An overview of the implementation of SeDeM and SSCD in various formulation developments.
Journal:
International journal of pharmaceutics
PMID:
36764417
Abstract
The Sediment Delivery Model explains experimental analysis and quantitative assessment of the powdered substance characterizing parameters, which offer pertinent data about the material's appropriateness for direct compression (DC) of tablet, which involves mathematical modeling and Semisolid Control Diagram using software like iTCM. The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for DC and the ratio of API to excipient is calculated. The DC is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. The SeDeM DES is based on quality by design (QbD) (ICH Q8) as it evaluates critical quality attributes that affect finished product's quality. This review mainly focuses on various dosage forms like Solid, Semisolid, Liquisolid, and Solidified liquid dosage forms. These techniques mainly characterize all substances using 12 parameters, resulting 12-sided regular polygon. However, parameters may increase or decrease according to the requirement of a particular dosage form like an Orodispersible tablet 15 and a Semisolid dosage form applying 5 parameters. The rationales behind limits for indexes are justified accordingly.