Dr Sune Klint Andersen, Janssen Pharmaceutica
Dr Eunice Costa, Hovione, Portugal
João Henriques, Hovione
Dr Eline Hermans, Janssen Pharmaceutica
Dr Ulrich Meier, Novartis
Dr Andrew Parker, Juniper Pharma Services
Dr Harald Stahl, GEA
Dr Joao Vicente, Hovione
Marianne Van Steenwinckel, Janssen Pharmaceutica
Take advantage of the opportunity to focus on spray drying technology and process and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the post-conference session where you can get a hands-on experience in spray drying yourself. You will learn in small groups how the spray drying result is affected by different equipment, parameter changes, solvents etc.
try, being an ideal process where the end-product must comply with precise quality standards regarding particle size distribution, residual moisture/solvent content, bulk density and morphology.
One advantage of spray drying is the remarkable versatility of the technology, evident when analysing the multiple applications and the wide range of products that can be obtained. From very fine particles for pulmonary delivery to big agglomerated powders for oral dosages, from amorphous to crystalline products and the potential for one-step formulations, spray drying offers multiple opportunities that no other single drying technology can claim.
Benefits of Spray Drying
High precision control over:
Degree of crystallinity
OVIs and residual solvents
Typical application in pre-formulated products
Improved bioavailability and stability
For products with unusual or difficult characteristics
Sticky or hygroscopic products
Slowly crystallizing products
Difficult to isolate products
Rapid drying for temperature sensitive materials
This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control as well as technicians, planners and plant designers, especially those involved with the manufacture of powders and granules, as e.g. in the manufacture of solid dosage forms for oral or pulmonary administration.
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.
Fundamentals of Spray Drying
Analytics and characterisation of spray dried products
- 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 vs Freeze Drying – How to choose the right technique?
- Short Overview of Solid dispersions
- Analytical tools
- Novel screening methods – single droplet spray drying
- Screening protein formulations
- Understanding cohesion/adhesion balances
- Correlating structure with performance
Development of Scaleable Spray Drying Processes for Solid Drug Product Manufacture
- Spray Drying of Pharmaceuticals: Formulation via spray drying, Scientific basics, Review of spray-dried pharmaceutical products
- How to conclude: Spray Drying or Freeze Drying
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. , A special focus is given to the scaleability of the SD processes.
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.
Trouble Shooting Session
- Usage of lab scale data and lab-scale limitations
- Product improvement during scale up
- Scale-up methodology
- Process development strategy
In this interactive session, all the key elements of the preceding lectures are
What to do if:
Amorphous Solid Dispersions – Manufacturing Technologies
Case Study: PAT Technology for Spray Drying
- Particles are too fine/coarse
- Yield is too low
- Final product moisture content is too high
- Different product characteristics after scale up
Integration of Quality-by-Design into Qualification and Validation of Spray Drying Processes
- PAT to support a theoretical spray dry model in scale-up
- FDA’s request for PAT to ensure product quality
- In line measurement of particle size and relative saturation
Supporting the development of oral dosage forms with Spray Drying
- Development of spray drying process using Quality-by-Design: Design of Experiments (DoE), Critical Process Parameters, Critical Material Attributes
- Risk assessments: Spray Drying Process, Spray Dryer Design
- Qualification and Validation of a Spray Dryer
- Process Validation: Scale-up, Control Strategy
- Special tests during qualification and validation
Case study: Application of Spray Drying for Inhalation Products
- Specific challenges of the formulation of Amorphous Solid Dispersions into tablets
- Bridging spray drying and tablet development
- Advantages and challenges of integrated ASD tablet development
- 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