Preparation and Optimization of Mouth/Orally Dissolving Tablets Using a Combination of Glycine, Carboxymethyl Cellulose and Sodium Alginate: A Comparison with Superdisintegrants

Abstract

The purpose of the research was to prepare metoclopramide HCl mouth/orally dissolving tablets (MDTs) using glycine, carboxy methyl cellulose and sodium alginate with sufficient mechanical integrity and disintegration time comparable to superdisintegrants. Application of Plackett-Burman design revealed that concentration of glycine (X₁), concentration of carboxy methyl cellulose (X₂) and tablet crushing strength (X₄) were found to actively influence the dependent variables (disintegration time in oral cavity (DT), wetting time (WT), porosity (P₀) and water absorption ratio (WA). Additional MDTs were prepared utilizing central composite design for estimating extended effect in a spherical domain. The regression statistics (performed using Statistica®−7.0) of quadratic model revealed that DT, WT, P₀ were 97% correlated with active factors (X₁, X₂ or X₄). The results revealed that optimized MDTs were capable of simulating DT comparable to MDTs containing croscarmellose sodium or crospovidone. Further, it can be envisaged that optimized MDTs were found to be superior to MDTs containing croscarmellose sodium or crospovidone in terms of friability and tablet crushing strength.

Keywords:

• mouth/orally dissolving tablets
• glycine
• CMC
• metoclopramide hydrochloride