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Floating matrix dosage form for dextromethorphan hydrobromide based on gas forming technique: in vitro and in vivo evaluation in healthy volunteers.
Eur J Pharm Sci. 2011 Jan 18; 42(1-2):99-105.EJ

Abstract

The objective of this study was to develop the dextromethorphan hydrobromide sustained-release (DMB-SR) tablets using floating technique to prolong the gastric residence time and compared their pharmacokinetic behavior with conventional sustained release tablets. DMB-SR floating tablets were prepared employing hydroxypropyl methylcellulose (HPMC) as hydrophilic gel material, sodium bicarbonate as gas-generating agent and hexadecanol as floating assistant agent. An orthogonal experiment design method was used to select the optimized formulation. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, floating characteristics, in vitro release and in vivo bioavailability. The optimized tablets were prepared with HPMC K4M 25 mg, sodium bicarbonate 20 mg and hexadecanol 18 mg. The prepared tablets could float within 3 min and maintain for more than 24 h. The data of physical parameters were all lie within the limits. Drug release at 12 h was more than 85%. The comparative pharmacokinetic study was performed by administration of the DMB-SR floating tablets and conventional DMB-SR tablets. The area under curve of plasma concentration-time (AUC) of floating tablets was slightly higher than that of reference tablets, T(max) was prolonged apparently. The results showed the floating tablets are a feasible approach for the sustained-release preparation of drugs, which have limited absorption sites in the stomach.

Authors+Show Affiliations

School of Pharmacy, Hebei University, Hebei Baoding, PR China. hbupharm@126.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21050887

Citation

Hu, Liandong, et al. "Floating Matrix Dosage Form for Dextromethorphan Hydrobromide Based On Gas Forming Technique: in Vitro and in Vivo Evaluation in Healthy Volunteers." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 42, no. 1-2, 2011, pp. 99-105.
Hu L, Li L, Yang X, et al. Floating matrix dosage form for dextromethorphan hydrobromide based on gas forming technique: in vitro and in vivo evaluation in healthy volunteers. Eur J Pharm Sci. 2011;42(1-2):99-105.
Hu, L., Li, L., Yang, X., Liu, W., Yang, J., Jia, Y., Shang, C., & Xu, H. (2011). Floating matrix dosage form for dextromethorphan hydrobromide based on gas forming technique: in vitro and in vivo evaluation in healthy volunteers. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 42(1-2), 99-105. https://doi.org/10.1016/j.ejps.2010.10.010
Hu L, et al. Floating Matrix Dosage Form for Dextromethorphan Hydrobromide Based On Gas Forming Technique: in Vitro and in Vivo Evaluation in Healthy Volunteers. Eur J Pharm Sci. 2011 Jan 18;42(1-2):99-105. PubMed PMID: 21050887.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Floating matrix dosage form for dextromethorphan hydrobromide based on gas forming technique: in vitro and in vivo evaluation in healthy volunteers. AU - Hu,Liandong, AU - Li,Li, AU - Yang,Xun, AU - Liu,Wei, AU - Yang,Jianxue, AU - Jia,Yanhong, AU - Shang,Chuang, AU - Xu,Hongxin, Y1 - 2010/11/02/ PY - 2010/07/06/received PY - 2010/09/15/revised PY - 2010/10/23/accepted PY - 2010/11/6/entrez PY - 2010/11/6/pubmed PY - 2011/4/7/medline SP - 99 EP - 105 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 42 IS - 1-2 N2 - The objective of this study was to develop the dextromethorphan hydrobromide sustained-release (DMB-SR) tablets using floating technique to prolong the gastric residence time and compared their pharmacokinetic behavior with conventional sustained release tablets. DMB-SR floating tablets were prepared employing hydroxypropyl methylcellulose (HPMC) as hydrophilic gel material, sodium bicarbonate as gas-generating agent and hexadecanol as floating assistant agent. An orthogonal experiment design method was used to select the optimized formulation. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, floating characteristics, in vitro release and in vivo bioavailability. The optimized tablets were prepared with HPMC K4M 25 mg, sodium bicarbonate 20 mg and hexadecanol 18 mg. The prepared tablets could float within 3 min and maintain for more than 24 h. The data of physical parameters were all lie within the limits. Drug release at 12 h was more than 85%. The comparative pharmacokinetic study was performed by administration of the DMB-SR floating tablets and conventional DMB-SR tablets. The area under curve of plasma concentration-time (AUC) of floating tablets was slightly higher than that of reference tablets, T(max) was prolonged apparently. The results showed the floating tablets are a feasible approach for the sustained-release preparation of drugs, which have limited absorption sites in the stomach. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/21050887/Floating_matrix_dosage_form_for_dextromethorphan_hydrobromide_based_on_gas_forming_technique:_in_vitro_and_in_vivo_evaluation_in_healthy_volunteers_ DB - PRIME DP - Unbound Medicine ER -