What’s New at AAPS: Equipment

The American Association of Pharmaceutical Scientists (AAPS) annual exhibition took place in Denver, Colorado, on November 13-17. Several hundred exhibitors were present from the worlds of drug formulation and delivery, related equipment and machinery and analytical and CRO services, and some had innovations on show. Here we round the key ones in equipment.

Fluid Air, a maker of solid dosage processing equipment for the pharmaceutical and other industries, showed the patent-pending PolarDry electrostatic spray dryer. This is being positioned as an alternative to conventional spray drying in the encapsulation of APIs in liquid formulations, giving final products with higher bulk densities and longer shelf lives.

The use of electrostatic technology, Fluid Air states, means that the solvent and carrier in each droplet pick up more electrons than the less conductive active. The active remains at the centre while the solvent and carrier are forced to the outer surface as their greater charge density leads them to repel each other. Thus solvent can be evaporated without the need for drying gases at around 200°C, which often degrade the end product. Instead, inlet drying temperatures are as low as 80°C.

Lichtenstein-based Pantec Biosolutions was showcasing Epimmun, a process for laser-assisted epidermal delivery using the company’s own PLEASE Professional medical device, which is the only ablative Class 1C laser currently on the market.

The device uses an Er:YAG laser, incorporated into the device, which has higher absorption in water than a CO2 laser and thus has less thermal conduction into the surrounding tissue and does less damage to it. Because of this, there is less carbonisation of the skin and minimal coagulation, so the passage created for drug delivery is wider and there is better API uptake. Tests are cited showing this to work even with APIs of very large molecule sizes, in powder, gel, cream and aqueous forms alike.

Using Epimmun, the company says, immunogens can be delivered painlessly to targeted skin layers with controlled dosage by adjusting the pore density and depth settings. The microporation process creates an inflammatory stimulus, thus potentially boosting the immune response. In addition, it can be used by semi-skilled staff rather than just fully qualified nurses.

From Biopharma Technology came the Lyotherm3, decribed as “the next step in frozen state solution analysis”, in pharma and other fields. Key benefits claimed include impedance capacity up to 14.0 MΩ, greater control over analysis via alarms and liquid nitrogen, simplified operation, logging every three seconds, automatic anomaly checking and removal and simplified data reading.

The Lyotherm3 is said to be unique in combining electrical and thermal techniques to “add a new dimension to data”: fixed dielectric analysis provides an indication of the sample track’s molecular mobility, while differential thermal analysis measures the difference in temperature between a sample and a reference.

Launched in May but shown at AAPS for the first time at an exhibition, the BIOne is a patent-pending single-use bioreactor for mammalian cell culture applications from Distek, a manufacturer of laboratory testing instruments. It comes pre-assembled and irradiated and comprises a headplate with a non-invasive DO sensor port, a non-invasive pH sensor port and two universal sensor ports with multiple potential applications.

The BIOne works by converting an existing benchtop glass bioreactor: the existing headplate should be removed and the BIOne instead into the glass vessel, where it will mold to and mimic the existing glass system, without any need to change the process. According to Distek, it increases throughput by eliminating assembly, cleaning and autoclaving, thus reducing turn-around times between runs. It is also compatible with most manufacturers’ glass vessels.

More conventionally, several new lab tablet presses were on show. Fette Compacting showed the FEC40, its first capsule filling machine, with what is claimed to be an unprecedented production output of 400,00 capsules/hour. The company says that it succeeded in transferring the basic technical principles of the double rotary press to capsule filling, accommodating an additional filling unit in the machine.

The FEC40 is designed with servo and torque meters so that each process step can be set separately. With “intelligent drive” technology, output volumes can be doubled without increasing machine cycle times. The machine is also extremely compact, meaning that no extra floor space is needed to accommodate it and production costs per unit number of capsules can be reduced by 30%, Fette claims.

Meanwhile, Korsch showcased the XL 100 Pro, a portable, ten-station rotary machine, fully instrumented and with integrated data acquisition and analysis capability.  The control system is also configured with full production controls for clinical manufacturing, including product recipe, press force control, single tablet rejections, and electronic audit trails for machine adjustment, press alarms, and rejected tablets. 

Finally, the Labcoat M and MX are the latest in a series of laboratory coaters for both research and formulation facilities from O’Hara Technologies. The former features a range of interchangeable pans from 0.8 kg to 10 kg of working capacity, plus an anti-bearding spray nozzle and a built-in peristaltic pump. Both incorporate blender and tray dry oven inserts with coating pans for multi-purpose use, thus reducing capital costs and reducing the amount of GMP space needed, the company claims.

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.