Solid dispersions are an efficient means for improving the dissolution rate and hence the bioavailability of a large range of hydrophobic drugs. Oil soluble actives can be delivered in soft capsules but the costs involved are higher than in a tablet. With the new PolarDryTM electrostatic spray dryer, we can create a solid dispersion of an oil soluble drug and deliver it in an oral disintegrating tablet.
Within the world of Oral Solid Dosage, the medications that command the highest premium tend to be the most difficult to process with predictably rare ingredients. These products often require the use of high-shear granulators, mills and Wurster coating fluid beds. These machines are workhorses, often running for decades while requiring only minimal maintenance. When they do fail, however, the result can be the rejection of not just one, but several very high value batches. To help you prevent such failures, here are the five most common areas that can be easily prevented through proper inspection.
Achieve optimal efficiency with the new and improved Granumill® 007. We have redesigned our impact and screening mill to maximize usability and increase performance. Fluid Air understands your unique situation and will build custom machine configurations specific to your needs and existing equipment.
A high-shear granulator or high-shear mixer uses a rotating impeller or high-speed rotor (or both) to create flow and shear. High-shear granulation is an effective way to turn powders into dense granules for tableting or coating. To create the granules, powders are added to the mixing bowl and the bowl is sealed. A large impeller rotates at slow speeds, spinning the powders into a vortex. After the powders are blended together, liquid is added to the product using a pump or pressurized container. A high-speed chopper tool located in the bowl shears the granules and removes air. The mixing continues until the desired granule size and density are achieved. Mixing processes vary from each application so when searching for a mixer, here are some key features to look for that can optimize your process and maximize your batch.
One of the final stages of producing any pharmaceutical or nutraceutical tablet, coating is the essential process that seals a raw tablet, often in order to protect the active ingredients in the drug, protect the stomach lining of the patient, or provide a delayed/time-sensitive release of the medication. In order to achieve these results, the coating process must run smoothly and evenly. Avoiding issues isn’t always an option, but eliminating them when they arise is possible. Here are a few troubleshooting tips to resolve three common tablet coating problems.
With the large variety of milling equipment on the market, it can be difficult to know which type of mill is appropriate for your process. The basic mechanical process of milling, also known as grinding, granulating, comminuting, etc., is generally used either:
- to break apart clumps or agglomerates– that may have developed during storage, transportation, or handling of a given material without altering the average/mean size of the particles which make up the material, a process often referred to as deagglomeration;
- to reduce the average/mean size of the particles in a given material, also known as particle size reduction.
Pharmaceutical companies sometimes choose to buy equipment second-hand, either from another pharmaceutical company or directly from the manufacturer of the equipment. While there exists a large and diverse market for used equipment, there are many things to consider before purchasing any used or refurbished system for processing pharmaceuticals. For example, while refurbished systems are often available at substantially lower prices than new ones, there may be undetected defects which will require repair. Additional overhead and maintenance requirements to get a refurbished machine running– like software upgrades, tracking down replacement components, system installation, integration with your existing process, possible re-validation procedures, etc.– can greatly increase the system’s total cost. Those who work for small R&D companies and start-ups often have trouble securing the necessary funding for a brand new machine. Large purchases leave small companies with little room for error, but with the current glut of systems in the used equipment market, how can you tell which will ultimately be worth the investment? Here are five questions to ask which should help determine which system will be right for you.
Purchasing a new fluid bed system isn’t easy. Fluidized beds are expensive, complex, and require a great deal of careful consideration and research before buying. Ordering a machine that can’t meet your process requirements could end up costing much more than anticipated, and there’s no single system available that will suit everyone’s needs. So, where should you start?
With the ubiquity of personal computers and mobile devices like smartphones and tablets at an all-time high, nearly everyone has become well-acquainted with the experience of computer glitches. These glitches can range from minor annoyances — like a window closing when you didn’t want it to — to serious problems, such as a program crashing without saving its data or a complete system shutdown. While these issues can be frustrating when they happen on a personal computer, the consequences of a potential controls malfunction when it comes to your pharmaceutical processing application can be far greater.
Wurster coating can be tricky, even in small-scale R&D batches. Larger-scale batches must be monitored carefully, as any mistake could result in costly product waste. Production size Wurster coaters with multiple coating partitions have two very critical process challenges to overcome: balancing the air flow to each coating zone, and the potential for clogged spray nozzles.
Everyone wants their equipment to look, feel, and run like it did when it was brand new, but years of operation and wear can take their toll on a system’s effectiveness. Constant advancements in processing technology and new federal regulations combined with everyday wear-and-tear can really make your formerly “state-of-the-art” piece of equipment feel like an antique– but purchasing a new system is expensive, and not always practical. Here are just a few of the ways that Fluid Air can revitalize your existing equipment, often at a fraction of the cost of a new machine.