Tags

Type your tag names separated by a space and hit enter

Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants.
Arch Pharm Res. 2011 Nov; 34(11):1945-56.AP

Abstract

The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets' hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity.

Authors+Show Affiliations

School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22139694

Citation

Sheshala, Ravi, et al. "Formulation and in Vivo Evaluation of Ondansetron Orally Disintegrating Tablets Using Different Superdisintegrants." Archives of Pharmacal Research, vol. 34, no. 11, 2011, pp. 1945-56.
Sheshala R, Khan N, Chitneni M, et al. Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants. Arch Pharm Res. 2011;34(11):1945-56.
Sheshala, R., Khan, N., Chitneni, M., & Darwis, Y. (2011). Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants. Archives of Pharmacal Research, 34(11), 1945-56. https://doi.org/10.1007/s12272-011-1115-y
Sheshala R, et al. Formulation and in Vivo Evaluation of Ondansetron Orally Disintegrating Tablets Using Different Superdisintegrants. Arch Pharm Res. 2011;34(11):1945-56. PubMed PMID: 22139694.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants. AU - Sheshala,Ravi, AU - Khan,Nurzalina, AU - Chitneni,Mallikarjun, AU - Darwis,Yusrida, Y1 - 2011/12/03/ PY - 2010/07/24/received PY - 2011/05/18/accepted PY - 2011/05/10/revised PY - 2011/12/6/entrez PY - 2011/12/6/pubmed PY - 2012/5/2/medline SP - 1945 EP - 56 JF - Archives of pharmacal research JO - Arch Pharm Res VL - 34 IS - 11 N2 - The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets' hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity. SN - 0253-6269 UR - https://www.unboundmedicine.com/medline/citation/22139694/Formulation_and_in_vivo_evaluation_of_ondansetron_orally_disintegrating_tablets_using_different_superdisintegrants_ L2 - https://dx.doi.org/10.1007/s12272-011-1115-y DB - PRIME DP - Unbound Medicine ER -