This page contains a Flash digital edition of a book.
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 tailor- made excipients, for instance, due to formulation or patent reasons. MEGGLE greatly benefits from a long-lasting experience in toll- manufacturing 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 pharma- ceutical 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 www.americanpharmaceuticalreview.com |


| 69


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76