A new design for the review and appraisal of semi-solid dosage forms: Semi-solid Control Diagram (SSCD)

Abstract

The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semi-solid Control Diagram (SSCD) is used as an instrument for studying and evaluating semi-solid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others.

Anti-Inflammatory Activity Evaluation of the Extract and Topical Pre-Formulation of Morus nigra Fruits

“…Visual inspection of the sample and overall appearance is performed by placing a sample amount on a glass plate. The radius final value for organoleptic properties parameter is determined by adding together the experimental values (eV) of each of the five following properties: homogeneity, colour, flow, absence of air and texture [16].…”

“…1). The experiment continues with the same procedure, always at one minute intervals, using increasing weights (2 gr, 5 gr and 10 gr) [16,17]. The radii are calculated and with them the corresponding surfaces.…”

“…The results for this parameter are determined using the values obtained after centrifugation. The values fluctuate between 0 -10, and were assigned as follows [16]:…”

“…The stability of the semi-solid formulation was evaluated under standard conditions and under stress conditions (high and low temperatures). Finished product: base gel (without blackberry extract) as control, and blackberry gel, under room temperature conditions [16].…”

Method and Critical Aspect of Semisolid Mixing

“…Semisolid preparations are generally used for topical delivery, which can avoid the first-pass metabolism, reduce side effects, provide immediate local effects, and increase patient compliance (5,6). Some semisolid systems can also control drug release, maintain stability, and improve the drug's pharmacokinetic profile (7)(8)(9). These advantages indeed correlate with the quality of the system.…”