title: Design and formulation of mebeverine HCl semisolid formulations for intraorally administration.
abstract: Gel formulations of mebeverine hydrochloride (MbHCl) containing hydroxypropylmethylcellulose (HPMC), metolose (MTL), and poloxamer 407 (PLX) were prepared to be used in the treatment of different oral painful conditions. HPMC was used as a mucoadhesive gel base while MTL and PLX were used to prepare sol-gel thermosensitive gels. MTL and PLX formulations showed proper sol-gel transition temperature for intraoral application. Formulations were evaluated in terms of their viscosity, mechanical properties, mucoadhesivity, stability, and in vitro drug release. The formulation prepared with 2% of HPMC K100M provided the highest viscosity at room temperature. However, the viscosity of HPMC-PLX mixture showed a significant increase at body temperature. The greatest mucoadhesion was also noted in HPMC-PLX combinations. Texture profile analysis exhibited the differences of the adhesion, hardness, elasticity, cohesiveness, and compressibility of the formulations. The release profiles of MbHCl were obtained, and non-Fickian release was observed from all the formulations. The formulations were stored at different temperature and relative humidity. No significant changes were observed at the end of the 3 months. HPMC-PLX formulation of MbHCl was chosen for in vivo studies, and it remained longer than dye solution on the rabbit's intraoral mucosal tissue. It was found worthy of further clinical evaluation.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, Ege University, 35100 Bornova, Izmir, Turkey. esra.baloglu@ege.edu.tr
authors.forename: Esra
authors.initials: E
authors.lastname: Baloğlu
authors.forename: Sinem Y
authors.initials: SY
authors.lastname: Karavana
authors.forename: Ismail Yuksel
authors.initials: IY
authors.lastname: Hyusein
authors.forename: Timur
authors.initials: T
authors.lastname: Köse
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004548:Elasticity; D005782:Gels / Q000737:chemistry; D006244:Hardness; D065347:Hypromellose Derivatives; D008297:Male; D008747:Methylcellulose / Q000031:analogs & derivatives; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D055585:Physical Phenomena; D020442:Poloxamer / Q000737:chemistry; D011817:Rabbits; D014783:Viscosity
chemical_list: D004304:Dosage Forms; D005782:Gels; D004364:Pharmaceutical Preparations; D020442:Poloxamer; D065347:Hypromellose Derivatives; D008747:Methylcellulose