Multisorb Technologies Helps Pharmaceutical Manufacturers Achieve True Quality by Design with its SimulsorbSM and SimuloxSM Services
Buffalo, NY - March 17, 2009
As part of the company’s proprietary Calculations through OperationsSM customer support program, Multisorb Technologies, a global leader in active packaging technology, highlights its value-added SimulSorbSM and SimulOxSM services.
These services are designed to help pharmaceutical manufacturers achieve true Quality by Design (QbD) by determining the right active packaging solution for maintaining a drug's chemical and physical characteristics over time.
QbD, a systematic approach of reaching quality standards by looking at the entire developmental system and product life cycle, brings to the forefront some of the essential, yet often overlooked elements of quality assurance assessment of a drug product. For example, maintaining the stability of a drug product formulation requires controlling the relative humidity and/or oxygen concentration of the headspace of a pharmaceutical package and the free moisture level of a drug product over time. But this critical step in the process is seldom taken into account until a problem arises late in the development or even approval process.
SimulSorbSM provides an analytical tool to pseudo-empirically predict the stability outcome of a drug product susceptible to moisture degradation under given conditions early in the development process. Similarly, SimulOxSM service offers an approach for the management of oxygen in pharmaceutical packaging. The analyses helps formulation chemists and packaging engineers provide drug manufacturing companies with specifications and recommendations for the ideal drug product and packaging combinations.
These services help pharmaceutical manufacturers avoid costly and time-consuming sorbent ranging studies, saving approximately 6-12 months of development time.
“An integral part of this value-added customer support initiative, our SimulSorbSM and SimulOxSM services bring precision and predictability to the process of choosing the right type, amount, and format of active packaging technology,” said Adrian Possumato, global director, healthcare packaging, Multisorb Technologies. “Our Calculations through OperationsSM program helps customers identify and incorporate the right moisture and/or oxygen management solution for preserving the efficacy of their drug products.”
