Application of polyhydroxyalkanoates as a novel tablet disintegrator in fast dissolving tablets and acute toxicity studies

Author(s): Anjali Mohan Nair, K.Karthik, K.S.G.Arul Kumaran, Sandeep George Simon,Alex Thomas, Shanthi Kuppusamy

The studywas conducted to investigate the application of Polyhydroxyalkanoates as pharmaceutical excipients (disintegrating agent), and to study its effect on the drug release rate of Diclofenac Sodium (Model Drug I) and Bambuterol Hydrochloride (Model Drug II) tablets. Polyhydroxyalkanoates are biopolymers produced by bacteria like Alcaligenes eutrophus, Ralstonia eutropha, and Bacillus subtilis as intracellular granules and these find a wide range of applications as drug carriers and formaking tissue engineeringmaterials. The tablets weremanufactured with various concentrations of Polyhydroxyalkanoates and evaluated for preformulation and post compression parameters. The results of preformulation studies showed excellent flow property for the formulations made with Polyhydroxyalkanoates in different concentrations. Polyhydroxyalkanoates was added withModel Drug I, and compressed to find out whether it could be used as a polymeric carrier. For comparison purpose, in another batch Hydroxy Propyl Methyl Cellulose was added and compressed. In vitro disintegration studies showed that Polyhydroxyalkanoates was disintegrating faster (45 seconds) than Hydroxy Propyl Methyl Cellulose (310 seconds), so we concluded that Polyhydroxyalkanoates cannot be used as a carrier and may be used as a disintegrant. For evaluating the disintegrant property, Polyhydroxyalkanoates was compared with a batch of high surfactant (Sodium Lauryl Sulphate) and the results showed that Polyhydroxyalkanoates disintegration (45 seconds) was comparable with Sodium Lauryl Sulphate disintegrating (210 seconds) as both the formulations disintegrated faster than with Hydroxy PropylMethyl Cellulose. Later, formulations were made for Fast Dissolving Tablets withModel Drug II, in the presence of Polyhydroxyalkanoates; it was found that the disintegration of ModelDrug IIwith Polyhydroxyalkanoates was 43 secondswhich was comparable with that of cross povidone used as super disintegrant (16seconds). The dissolution rate for Diclofenac tablets made with Hydroxy Propyl Methyl Cellulose, Polyhydroxyalkanoates and Sodium Lauryl Sulphate were 82.98%, 73.57% and 65.94%and the dissolution rate for Bambuterol hydrochloride tablets made with Polyhydroxyalkanoates and cross povidone were 48.97% and 59.13% respectively. Based on the results of pre formulations and post compression studies, Polyhydroxyalkanoates can be considered as a potential drug carrier.

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