Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

Tarja Limnell; Teemu Heikkilä; Hélder A. Santos; Sanna Sistonen; Sanna Hellstén; Timo Laaksonen; Leena Peltonen; Narendra Kumar; Dmitry Yu Murzin; Marjatta Louhi-Kultanen; Jarno Salonen; Jouni Hirvonen; Vesa-Pekka Lehto

doi:10.1016/j.ijpharm.2011.06.050

Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

Tarja Limnell^*
, Teemu Heikkilä
, Hélder A. Santos
, Sanna Sistonen
, Sanna Hellstén
, Timo Laaksonen
, Leena Peltonen
, Narendra Kumar
, Dmitry Yu Murzin
, Marjatta Louhi-Kultanen
, Jarno Salonen
, Jouni Hirvonen
, Vesa-Pekka Lehto

^*Tämän työn vastaava kirjoittaja

Tutkimustuotos: Lehtiartikkeli › Artikkeli › Tieteellinen › vertaisarvioitu

63 Sitaatiot (Scopus)

Abstrakti

Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 °C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery.

Alkuperäiskieli	Englanti
Sivut	242-251
Sivumäärä	10
Julkaisu	International Journal of Pharmaceutics
Vuosikerta	416
Numero	1
DOI - pysyväislinkit	https://doi.org/10.1016/j.ijpharm.2011.06.050
Tila	Julkaistu - 15 syysk. 2011
OKM-julkaisutyyppi	A1 Julkaistu artikkeli, soviteltu

Rahoitus

The financial support from the Academy of Finland ( grants nos. 118002, 122314, 122828, 123037, 127099, 136875 and 202258 ), University of Helsinki Research Funds ( grant no. 490039 ), Finnish Academy of Science and Letters, Turku University Foundation, Emil Aaltonen Foundation, Otto Malm Foundation and the Finnish Society of Physical Pharmacy is acknowledged. Prof. T. Salmi (Laboratory of Industrial Chemistry, Åbo Akademi University) is acknowledged for scientific collaboration. MSc J. Riikonen and MSc E. Mäkilä are acknowledged for technical assistance with the laser diffraction method and LPh M. Heinonen for technical assistance with the SEM imaging (Department of Physics, University of Turku). S.H. acknowledges the Graduate School in Chemical Engineering for financial support and Dr. S.-P. Reinikainen and Dr. J. Kohonen for their help with the multivariate modeling.

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Limnell, T., Heikkilä, T., Santos, H. A., Sistonen, S., Hellstén, S., Laaksonen, T., Peltonen, L., Kumar, N., Murzin, D. Y., Louhi-Kultanen, M., Salonen, J., Hirvonen, J., & Lehto, V.-P. (2011). Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles. International Journal of Pharmaceutics, 416(1), 242-251. https://doi.org/10.1016/j.ijpharm.2011.06.050

@article{bd7beee6fdee4bd7a8483b863a360b9b,

title = "Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles",

abstract = "Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 °C/56\% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery.",

keywords = "Chemical, Drug release, Indomethacin, Mesoporous silica, Physical, Stability",

author = "Tarja Limnell and Teemu Heikkil{\"a} and Santos, \{H{\'e}lder A.\} and Sanna Sistonen and Sanna Hellst{\'e}n and Timo Laaksonen and Leena Peltonen and Narendra Kumar and Murzin, \{Dmitry Yu\} and Marjatta Louhi-Kultanen and Jarno Salonen and Jouni Hirvonen and Vesa-Pekka Lehto",

note = "Funding Information: The financial support from the Academy of Finland ( grants nos. 118002, 122314, 122828, 123037, 127099, 136875 and 202258 ), University of Helsinki Research Funds ( grant no. 490039 ), Finnish Academy of Science and Letters, Turku University Foundation, Emil Aaltonen Foundation, Otto Malm Foundation and the Finnish Society of Physical Pharmacy is acknowledged. Prof. T. Salmi (Laboratory of Industrial Chemistry, {\AA}bo Akademi University) is acknowledged for scientific collaboration. MSc J. Riikonen and MSc E. M{\"a}kil{\"a} are acknowledged for technical assistance with the laser diffraction method and LPh M. Heinonen for technical assistance with the SEM imaging (Department of Physics, University of Turku). S.H. acknowledges the Graduate School in Chemical Engineering for financial support and Dr. S.-P. Reinikainen and Dr. J. Kohonen for their help with the multivariate modeling. Copyright: Copyright 2012 Elsevier B.V., All rights reserved.",

