Miniaturization Pharmaceutical Technology (MPTech®) - An API Manufacturing Process to Increase the Operational Efficiency and Its Impact and Benefits on Patients | CPhI North America

 

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Miniaturization Pharmaceutical Technology (MPTech®) - An API Manufacturing Process to Increase the Operational Efficiency and Its Impact and Benefits on Patients

José Ángel Marañón, Ph.D. (Executive Vice President, Tradichem Industrial Services)

Location: E353b

Date: Tuesday, April 30

Time: 3:00pm - 3:45pm

Track: Drug Development

Vault Recording: TBD

Operational efficiency is defined as the search of the minimization of waste and
maximization of resource for providing quality goods and services to consumers.
Operational efficiency is concerned with designing new work processes that improve
quality and productivity. We hereby introduce a new technology that implemented during
the API manufacturing has a direct impact in the cost reduction of the solid finished
dosage forms (Capsules, tablets, softgels).

The MPTech process on an API is a physical transformation process of an API, modifying
some physical parameters as cristalization, bonding capability and increase of the Van
Der Waals forzes on the API to prepare pharmaceutical compositions considerably
reducing the amount of excipients needed for the formulation. This reduction can be by
50%. This physically transformed API has equivalent properties than the previous one in
terms of uniformity and solubility, and disintegration and for sure identical purity to the
previous one.

The possibility of reducing so drastically the amount of excipients needed in the
formulation of the dosage forms entails both economic and therapeutic advantages.
Thus, on the one hand, less excipients are required and also the production times are
shortened. Furthermore, the reduction of the volume facilitates the ingestion of the
dosage form by the patient and enables a better compliance of the therapeutic regime.
MPTech is a 7 stage process undergone in a Europe GMP site.

The session will explore not only in this innovative patented technology, but also on the innovation paradigm, where the influence on the industrial process (upstream) has a direct impact on patients (downstream).