Application of Powder-Layering Technology and Film Coating for Manufacture of Sustained-Release Pellets Using a Rotary Fluid Bed Processor

Vuppala, Murali K.; Parikh, Dilip M.; Bhagat, Hitesh R.

doi:10.3109/03639049709150770

Cited by 30 publications

(16 citation statements)

References 6 publications

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“…The fluidizing air enters the fluidizing chamber through a small gap between the rotating friction plate and the wall of the product chamber. Several different names, such as rotary processor, 2 rotary fluidized bed, 3 rotary fluid bed granulator, 4 rotor fluidized bed granulator, 5 or fluid bed roto-granulator, 6 have been used in the literature. In this article, the term rotary processor is used.…”

Section: Introductionmentioning

confidence: 99%

Wet granulation in rotary processor and fluid bed: Comparison of granule and tablet properties

Kristensen

Hansen²

2006

AAPS PharmSciTech

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The aim of the present study was to investigate and compare granule and tablet properties of granules prepared by wet granulation in a rotary processor or a conventional fluid bed. For this purpose the working range of selected process variables was determined and a factorial study with 3 factors (equipment type, filler type, and liquid addition rate) and 1 covariate (fluidizing air flow rate) was performed. Two grades of calcium carbonate with different size and shape characteristics were applied, and the liquid addition and fluidizing air flow rates were investigated in the widest possible range. Dry mixtures of microcrystalline cellulose, polyvinyl povidone, calcium carbonate, and riboflavin, in a 10:5:84:1 ratio, were granulated in both types of equipment. The granulation end point was determined manually in the fluid bed and by torque measurements in the rotary processor. The filler type had a more pronounced effect on granular properties in the fluid bed, but the rotary processor showed a higher dependency on the investigated process variables. The rotary processor gave rise to more dense granules with better flow properties, but the fluid bed granules had slightly better compressional properties. Furthermore, the distribution of a low-dose drug was found to be more homogeneous in the rotary processor granules and tablets. Generally, wet granulation in a rotary processor was found to be a good alternative to conventional fluid bed granulation, especially when cohesive powders with poor flow properties or formulations with low drug content are to be granulated by a fluidizing air technique.

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Section: Introductionmentioning

confidence: 99%

Wet granulation in rotary processor and fluid bed: Comparison of granule and tablet properties

Kristensen

Hansen²

2006

AAPS PharmSciTech

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“…Too much binder may result in hard agglomerates that do not compress well, too little can lead to too friable granules. Finally the operation type (either discontinuous or continuous airflow mode) also affects the granulation process and the upper and lower LOD limits [13,[17][18][19][20][21][22][23][24][25][26]]. …”

Section: Process Variablesmentioning

confidence: 99%

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Lyngberg

Bijnens

Geens

et al. 2016

Methods in Pharmacology and Toxicology

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Historically application of mechanistic modeling approaches to processing steps in pharmaceutical oral solid dosage form manufacturing have been limited compared to similar efforts for small molecule synthesis. One plausible explanation may be that there has been a lack of fundamental governing equations for drug product processes. The general similarity of oral solid dosage form processes from product to product make models in this area highly reusable and they can be used for purposes such as reducing scale-up and technology transfer times as well as reducing material usage for these activities. In this chapter we describe three mechanistic models used in oral solid dosage form process development and manufacturing from the perspective of how they are developed, used, and linked with supporting empirical data. The three models cover fluid bed granulation, tablet coating, and spray drying. The focus of the chapter is to illustrate the importance of embedding the models into existing development, scale-up, and manufacturing workstreams such as to create a model enhanced workstream that is more efficient, faster, and better routed in science than the fully empirical approach. Such workstreams require verification of their performance before being fully operational which is also discussed.

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“…The rotary processor can be considered as a hybrid version of a fluidized bed and a spheronizer. It is referred by different names like the rotary processor,90 rotary fluidized bed,91 rotary fluid‐bed granulator,92 rotor fluidized bed granulator,93 or fluid‐bed roto‐granulator94 in the literature. A schematic of the fluid‐bed rotor granulator is shown in Figure 8.…”

Section: Fluidized Rotor Processor: Granulation and Spheronizationmentioning

confidence: 99%

Fluidization technologies: Aerodynamic principles and process engineering

Dixit

Puthli

2009

Journal of Pharmaceutical Sciences

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Application of Powder-Layering Technology and Film Coating for Manufacture of Sustained-Release Pellets Using a Rotary Fluid Bed Processor

Cited by 30 publications

References 6 publications

Wet granulation in rotary processor and fluid bed: Comparison of granule and tablet properties

Wet granulation in rotary processor and fluid bed: Comparison of granule and tablet properties

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Fluidization technologies: Aerodynamic principles and process engineering

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