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May 21, 2009 - May 21, 2009 Courtyard by Marriott-Princeton 3815 US Route 1 Princeton, NJ 08540 USA |
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| Register for the free Formulations Seminar or contact us for more information |
Learn how to close the formulations knowledge gap and speed process development by tracking your particles in real time during granulation through disintegration and dissolution. METTLER TOLEDO FBRM® (formerly Lasentec®) probes provide in-process real time measurements of particle change and are used to understand, optimize, and troubleshoot formulation variability from granulation to disintegration and dissolution. FBRM® Process Analytical Technologies (PAT) are installed directly in fluid beds and high shear granulators, directly after roller compactors, and directly in dissolution systems. FBRM® is used to:
- Track granule growth in real time allowing for faster process development and optimized batch consistency
- Track particle properties during granule and tablet disintegration and dissolution and correlate results directly with upstream raw materials, blending, granulation, and tableting variable
Presentations will be given by industry experts as well as METTLER TOLEDO specialists, including:
Joseph Ceballos, Pfizer Inc. - Online Particle Characterization of Dry Granulation by FBRM®
This talk will focus on the robustness of the probe in the fluid bed and correlating at-line/in-line data to evaluate equipment performance.
High shear wet granulation is a common unit operation in solid dosage formulation, yet a mechanistic understanding is not well known. One goal of high shear granulation is to yield a repeatable granule size and granule shape distribution at the batch endpoint. This is necessary for consistent downstream drying, milling, flow properties, and content uniformity. However, inconsistencies often occur during granulation development and scale up due to changing API, raw materials, or changing process dynamics such as segregation, agglomeration, or breakage.
Dr. Xue will present and discuss the objectives, challenges, experience, and results of the Pfizer ATI Team exploration of powder dosing technologies.
Dissolution and disintegration testing are well established as standard analytical tests used during pharmaceutical development. Yet, if dissolution is inconsistent, what is the root cause? Was the internal tablet or capsule structure inconsistent? Were the particle disintegration and erosion mechanisms inconsistent? Was there an upstream processing inconsistency that resulted in poor tablet properties?
One goal of high shear granulation is to yield a repeatable endpoint granule size and granule shape distribution. This is necessary for consistent downstream flow properties, tablet consistency, and content uniformity. However, inconsistencies often occur during granulation development and scale up due to changing raw materials, vessel-blade geometry, or process dynamics such as segregation and over wetting.
Introducing QUANTOS
We are pleased to introduce QUANTOS - a new breed of instrument for the laboratory bench top. QUANTOS
provides a new and advantageous approach to the challenges of repetitive dosing of powder API, samples, and standards in formulations development. Precise dosing of small amounts of powder in pharmaceutical/formulations development is difficult, time consuming, and a potentially hazardous task. Often, the scientist or engineer is in contact with highly potent Active Pharmaceutical Ingredients (APIs), and dosing may be hindered by electrostatic or hygroscopic effects.
QUANTOS helps significantly improve:
QUANTOS is a winner of the Association for Laboratory Automation's (ALA) New Product Award (NPA) Designation for 2009.
Venue
This free one day event will take place at the Courtyard by Marriott-Princeton
Continuing Education in Formulations
As part of the METTLER TOLEDO commitment to education, we offer complimentary educational webinars that explore topics of interest to Scientists and Engineers working in Formulations.
Formulations Seminar Agenda
(pdf)
May 21, 2009