New perspective to develop memantine orally disintegrating tablet formulations: SeDeM expert system

Abstract

Nowadays pharmaceutical industries and regulatory authorities suggest new approaches such as Quality by Design principles to reduce experiments of formulation studies, improve product quality, save cost and time. SeDeM Expert System is a predictive approach for the preformulation studies and it provides information about suitability of API for direct compression by evaluating 12 parameters. The system also allows selecting appropriate excipients by determining same parameters to improve compressibility of API. The objective of this study was to develop direct compressed memantine orally disintegrating tablets using SeDeM Expert System. Memantine was found to have poor flow and compressibility properties. Three different direct compressibility and super disintegrating agents (Ludiflash, Ludipress and Parteck) were used to improve compressibility of memantine and according to SeDeM diagrams, Parteck was selected for final formulation. Memantine direct compressed tablets showed proper friability, hardness and thickness. The disintegration time of the tables were found below 15 s which was suitable for ODTs. It was found that SeDeM Expert System was easy to use and application of this method provided to develop memantine direct compressed ODT formulation was successful.

Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives

“…Some processed excipients like Ludiflash, Pharmaburst, F-melt, and modified chitosan are introduced to improve formulations, decrease wastage of material, and tackle problems such as compressibility, hygroscopicity, flowability, palatability, dissolution, and disintegration. These excipients are designed by the SeDeM expert system which includes several parameters in assessing excipients to attain a suitable powder characteristic prior to compression [23,24]. Excipients like mannitol are used as diluents, but its modified type has many other valuable characteristics like higher stability, increased total surface size, and larger pore size that finally lead to a cost-effective product [25].…”

SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™

“…In SeDeM-based assessment, twelve micromeritics parameters are linearized for the comparative evaluation of the physical characteristics of powders. This system has been used frequently for the pre-formulation assessment of immediate release dosage forms, for example, Gülbağ et al, in 2018 applied SeDeM as an expert tool to develop directly compressed memantine orally disintegrating tablets, using Ludiflash ® , Ludipress ® , and Parteck ® to improve compressibility of the drug (Gülbağ et al, 2018). In the current study for prolonged and effective pain management, controlled release tramadol osmotic tablet formulation was developed, and the SeDeM expert tool was applied for precompression evaluation of formulation ingredients.…”

Mathematical approaches for powders and multiparticulate units processability characterization in pharmaceutical development

“…Some parameter limits suggested should be further analyzed and revised. For example, powder flow is expressed for a 100 g sample, but it may be lowered to 40 g, as suggested by Gülbağ et al (29), to obtain relevant data, particularly when the amount of the sample available is limited. Compact hardness (0-200 N) could be replaced by compact tensile strength, which is a more standardized parameter describing mechanical properties and enabling comparison between compacts of different sizes.…”