Abstract

DEVELOPMENT AND EVALUATION OF LYOPHILE ORALLY DISINTEGRATING TABLETS OF OMEPRAZOLE PELLETS

Grasiela Facco, Vanderson Galan and Élcio José Bunhak*

ABSTRACT

Omeprazole is commonly used in the treatment of acid-peptic disorders, being released quickly in the initial part of the intestine. To innovate and improve the administration, availability of the drug and adherence to treatment, new oral technologies are being developed, such as orally disintegrating tablets (ODTs), designed to dissolve immediately in contact with saliva in the oral cavity without the need for water. Lyophilization technique is the most studied technique due to the advantages derived from a lyophilized disintegrating tablet. Fluidized bed coating of pellets with different sizes was performed, obtaining high sphericity and adequate density, humidity, and good application performance. For the orally disintegrating matrix (hydrophilic matrix, inert and inexpensive) produced from lyophilization, the concentration of 50:50 gelatin (5%) and mannitol resulted in tablets with good appearance, uniformity, hardness and sufficient resistance to deformation and presenting ideal disintegration for orally disintegrating forms according to official compendiums. The dissolution profile of Omeprazole was satisfactory, thus corroborating positive results for the treatment of stomach disorders, making it a viable and efficient alternative.

Keywords: Oral drug delivery; Lyophilization; Tablets; Multiparticulates; Dissolution rate.