Priprava i karakterizacija minitableta

master's thesis

• Title (english): Preparation and characterization of mini-tablets
• Author: Katarina Jozinović
• Mentor: Krunoslav Žižek (mentor)
• Committee member: Krunoslav Žižek (predsjednik povjerenstva)
• Committee member: Domagoj Vrsaljko (član povjerenstva)
• Committee member: Zvjezdana Findrik Blažević (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2021-07-16, Croatia
• Scientific / art field, discipline and subdiscipline: TECHNICAL SCIENCES; Chemical Engineering

Abstract

Lurasidon-hidroklorid je djelatna tvar izrazito male topljivosti u vodenom mediju što otežava njegovu primjenu u liječenju psihičkih poremećaja. S ciljem povećanja njegove topljivosti pripravljene su čvrste disperzije djelatne tvari u matrici hidrofilnog polimera, poli(etilen-glikola) (PEG) procesom liofilizacije. Dobivene čvrste disperzije karakterizirane su diferencijalnom pretražnom kalorimetrijom, rendgenskom difrakcijskom analizom praha i infracrvenom spektroskopijom. Testirana je prividna topljivost djelatne tvari u čvrstim disperzijama. U pripravi minitableta promjera 3 mm korišteni su liofilizati i granulirane mješavine s ugrađenom djelatnom tvari. Korišteni su manitol, natrijeva kroskarmeloza te mikrokristalna celuloza kao pomoćne tvari. Karakterizacija minitableta uključivala je ispitivanje ujednačenosti masa te testiranje njihove raspadljivosti. Vrijeme raspadljivosti za sve tablete manje je od 3 minute. Profili oslobađanja ukazuju na poboljšanu topljivost i brže oslobađanje djelatne tvari iz minitableta pripravljenih iz čvrstih disperzija u odnosu na one koje sadrže čisti netretirani lurasidon-hidroklorid (LRS HCl) i one s granuliranom mješavinom djelatne tvari i polimera. Dodatno, minitablete pokazuju brže oslobađanje djelatne tvari u odnosu na raspadljiv oralni dozirni oblik promjera 8 mm. Testirana je primjenjivost modela u opisu profila oslobađanja lurasidon-hidroklorida.

Abstract (english)

Lurasidone hydrochloride is a drug of extremely low solubility in an aqueous medium, which makes it difficult to use in the treatment od mental disorders. In order to increase its solubility, solid dispersions of a drug in a hydrophilic polymer matrix, poly(ethylene glycol) (PEG) were prepared by the lyophilization process. Obtained solid dispersions were characterized by differential scanning calorimetry, X-ray powder difraction analysis and infrared spectroscopy. The apparent solubility of drug was tested in solid dispersions. Lyophilisates and granulated mixtures with incoporated active substance were used in the preparation of mini-tablets with 3 mm in diameter. Mannitol, sodium croscarmellose and microcrystalline cellulose were used as excipients. Characterization of mini-tablets involved testing the mass uniforimity and its disintegration. Disintegration time for all tablets was less than 3 minutes. Release profiles indicate improved solubility and faster drug release from mini-tablets prepared from solid dispersions in comparison to those containing pure untreated lurasidone hydrochloride (LRS HCl) and those with granulated mixture of drug and polymer. Additionally, mini-tablets show faster drug release in comparision to the disintegrated oral dosage form with 8 mm in diameter. The applicability of models was tested to describe release profiles for lurasidone hydrochloride.

• Keywords: lurasidon-hidroklorid; poboljšanje topljivosti lijeka; čvrsta disperzija; liofilizacija; granuliranje; minitableta; oslobađanje djelatne tvari
• Keywords (english): lurasidone hydrochloride; drug solubility improvement; solid dispersion; lyophilization; granulation; mini-tablet; drug release
• Language: croatian
• URN:NBN: urn:nbn:hr:149:627256
• Study programme: Title: Chemical Engineering - Graduate study; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra inženjer/inženjerka kemijskog inženjerstva (magistar/magistra inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2021-07-16
• Created on: 2023-04-11 09:48:47