Spray drying is the breakthrough technology that presents R&D
technologists with an alternative to remedy some of the formulation challenges
in today's, modern pharmaceutical business.
Spray drying provides
unprecedented particle control and allows previously unattainable delivery
methods and molecular characteristics. These advantages allow exploration into
employing previously unattainable delivery methods and molecular
characteristics.
Niro is the market leader in spray drying technology
and has spent more than a decade refining the technology specifically for use
within the area of final solid dosage drug forms.
Spray
drying offers several advantages over existing technologies, for example:
Bioavailability Since many modern therapeutic
compounds are most stable in a crystalline form they often display poor aqueous
solubility and low dissolution rates – reducing the bioavailability of the API
and slowing absorption. With spray drying you can co-precipitate an API with a
polymer in a stable amorphous solid dispersion, thereby greatly improving the
dissolution rate. Spray drying has the potential to open doors for new,
important treatments that are currently shelved due to low bioavailability.
Encapsulation Encapsulation offers drug developers
a number of commercial and medial advantages. Spray drying, as well as spray
congealing, makes it possible to create particles in order to fashion specific
controlled-release patterns and other properties. Sustained release of some
antibiotics allows for a reduction in dosage, a reduction of concentration
peaks and offers an effective way of treatment for chronic illnesses. In
addition to reducing side effects, on a more practical level, enhanced taste
masking can be achieved as can physical protection of the API.
Aseptic production Spray drying offer a number of
advantages over other aseptic drying methods such as freeze drying. By
precisely controlling the drying process, spray drying gives far greater
command over the shape, density and morphology of the final product.
Inhalation
Pain-free and self-administered
delivery systems are preferred by patients and medical professions whenever
possible. This expanding field of drug delivery has, until now, been difficult
to develop from small-scale to commercial levels of production. Niro has
developed highly specialised spray drying nozzles that give increased particle
engineering capabilities, even on large-scale – making it possible to
accurately manipulate aerodynamic particle size and properties. Niro's spray
drying technologies make it easier than ever to efficiently produce therapies
in the form of free-flowing particles that are ideally suited for inhalation.
Compressibility Solid dosage pharmaceuticals have
often required a separate granulation step to produce a powder that has the
correct flow properties to accommodate a high-speed tablet press. By using
spray drying, granulation can now be an integrated part of a continuous
process. This produces a more efficient, streamlined production system and
reduces costs too.
How spray drying works
Spray drying is a very fast method of drying due to the very large surface
area created by the atomization of the liquid feed. As a consequence, high heat
transfer coefficients are generated and the fast stabilisation of the feed at
moderate temperatures makes this method very attractive for heat sensitive
materials.
There are four basic stages of the spray drying technique:
- Atomization: A liquid feed stock is atomized into droplets
via either a nozzle or a rotary atomizer. Nozzles use pressure or compressed
gas to atomize the feed while a rotary atomiser use a wheel rotating at high
speed.
- Drying: Heated process gas (air or nitrogen) is brought
into contact with the atomized feed using a gas disperser – leading to
evaporation.
- Particle formation: As the liquid rapidly evaporates from
the droplet, a particle forms and falls to the bottom of the chamber.
- Recovery: The powder is recovered from the exhaust gases
using a cyclone or bag filter. The whole process generally takes no more than a
few seconds.
Spray drying is relatively easy to replicate on a large-scale. Niro has
supplied industrial-scale spray drying plants for over 50 years. This robust
process can easily maintain all critical process parameters throughout the
batch and information for the batch record can be monitored or logged,
depending on the type of system selected.
Niro has extensive experience
of supplying spray drying plant and systems that have to be validated and
approved by regulators. The precise control of parameters provides a high
degree of assurance that the process consistently produces a product that meets
set specifications.
Read further about spray drying and spray dryer technology from GEA Niro A/S
here.
From drug development to drug production
As
an experienced process development partner, Niro can help meet your needs in
many areas. From investigating how spray drying can enhance your drug
formulation, through process development, producing clinical trials material
and large-scale production tests, Niro's experienced technologists and
equipment are there to help you.
The GEA Pharma Systems Test
Station
Niro also operates the world's only cGMP certified
pharmaceutical test station for spray drying. Certified for clinical trials
material, the station meets the European Union's requirements for the
production of 'Investigational Medicinal Products' (IMP) and is exclusively
there to aid customers in drug development projects. This facility allows
customers to start all essential product development work, while limiting the
need for upfront investment in spray drying equipment.
If you want to
know more about the spray drying process and how the technology can be applied
for formulating solid dosage pharmaceutical products, please contact the GEA
Pharma Systems Division at: pharma@niro.dk