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

Anna Nardi-Ricart,Lara Bachs-Demiquel,Faviola Villca-Pozo,Marc Suñé-Pou,Maria Jose Linares,Encarna García-Montoya,Isaac Nofrerias-Roig,Manel Roig-Carreras,Josep Maria Suñé-Negre,Pilar Pérez-Lozano

doi:10.1371/journal.pone.0201643

Anna Nardi-Ricart, Lara Bachs-Demiquel + Show 8 more

Open Access

https://doi.org/10.1371/journal.pone.0201643

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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.

Highlights

There are a large number of semisolid preparations, corresponding to different pharmaceutical dosage forms differentiating each other by their consistency and rheological characters
From the results obtained from the development of this experimental project, it is concluded that: 1. The Semi-solid Control Diagram (SSCD) could be an excellent tool for the galenic characterization of semi-solid pharmaceutical dosage forms as SeDeM is for solid pharmaceutical dosage forms
The Semi-solid Control Diagram (SSCD) is of great use for formulation studies since it allows the effect of adding different excipients to a base semi-solid formulation to be studied, as well as, it is useful to know the performance of comparative studies of the same excipient from different suppliers

Summary

Introduction

There are a large number of semisolid preparations, corresponding to different pharmaceutical dosage forms differentiating each other by their consistency and rheological characters. These forms are normally presented in the form of creams, gels, emulsions, ointments or pastes [1]. Water in oil (W/O) creams are lipophilic emulsions in which the external hydrophobic phase is a gel (hydrocarbon gel, oleogel or lipogel). This provides the formulation its good spreading properties [2]. They contain one or more active ingredients dissolved or uniformly dispersed in a suitable base and any suitable excipients such as emulsifiers, viscosity increasing agents, antimicrobials agents, antioxidants or stabilizing agents [3].

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