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May
22
ragupathyrenganathan
Commercialising Discovery – Spray drying is the breakthrough technology for the formulation challenges in today’s, modern pharmaceutical business.
Formulation Discussion
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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.

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:

  1. 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.
  2. Drying: Heated process gas (air or nitrogen) is brought into contact with the atomized feed using a gas disperser – leading to evaporation.
  3. Particle formation: As the liquid rapidly evaporates from the droplet, a particle forms and falls to the bottom of the chamber.
  4. 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.

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 Niro Pharma 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.



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