Open Access Peer-reviewed Review

SeDeM Expert System: A review and new perspectives

Article Sidebar

SeDeM Diagram
Download PDF Download HTML
Submitted   Apr 4, 2019
Published   Apr 24, 2019
Issue    Vol 1 No 1 (2019)
DOI   10.25082/JPBR.2019.01.005

Views

3813

Downloads

2820

Citations

PlumX Metrics

Main Article Content

Huimin Sun corresponding author
National Institutes for Food and Drug Control, Beijing 100050, China
Mingxian Gu
Chongqing University of Science and Technology, Chongqing 401331, China
Tianbing Guan
Chongqing University of Science and Technology, Chongqing 401331, China
Shulin Wan
Chongqing University of Science and Technology, Chongqing 401331, China
Han Zhang
Chongqing University of Science and Technology, Chongqing 401331, China
Xuelian Li
Chongqing University of Science and Technology, Chongqing 401331, China
Songtao Kong
Chongqing University of Science and Technology, Chongqing 401331, China
Jianbing Ren
Chongqing University of Science and Technology, Chongqing 401331, China; Chongqing LIYUN Nozzle Co., Ltd., Chongqing 401332, China
Chuanyun Dai
Chongqing University of Science and Technology, Chongqing 401331, China

Abstract

The SeDeM Expert System was first known as a galenic pre-formulation system, which was based on the experimental research and quantitative determination of powdered substances. And the mathematical formula provided by the SeDeM Expert System has plays an important role in the study of powder properties. The system can be used not only to evaluate the powder direct compression (DC) of excipients and active pharmaceutical ingredients (API's), but also to predict the possible formulations, so it can reduce unnecessary research and trials, and shorten the time of development. In this paper, the research development and application of SeDeM Expert System in DC was summarized, and the results showed that with a few exceptions, the system was skilled in predicting acceptable tablet formulations. Finally, the new application prospect of the system is presented, including the application of the Internet traffic and content management (iTCM) database and the new co-processed excipients.

Keywords
SeDeM Expert System, radar graph, powder, direct compression, pre-formulation, co-processed

Article Details

How to Cite
Sun, H., Gu, M., Guan, T., Wan, S., Zhang, H., Li, X., Kong, S., Ren, J., & Dai, C. (2019). SeDeM Expert System: A review and new perspectives. Journal of Pharmaceutical and Biopharmaceutical Research, 1(1), 36-47. https://doi.org/10.25082/JPBR.2019.01.005
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

References

  1. Chun-Sheng G. Direct compression technique:a promoter of pharmaceutical industrial development. Journal of International Pharmaceutical Research, 2009, 36(1): 1-5.
  2. Li Z, Zhao L, Lin X, et al. Direct compaction: An update of materials, trouble-shooting, and application. International Journal of Pharmaceutics, 2017, 529(1-2):5 43. https://doi.org/10.1016/j.ijpharm.2017.07.035
  3. JM SN, Carreras R, García F, et al. Nueva metodología de preformulación galénica para la caracterización de sustancias en relación a su viabilidad para la compresión: Diagrama SeDeM. Cienc Tecnol Pharm, 2005, 15(3): 125-136.
  4. Neǵre JMS, Carreras MR, García RF, et al. SeDeM Diagram: an expert system for preformation, characterization and optimization of tablets obtained by direct compression. Formulation Tools for Pharmaceutical Development. Elsevier, 2013: 109-135. https://doi.org/10.1533/9781908818508.109
  5. Rowe RC, Sheskey PJ, Cook WG, et al. Handbook of Pharmaceutical Excipients Pharmaceutical development and technology. 2006, 18(2): 544. https://doi.org/10.3109/10837450.2012.751408
  6. Josep M. Suñé-Negre, Pilar Pérez-Lozano, Roig M , et al. Optimization of parameters of the SeDeM Diagram Expert System: Hausner index (IH) and relative humidity (%RH). European Journal of Pharmaceutics & Biopharmaceutics, 2011, 79(2): 0-472. https://doi.org/10.1016/j.ejpb.2011.04.002
  7. Negre JMS, Montoya EG, Lozano PPr, et al. SeDeM diagram: a new expert system for the formulation of drugs in solid form. Expert systems for human, materials and automation. InTech, 2011: 392.
  8. RC M. United States Pharmacopeia-National Formulary. JExcipients and Food Chem. 2015, 6(3): 61-64.
  9. Reynolds GK, Campbell JI and Roberts RJ. A compressibility based model for predicting the tensile strength of directly compressed pharmaceutical powder mixtures. International Journal of Pharmaceutics, 2017, 531(1): 215-224. https://doi.org/10.1016/j.ijpharm.2017.08.075
  10. Nofrerias I, Nardi A, Sune-Pou M, et al. Optimization of the Cohesion Index in the SeDeM Diagram Expert System and application of SeDeM Diagram: An improved methodology to determine the Cohesion Index. PLoS One, 2018, 13(9): e0203846. https://doi.org/10.1371/journal.pone.0203846
  11. Aguilar-Diaz JE, Garcia-Montoya E, Sune-Negre JM, et al. Predicting orally disintegrating tablets formulations of ibuprophen tablets: an application of the new SeDeM-ODT expert system. European journal of pharmaceutics and biopharmaceutics, 2012; 80(3): 638-648. https://doi.org/10.1016/j.ejpb.2011.12.012
  12. Zhang Y, Che E, Zhang M, et al. Increasing the dissolution rate and oral bioavailability of the poorly water-soluble drug valsartan using novel hierarchical porous carbon monoliths. International Journal of Pharmaceutics, 2014, 473(1-2): 375-383. https://doi.org/10.1016/j.ijpharm.2014.07.024
  13. Zhang Y, Xu B, Wang X, et al. Setting up multivariate specifications on critical raw material attributes to ensure consistent drug dissolution from high drug-load sustained-release matrix tablet. Drug development and industrial pharmacy, 2018, 44(11): 1733-1743. https://doi.org/10.1080/03639045.2018.1492608
  14. Perez P, Sune-Negre JM, Minarro M, et al. A new expert systems (SeDeM diagram) for control batch powder formulation and preformulation drug products. European journal of pharmaceutics and biopharmaceutics, 2006, 64(3): 351-359. https://doi.org/10.1016/j.ejpb.2006.06.008
  15. Aguilar-Diaz JE, Garcia-Montoya E, Perez-Lozano P, et al. The use of the SeDeM Diagram expert system to determine the suitability of diluents-disintegrants for direct compression and their use in formulation of ODT. European journal of pharmaceutics and biopharmaceutics , 2009, 73(3): 414-423. https://doi.org/10.1016/j.ejpb.2009.07.001
  16. Joseph MSN, Perez-Lozano P, Minarro M, et al. Application of the SeDeM Diagram and a new mathematical equation in the design of direct compression tablet formulation. European journal of pharmaceutics and biopharmaceutics, 2008, 69(3): 1029-1039. https://doi.org/10.1016/j.ejpb.2008.01.020
  17. Sulin Wan, Rui Yang, Han Zhang, et al. Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient. AAPS PharmSciTech, 2019, 20(3): 105. https://doi.org/10.1208/s12249-019-1320-4
  18. Sune-Negre JM, Roig M, Fuster R, et al. New classification of directly compressible (DC) excipients in function of the SeDeM Diagarm Expert System. International Journal of Pharmaceutics. 2014, 470(1-2): 15-27. https://doi.org/10.1016/j.ijpharm.2014.04.068
  19. Scholtz JC, Steenekamp JH, Hamman JH, et al. The SeDeM Expert Diagram System: Its performance and predictability in direct compressible formulations containing novel excipients and different types of active ingredients. Powder Technology, 2017, 312: 222-236. https://doi.org/10.1016/j.powtec.2017.02.019
  20. Singh I and Kumar P. Preformulation studies for direct compression suitability of cefuroxime axetil and paracetamol: a graphical representation using SeDeM diagram. Acta poloniae pharmaceutica, 2012, 69(1): 87-93.
  21. Aguilar JE, Montoya EG, Lozano PP, et al. New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression. Formulation tools for pharmaceutical development, 2013: 137-154. https://doi.org/10.1533/9781908818508.137
  22. Campiñez MD, Casas M, Caraballo I. Characterisation of the Ability of Carbamazepine for Processing It through Direct Compression Applying the New Expert System SeDeM. International Journal of Clinical Pharmacology & Pharmacotherapy, 2016, 1(1): 105. https://doi.org/10.15344/2456-3501/2016/105
  23. Dasankoppa FS, Sajjanar VM, Sholapur H, et al. Application of SeDeM ODT Expert System in Formulation Development of Orodispersible Tablets of Antihyperlipidemic Agent. Journal of Young Pharmacists, 2017, 9(2): 203-208. https://doi.org/10.5530/jyp.2017.9.40
  24. Sipos E, Oltean AR, Szabó ZI, et al. Application of SeDeM expert systems in preformulation studies of pediatric ibuprofen ODT tablets. Acta pharmaceutica. 2017, 67(2): 237-246. https://doi.org/10.1515/acph-2017-0017
  25. Campinez MD, Benito E, Romero-Azogil L, et al. Development and characterization of new functionalized polyurethanes for sustained and site-specific drug release in the gastrointestinal tract. European journal of pharmaceutical sciences, 2017, 100: 285-295. https://doi.org/10.1016/j.ejps.2017.01.017
  26. Sauri J, Millan D, Sune-Negre JM, et al. The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression. International Journal of Pharmaceutics, 2014, 461(1-2): 38-45. https://doi.org/10.1016/j.ijpharm.2013.11.029
  27. Ofori-Kwakye K, Mfoafo KA, Kipo SL, et al. Development and evaluation of natural gum-based extended release matrix tablets of two model drugs of different water solubilities by direct compression. Saudi Pharmaceutical Journal, 2016, 24(1): 82-91. https://doi.org/10.1016/j.jsps.2015.03.005
  28. Khan A, Iqbal Z, Rehman Z, et al. Application of SeDeM Expert system in formulation development of effervescent tablets by direct compression. Saudi Pharmaceutical Journal, 2014, 22(5): 433-444. https://doi.org/10.1016/j.jsps.2013.07.002
  29. Khan A, Iqbal Z, Ibrahim M, et al. Prediction of the effect of taste masking on disintegration behavior, mechanical strength and rheological characteristics of highly water soluble drug (itopride HCl); an application of SeDeM-ODT expert system. Powder Technology, 2015, 284: 411-417. https://doi.org/10.1016/j.powtec.2015.06.062
  30. Campinez MD, Ferris C, de Paz MV, et al. A new biodegradable polythiourethane as controlled release matrix polymer. International Journal of Pharmaceutics, 2015, 480(1-2): 63-72. https://doi.org/10.1016/j.ijpharm.2015.01.011
  31. Florez Borges P, Garcia-Montoya E, Perez-Lozano P, et al. The role of SeDeM for characterizing the active substance and polyvinyilpyrrolidone eliminating metastable forms in an oral lyophilizate-A preformulation study. PLoS One, 2018, 13(4): e0196049. https://doi.org/10.1371/journal.pone.0196049
  32. Zhang Y, Xu B, Sun F, et al. Physical fingerprint for quality control of traditional Chinese medicine extract powders. China Journal of Chinese Materia Medica, 2016, 41(12): 2221-2227.
  33. Hamman H, Hamman J, Wessels A, et al. Development of multiple-unit pellet system tablets by employing the SeDeM expert diagram system I: pellets with different sizes. Pharmaceutical development and technology, 2018, 23(7): 706-714. https://doi.org/10.1080/10837450.2017.1342657
  34. Hamman H, Hamman J, Wessels A, et al. Development of multiple-unit pellet system tablets by employing the SeDeM expert diagram system II: pellets containing different active pharmaceutical ingredients. Pharmaceutical development and technology, 2019, 24(2): 145-156. https://doi.org/10.1080/10837450.2018.1435691
  35. Wen C, Zhang J, Zhang H, et al. Advances in ultrasound assisted extraction of bioactive compounds from cash crops-A review. Ultrason Sonochem, 2018, 48: 538-549. https://doi.org/10.1016/j.ultsonch.2018.07.018
  36. Reimerdes D. The near future of tablet excipients. Manufacturing chemist, 1993, 64(7): 14-15.
  37. Russell R. Synthetic excipients challenge all-natural organics: Offer advantages. Pharmaceutical technology, 2004, 28(4): 38-50.
  38. Garg N, Pandey P, Kaushik D, et al. Development of novel multifunction directly compressible co-processed excipient by melt granulation technique. International Journal of Pharmaceutical Investigation, 2015, 5(4): 266-274. https://doi.org/10.4103/2230-973X.167692
  39. Chauhan SI, Nathwani SV, Soniwala MM, et al. Development and Characterization of Multifunctional Directly Compressible Co-processed Excipient by Spray Drying Method. AAPS PharmSciTech, 2017, 18(4): 1293-1301. https://doi.org/10.1208/s12249-016-0598-8
  40. Gohel MC and Jogani PD. A review of co-processed directly compressible excipients. Journal of Pharmacy & Pharmaceutical Sciences, 2004, 8(1): 76-93.