year = "2011",

month = sep,

day = "15",

doi = "10.1016/j.ijpharm.2011.06.050",

language = "English",

volume = "416",

pages = "242--251",

journal = "International Journal of Pharmaceutics",

issn = "0378-5173",

publisher = "Elsevier",

number = "1",

}

Limnell, T, Heikkilä, T, Santos, HA, Sistonen, S, Hellstén, S, Laaksonen, T, Peltonen, L, Kumar, N , Murzin, DY, Louhi-Kultanen, M, Salonen, J, Hirvonen, J & Lehto, V-P 2011, 'Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles', International Journal of Pharmaceutics, Vuosikerta 416, Nro 1, Sivut 242-251. https://doi.org/10.1016/j.ijpharm.2011.06.050

TY - JOUR

T1 - Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

AU - Limnell, Tarja

AU - Heikkilä, Teemu

AU - Santos, Hélder A.

AU - Sistonen, Sanna

AU - Hellstén, Sanna

AU - Laaksonen, Timo

AU - Peltonen, Leena

AU - Kumar, Narendra

AU - Murzin, Dmitry Yu

AU - Louhi-Kultanen, Marjatta

AU - Salonen, Jarno

AU - Hirvonen, Jouni

AU - Lehto, Vesa-Pekka

N1 - Funding Information: The financial support from the Academy of Finland ( grants nos. 118002, 122314, 122828, 123037, 127099, 136875 and 202258 ), University of Helsinki Research Funds ( grant no. 490039 ), Finnish Academy of Science and Letters, Turku University Foundation, Emil Aaltonen Foundation, Otto Malm Foundation and the Finnish Society of Physical Pharmacy is acknowledged. Prof. T. Salmi (Laboratory of Industrial Chemistry, Åbo Akademi University) is acknowledged for scientific collaboration. MSc J. Riikonen and MSc E. Mäkilä are acknowledged for technical assistance with the laser diffraction method and LPh M. Heinonen for technical assistance with the SEM imaging (Department of Physics, University of Turku). S.H. acknowledges the Graduate School in Chemical Engineering for financial support and Dr. S.-P. Reinikainen and Dr. J. Kohonen for their help with the multivariate modeling. Copyright: Copyright 2012 Elsevier B.V., All rights reserved.

PY - 2011/9/15

Y1 - 2011/9/15

N2 - Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 °C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery.

AB - Stability of high indomethacin (IMC) content formulations based on ordered mesoporous silica MCM-41 and SBA-15 materials was studied before and after a 3 month storage in stressed conditions (30 °C/56% RH). Overall, the physical stability of the samples was found satisfactory after the storage. However, some issues with the chemical stability were noted, especially with the MCM-41 based samples. The stability issues were evident from the decreased HPLC loading degrees of the drug after stressing as well as from the observed extra peaks in the HPLC chromatograms of the drug in the stressed samples. Drug release from the mesoporous formulations before stressing was rapid at pH 1.2 in comparison to bulk crystalline IMC. The release profiles also remained similar after stressing. Even faster and close to complete IMC release was achieved when the pH was raised from 1.2 to 6.8. To our knowledge, this is the first report of chemical stability issues of drugs in mesoporous silica drug formulations. The present results encourage further study of the factors affecting the chemical stability of drugs in mesoporous silica MCM-41 and SBA-15 formulations in order to realize their potential in oral drug delivery.

KW - Chemical

KW - Drug release

KW - Indomethacin

KW - Mesoporous silica

KW - Physical

KW - Stability

UR - https://www.scopus.com/pages/publications/80051801637

U2 - 10.1016/j.ijpharm.2011.06.050

DO - 10.1016/j.ijpharm.2011.06.050

M3 - Article

C2 - 21763766

AN - SCOPUS:80051801637

SN - 0378-5173

VL - 416

SP - 242

EP - 251

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

IS - 1

ER -

Physicochemical stability of high indomethacin payload ordered mesoporous silica MCM-41 and SBA-15 microparticles

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