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Characterization and Optimization of Capryol-90, Polysorbate-80, And Peg-400 Proportion in Mefenamic Acid Self Nanoemulsifying Drug Delivery System (SNEDDS) With Simplex-Lattice-Design

Science and Technology Indonesia · Vol. 3 No. 4 (2018) · hlm. 164–172

DOI
10.26554/sti.2018.3.4.164-172
ISSN
2580-4391, 2580-4405
Terbit
2018-10-26
Penerbit
Research Center of Inorganic Materials and Coordination Complexes, FMIPA Universitas Sriwijaya
Bahasa
eng

Abstrak

Mefenamic acid as pain relief drug belongs to the biopharmaceutics classification system (BCS) class II which is practically insoluble in water causing extremely low dissolution in gastrointestinal tract. The self nanoemulsifying drug delivery system (SNEDDS) is a new innovation pharmaceutical dosage form that has effectively known to increase solubilization of hydrophobic drug in polar solvent. In this study the capryol-90 was selected as oil phase in SNEDDS as it showed maximal solubility of mefenamic acid (20 mg/mL). Combination of polysorbate-80 and PEG-400 as a generally regarded as safe (GRAS) excipient were used as surfactant and co-surfactant in SNEDDS due to its high HLB property that can increase mefenamic acid solubility in water. The ternary phase diagram of capryol-90, polysorbate-80, and PEG-400 was constructed in advance to obtain the component concentration of spontaneous nanoemulsion region. Model simplex-lattice-design cooperated in Design-Expert®10 was used to define SNEDDS mefenamic acid formula. Optimized mefenamic acid SNEDDS formula consisted of 20% capryol-90, 31.62% polysorbate-80, and 48.38% PEG-400. Characterization study of Optimized mefenamic acid SNEDDS formula showed improvement of drug content (102.820 ± 4.950)%, emulsification time (421.015 ± 1.290) second, and viscosity (0.927 ± 0.017) mm2/s 30oC. One way ANOVA statistical analysis result of optimal formula SNEDDS (105.210 ± 4.425)% of drug content, commercial generic caplet (0.917 ± 0.094)%, and mefenamic acid powder capsule (10.446 ± 0,333)% gave significant value (sig*) below than 0.05. Optimal formula proved that SNEDDS can significantly increase mefenamic acid dissolution of pH 7.4 (ileum fluid). The optimal formula of mefenamic acid SNEDDS successfully formed an uniformity droplet size (PDI 0.18) with mean size 241.9 nm and the surface charge has a value of -16.5 mV respectively.

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Aldes LesbaniSriwijaya University7
Risfidian MohadiSriwijaya University5
Nur AhmadSriwijaya University3
Idha RoyaniSriwijaya University3
Yulizah HanifahSriwijaya University3
Amri AmriSriwijaya University3
Rennie Puspa NovitaSriwijaya University2
Vicky AndreanSriwijaya University2
Alfan WijayaSriwijaya University1
Rohmatullaili RohmatullailiSriwijaya University1
Sahrul WibiyanSriwijaya University1
Yusuf Mathiinul HakimSriwijaya University1
Rahma Dinta AstutiSriwijaya University1
Jefri JefriSriwijaya University1
Suheryanto SuheryantoSriwijaya University1
Neza Rahayu PalapaSriwijaya University1
Arini Fousty BadriSriwijaya University1
Fitri Suryani ArsyadSriwijaya University1
Muhammad SaidSriwijaya University1
Afan WijayaAfiliasi tidak diketahui1
Erni Salasia FitriSriwijaya University1
Indah SolihahSriwijaya University1
Soilia FertilitaSriwijaya University1
Herlina HerlinaSriwijaya University1
Oktia CharmilaSriwijaya University1
Fitrya FitryaSriwijaya University1
Tia ShabrinaSriwijaya University1
Diva YulanriSriwijaya University1

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Metadata asli (oai_dc) 
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	<dc:title xml:lang="en-US">Characterization and Optimization of Capryol-90, Polysorbate-80, And Peg-400 Proportion in Mefenamic Acid Self Nanoemulsifying Drug Delivery System (SNEDDS) With Simplex-Lattice-Design</dc:title>
	<dc:creator>Mardiyanto, Mardiyanto</dc:creator>
	<dc:creator>Fithri, Najma Annuria</dc:creator>
	<dc:creator>Tandry, Martina</dc:creator>
	<dc:description xml:lang="en-US">Mefenamic acid as pain relief drug belongs to the biopharmaceutics classification system (BCS) class II which is practically insoluble in water causing extremely low dissolution in gastrointestinal tract. The self nanoemulsifying drug delivery system (SNEDDS) is a new innovation pharmaceutical dosage form that has effectively known to increase solubilization of hydrophobic drug in polar solvent. In this study the capryol-90 was selected as oil phase in SNEDDS as it showed maximal solubility of mefenamic acid (20 mg/mL). Combination of polysorbate-80 and PEG-400 as a generally regarded as safe (GRAS) excipient were used as surfactant and co-surfactant in SNEDDS due to its high HLB property that can increase mefenamic acid solubility in water. The ternary phase diagram of capryol-90, polysorbate-80, and PEG-400 was constructed in advance to obtain the component concentration of spontaneous nanoemulsion region. Model simplex-lattice-design cooperated in Design-Expert®10 was used to define SNEDDS mefenamic acid formula. Optimized mefenamic acid SNEDDS formula consisted of 20% capryol-90, 31.62% polysorbate-80, and 48.38% PEG-400. Characterization study of Optimized mefenamic acid SNEDDS formula showed improvement of drug content (102.820 ± 4.950)%, emulsification time (421.015 ± 1.290) second, and viscosity (0.927 ± 0.017) mm2/s 30oC. One way ANOVA statistical analysis result of optimal formula SNEDDS (105.210 ± 4.425)% of drug content, commercial generic caplet (0.917 ± 0.094)%, and mefenamic acid powder capsule (10.446 ± 0,333)% gave significant value (sig*) below than 0.05. Optimal formula proved that SNEDDS can significantly increase mefenamic acid dissolution of pH 7.4 (ileum fluid). The optimal formula of mefenamic acid SNEDDS successfully formed an uniformity droplet size (PDI 0.18) with mean size 241.9 nm and &amp;nbsp;the surface charge has a value of -16.5 mV respectively.</dc:description>
	<dc:publisher xml:lang="en-US">Research Center of Inorganic Materials and Coordination Complexes, FMIPA Universitas Sriwijaya</dc:publisher>
	<dc:date>2018-10-26</dc:date>
	<dc:type>info:eu-repo/semantics/article</dc:type>
	<dc:type>info:eu-repo/semantics/publishedVersion</dc:type>
	<dc:type xml:lang="en-US">Peer-reviewed Article</dc:type>
	<dc:format>application/pdf</dc:format>
	<dc:identifier>http://sciencetechindonesia.com/index.php/jsti/article/view/135</dc:identifier>
	<dc:identifier>10.26554/sti.2018.3.4.164-172</dc:identifier>
	<dc:source xml:lang="en-US">Science and Technology Indonesia; Vol. 3 No. 4 (2018): October; 164-172</dc:source>
	<dc:source>2580-4391</dc:source>
	<dc:source>2580-4405</dc:source>
	<dc:language>eng</dc:language>
	<dc:relation>http://sciencetechindonesia.com/index.php/jsti/article/view/135/88</dc:relation>
	<dc:rights xml:lang="en-US">Copyright (c) 2018 Mardiyanto Mardiyanto; Najma Annuria Fithri, Martina Tandry</dc:rights>
</oai_dc:dc>