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Development of Fast Dissolving Tablets Containing Fexofenadine Hydrochloride Prepared by Lyophilization Technique



Author(s)

Rajendra Kotadiya and Bhavin Bhalani

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DOI:10.17265/2328-2150/2019.10.002

Objectives: To improve the aqueous solubility and dissolution of fexofenadine HCl, an attempt was made to prepare its fast dissolving tablets by lyophilization technique. Methods: For the preparation of lyophilized tablets (F1-F32), the drug was dispersed in a hydrated solution of water-soluble polymers (gelatin/maltodextrin/acacia) containing glycine and mannitol. The blend was pelted down into the patches of a blister pack, frozen down and then lyophilized. Different characterization parameters viz. differential scanning calorimetry, hardness, weight variation, X-ray diffraction (XRD), scanning electron microscopy (SEM), mercury porosimetry, solubility, wetting time and water absorption ratio, lyophilization tablet index, drug content, in vitro dissolution and stability were evaluated. Key findings: Tablets (F32) containing acacia were found to have fast disintegration and relatively higher mechanical strength with improved drug solubility. X-ray diffractogram and scanning electron micrograph indicated decrease in crystallinity of drug and a good porous structure property for prepared tablet, respectively. Dissolution study showed complete drug released within 5 min. Moreover, tablets (F32) were found to be stable for one month at 25 ± 2 °C/60 ± 5% relative humidity.

Lyophilization, fexofenadine HCl, SEM, XRD, lyophilized tablet index (LTI), mercury porosimetry, wetting time.

Kotadiya, P., et al. 2019. “Development of Fast Dissolving Tablets Containing Fexofenadine Hydrochloride Prepared by Lyophilization Technique.” Journal of Pharmacy and Pharmacology 7 (10): 527-540.