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Prilling of API/fatty acid suspensions : screening of additives for drug release modification

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Abstract
Current study screened additives which could modify the drug release from prills made of an active pharmaceutical ingredient/fatty acid (API/FA) suspension, without negatively influencing the processability and/or stability of the formulation. Therefore, 11 additives (i.e. emulsifiers, pore-formers and FA-based lubricants) were added in a 20% concentration to a paracetamol/behenic acid formulation. Two additives, Kolliphor (R) P338 and P407 provided complete drug release in less than 1 h, as their thermoreversible gel formation resulted in a disintegration of the prills. Lower Kolliphor (R) P338 or P407 concentrations (2.5-10%) resulted in a complete but slower drug release in 24 h as the prills no longer disintegrated and the release mechanism was dominated by pore-formation. Prills with a robust drug release profile (i.e. independent of pH and surfactant concentration of the dissolution medium) were obtained after the addition of >= 5% Kolliphor (R) P338 or P407 to the FA-based formulation. Based on a 6-month stability study, it was concluded that Kolliphor (R) P407 was a suitable additive to modify the drug release profile of API/FA suspension-based prills when formulations were stored below 25 degrees C at low relative humidity.
Keywords
Prilling, Controlled release, Multiparticulate dosage forms, Fatty acids, Paracetamol, Poloxamers, FATTY-ACIDS, POLOXAMERS, DISINTEGRATION, ACETAMINOPHEN, MICROSPHERES, PREDICTION, STABILITY, RHEOLOGY, POLYMER, AGENTS

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MLA
De Coninck, Elien, et al. “Prilling of API/Fatty Acid Suspensions : Screening of Additives for Drug Release Modification.” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 576, 2020, doi:10.1016/j.ijpharm.2020.119022.
APA
De Coninck, E., Vanhoorne, V., Boone, M., Van Assche, G., De Geest, B., De Beer, T., & Vervaet, C. (2020). Prilling of API/fatty acid suspensions : screening of additives for drug release modification. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 576. https://doi.org/10.1016/j.ijpharm.2020.119022
Chicago author-date
De Coninck, Elien, Valérie Vanhoorne, Matthieu Boone, G Van Assche, Bruno De Geest, Thomas De Beer, and Chris Vervaet. 2020. “Prilling of API/Fatty Acid Suspensions : Screening of Additives for Drug Release Modification.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 576. https://doi.org/10.1016/j.ijpharm.2020.119022.
Chicago author-date (all authors)
De Coninck, Elien, Valérie Vanhoorne, Matthieu Boone, G Van Assche, Bruno De Geest, Thomas De Beer, and Chris Vervaet. 2020. “Prilling of API/Fatty Acid Suspensions : Screening of Additives for Drug Release Modification.” INTERNATIONAL JOURNAL OF PHARMACEUTICS 576. doi:10.1016/j.ijpharm.2020.119022.
Vancouver
1.
De Coninck E, Vanhoorne V, Boone M, Van Assche G, De Geest B, De Beer T, et al. Prilling of API/fatty acid suspensions : screening of additives for drug release modification. INTERNATIONAL JOURNAL OF PHARMACEUTICS. 2020;576.
IEEE
[1]
E. De Coninck et al., “Prilling of API/fatty acid suspensions : screening of additives for drug release modification,” INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 576, 2020.
@article{8654810,
  abstract     = {{Current study screened additives which could modify the drug release from prills made of an active pharmaceutical ingredient/fatty acid (API/FA) suspension, without negatively influencing the processability and/or stability of the formulation. Therefore, 11 additives (i.e. emulsifiers, pore-formers and FA-based lubricants) were added in a 20% concentration to a paracetamol/behenic acid formulation. Two additives, Kolliphor (R) P338 and P407 provided complete drug release in less than 1 h, as their thermoreversible gel formation resulted in a disintegration of the prills. Lower Kolliphor (R) P338 or P407 concentrations (2.5-10%) resulted in a complete but slower drug release in 24 h as the prills no longer disintegrated and the release mechanism was dominated by pore-formation. Prills with a robust drug release profile (i.e. independent of pH and surfactant concentration of the dissolution medium) were obtained after the addition of >= 5% Kolliphor (R) P338 or P407 to the FA-based formulation. Based on a 6-month stability study, it was concluded that Kolliphor (R) P407 was a suitable additive to modify the drug release profile of API/FA suspension-based prills when formulations were stored below 25 degrees C at low relative humidity.}},
  articleno    = {{119022}},
  author       = {{De Coninck, Elien and Vanhoorne, Valérie and Boone, Matthieu and Van Assche, G and De Geest, Bruno and De Beer, Thomas and Vervaet, Chris}},
  issn         = {{0378-5173}},
  journal      = {{INTERNATIONAL JOURNAL OF PHARMACEUTICS}},
  keywords     = {{Prilling,Controlled release,Multiparticulate dosage forms,Fatty acids,Paracetamol,Poloxamers,FATTY-ACIDS,POLOXAMERS,DISINTEGRATION,ACETAMINOPHEN,MICROSPHERES,PREDICTION,STABILITY,RHEOLOGY,POLYMER,AGENTS}},
  language     = {{eng}},
  pages        = {{12}},
  title        = {{Prilling of API/fatty acid suspensions : screening of additives for drug release modification}},
  url          = {{http://dx.doi.org/10.1016/j.ijpharm.2020.119022}},
  volume       = {{576}},
  year         = {{2020}},
}

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