The pharmaceutical and nutraceutical industries are constantly looking for ways to develop robust and efficient processes across their oral solid dosage (OSD) portfolios. Producing a quality tablet or capsule should start much earlier than when the tablet press or capsule hopper is filled with powder or granules. Unfortunately, optimizing this part of the manufacturing process seems daunting and is quite often overlooked. Properly granulated product increases flow, compressibility and bulk density, while also reducing fines and segregation. These are the primary reasons we granulate, and Syntegon offers perfectly sized fluid beds to allow OSD manufacturers in both the pharmaceutical and nutraceutical industries the opportunity to streamline their granulation recipe. Let’s take a look at how we determine the correct granulation pathway as well as how Syntegon makes scale-up from R&D to production a breeze.
Fluid-bed wet granulation offers some very distinct advantages for OSD manufacturers. The ultimate goal of a robust fluid-bed granulation process is to allow your tablet presses and capsule fillers to perform at the highest level possible, while maintaining optimal yields batch after batch. In addition to the increased yields of a properly granulated product, one of the most important improvements an OSD manufacturer will notice is a drastic reduction in costs. Granulating in-house can ultimately eliminate a company’s reliance on suppliers and allows utmost control of product from raw powder through final packaging. Now that we have listed the main drivers to granulate product in-house, you may be asking where to begin?
Once wet granulation has been identified as the best way to create the perfect granule for your OSD product, lab equipment for your R&D team should be the next step in understanding how to formulate and create a recipe for your product. Syntegon offers two lab-sized fluid beds backed by the expertise of our Huettlin team in Schopfheim, Germany. Huettlin fluid beds utilize the highest level of spray technology offered in the industry across our entire line of R&D, Pilot, and Production machines. For this article, we will focus specifically on our Solidlab 1 and Solidlab 2 R&D machines. These two machines allow for efficient development of your fluid-bed granulation process in a compact, modular layout. Offering reproducible and consistent results with an easy to use HMI, making the move from R&D to a Pilot or Production fluid-bed becomes a painless process with Huettlin equipment.
The Syntegon Solidlab 1 (SL1) can granulate batches from 0.05-1 kg, making this machine perfectly sized for feasibility studies. The Solidlab 1 offers seven total processing functions within the same unit, allowing for: mixing, drying, granulating, powder coating, pellet coating, tablet coating (drum coater attachment), and blending (multi-mix drum attachment). The small batch size allows the operator to truly examine and understand each recipe and make adjustments as needed. Every parameter of the granulation process is recorded by the operating software and all changes are electronically documented. The Solidlab 1 is fitted with options to spray from the bottom or the top, depending on your processing needs. All of our fluid beds are fitted with a patented three-component nozzle as well, which allows for optimum spray rates and superior cleanability.
Moving into the next larger lab-scale fluid bed is Syntegon’s Solidlab 2 (SL2). Building on the functionality and ease of use of the Solidlab 1, the Solidlab 2 offers eight processing functions with batch sizes ranging from 0.25-12kg. An extra processing function on the Solidlab 2 allows for tablet sugar coating in addition to the same seven functions as featured on the Solidlab 1. Scale up into a pilot or production unit could not be any easier from the SL2, since the machine is constructed much the same as a full-production fluid bed. Using a common air-handling unit, diskjet technology, and three-component spray nozzle as all of our production machines, the best process results are achieved and can be easily duplicated once scaled up into full production.
Syntegon has been developing cutting-edge fluid-bed equipment for well over 30 years with our Huettlin team of experts. The revolutionary design of our fluid beds produces the most technologically advanced and efficient fluid-bed processes in the industry. Getting started with fluid bed granulation could not be any easier than with our Solidlab 1 and Solidlab 2 machines. We would appreciate the opportunity to help improve your granulation and drying processes.
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