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Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure.
Drug Dev Ind Pharm. 2014 Jan; 40(1):23-32.DD

Abstract

OBJECTIVE

The aim of this study was to investigate the influence of process parameters, binder content and binder addition method on characteristics of the granules obtained by melt granulation (MG) in fluidized bed.

METHODS

Spray-on experiments were performed according to 2(3) full factorial design. The effect of binder content, molten binder feed rate, and spray air pressure on granule size and size distribution, granule shape, flowability and drug release rate was investigated. In the in situ experiments, the influence of binder particle size and binder content was evaluated. Solid-state characterization was performed by means of differential scanning calorimetry, X-ray powder diffraction and Fourier transform infrared spectroscopy.

RESULTS

Size of the granules obtained by spray-on procedure was significantly influenced by binder content and spray air pressure, while the width of particle size distribution was mainly affected by binder feed rate. Spray air pressure showed the most significant influence on granule shape. It was shown that smooth and spherical particles with good flow properties may be obtained by both procedures, spray-on and in situ MG. The results obtained indicated the influence of agglomeration mechanism on granule sphericity, with higher degree of granule sphericity observed when immersion and layering was the dominant mechanism. Paracetamol release from granulates was very rapid, but after compression of the granules into tablets, drug release was considerably slower. Solid-state analysis confirmed that the physical form of the granulate components remained unaffected after the MG process.

CONCLUSION

The results presented indicate that MG in fluidized bed could be a good alternative to conventional granulation techniques.

Authors+Show Affiliations

Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Belgrade , Belgrade , Serbia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23294368

Citation

Mašić, Ivana, et al. "Melt Granulation in Fluidized Bed: a Comparative Study of Spray-on Versus in Situ Procedure." Drug Development and Industrial Pharmacy, vol. 40, no. 1, 2014, pp. 23-32.
Mašić I, Ilić I, Dreu R, et al. Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure. Drug Dev Ind Pharm. 2014;40(1):23-32.
Mašić, I., Ilić, I., Dreu, R., Ibrić, S., Parojčić, J., & Srčič, S. (2014). Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure. Drug Development and Industrial Pharmacy, 40(1), 23-32. https://doi.org/10.3109/03639045.2012.744415
Mašić I, et al. Melt Granulation in Fluidized Bed: a Comparative Study of Spray-on Versus in Situ Procedure. Drug Dev Ind Pharm. 2014;40(1):23-32. PubMed PMID: 23294368.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure. AU - Mašić,Ivana, AU - Ilić,Ilija, AU - Dreu,Rok, AU - Ibrić,Svetlana, AU - Parojčić,Jelena, AU - Srčič,Stanko, Y1 - 2013/01/07/ PY - 2013/1/9/entrez PY - 2013/1/9/pubmed PY - 2014/8/30/medline SP - 23 EP - 32 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 40 IS - 1 N2 - OBJECTIVE: The aim of this study was to investigate the influence of process parameters, binder content and binder addition method on characteristics of the granules obtained by melt granulation (MG) in fluidized bed. METHODS: Spray-on experiments were performed according to 2(3) full factorial design. The effect of binder content, molten binder feed rate, and spray air pressure on granule size and size distribution, granule shape, flowability and drug release rate was investigated. In the in situ experiments, the influence of binder particle size and binder content was evaluated. Solid-state characterization was performed by means of differential scanning calorimetry, X-ray powder diffraction and Fourier transform infrared spectroscopy. RESULTS: Size of the granules obtained by spray-on procedure was significantly influenced by binder content and spray air pressure, while the width of particle size distribution was mainly affected by binder feed rate. Spray air pressure showed the most significant influence on granule shape. It was shown that smooth and spherical particles with good flow properties may be obtained by both procedures, spray-on and in situ MG. The results obtained indicated the influence of agglomeration mechanism on granule sphericity, with higher degree of granule sphericity observed when immersion and layering was the dominant mechanism. Paracetamol release from granulates was very rapid, but after compression of the granules into tablets, drug release was considerably slower. Solid-state analysis confirmed that the physical form of the granulate components remained unaffected after the MG process. CONCLUSION: The results presented indicate that MG in fluidized bed could be a good alternative to conventional granulation techniques. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/23294368/Melt_granulation_in_fluidized_bed:_a_comparative_study_of_spray_on_versus_in_situ_procedure_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2012.744415 DB - PRIME DP - Unbound Medicine ER -