Role of Multivariate monitoring– A step towards getting Pharmaceutical Industry 4.0 ready!
The pharmaceutical industry is heading in the right direction with use of advanced data analytics and advanced controls but there is still significant work to be done. The level of process improvements that can be gained by adopting newer manufacturing technologies is evident when benchmarking biopharma and Pharmaceutical industry with other high tech Silicon Valley industries which have been forced to innovate in order to guarantee their survival in the markets.
DFE Pharma, leading in excipient expertise intends to showcase the growing need for having Multivariate oversight to ensure product success throughout the lifecycle of the finished product. This will be illustrated of trending of production data using Multivariate monitoring for a functional excipient- SuperTab® 21AN.
Re-imagining your Orally Dispersible Tablets formulation excipients, introducing a new lactose product (SuperTab® 50ODT)
The sensory aspects of polyols for ODT’s are favorable regarding smoothness, sweetness and a cooling sensation. Utilizing proprietary spray drying technique- a lactose monohydrate product has been developed based on sensory evaluation model using CATA (Check all that applies) & RATA (Rate all that applies) concepts. CATA constituted Sweet Dextro (grape sugar), Chalky,Soft/creamy, Granular, Powdery, Dissolves into paste, Melts immediately, Crumbling at end. RATA constituted Sweet, Paper, Dissolving speed, Amount of effort needed.
MVA (Multi Variate Analysis) was used to monitor, evaluate the sensory perception of tablets. The study shows that using these CATA & RATA screening techniques-the Organoleptic properties of commonly used pharmaceutical excipient such as lactose can be modified to suit ODT application.
Additionally spray dried particle due to its porous nature offers a fast disintegration time leads to a smooth tablet perception in mouth and thus contributing favorable organoleptic requirements of ODT’s. These attributes of SuperTab® 50 ODT offers new excipient for development of ODT’s.