Quality by Design (QbD) is a fundamental pharmaceutical quality model to be considered in the development of pharmaceutical products and processes, introduced by FDA and supported by ICH. A new and innovative thymoquinone-loaded vesicular system for the treatment of vitiligo was carried out following QbD principles. Thimoquinone (TQ) is a natural bioactive compound, which is extracted from Nigella Sativa seeds, with many therapeutic properties. Ethosomes composed of phospholipid, ethanol and water obtained by thin layer evaporation technique resulted the suitable nanocarriers for enhanced transdermal drug delivery. Influential factors were classified in different categories (formulation, process, method, environment) and critical process parameters were selected. Critical quality attributes were represented by vesicle size (size), dimensional uniformity (PDI) and encapsulation efficiency of TQ (EE%). Size and PDI studies were carried out using dynamic light scattering, while EE% was evaluated by a fast capillary electrophoresis method assaying the free TQ after ultracentrifugation. Experimental design tools made it possible to better understand the interactions among all the variables and to obtain the appropriate Design Space (DS). A three factors design allowed the contour plots to be drawn and the DS to be defined in combination with Monte-Carlo simulations. The DS was visualized by means of probability maps and included all the operative conditions, which led to fulfill the requirements of the quality product with a degree of probability π≥90%. Ex vivo studies were carried out by Franz diffusion cells and pointed out that the TQ-loaded ethosomal system improved the penetration of TQ into the skin.

Quality by design in the optimization of a nanosystem-ethosomal formulation for topical treatment of vitiligo / Pasquini, Benedetta; Mennini, Natascia; Caprini, Claudia; Orlandini, Serena; Mura, Paola; Furlanetto, Sandra. - STAMPA. - (2016), pp. 155-155. (Intervento presentato al convegno Merck Young Chemists Symposium tenutosi a Rimini, Italy nel 25-27 Ottobre 2016).

Quality by design in the optimization of a nanosystem-ethosomal formulation for topical treatment of vitiligo

PASQUINI, BENEDETTA;MENNINI, NATASCIA;CAPRINI, CLAUDIA;ORLANDINI, SERENA;MURA, PAOLA ANGELA;FURLANETTO, SANDRA
2016

Abstract

Quality by Design (QbD) is a fundamental pharmaceutical quality model to be considered in the development of pharmaceutical products and processes, introduced by FDA and supported by ICH. A new and innovative thymoquinone-loaded vesicular system for the treatment of vitiligo was carried out following QbD principles. Thimoquinone (TQ) is a natural bioactive compound, which is extracted from Nigella Sativa seeds, with many therapeutic properties. Ethosomes composed of phospholipid, ethanol and water obtained by thin layer evaporation technique resulted the suitable nanocarriers for enhanced transdermal drug delivery. Influential factors were classified in different categories (formulation, process, method, environment) and critical process parameters were selected. Critical quality attributes were represented by vesicle size (size), dimensional uniformity (PDI) and encapsulation efficiency of TQ (EE%). Size and PDI studies were carried out using dynamic light scattering, while EE% was evaluated by a fast capillary electrophoresis method assaying the free TQ after ultracentrifugation. Experimental design tools made it possible to better understand the interactions among all the variables and to obtain the appropriate Design Space (DS). A three factors design allowed the contour plots to be drawn and the DS to be defined in combination with Monte-Carlo simulations. The DS was visualized by means of probability maps and included all the operative conditions, which led to fulfill the requirements of the quality product with a degree of probability π≥90%. Ex vivo studies were carried out by Franz diffusion cells and pointed out that the TQ-loaded ethosomal system improved the penetration of TQ into the skin.
2016
Proceedings of the Merck Young Chemists Symposium
Merck Young Chemists Symposium
Rimini, Italy
Pasquini, Benedetta; Mennini, Natascia; Caprini, Claudia; Orlandini, Serena; Mura, Paola; Furlanetto, Sandra
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1061953
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