Soy polysaccharides represent a multipurpose class of chemicals that include both therapeutical and technological properties. Since they have been first time introduced in the pharmaceutical field, Soy polysaccharides were used in two different pharmaceutical formulations; sublingual tablets and in colon drug delivery. For the sublingual tablets, Soy polysaccharides under the brand name of Emcosoy© – were used as a superdisintegrant in concentrations between 4-8% showing comparable results with the artificial superdisintegrants (sodium starch glycolate, sodium croscarmellose, and polyvinylpyrrolidone). The second technological field where Soy polysaccharides were used is represented by colon drug delivery where it was used in combination with ethylcellulose showing a prolonged lag time compared to the results found in the literature. The medicinal effect of these polysaccharides consists of treating diarrhea. As it will be presented in the article, these chemical compounds tend to decrease the aqueous stool time in patients with diarrhea and to conduct to a softer stool in healthy patients. In conclusion, these polysaccharides present multiple purposes possessing a medicinal effect and also the possibility of being used as a double-faceted pharmaceutical excipient.
Objective: The aim of this study is to develop lactose-free orodispersible tablets with loratadine for patients with lactose intolerance.
Materials and methods: Seven compositions (F1-F7) of 10 mg loratadine were prepared in form of orally disintegrating tablets, by direct compression, using croscarmellose sodium and pre-gelatinized starch in various concentrations as superdisintegrants, diluted with microcrystalline cellulose and combined with mannitol and maltodextrin as binder agents. The tablets had been studied in terms of their pharmacotechnical characteristics, by determining: the weight uniformity of the tablets, their friability, breaking strength and disintegration time, drug content and the dissolution profile of loratadine. The statistical analyses were performed with GraphPad Prism Software Inc. As dependent variables, both the hardness of the tablets and their disintegration ability differ between batches due to their compositional differences (as independent variables). DDSolver were used for modeling the kinetic of the dissolution processes by fitting the dissolution profiles with time-dependent equations (Zero-order, First-order, Higuchi, Korsmeyer-Peppas, Peppas-Sahlin).
Results: All proposed formulas shows rapid disintegration, in less than 15 seconds, and the dissolution loratadine spans a period of about 10 minutes. Akaike index as well as R2 adjusted parameter have demonstrated that the studied dissolution profiles are the best fitted by Zero-order kinetic.
Conclusion: In conclusion, association of croscarmellose sodium (7.5%) with pre-gelatinized starch (6%) as superdisintegrants and mannitol as the binder agent (35%), positively influences the dissolution properties of loratadine from orally fast dispersible tablets.