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Published on:16 Nov 2013
Indian Journal of Pharmaceutical Education and Research, 2013; 47(3):56-63
Pharmaceutical Research | doi:10.5530/ijper.47.3.9

Design and Evaluation of Rapidly Disintegrating Tablets of Racecadotril with Enhanced in-vitro Dissolution Achieved by Solid Dispersion Technique


Authors and affiliation (s):

Gautam Singhvi*, Gautham Gampa, Nilesh Yadav, Vipin Kumar and Ravi Ukawala
Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani (Raj.), India 333031

Abstract:

Racecadotril is an antidiarrheal drug which acts as a peripherally acting enkephalinase inhibitor. It is a solubility limited compound and thus the bioavailability can be improved by increasing its aqueous solubility. Solid dispersions of racecadotril were prepared using polymers β-cyclodextrin, poloxamer 188 (Lutrol F 68) and poloxamer 407 (Lutrol F127) in different proportions (1:1, 1:3, 1:5 and 1:10). Solvent evaporation method was employed using methanol as solvent. The solid dispersion complexes were also characterized using FT-IR, DSC and XRD. The optimized dispersions were formulated into rapid disintegrating tablets using Kollidon® CL-SF and sodium starch glycolate (SSG) as disintegrants with proportion of 2%, 3%, and 4%. The disintegration time, mean dissolution time (MDT), T50 and T90 of the formulated tablets were evaluated and compared with the marketed formulation. The pure drug showed aqueous solubility of 18.89 μg/ml while the solid dispersions with poloxamer 188 and poloxamer 407 in ratios 1:5 showed solubility of 70.75 μg/ml and 58.07 μg/ml. There was a 3 fold increase in drug solubility. The disintegration time of all the formulations were found to be less than 42 sec. Both Kollidon® CL-SF and SSG decreased the T50 and T90 values but Kollidon® CL-SF at a concentration of 4% was found to show the best results (T50 = 10.63 ± 0.17, T90 = 35.31 ± 0.57 and MDT = 13.85 ± 0.27 min). This was further compared with marketed formulation. The difference (f1) and similarity (f2) factors was found to be 89.91 and 21.11 respectively. The results suggest that the designed formulation is improved than the marketed formulation. The improved solubility, dissolution and drug release may be highly beneficial in improving the overall bioavailability of RDT.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs