Generic placeholder image

Current Drug Research Reviews


ISSN (Print): 2589-9775
ISSN (Online): 2589-9783

Review Article

SeDeM Expert System, an Innovative Tool for Developing Directly Compressible Tablets: A Review

Author(s): Inderbir Singh*, Ajay Kumar Thakur, Rajni Bala and Reecha Madan

Volume 13, Issue 1, 2021

Published on: 28 September, 2020

Page: [16 - 24] Pages: 9

DOI: 10.2174/2589977512666200928113716

Price: $65


Background: SeDeM (Sediment Delivery Model) expert system is a preformulation tool employed for evaluating direct compression suitability of various excipients. SeDeM is a 12 parameters derived diagram and SeDeM-ODT (Sediment Delivery Model-Orodispersible tablets) is a 15 parameters derived diagram that can be used as a research tool for reducing the product development time. The best possible excipients for a specified pharmaceutical active ingredient could be screened for direct compression suitability.

Objective: SeDeM expert system has been successfully used and implemented for characterizing galenic properties of pharmaceutical excipients, direct compression suitability of excipients, development of ODT formulations, development of sustained-release formulations, and development of tablets of taste-masked drugs.

Conclusion: In the present review paper, the development and applications of SeDeM and SeDeMODT systems have been discussed in detail.

Keywords: SeDeM, SeDeM-ODT, direct compression, excipients, tablets, application.

