Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters
Само за регистроване кориснике
2018
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Hot-melt coating is a novel and cost-effective solvent-free coating technique. Commonly used excipients for hot-melt coating are lipid substances. In this work, modified fluidized-bed system was applied for coating, and additional components were used to melt and convey the excipient to the fluidized-bed apparatus. Granules containing 20% (w/w) paracetamol were coated with Precirol((R)) ATO 5 at 9.1% (w/w) coating level. The aims of this study were to define a relationship between the three process parameters (fluidization airflow, atomization air pressure and spray rate) and characteristics of the coated granules using Box-Behnken experimental design, and to identify the design space for hot-melt coating of granules with desired mechanical and drug release properties. Response surface methodology was used for data analysis and modeling. We have found that interactions between the selected input parameters have pronounced influence on coated granules size, flowability and initial drug ...release rate. In addition, granules size distribution is strongly influenced by fluidization airflow and atomization air pressure. Granules flowability, and total and partial areas under the drug release curve were recognized as critical quality attributes of the coated granules. Design space was determined by all three process parameters which can be referred to as critical process parameters.
Кључне речи:
Granules / Paracetamol / Glycerol distearate / Size distribution / Flowability / Drug releaseИзвор:
Journal of Drug Delivery Science and Technology, 2018, 46, 274-284Издавач:
- Elsevier Science BV, Amsterdam
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: 10.1016/j.jddst.2018.05.030
ISSN: 1773-2247
WoS: 000438500700033
Scopus: 2-s2.0-85047633248
Институција/група
PharmacyTY - JOUR AU - Milanović, Ana AU - Aleksić, Ivana AU - Ibrić, Svetlana AU - Parojčić, Jelena AU - Cvijić, Sandra PY - 2018 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3034 AB - Hot-melt coating is a novel and cost-effective solvent-free coating technique. Commonly used excipients for hot-melt coating are lipid substances. In this work, modified fluidized-bed system was applied for coating, and additional components were used to melt and convey the excipient to the fluidized-bed apparatus. Granules containing 20% (w/w) paracetamol were coated with Precirol((R)) ATO 5 at 9.1% (w/w) coating level. The aims of this study were to define a relationship between the three process parameters (fluidization airflow, atomization air pressure and spray rate) and characteristics of the coated granules using Box-Behnken experimental design, and to identify the design space for hot-melt coating of granules with desired mechanical and drug release properties. Response surface methodology was used for data analysis and modeling. We have found that interactions between the selected input parameters have pronounced influence on coated granules size, flowability and initial drug release rate. In addition, granules size distribution is strongly influenced by fluidization airflow and atomization air pressure. Granules flowability, and total and partial areas under the drug release curve were recognized as critical quality attributes of the coated granules. Design space was determined by all three process parameters which can be referred to as critical process parameters. PB - Elsevier Science BV, Amsterdam T2 - Journal of Drug Delivery Science and Technology T1 - Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters VL - 46 SP - 274 EP - 284 DO - 10.1016/j.jddst.2018.05.030 ER -
@article{ author = "Milanović, Ana and Aleksić, Ivana and Ibrić, Svetlana and Parojčić, Jelena and Cvijić, Sandra", year = "2018", abstract = "Hot-melt coating is a novel and cost-effective solvent-free coating technique. Commonly used excipients for hot-melt coating are lipid substances. In this work, modified fluidized-bed system was applied for coating, and additional components were used to melt and convey the excipient to the fluidized-bed apparatus. Granules containing 20% (w/w) paracetamol were coated with Precirol((R)) ATO 5 at 9.1% (w/w) coating level. The aims of this study were to define a relationship between the three process parameters (fluidization airflow, atomization air pressure and spray rate) and characteristics of the coated granules using Box-Behnken experimental design, and to identify the design space for hot-melt coating of granules with desired mechanical and drug release properties. Response surface methodology was used for data analysis and modeling. We have found that interactions between the selected input parameters have pronounced influence on coated granules size, flowability and initial drug release rate. In addition, granules size distribution is strongly influenced by fluidization airflow and atomization air pressure. Granules flowability, and total and partial areas under the drug release curve were recognized as critical quality attributes of the coated granules. Design space was determined by all three process parameters which can be referred to as critical process parameters.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Drug Delivery Science and Technology", title = "Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters", volume = "46", pages = "274-284", doi = "10.1016/j.jddst.2018.05.030" }
Milanović, A., Aleksić, I., Ibrić, S., Parojčić, J.,& Cvijić, S.. (2018). Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters. in Journal of Drug Delivery Science and Technology Elsevier Science BV, Amsterdam., 46, 274-284. https://doi.org/10.1016/j.jddst.2018.05.030
Milanović A, Aleksić I, Ibrić S, Parojčić J, Cvijić S. Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters. in Journal of Drug Delivery Science and Technology. 2018;46:274-284. doi:10.1016/j.jddst.2018.05.030 .
Milanović, Ana, Aleksić, Ivana, Ibrić, Svetlana, Parojčić, Jelena, Cvijić, Sandra, "Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters" in Journal of Drug Delivery Science and Technology, 46 (2018):274-284, https://doi.org/10.1016/j.jddst.2018.05.030 . .