Naslov
Formulation and characterization of lurasidone hydrochloride orally disintegrating tablets.

Autori
Barbarić, Joško ; Brnadić, Gabriela ; Filakovac, Mirna ; Malekinušić, Nikolina ; Tomljanović, Ivona ; Žižek, Krunoslav.

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Book of Abstracts, XII. Central European Symposium on Pharmaceutical Technology and Regulatory Affairs / Hankó, Zoltán. - Budimpešta : Acta Pharmaceutica Hungarica., 2018, 183-184

Skup
12th Central European Symposium on Pharmaceutical Technology and Regulatory Affairs

Mjesto i datum
Szeged, Mađarska, 19.09.2018. - 22.09.2018

Vrsta sudjelovanja
Poster

Vrsta recenzije
Podatak o recenziji nije dostupan

Ključne riječi
Lurasidone hydrochloride ; orally disintegrating tablets ; fluidized bed melt granulation ; crosscarmellose sodium ; disintegration testing ; dissolution testing.
(Lurasidone hydrochloride ; orally disintegrating tablets ; fluidized bed melt granulation ; crosscarmellose sodium ; disintegration testing ; dissolution testing)

Sažetak
INTRODUCTION Lurasidone hydrochloride (LRS HCl) is an atypical antipsychotic drug used for the treatment of schizophrenia and bipolar depression. Compliance of patients suffering from mental illnesses often poses a significant problem making administration and dosing of a drug quite challenging. In order to facilitate drug administration, a novel oral drug delivery system, an orally disintegrating tablet (ODT) of lurasidone hydrochloride has been prepared and characterized within this research. This type of tablet disintegrates in the oral cavity before swallowing in less than 3 minutes [1]. MATERIALS AND METHODS Various tabletting mixtures have been prepared by melt granulation technique using Uni-Glatt (Glatt GmbH, Germany) fluid bed granulator. Mixtures were compressed to 8 mm diameter tablets using TDP-5T single punch tablet press (Zhejiang, China). Following materials were used: mannitol (MAN), microcrystalline cellulose (MCC) PH102, lactose anhydrous, croscarmellose sodium (CS), polyethylene glycol (PEG) 4000, magnesium stearate (MS) and lurasidone hydrochloride (LRS HCl). Mass and hardness uniformity and disintegration tests were performed in order to determine the optimal formulation parameters. Content uniformity and dissolution tests were carried out to study the effect of croscarmellose sodium (a superdisintegrant) on tablet disintegration rate and solubility of LRS HCl. Drug content has been determined using an appropriate UV/Vis spectrophotometric method. The effect of superdisintegrant addition method (in- situ or spray-coating method) has been studied as well. RESULTS Tablets produced using combination of mannitol and microcrystalline cellulose proved to have the most favorable ratio of hardness and disintegration time. Therefore, such combination of excipients was used in the experiments in which LRS HCl was embedded in the tabletting mixture. Content uniformity test has shown significant deviation from the target value in tablets produced using in-situ addition method. Dissolution profiles show a slight increase in drug solubility in tablets where superdisintegrant was used. CONCLUSIONS Tablets in which superdisintegrant was added by in-situ method show the lowest disintegration time. When compared to other formulations, a slight increase in drug solubility was noticed as well.

Izvorni jezik
Engleski

Znanstvena područja
Kemijsko inženjerstvo

POVEZANOST RADA