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 ...

Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 01, Seite 66 (2025))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 2,1: Process technology and QbD concept*Part 1,1 see Pharm. Ind. 2022;84(12):1440–1450, Part 1,2 see Pharm. Ind. 2023;85(2): 187–197 · Pöllinger N · Glatt Pharmaceutical Services
QbD Wurster Bottomspray DoE Process Optimisation Process Parameters Multiparticulate drug delivery systems are widely used in the pharmaceutical industry due to their formulation flexibility for the manufacturers and clinical benefits they offer to the patients. They are developed in a wide range of sizes, i.e. as small as 150 μm or as large as 2–3 mm in diameter and offer superior clinical and technical advantages over many other specialised drug delivery technologies [ 92 ]. Among the pelletisation techniques available, the fluid bed Wurster bottomspray process is a production method of a great interest as it offers the various advantages in a ...