Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 08, Seite 758 (2025))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 2,4: Efficient Scale up Strategies for all process parameters*Part 1,1 see Pharm. Ind. 2022;84(12):1440–1450, Part 1,2 see Pharm. Ind. 2023;85(2):187–197, Part 2,1 see Pharm. Ind. 2025;87(1):66–71, Part 2,2 see Pharm. Ind. 2025;87(4):368–373, Part 2,3 see Pharm. Ind. 2025;87(6):566–572. · Pöllinger N · Glatt Pharmaceutical Services
Atomisation Air Scale Up QbD Approach Process Economy Case Studies Atomizing air is critical in drug layering and coating applications. The air pressure is usually set during development to create a specific droplet size at the nozzle. In general, droplet size should be small relative to the particle size of the product to be coated [ 92 ]. Ideally, the droplet size is maintained during scale up to ensure the droplets are small enough to impinge a single particle only. Figure 60 shows that droplet size increases with increasing spray rate when the atomizing air pressure respective volume are kept constant ...

Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 06, Seite 566 (2025))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 2,3: Scale up for fluid bed Wurster bottomspray processes*Part 1,1 see Pharm. Ind. 2022;84(12):1440–1450, Part 1,2 see Pharm. Ind. 2023;85(2):187–197, Part 2,1 see Pharm. Ind. 2025;87(1):66–71, Part 2,2 see Pharm. Ind. 2025;87(4):368–373. · Pöllinger N · Glatt Pharmaceutical Services
Wurster Bottomspray Process Parameters Scale Up Spray Nozzle Air Conditions As discussed earlier, a robust, reproducible and effective lab scale process is the prerequisite for scale up to pilot and commercial scales. A precise scale up concept and plan must be available – a try and error approach is risky, often very expensive and moreover no longer accepted by the health authorities. The fluid bed Wurster bottomspray process goes along with a clear and consistent scale up philosophy – the same is true also for other fluid bed processes. FDA is currently focusing on the Quality by Design (QbD) concept ...

Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 04, Seite 368 (2025))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 2,2: DoE case studies for process development and optimisation*Part 1,1 see Pharm. Ind. 2022;84(12):1440–1450; Part 1,2 see Pharm. Ind. 2023;85(2): 187–197; Part 2,1 see Pharm. Ind. 2025;87(1):66–71 · Pöllinger N · Glatt Pharmaceutical Services
Process Development Critical Parameters Process Optimisation Statistical Evaluation Process Humidity The Design of Experiments (DoE) concept for process optimisation can be performed for process screening, modelling and optimisation. It is a systematic approach using statistical methods with the aim to gain best results with a limited number of experiments and an adequate data collection. Valid and defensible results and conclusions can be achieved in a time and money saving approach. Most critical parameters can be fixed up as per regulatory requirement [ 93 ]. The DoE case studies presented focus on the process development and optimisation; product formulation aspects are ...