title: Formulation and Taste Masking of Ranitidine Orally Disintegrating Tablet.
abstract: Orally Disintegrating Tablets (ODT) have the advantages of both solid dosage form specially the stability and ease of handling and liquid dosage forms including ease of swallowing and pre-gastric absorption. We focused on taste masking and formulation of ranitidine ODT which disintegrates rapidly in the mouth within 60 sec using super-disintegrants, special polymers, water soluble and even insoluble excipients, sweeteners and essence. Various formulations were designed and made in four series. The amount of ranitidine in each formulation was 150 mg, and the final weight of tablets was around 500 mg. Prepared formulations were evaluated in terms of several physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Several taste masking techniques were investigated in each series of formulation, in order to cover the bitter taste of wranitidine. These included the addition of sweetener, granulation, solid dispersion with soluble and insoluble agents and complex formation with cellulose derivatives. The best formulation(s) in each group was/were chosen for taste evaluations with the help of 10 volunteers. Finally, formulation F14 was selected as the ultimate formulation, based on its better taste and shorter disintegration time (around 5 seconds). Formulation F14 contained Na CMC, avicel, Na starch glycolate, xylitol, saccharin, Na benzoate and menthol. The chosen formulation successfully passed the complementary evaluations such as assay of active ingredient and dissolution time. Na CMC was found to be acceptable in terms of decreasing disintegration time and enhanced taste masking potential and can be used in further ODT formulations.
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Hesari
authors.affiliation: Deptartment of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran 1417614411, Iran.
authors.forename: Akram
authors.initials: A
authors.lastname: Shafiee
authors.affiliation: Department of Pharmaceutics School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Shirin
authors.initials: S
authors.lastname: Hooshfar
authors.affiliation: Stem Cell Research Center, Department of Biochemistry, School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.
authors.forename: Naser
authors.initials: N
authors.lastname: Mobarra
authors.affiliation: Department of Pharmaceutics School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Seyed Alireza
authors.initials: SA
authors.lastname: Mortazavi
keywords: Orally Disintegrating Tablets (ODT); Ranitidine HCl; Sodium CMC; Taste masking; Xylitol