Orally Disintegrating Tablets (ODT) are a drug dosage form that is gaining increasing attention due to the advantages compared to conventional oral dosage forms, mainly represented by the possibility of disintegrating in the saliva in a very short period of time. Frovatriptan (FRO) is one of the safest triptans, administered as a rescue treatment for immediate pain relief of acute migraine headache attacks. Based on these premises, in this study an ODT formulation of FRO was developed with the aim of achieving an easier oral administration together with a faster dissolution and absorption of the drug and, consequently, a more rapid onset of action. The development of ODTs was carried out following innovative Quality by Design principles [1] for the pharmaceutical industry, aimed at making the regulatory approval process more flexible without compromising patient safety. In this context, Design of Experiments strategies play a key role. The direct compression method was chosen for ODTs production, due to its advantages with respect to other available manufacturing processes, including greater stability of the active ingredient and lower operative costs. After selecting by compatibility studies the suitable excipients, investigation on Knowledge Space (KS) was carried out by means of a screening matrix in order to evaluate the effect of five different variables (diluent, lubricant, superdisgregant kind, compression force and superdisgregant amount) on the selected control quality attributes (tablets disintegration time, tablets hardness and friability, percentage of drug released at 1 min in simulated saliva). The amount of drug released was evaluated by means of a fast capillary electrophoresis method, optimized by applying a Box-Behnken Design with voltage, temperature, pH and concentration of the background electrolyte as selected factors. The screening step on KS constituted the basis for finding Design Space by means of Response Surface Methodology with the aid of Monte-Carlo simulations.

Quality by Design and capillary electrophoresis for developing orally disintegrating tablets containing frovatriptan / N. Mennini; S. Furlanetto; S. Orlandini; B. Pasquini; P. Mura. - ELETTRONICO. - (2013), pp. 167-167. (Intervento presentato al convegno XXIV Congresso della Divisione di Chimica Analitica della Società Chimica Italiana tenutosi a Sestri Levante (Genova) nel 15-19 Settembre 2013).

Quality by Design and capillary electrophoresis for developing orally disintegrating tablets containing frovatriptan

MENNINI, NATASCIA;FURLANETTO, SANDRA;ORLANDINI, SERENA;PASQUINI, BENEDETTA;MURA, PAOLA ANGELA
2013

Abstract

Orally Disintegrating Tablets (ODT) are a drug dosage form that is gaining increasing attention due to the advantages compared to conventional oral dosage forms, mainly represented by the possibility of disintegrating in the saliva in a very short period of time. Frovatriptan (FRO) is one of the safest triptans, administered as a rescue treatment for immediate pain relief of acute migraine headache attacks. Based on these premises, in this study an ODT formulation of FRO was developed with the aim of achieving an easier oral administration together with a faster dissolution and absorption of the drug and, consequently, a more rapid onset of action. The development of ODTs was carried out following innovative Quality by Design principles [1] for the pharmaceutical industry, aimed at making the regulatory approval process more flexible without compromising patient safety. In this context, Design of Experiments strategies play a key role. The direct compression method was chosen for ODTs production, due to its advantages with respect to other available manufacturing processes, including greater stability of the active ingredient and lower operative costs. After selecting by compatibility studies the suitable excipients, investigation on Knowledge Space (KS) was carried out by means of a screening matrix in order to evaluate the effect of five different variables (diluent, lubricant, superdisgregant kind, compression force and superdisgregant amount) on the selected control quality attributes (tablets disintegration time, tablets hardness and friability, percentage of drug released at 1 min in simulated saliva). The amount of drug released was evaluated by means of a fast capillary electrophoresis method, optimized by applying a Box-Behnken Design with voltage, temperature, pH and concentration of the background electrolyte as selected factors. The screening step on KS constituted the basis for finding Design Space by means of Response Surface Methodology with the aid of Monte-Carlo simulations.
2013
Atti del XXIV Congresso della Divisione di Chimica Analitica della Società Chimica Italiana
XXIV Congresso della Divisione di Chimica Analitica della Società Chimica Italiana
Sestri Levante (Genova)
N. Mennini; S. Furlanetto; S. Orlandini; B. Pasquini; P. Mura
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/819887
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