Research & Development
Laboratory
Research and development have always been in Microsphere's DNA. In our facility we have two R&D laboratories: one in partnership with Sferalp.
In 2023, Microsphere expanded our R&D team, laboratory area and acquired new equipment as part of a wider effort to grow this department.
Microsphere’s R&D can process both aqueous and organic solvents as well as high potent compounds.
Capabilities
Spray dryer pilot equipment
Spray dryer ProCept modular 4M8Trix
- Processing capability of 0.1-15mL/min (0.01-1 L/h) water (0.1g - 1kg dry product batch size)
- Closed & open loop system
- Containment for HPAPI compound available
Polardry ® the innovative Electrostatic spray dryer
- Electrostatic technology drives water/solvent to the shell and active ingredients to the core
- An almost perfect encapsulation can be obtained - extending the shelf-life of the product
- Indictated for thermolabile material
- Lower operating temperature (output between 35-60°C) avoids degradation of API
- Particle size up to 250 μm
Analytical Instrumentation
Chromatography
- HPLC ELSD-DAD detector (Shimadzu)
- G-FID (Shimadzu)
Spectroscopy
- FT-IR
- UV-VIS (Agilent)
Particle size & shape
- Laser diffraction (Malvern Mastersizer)
- DLS - Dynamic Light Scattering (Sympatec Nanophox)
- Optical Microscopy & SEM (Hitachi)
- X-Ray diffraction XRPD (Malvern Aeris)
Wet chemistry
- Volumetric and Coulometric Karl-Fischer titration (Metrohm)
- Water Activity test (Novasina)
Inhalation drug testing
- NGI - Next Generation Impactor
- DUSA - Dosage Unit Sample Apparatus
Blending and mixing
- Turbula 2F Mixer
- Gea Soavi Panda
- High Shear Mixer
QbD and DoE
Microsphere's QbD development approach from DoE to a robust commercial manufacturing
Identifyobjectives
Select factors and levels (risk assessment)
Experimentaldesign
Analyzeand correlate
Optimizeand validate
We apply, from the earliest phase, the Design of Experiments (DoE) method; a systematic and efficient approach for planning, conducting, analyzing, and optimizing the output of processes or systems, while minimizing the variability of the product.
We perform:
- Solvent screening
- Optimization of drying and atomization process variables to meet CQAs
- Definition of design space and normal operating range (NOR)
- Scale-up based on the drying kinetics (temperature and humidity) and droplet size
- Formulation development
- Excipient selection
- Nano-emulsion preparation
Mixing empirical & statistical approaches for spray drying development
CPPs, CMAs, TFFC, Solvent ratio, Excipient ratio
MVDA (Black box)
CQAs, Particle size performance, residual solvent release
Electrostatic Spray Dryer
At Microsphere we pride ourselves on being one of the few companies in the world to own and operate the PolarDry Electrostatic spray dryer in pharmaceutical environment. Electrostatic spray drying uses significantly lower evaporation temperatures than conventional spray drying thereby protecting the API or drug product, this is particularly useful if they are thermolabile.
The almost perfect encapsulation of the API and drug product helps to extend its shelf life.
