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.
Highlights
Pellets, microcapsules, as well as other solid particles can form multiple-unit dosage forms
We present an application of a knowledge discovery technique, called dominance-based rough set approach (DRSA)
The aim of this study was to search and discover dependences occurring between technological data describing the composition, properties and process of formulation of tablets with floating pellets and their quality expressed as similarity in active pharmaceutical ingredients (APIs) release profile before and after tableting
Summary
Microcapsules, as well as other solid particles can form multiple-unit dosage forms. By a proper modification, such forms allow a modified or constant release rate, whereby the concentration of the drug is maintained within therapeutic limits for a longer period of time. An appropriate release profile allows controlled absorption of active pharmaceutical ingredients (APIs) in the specific part of the gastrointestinal tract, providing a desirable therapeutic effect and reduces side effects. A special type of multiparticulate drug delivery systems is a multiple unit pellet system (MUPS) in which microparticles or pellets are compressed to obtain a tablet. MUPS allow the masking of the taste of active substances, the obtainment of enteric tablets for APIs sensitive to low pH, and the ability to modify or control the release of orally disintegrating dosage forms for geriatric or pediatric patients [1,2]
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