Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure
Само за регистроване кориснике
2014
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
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.
Кључне речи:
Binder addition procedure / fluid bed / growth mechanism / hot melt / spray-onИзвор:
Drug Development and Industrial Pharmacy, 2014, 40, 1, 23-32Издавач:
- Informa Healthcare, London
Финансирање / пројекти:
- Развој производа и технологија које обезбеђују жељено ослобађање лековитих супстанци из чврстих фармацеутских облика (RS-MESTD-Technological Development (TD or TR)-34007)
DOI: 10.3109/03639045.2012.744415
ISSN: 0363-9045
PubMed: 23294368
WoS: 000328199300004
Scopus: 2-s2.0-84890545646
Институција/група
PharmacyTY - JOUR AU - Mašić, Ivana AU - Ilić, Ilija AU - Dreu, Rok AU - Ibrić, Svetlana AU - Parojčić, Jelena AU - Srcić, Stanko PY - 2014 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2179 AB - 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. PB - Informa Healthcare, London T2 - Drug Development and Industrial Pharmacy T1 - Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure VL - 40 IS - 1 SP - 23 EP - 32 DO - 10.3109/03639045.2012.744415 ER -
@article{ author = "Mašić, Ivana and Ilić, Ilija and Dreu, Rok and Ibrić, Svetlana and Parojčić, Jelena and Srcić, Stanko", year = "2014", 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.", publisher = "Informa Healthcare, London", journal = "Drug Development and Industrial Pharmacy", title = "Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure", volume = "40", number = "1", pages = "23-32", doi = "10.3109/03639045.2012.744415" }
Mašić, I., Ilić, I., Dreu, R., Ibrić, S., Parojčić, J.,& Srcić, S.. (2014). Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure. in Drug Development and Industrial Pharmacy Informa Healthcare, London., 40(1), 23-32. https://doi.org/10.3109/03639045.2012.744415
Mašić I, Ilić I, Dreu R, Ibrić S, Parojčić J, Srcić S. Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure. in Drug Development and Industrial Pharmacy. 2014;40(1):23-32. doi:10.3109/03639045.2012.744415 .
Mašić, Ivana, Ilić, Ilija, Dreu, Rok, Ibrić, Svetlana, Parojčić, Jelena, Srcić, Stanko, "Melt granulation in fluidized bed: a comparative study of spray-on versus in situ procedure" in Drug Development and Industrial Pharmacy, 40, no. 1 (2014):23-32, https://doi.org/10.3109/03639045.2012.744415 . .