P10A.5412
Course Information
Course Semester Plan
Course Information
| No | Module Name | Pharmaceutical Engineering |
| 1 | Code of Subjects | P10A.5412 |
| 2 | Study load | 2(2-0) credits |
| 3 | Semester | 5 |
| 4 | Precondition | There is no |
| 5 | Competence | After completing this course, students are able to apply a comprehensive quality assurance concept (Total Quality Management / TQM) related to the processing of pharmaceutical products when increasing their product capacity (Scale Up) |
| 6 | Elements of Competency | MKK |
| 7 | Type Competency | Supporting competence |
| 8 | Syllabus | This course contains the following subjects: Introduction to Pharmaceutical Engineering, Relationship between CPP and QTPP, Introduction to Transfer Technology, Mass Transfer, Heat and Momentum, Crystallization, Powder Handling, Scale Up, Scale Up for Pharmaceutical Raw Material products, Solids Preparations, Liquid Preparations – Semisolides, and Biotechnology Preparations, Quality Risk Management. |
| 9 | Attribute Soft Skill | Ethics, awareness, discipline |
| 10 | Learning methods | Lecture and discussion |
| 11 | Learning Media | LCD Projector |
| 12 | Appraisal | Task (20%); Mid Exam (40%); Final Exam (40%) |
| 13 | Lecturer | Dr. Yoga Windhu Wardhana, M.Si., and Apt. Dr. Dolih Ghozali, M.S., Apt. |
| 14 | References | Dengale, S.J., Grohganz, H., Rades, T., L¨obmann, K., 2016. Recent advances in co- amorphous drug formulations. Adv. Drug Deliv. Rev. 100, 116–125. https://doi.org/ 10.1016/j.addr.2015.12.009. Dengale, S.J., Ranjan, O.P., Hussen, S.S., Krishna, B.S.M., Musmade, P.B., Gautham Shenoy, G., Bhat, K., 2014. Preparation and characterization of co-amorphous ritonavir-indomethacin systems by solvent evaporation technique: Improved dissolution behavior and physical stability without evidence of intermolecular interactions. Eur. J. Pharm. Sci. 62, 57–64. https://doi.org/10.1016/j. ejps.2014.05.015. Dening, T.J., Taylor, L.S., 2018. Supersaturation potential of ordered mesoporous silica delivery systems. Part 1: Dissolution performance and drug membrane transport rates. Mol. Pharm. 15, 3489–3501. https://doi.org/10.1021/acs. molpharmaceut.8b00488. Dening, T.J., Zemlyanov, D., Taylor, L.S., 2019. Application of an adsorption isotherm to explain incomplete drug release from ordered mesoporous silica materials under supersaturating conditions. J. Control. Release 307, 186–199. https://doi.org/ 10.1016/j.jconrel.2019.06.028. Skorupska, E., Jeziorna, A., Potrzebowski, M.J., 2016. Thermal solvent-free method of loading of pharmaceutical cocrystals into the pores of silica particles: A case of naproxen/picolinamide cocrystal. J. Phys. Chem. C 120, 13169–13180. https://doi. org/10.1021/acs.jpcc.6b05302. Skorupska, E., Ka´zmierski, S., Potrzebowski, M.J., 2017. Solid state NMR characterization of ibuprofen:nicotinamide cocrystals and new idea for controlling release of drugs embedded into mesoporous silica particles. Mol. Pharm. 14, 1800–1810. https://doi.org/10.1021/acs.molpharmaceut.7b00092. Skorupska, E., Paluch, P., Jeziorna, A., Potrzebowski, M.J., 2015. NMR study of BA/FBA cocrystal confined within mesoporous silica nanoparticles employing thermal solid phase transformation. J. Phys. Chem. C 119, 8652–8661. https://doi.org/10.1021/ jp5123008. Zhao Z, Katai H, Higashi K, Ueda K, Kawakami K, Moribe K. Cryo-TEM and AFM observation of the time-dependent evolution of amorphous probucol nanoparticles formed by the aqueous dispersion of ternary solid dispersions. Molecular pharmaceutics. 2019 Mar 29;16(5):2184-98. Okada H, Ueda K, Yasuda Y, Higashi K, Inoue M, Ito M, Noguchi S, Kawakami K, Moribe K. Correlation between drug dissolution and resistance to water-induced phase separation in solid dispersion formulations revealed by solid-state NMR spectroscopy. International journal of pharmaceutics. 2020 Mar 15;577:119086. Budiman A, Higashi K, Ueda K, Moribe K. Effect of drug-coformer interactions on drug dissolution from a coamorphous in mesoporous silica. International Journal of Pharmaceutics. 2021 May 1;600:120492. Sunazuka Y, Ueda K, Higashi K, Tanaka Y, Moribe K. Combined effects of the drug distribution and mucus diffusion properties of self-microemulsifying drug delivery systems on the oral absorption of fenofibrate. International journal of pharmaceutics. 2018 Jul 30;546(1-2):263-71. Ueda, K., Higashi, K. and Moribe, K., 2021. Amorphous Drug Solubility and Maximum Free Drug Concentrations in Cyclodextrin Solutions: A Quantitative Study Using NMR Diffusometry. Molecular Pharmaceutics, 18(7), pp.2764-2776. Shevchenko, A., Miroshnyk, I., Pietilä, L.O., Haarala, J., Salmia, J., Sinervo, K., Mirza, S., van Veen, B., Kolehmainen, E. and Yliruusi, J., 2013. Diversity in itraconazole cocrystals with aliphatic dicarboxylic acids of varying chain length. Crystal growth & design, 13(11), pp.4877-4884. |
Course Semester Plan