towards tailormade excipients, for instance, due to formulation or patent reasons. MEGGLE greatly benefits from a long-lasting experience in tollmanufacturing and established procedures to widely fulfill customer expectations.
What are the formulator’s expectations from an excipient manufacturer?
MEGGLE’s long-standing face-to-face contacts to pharmaceutical customers enable a deep insight into formulators’ prospects. In this case, congruent needs and well-defined expectations may be identified. Sound technical support in individual formulation work under special consideration of MEGGLE’s excipients is deemed to be very welcome from the beginning of a project through the whole life cycle.
Furthermore, MEGGLE is highly encouraged to provide additional data, e.g. during manufacturing as summary statistics, statistical relevant IPC data or data on attributes beyond the CoA/ pharmacopeiae requirements, or within the QbD construct. Full traceability of collected knowledge within the product history exists. MEGGLE is happy to share scientific-based excipient performance knowledge under exceptional conditions, as specific modifications, or non-evident risks, helping customers to identify risk, incompatibilities, or other non-common issues. MEGGLE is very proactive in discussions and evaluations so that lactose could give exemplarily proof of its safety and harmless toxicological profile as a traditionally, long-used excipient, at an early stage underpinned by dedicated publications.
Are there trends in the pharmaceutical industry?
Depending on market sector and individual pharmaceutical company, the pharmaceutical industry may be driven by cost. More and more specific investment in selected therapeutic categories demonstrate this. New fields of activity are strictly chosen by e.g. minimizing regulatory hurdles, and efforts for clinical development. Competition has also reached pharmaceutical development and manufacture. There is increased awareness of quality standards. Excipients have been recognized as an important factor enabling targeted formulations, changing the concept from “inert and cheap” to “high functionality”. A growing need to overcome challenging properties of new APIs and biologicals for innovative dosage forms or stream-lining existing processes may be observed. Novel/new excipients will play a critical role for new therapies.
What can excipient companies contribute to new therapies, or the optimization of existing dosage forms?
The excipient industry already follows two pathways: the introduction of completely new chemical entities (NCEs), a new chemical grade of an existing material and/or a meaningful physical combination of established excipients by an unique transformative process, leading to engineered particles, CPEs. The later have been proven being an elegant way creating needed synergies and fairly new functionalities while significantly reducing regulatory burden and hence development time. CPEs also fit perfectly into recent innovative approaches, for they reduce unwanted variability and exhibit desired functionalities. Development of NCEs is another topic. Here, more team-work between Pharma and Excipient Industries will be needed. Excipient Industries is willing to support innovation, specific solutions and continuous improvement of medication; however, there is still space for greater confidence. More communication could be constructive by rapidly driving development efforts in the right direction. Above all, the regulatory and legislative environment is still too slow to apply new paradigms with regard to safety and longer patent exclusivity.
What is the excipient of the future? Sooner or later, the distinct border between API/excipient will blur. The superior understanding of an excipient’s pharmacology and the API-excipient interaction will increasingly impact dosage form, stability, and individualized therapy schemas of future medications. Continuous, optimized, high-volume processes will enable the manufacture of pharmacologically and economically based tailor-made solutions with designed performance, leading to robust formulations. Excipients will take on more responsibility in formulations.
About MEGGLE
MEGGLE AG, with its headquarters in the Bavarian city of Wasserburg (Germany), serves as a holding company for various business activities in the dairy industry and whey processing. MEGGLE has a proud history of more than 125 years in the dairy market.
The business group Excipients & Technology produces pharmaceutical excipients for direct compression, granulation, capsules, sachets, powder blends and dry powder inhalers. With its broad product portfolio, intelligent innovations and exceptional product quality, MEGGLE took a leading role in the global business of pharmaceutical excipients.
For more information please visit www.meggle-pharma.com