Application of Dominance-Based Rough Set Approach for Optimization of Pellets Tableting Process

Abstract

Multiple-unit pellet systems (MUPS) offer many advantages over conventional solid dosage forms both for the manufacturers and patients. Coated pellets can be efficiently compressed into MUPS in classic tableting process and enable controlled release of active pharmaceutical ingredient (APIs). For patients MUPS are divisible without affecting drug release and convenient to swallow. However, maintaining API release profile during the compression process can be a challenge. The aim of this work was to explore and discover relationships between data describing: composition, properties, process parameters (condition attributes) and quality (decision attribute, expressed as similarity factor f2) of MUPS containing pellets with verapamil hydrochloride as API, by applying a dominance-based rough ret approach (DRSA) mathematical data mining technique. DRSA generated decision rules representing cause–effect relationships between condition attributes and decision attribute. Similar API release profiles from pellets before and after tableting can be ensured by proper polymer coating (Eudragit® NE, absence of ethyl cellulose), compression force higher than 6 kN, microcrystalline cellulose (Avicel® 102) as excipient and tablet hardness ≥42.4 N. DRSA can be useful for analysis of complex technological data. Decision rules with high values of confirmation measures can help technologist in optimal formulation development.

Rough Sets Turn 40: From Information Systems to Intelligent Systems

“…We referred to rough set software packages for data mining and machine learning [24], [68], [83], as well as other technologies which utilize rough set approximation principles for their internal purposes [62]. We also recalled several (out of many) applications of rough set methods in real-world data analysis, including biomedical and healthcare applications whereby interpretability of decision models is of special importance [66], [67], [84], [91].…”

“…When thinking about the future it is also worth referring to the history. That reflected one more objective: acknowledging the 40th anniversary of rough sets [1], their founder [5], as well as some of relevant past and present events such as FedCSIS 2012 (rough set papers published exactly 10 years ago) [47], [48], [51], [53], [54], [57], [58], [59], [61], [64], [66], the PP-RAI 2022 rough set contest [69], [70], [72], [73], [77], [78], [81], [82], [83], [84], [89], [90], [91], [95], [96], [97], [98], [101], [105], [106] and celebration of the 30th CS&P -the event series whereby this paper's topics have been regularly addressed [36], [40], [44], [103], [116], [123].…”

“…Papers [89], [90], [91] illustrate more real-world applications of rough set methods in the area of biomedicine. The first paper uses rough set approximations built over neighborhood-based information granules [92].…”

An Approach to Investigate Fairness Using Dominance-Based Rough Sets Analysis - How Fair Were the Covid-19 Restriction Decisions in the UK?

“…Here, from the analysis, hidden patterns and decision rules are discovered, revealing how economic growth often conflicts with environmental sustainability. Analysis of the relationships in multiple-unit pellet systems (MUPS) is explored using DRSA in [15]. Here, extracted decision rules indicate properties to ensure consistent desired results, aiding technologists in optimal formulation development.…”

Cushion-coated pellets for tableting without external excipients

“…In the development of a MUPS by tableting of coated pellets, not only the core, coating composition and the cushioning excipient characteristics have to properly be selected, but also the compression parameters need to be taken into account, particularly with regard to compression force, tableting speed, tooling design and powder feeder type (Karolak et al, 2020;Vasiljević et al, 2021;Xu et al, 2016).…”