Graphical Abstract
Jivraj I, Martini LG, Thomson CM. An overview of the different excipients useful for the direct compression of tablets. Pharm Sci Technol Today 2000; 3(2): 58-63.
[] [PMID: 10664574]
Crooks MJ, Ho R. Ordered mixing in direct compression of tablets. Powder Technol 1976; 14: 161-7.
International Conference on Harmonization (ICH). Guidance for industry: Q8 (R2) pharmaceutical development, ICH harmonised tripartite guideline, step 4 2009.
Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008; 25(4): 781-91.
[] [PMID: 18185986]
Aguilar-Díaz JE, García-Montoya E, Pérez-Lozano P, Suñe-Negre JM, Miñarro M, Ticó JR. 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. Eur J Pharm Biopharm 2009; 73(3): 414-23.
[] [PMID: 19602435]
Suñé-Negre J, Garcia E, Lozano P, Díaz J, Carreras M, Fuster R, et al. SeDeM diagram: A new expert system for the formulation of drugs in solid form. Intech Open 2011.
Aguilar-Díaz JE, García-Montoya E, Pérez-Lozano P, Suñé-Negre JM, Miñarro M, Ticó JR. SeDeM expert system a new innovator tool to develop pharmaceutical forms. Drug Dev Ind Pharm 2014; 40(2): 222-36.
[] [PMID: 23343308]
Pérez P, Suñé-Negre JM, Miñarro M, et al. A new expert systems (SeDeM diagram) for control batch powder formulation and preformulation drug products. Eur J Pharm Biopharm 2006; 64(3): 351-9.
[] [PMID: 16949262]
Suñé-Negre JM, Pérez-Lozano P, Miñarro M, et al. Application of the SeDeM Diagram and a new mathematical equation in the design of direct compression tablet formulation. Eur J Pharm Biopharm 2008; 69(3): 1029-39.
[] [PMID: 18367387]
Scholtz JC, Steenekamp JH, Hamman JH, Tiedt LR. The SeDeM Expert Diagram System: Its performance and predictability in direct compressible formulations containing novel excipients and different types of active ingredients. Powder Technol 2017; 312: 222-36.
Hamman H, Hamman J, Wessels A, Scholtz J, Steenekamp JH. Development of multiple-unit pellet system tablets by employing the SeDeM expert diagram system I: Pellets with different sizes. Pharm Dev Technol 2018; 23(7): 706-14.
[] [PMID: 28612663]
Dai S, Xu B, Shi G, et al. SeDeM expert system for directly compressed tablet formulation: A review and new perspectives. Powder Technol 2019; 342: 517-27.
Nofrerias I, Nardi A, Suñé-P M, et al. Comparison between microcrystalline celluloses of different grades made by four manufacturers using the sedem diagram expert system as a pharmaceutical characterization tool. Powder Technol 2019; 342: 780-8.
Hamman H, Hamman J, Wessels A, Scholtz J, Steenekamp J. Development of multiple-unit pellet system tablets by employing the SeDeM expert diagram system II: Pellets containing different active pharmaceutical ingredients. Pharm Dev Technol 2019; 24(2): 145-56.
[] [PMID: 29394129]
Nofrerias I, Nardi A, Suñé-Pou M, et al. Formulation of direct compression zidovudine tablets to correlate the SeDeM dagram expert system and the rotary press simulator styl’one results. AAPS PharmSciTech 2019; 21(1): 1.
[] [PMID: 31712905]
Zieschang L, Klein M, Jung N, Krämer J, Windbergs M. Formulation development of medicated chewing gum tablets by direct compression using the SeDeM-Diagram-Expert-System Eur J Pharm Biopharm 2019; 144: 68-78.
Aguilar-Díaz JE, García-Montoya E, Suñe-Negre JM, Pérez-Lozano P, Miñarro M, Ticó JR. Predicting orally disintegrating tablets formulations of ibuprophen tablets: An application of the new SeDeM-ODT expert system. Eur J Pharm Biopharm 2012; 80(3): 638-48.
[] [PMID: 22245156]
Khan A, Iqbal Z, Ibrahim M, Nasir F, Ullah Z. 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 Technol 2015; 284: 411-7.
Gülbağ S, Yılmaz Usta D, Gültekin HE, et al. New perspective to develop memantine orally disintegrating tablet formulations: SeDeM expert system. Pharm Dev Technol 2018; 23(5): 512-9.
[] [PMID: 28657404]
Díaz JE, Garcia E, Pérez-Lozano P, Suñé-Negre J, Carmona M, Ticó J. New SeDeM-ODT expert system: An expert system for formulation of orodispersible tablets obtained by direct compression Woodhead Publishing Ltd. 2013; pp. pp. 137-154.
Sipos E, Oltean AR, Szabó ZI, Rédai E-M, Nagy GD. Application of SeDeM expert systems in preformulation studies of pediatric ibuprofen ODT tablets. Acta Pharm 2017; 67(2): 237-46.
[] [PMID: 28590910]
Saurí J, Millán D, Suñé-Negre JM, et al. The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression. Int J Pharm 2014; 461(1-2): 38-45.
[] [PMID: 24284019]
Ofori-Kwakye K, Mfoafo KA, Kipo SL, Kuntworbe N, Boakye-Gyasi ME. Development and evaluation of natural gum-based extended release matrix tablets of two model drugs of different water solubilities by direct compression. Saudi Pharm J 2016; 24(1): 82-91.
[] [PMID: 26903772]
Campiñez 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. Eur J Pharm Sci 2017; 100: 285-95.
[] [PMID: 28108361]
Singh I, Sharma B, Arora G. Application of SeDeM expert system in formulation and development of fast disintegrating tablets using starchglycine conjugates as superdisintegrant. Marmara Pharm J 2019; 23(5)
Wan S, Yang R, Zhang H, 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.
[] [PMID: 30746569]
Suñé-Negre JM, Roig M, Fuster R, et al. New classification of Directly Compressible (DC) excipients in function of the SeDeM Diagarm Expert System. Int J Pharm 2014; 470(1-2): 15-27.
[] [PMID: 24792976]
Singh I, Kumar P. Preformulation studies for direct compression suitability of cefuroxime axetil and paracetamol: A graphical representation using SeDeM diagram. Acta Pol Pharm 2012; 69(1): 87-93.
[PMID: 22574511]
Nardi-Ricart A, Nofrerias-Roig I, Suñé-Pou M, et al. Formulation of sustained release hydrophilic matrix tablets of tolcapone with the Application of SeDeM diagram: Influence of Tolcapone’s particle size on sustained release. Pharmaceutics 2020; 12(7): 674.
[] [PMID: 32708961]
Campiñez MD, Ferris C, de Paz MV, Aguilar-de-Leyva A, Galbis J, Caraballo I. A new biodegradable polythiourethane as controlled release matrix polymer. Int J Pharm 2015; 480(1-2): 63-72.
[] [PMID: 25579868]
Khan A. Optimization of the process variables of roller compaction, on the basis of granules characteristics (flow, mechanical strength, and disintegration behavior): An application of SeDeM-ODT expert system. Drug Dev Ind Pharm 2019; 45(9): 1537-46.
[] [PMID: 31210544]
Ahmed FR, Shoaib MH, Yousuf RI, et al. Clay nanotubes as a novel multifunctional excipient for the development of directly compressible diclofenac potassium tablets in a SeDeM driven QbD environment. Eur J Pharm Sci 2019; 133: 214-27.
[] [PMID: 30951825]
Casas M, Galdón E, Ojeda DJ, Caraballo I. Thermoplastic polyurethane as matrix forming excipient using direct and ultrasound-assisted compression. Eur J Pharm Sci 2019; 136: 104949.
[] [PMID: 31170527]
Flórez Borges P, García-Montoya E, Pérez-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.
[] [PMID: 29689061]
Khan A, Iqbal Z, Rehman Z, et al. Application of SeDeM Expert system in formulation development of effervescent tablets by direct compression. Saudi Pharm J 2014; 22(5): 433-44.
[] [PMID: 25473332]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy