Seeing the Micro Picture

Seeing the Micro Picture Seeing the Micro Picture Seeing the Micro PictureThe term microfluidics has many researchers abuzz in the present, with new developments and innovations coming out daily. However, just as many are excited about its future. Count Nicole Nastaran Hashemi, an Iowa State University assistant professor of mechanical engineering, among them. She says her team has seen how microfibers can be made to grow cells and strengthen damaged tissue, and the future applications are numerous.The Importance of FiberI had been working with microfluidics for a while, partly using them to create biosensors, Hashemi explains. I got interested in using them to create specific advanced materials, particularly for healthcare, because I thought it could be a large benefit. There welches a great amount of potential opportunity. I came up with the idea of using microfluidics for creating microfibers and we started using them as a scaffold to grow neurons on them. We saw it improve the pr operty, which welches very exciting.A key challenge was making the fiber in a way that would have specific cross-sections. Playing with them in microfluidic channels can create any cross-sectional area we want, she says. We want to have specific patterns, specific architecture for different tissue engineering applications. We were using smooth fibers but eventually I would like to expand so we can direct, basically, the growth of the neurons. I have been interested in directional growth and we wanted to see how fibers or how the size or the pattern of the cells could affect the differentiation of the cells.Neural stem cells on the microfibers fabricated by Nicole Hashemi and her team. Image Ashley Christopherson / Iowa State UniversityThe fibers in their work have been roughly 5 microns to 20 microns, she estimates. Microchannels utilized silicon wafers when it came to patterning.Hashemi says the hope was that, by using scaffolds, neurons could make connections with each other, and even transfer signals. We saw that when using ansicht fibers, she says of the work, which was partly supported by a grant from the Office of Naval Research. We saw neurons basically align parallel to the axis of fibers.Another advantage of microfibers when it comes to scaffolds is that they are conduits that do not involve voltage, something that can potentially cause damage, she says.Goals in SightIn the long run, Hashemi thinks she wants to encapsulate cells inside the fibers. But when you actually look back, it was even a challenge to begin with in terms of being able to put the cells on the fibers where they would survive, she says, finding it surprising that the shapes of fibers would affect differentiation of the cells.A further goal, she notes, is that their work will also help in understanding brain injuries better, with a focus on microcavities. If we could make strides here, that could open things up for people who are going through something so difficult, she says.Hashemi even believes their work can extend to other areas such as muscle tissue and vessels. The change from these kinds of adjustments can be amazing, she says. I think there are possibly many organs where this could have an effect.Eric Butterman is an independent writer.The change from these kinds of adjustments can be amazing. I think there are possibly many organs where this could have an effect.Prof. Nicole Nastaran Hashemi, Iowa State University

The Hidden Truth on How to Do a Resume for Free

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3D-Printed Drugs What Does the Future Hold

3D-Printed Drugs What Does the Future Hold 3D-Printed Drugs What Does the Future Hold In August 2015, the U.S. Food and Drug Administration (FDA) approved Aprecia Pharmaceuticals Companys SPRITAM levetiracetam for oral use in treating epileptic seizures. Whats mora, SPRITAM is manufactured using a 3D printing process to produce a porous formulation that rapidly disintegrates with a sip of liquid. This is the first time a drug product manufactured by 3D printing technology has been approved by the FDA.Aprecia achieved this using a proprietary technology platform that combines formulation science with the unique manufacturing capabilities of 3D printing. This allows the manufacture of medicines that rapidly disintegrate with a sip of liquid even at high dose loadsgood news for millions of people who have difficulty swallowing pills. Aprecia holds an exclusive license for pharmaceutical applications using this 3D printing technology, which could ultimately reduce the overall cost of dru g manufacturing by eliminating steps, improving throughput, and reducing the manufacturing footprint.Thomas G. West, chemical engineer, project director, and manager of intellectual property for Aprecia Pharmaceuticals Company, discusses their ZipDose technology in more detail and how it may impact drug manufacturing in the future.ASME Why didyour companypursue 3D-printing for this drug?West 3D printing enables the creation of new physical structures that can exhibit new or different functionality. For SPRITAM, we used 3D printing to create unitary porous structures that readily disperse in the mouth in response to a sip of liquid, regardless of size of the units. The result is a premeasured solid dosage form of a high-dose medicine that does not need to be swallowed intact.How ZipDose technology works. Image ZipDoseWe believe this type of dosage form may be most helpful to specific patient segments that often have swallowing difficulties, including children, the elderly, and those dealing with the complications of stroke, Alzheimers disease, head and neck tumors, and certain other neurological disorders.Was there anything about the drug that made it especially favorable for 3D printing?Formulation and material science are integral components of adapting material platzdeckchens to the 3D-printing process. When combined with appropriately selected excipients, the active ingredient levetiracetam exhibits desirable parteicle properties amenable to the powder spreading and liquid printing steps of our manufacturing process. Its high solubility in water set the tone for formulation strategy in attaining the right balance of handling and dispersion properties for the finished drug product. Solubility in water is not a requirement of the process, but does impact decisions on excipient selection.Although these properties were helpful in our lead product candidate, they areue not uniq or exclusive to levetiracetam. We believe there is a wide range of active pharmaceuti cal ingredients that can be formulated for use in this process.How does 3D printing of SPRITAM enhance the patient experience?Many people are familiar with some type of fast melt tablet-computer made by other techniques. Often these are small in size and dosage (for example, under 50 mg) and larger units may disperse in the mouth more slowly than the smaller ones. In our experience, few products are offered above 100 mg in strength. ZipDose dosage forms do not have a tradeoff between size and speed, accommodating very large doses of medicine (up to 1,000 mg) and still dispersing in the mouth within seconds when taken with just a sip of liquid.This breakthrough will enable some of the largest tablets and capsules to be offered in a fast-melt format for the very first time, providing a new dosing option for patients who may struggle with swallowing large tablets or capsules intact.What innovative aspects of this breakthrough would be of interest to mechanical engineers?Many engineers may be more familiar with other types of 3D printing, such as fused deposition modeling or stereolithography, and the progression from use in appearance or concept models to use in functional mechanical parts.From this perspective, several aspects of our work may be interesting. The process we use has two material inputs powder and liquid. Sometimes referred to as binder jetting onto powder, it comprises an alternating sequence of spreading thin layers of powder and selectively depositing droplets of liquid to bind the powder together, building the part vertically and forming each new layer upon the preceding layers. It can use a variety of materials in addition to polymers, including small molecule organic compounds, and thermal exposure of these materials is limited.The materials we use are customary in pharmaceutical formulations, but their deployment in the process is deliberate and unique. Rather than making highly dense parts, for ZipDose units we very selectively bind the pow der together while maintaining a high degree of porosity. In the end, the density of the finished part roughly resembles that of the starting powder in bulk, but at a local level the powder particles have become a physically interconnected network that can be packaged, shipped, and administered to a patient.What surprised company scientists the most during research and development?One of the biggest surprises was the amount of drug that could be incorporated in this type of dosage form. Our early work looked at smaller strengths in the 10 mg to 300 mg range and moved up from there over time. Using a drug in the cardiometabolic space as a model compound, we first demonstrated dose loading up to 1,000 mg in the ZipDose format. These learnings were then applied to the development program for SPRITAM, which actually has a top strength of 1,000 mg.How will this technology breakthrough impact drug manufacturing over the next few years?Our commercial approach is based on large centralized manufacturing under the existing regulatory paradigm. To support these goals, it was necessary to design and build our own large-format 3D printing machines, which are proprietary to Aprecia Pharmaceuticals. These machines are designed for increased throughput while complying with applicable current good manufacturing practices that are required of pharmaceutical products.Over the next few years, we expect to develop and commercialize additional product candidates on the ZipDose platform for the central nervous system therapeutic area for the U.S. market. Over time we may also pursue opportunities in other markets and other therapeutic areas, either alone or in partnership with other companies, which may include developing line extensions on the brand products of partners.Beyond the Zipdose platform, we believe there are other platform opportunities for using our form of 3D printing to develop and commercialize dosage forms exhibiting controlled release or multiphasic release, or co ntaining fixed-dose combinations of multiple active ingredients.fruchtmark Crawford is an independent writer.Learn more about 3D printing challenges and trends atAM3D Conference Expo. For Further Discussion This breakthrough will enable some of the largest tablets and capsules to be offered in a fast-melt format, providing a new dosing option for patients who struggle with swallowing large tablets or capsules.Thomas G. West, Pharmaceuticals Company