Effect of Mannitol on Physical Characters of Lyophilized Fast-Disintegrating Tablets

Samia Omar,Fathy Abdalla,Noha Abdelgawad

doi:10.21608/aprh.2017.4044

Abstract

Objectives:Fast-disintegrating tablets (FDTs) also known as orally-disintegrating tablets, orodispersible tablets, fast-melting tablets, rapid-melt tablets are a relatively new dosage form. They are tablets that when placed in the mouth, disintegrate upon coming in contact with the saliva without further need for water or chewing to be swallowed. In order to achieve fast disintegration, tablets are formulated to be highly porous, which unfortunately greatly reduces the mechanical strength of the tablets. The main challenge in formulating FDTs is achieving a balance between fast disintegration and good mechanical strength. Methods: The formulation of, lyophilized fast-disintegrating tablets (LFDTs) is comprised of mainly a binder e.g. gelatin, a lyoprotectant as glycine, as well as mannitol a bulking agent and disintegration enhancer for the manufacture of LFDTs. The effect of mannitol concentration on physical characters of LFDTs, namely, friability, hardness and in-vitro disintegration time was investigated over the range of 10% to 70% w/v. Design-Expert® software v.7 (Stat-Ease Inc., Minneapolis, MN, USA) was used to analyze the obtained results. Results: It was observed that increasing mannitol concentration enhanced the mechanical properties of the LFDTs. Where, it decreased friability and increased hardness. The relationship between mannitol concentration and the in-vitro disintegration time was found to be parabolic. Conclusion: The study encouraged 40% w/v as an optimum concentration of mannitol for ultimate LFDTs formulation.

Highlights

Fast-disintegrating tablets (FDTs) are tablets that disintegrate upon coming in contact with the saliva in the oral cavity without further need for water or chewing to be swallowed
Fast disintegration usually means the disintegration of tablets in less than one minute, where it is preferred to have disintegration as soon as possible within 60 seconds 1
FDTs combine the advantages of solid dosage forms like good stability, accurate dosing, and portability with the advantages of liquid dosage forms like ease of administration, which makes it especially suitable for people who suffer from dysphagia, travelling patients, patients with little access to water, bedridden or developmentally disabled patients

Summary

Introduction

Fast-disintegrating tablets (FDTs) are tablets that disintegrate upon coming in contact with the saliva in the oral cavity without further need for water or chewing to be swallowed. FDA-CDER Nomenclature Standards Committee developed the following definition for an orally-disintegrating tablet (ODT) as a new dosage form in 1998: “A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue” 2. FDTs combine the advantages of solid dosage forms like good stability, accurate dosing, and portability with the advantages of liquid dosage forms like ease of administration, which makes it especially suitable for people who suffer from dysphagia, travelling patients, patients with little access to water, bedridden or developmentally disabled patients. Ease of administration enhances patient http://aprh.journals.ekb.eg/ 228

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Conclusion