Spray Drying With Guided Tour at the Hovione Site (without workshop)

Programme

Fundamentals of Spray Drying
Identification of Critical Process Parameters
Control of those Process Parameters
Influence of these Process Parameters on Product Quality
Example of setting up a Spray Drying Process

Spray drying from a particle perspective
Gas temperature and humidity
Drying at particle level
Stickiness (time, temperature and humidity)
CFD models and drying kinetic analysis

Spray Drying vs Freeze Drying – How to choose the right technique?
Fundamentals of Freeze Drying
Spray Drying of Pharmaceuticals
Formulation via spray drying
Scientific basics
Review of spray-dried pharmaceutical products
How to conclude: Spray Drying or Freeze Drying

Development of Scaleable Spray Drying Processes for Solid Drug Product Manufacture
The presentation starts from the target properties of pharmaceutical intermediates and products for oral solid dosage forms and for dry powder inhalation, viewing SD as a particle design tool. Examples of various product types, such as amorphous drug substances, solid dispersions, granulates and inhalable powder, are given. SD is then compared to other drying/ agglomeration processes more common in the pharma industry. A systematic approach for development of products/ processes by means of spray drying is illustrated, following the methodology proposed e.g. in a publication by Dobry et al. A special focus is given to the scaleability of the SD processes. Scale-up of pharma manufacturing processes asks some specific requirements from developers as well as from equipment to be used.

Validation and the usage of QbD for Spray Drying
Risk assessment in the context of qualification and validation
Development of spray drying process using DoE
Three stage DoE
Parameter screening (CCF design with 3 variables + extension)
Raw material variability
Process Validation
PAT: Inline particle sizing and NIR used to monitor the spray drying process
Special test during qualification and validation

Scale-up of a Spray Drying Process
The bench scale spray drying units can be found in most of the material characterisation and drug development teams, being also used as production units of high-value low-volume drugs. However, it is often underestimated the valuable information that lab experiments can give to help in a successful process scale-up. In this presentation a scale-up methodology will be presented where insight will be given on what and how lab scale data can be used, as well as, how scaling-up can be used to improve product properties.
Usage of lab scale data
Product improvement during scale up
Methodology for scale up of SD processes

Trouble Shooting Session
In this interactive session, all the key elements of the preceding lectures are brought
together. A systematic approach is presented and discussed with regards to the possible measures which could be taken:
What to do if:
Particles are too fine/coarse
Yield is too low
Final product moisture content is too high
Different product characteristics after scale up

Case study: Enhancing the bioavailability of poorly soluble drugs using spray drying: scaling up from lab scale to commercial scale
Short introduction on amorphous solid dispersions
Manufacturing technologies
Case study of itraconazole (Sporanox®)
Case study of etravirine (Intelence®)

Case study: Application of Spray Drying for oral dosage forms
Improving oral dosage forms performance through spray drying
Case-study 1 – Laboratory scale challenges
Focus on laboratory scale unit limitations
How to improve powder properties at laboratory scale
Strategies to formulate poor flowing SD powders

Case-study – Commercial challenges
Focus on adjusting powder properties for locked formulations
How to develop a commercial process
Strategies to cope with challenging targets (e.g. density, PS)

Case study: Application of Spray Drying for Inhalation Products
Introduction: applications of spray drying for inhalation products (carrier-based and
composite formulations)
Critical quality attributes: an overview for composite formulations via spray drying
Spray drying process: Thermodynamics aspects specific of Inhalation products
Spray drying process: Atomization aspects (controlling particle size and morphology)
Composite DPI formulations through spray drying

Site Visit at Hovione on Thursday, 9 June 2016
cGMP Spray Drying Equipment and Facility

Part of the programme on the third day of the conference is a guided tour at the Hovione site.

In line with the latest developments on spray drying technologies and with the increasing demand for highly defined particles properties in the pharmaceutical industry, Hovione has installed and commissioned a range of spray drying units able to operate under the most stringent cGMP conditions.

These laboratorial, pilot and industrial scale units allow Hovione to offer from a few grams to full scale commercial production. With FDA-inspected plants Hovione is capable to manufacture spray dried material under cGMP conditions.

The guided tour will include a visit of the spray dryer building where pilot, small and full commercial scale equipment can be seen. Moreover the production control room and the analytical labs will be part of the guided tour.