Characterization of factors affecting the release of low-solubility drug from prolonged release tablets
Diclofenac sodium (2-[(2,6-dichlorophenyl)amino]benzeneacetic acid monosodium salt) was investigated as a low-solubility drug and Naklofen ® retard prolonged release tablets, containing 100 mg of diclofenac sodium as a prolonged release lipophilic matrix system using factorial design approach. First...
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| Published in: | Analytica chimica acta Vol. 502; no. 1; pp. 107 - 113 |
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| Main Authors: | , , |
| Format: | Journal Article |
| Language: | English |
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Elsevier B.V
23-01-2004
Elsevier |
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| Abstract | Diclofenac sodium (2-[(2,6-dichlorophenyl)amino]benzeneacetic acid monosodium salt) was investigated as a low-solubility drug and Naklofen
® retard prolonged release tablets, containing 100
mg of diclofenac sodium as a prolonged release lipophilic matrix system using factorial design approach. First, the solubility characteristics of diclofenac sodium in aqueous media with various ionic strengths, ionic compositions and pH in the range of 1–8 were determined. The obtained results showed that the solubility of diclofenac sodium depends mainly on pH of the aqueous medium and less on the composition and ionic strength of the medium. Next, the estimation of the effects of six different factors (type of the dissolution apparatus, rotation speeds of the stirring elements, pH, ionic strengths of dissolution medium, the applied salt, and the producer of the on-line connected dissolution apparatus and UV spectrophotometer) on the release of diclofenac sodium, using the two-level six-factorial design was investigated. It was found that rotation speeds of the stirring elements, pH, and ionic strengths of the dissolution medium have a significant impact on the drug release and should be further followed in future drug release analyses. The advantages of the factorial design approach are obvious in this work. It is a very economic way of obtaining the maximum amount of information in a short period of time, especially in the case of prolonged release formulations where each experiment requires at least 24
h. |
|---|---|
| AbstractList | Diclofenac sodium (2-[(2,6-dichlorophenyl)amino]benzeneacetic acid monosodium salt) was investigated as a low-solubility drug and Naklofen
® retard prolonged release tablets, containing 100
mg of diclofenac sodium as a prolonged release lipophilic matrix system using factorial design approach. First, the solubility characteristics of diclofenac sodium in aqueous media with various ionic strengths, ionic compositions and pH in the range of 1–8 were determined. The obtained results showed that the solubility of diclofenac sodium depends mainly on pH of the aqueous medium and less on the composition and ionic strength of the medium. Next, the estimation of the effects of six different factors (type of the dissolution apparatus, rotation speeds of the stirring elements, pH, ionic strengths of dissolution medium, the applied salt, and the producer of the on-line connected dissolution apparatus and UV spectrophotometer) on the release of diclofenac sodium, using the two-level six-factorial design was investigated. It was found that rotation speeds of the stirring elements, pH, and ionic strengths of the dissolution medium have a significant impact on the drug release and should be further followed in future drug release analyses. The advantages of the factorial design approach are obvious in this work. It is a very economic way of obtaining the maximum amount of information in a short period of time, especially in the case of prolonged release formulations where each experiment requires at least 24
h. |
| Author | Kincl, M Veber, M Vrečer, F |
| Author_xml | – sequence: 1 givenname: M surname: Kincl fullname: Kincl, M email: maja.kincl@krka.biz organization: Physicochemical Development Department, R&D, Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo Mesto, Slovenia – sequence: 2 givenname: F surname: Vrečer fullname: Vrečer, F organization: New Formulations Research Department, R&D, Krka, d.d., Novo Mesto, Slovenia – sequence: 3 givenname: M surname: Veber fullname: Veber, M organization: University of Ljubljana, Faculty of Chemistry and Chemical Technology, Ljubljana, Slovenia |
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| CitedBy_id | crossref_primary_10_1016_j_ijpharm_2014_07_031 crossref_primary_10_1080_03639040600685167 crossref_primary_10_1016_j_molstruc_2022_132446 crossref_primary_10_3390_pharmaceutics15112587 crossref_primary_10_1080_03639040802710243 crossref_primary_10_1080_10717544_2022_2032873 crossref_primary_10_1590_S1984_82502011000200011 crossref_primary_10_1016_j_jpba_2004_11_041 crossref_primary_10_1016_j_carres_2009_01_011 crossref_primary_10_1016_j_carbpol_2014_01_018 crossref_primary_10_1007_s10337_010_1895_0 crossref_primary_10_1208_pt0804097 crossref_primary_10_4155_bio_13_23 crossref_primary_10_1016_S1773_2247_08_50024_4 crossref_primary_10_1016_j_colsurfb_2015_03_052 crossref_primary_10_1208_s12249_011_9696_9 crossref_primary_10_3109_08982104_2013_826241 crossref_primary_10_1002_er_5214 crossref_primary_10_1016_j_jpba_2005_09_009 |
| Cites_doi | 10.1023/A:1007526826979 10.1016/S0099-5428(08)60366-4 10.1023/A:1011984216775 10.1016/S0378-5173(00)00509-3 10.1016/S0169-409X(00)00130-7 10.3109/10837459709031444 |
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| Keywords | pH Fractional factorial designs Ionic strengths Two-level designs Prolonged release tablets Drug Stirring Solubility Dissolution Diclofenac Sodium Ionic strength Aqueous medium Tablet Factorial design Release |
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| Snippet | Diclofenac sodium (2-[(2,6-dichlorophenyl)amino]benzeneacetic acid monosodium salt) was investigated as a low-solubility drug and Naklofen
® retard prolonged... |
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| SubjectTerms | Analysis Biological and medical sciences Fractional factorial designs General pharmacology Ionic strengths Medical sciences Pharmacology. Drug treatments Prolonged release tablets Two-level designs |
| Title | Characterization of factors affecting the release of low-solubility drug from prolonged release tablets |
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