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Development and evaluation of Ketoprofen sustained release matrix tablet using Hibiscus rosa-sinensis leaves mucilage.
Saudi Pharm J. 2017 Jul; 25(5):770-779.SP

Abstract

Currently, the use of natural gums and mucilage is of increasing importance in pharmaceutical formulations as valuable drug excipient. Natural plant-based materials are economic, free of side effects, biocompatible and biodegradable. Therefore, Ketoprofen matrix tablets were formulated by employing Hibiscus rosa-sinensis leaves mucilage as natural polymer and HPMC (K100M) as a synthetic polymer to sustain the drug release from matrix system. Direct compression method was used to develop sustained released matrix tablets. The formulated matrix tablets were evaluated in terms of physical appearance, weight variation, thickness, diameter, hardness, friability and in vitro drug release. The difference between the natural and synthetic polymers was investigated concurrently. Matrix tablets developed from each formulation passed all standard physical evaluation tests. The dissolution studies of formulated tablets revealed sustained drug release up to 24 h compared to the reference drug Apo Keto® SR tablets. The dissolution data later were fitted into kinetic models such as zero order equation, first order equation, Higuchi equation, Hixson Crowell equation and Korsmeyer-Peppas equation to study the release of drugs from each formulation. The best formulations were selected based on the similarity factor (f2) value of 50% and more. Through the research, it is found that by increasing the polymers concentration, the rate of drug release decreased for both natural and synthetic polymers. The best formulation was found to be F3 which contained 40% Hibiscus rosa-sinensis mucilage polymer and showed comparable dissolution profile to the reference drug with f2 value of 78.03%. The release kinetics of this formulation has shown to follow non-Fickian type which involved both diffusion and erosion mechanism. Additionally, the statistical results indicated that there was no significant difference (p > 0.05) between the F3 and reference drug in terms of MDT and T50% with p-values of 1.00 and 0.995 respectively.

Authors+Show Affiliations

School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.School of Pharmacy, Management & Science University, 40100 Shah Alam, Selangor Darul Ehsan, Malaysia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28725150

Citation

Kaleemullah, M, et al. "Development and Evaluation of Ketoprofen Sustained Release Matrix Tablet Using Hibiscus Rosa-sinensis Leaves Mucilage." Saudi Pharmaceutical Journal : SPJ : the Official Publication of the Saudi Pharmaceutical Society, vol. 25, no. 5, 2017, pp. 770-779.
Kaleemullah M, Jiyauddin K, Thiban E, et al. Development and evaluation of Ketoprofen sustained release matrix tablet using Hibiscus rosa-sinensis leaves mucilage. Saudi Pharm J. 2017;25(5):770-779.
Kaleemullah, M., Jiyauddin, K., Thiban, E., Rasha, S., Al-Dhalli, S., Budiasih, S., Gamal, O. E., Fadli, A., & Eddy, Y. (2017). Development and evaluation of Ketoprofen sustained release matrix tablet using Hibiscus rosa-sinensis leaves mucilage. Saudi Pharmaceutical Journal : SPJ : the Official Publication of the Saudi Pharmaceutical Society, 25(5), 770-779. https://doi.org/10.1016/j.jsps.2016.10.006
Kaleemullah M, et al. Development and Evaluation of Ketoprofen Sustained Release Matrix Tablet Using Hibiscus Rosa-sinensis Leaves Mucilage. Saudi Pharm J. 2017;25(5):770-779. PubMed PMID: 28725150.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and evaluation of Ketoprofen sustained release matrix tablet using Hibiscus rosa-sinensis leaves mucilage. AU - Kaleemullah,M, AU - Jiyauddin,K, AU - Thiban,E, AU - Rasha,S, AU - Al-Dhalli,S, AU - Budiasih,S, AU - Gamal,O E, AU - Fadli,A, AU - Eddy,Y, Y1 - 2016/11/10/ PY - 2015/10/22/received PY - 2016/10/07/accepted PY - 2017/7/21/entrez PY - 2017/7/21/pubmed PY - 2017/7/21/medline KW - HPMC KW - Hibiscus rosa-sinensis KW - Ketoprofen KW - Mucilage KW - Sustained release SP - 770 EP - 779 JF - Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society JO - Saudi Pharm J VL - 25 IS - 5 N2 - Currently, the use of natural gums and mucilage is of increasing importance in pharmaceutical formulations as valuable drug excipient. Natural plant-based materials are economic, free of side effects, biocompatible and biodegradable. Therefore, Ketoprofen matrix tablets were formulated by employing Hibiscus rosa-sinensis leaves mucilage as natural polymer and HPMC (K100M) as a synthetic polymer to sustain the drug release from matrix system. Direct compression method was used to develop sustained released matrix tablets. The formulated matrix tablets were evaluated in terms of physical appearance, weight variation, thickness, diameter, hardness, friability and in vitro drug release. The difference between the natural and synthetic polymers was investigated concurrently. Matrix tablets developed from each formulation passed all standard physical evaluation tests. The dissolution studies of formulated tablets revealed sustained drug release up to 24 h compared to the reference drug Apo Keto® SR tablets. The dissolution data later were fitted into kinetic models such as zero order equation, first order equation, Higuchi equation, Hixson Crowell equation and Korsmeyer-Peppas equation to study the release of drugs from each formulation. The best formulations were selected based on the similarity factor (f2) value of 50% and more. Through the research, it is found that by increasing the polymers concentration, the rate of drug release decreased for both natural and synthetic polymers. The best formulation was found to be F3 which contained 40% Hibiscus rosa-sinensis mucilage polymer and showed comparable dissolution profile to the reference drug with f2 value of 78.03%. The release kinetics of this formulation has shown to follow non-Fickian type which involved both diffusion and erosion mechanism. Additionally, the statistical results indicated that there was no significant difference (p > 0.05) between the F3 and reference drug in terms of MDT and T50% with p-values of 1.00 and 0.995 respectively. SN - 1319-0164 UR - https://www.unboundmedicine.com/medline/citation/28725150/Development_and_evaluation_of_Ketoprofen_sustained_release_matrix_tablet_using_Hibiscus_rosa_sinensis_leaves_mucilage_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1319-0164(16)30111-6 DB - PRIME DP - Unbound Medicine ER -