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Solid-state interaction of ibuprofen with magnesium stearate and product characterization thereof.
Drug Dev Ind Pharm. 2020 Aug; 46(8):1308-1317.DD

Abstract

Solid-state compatibility of API with excipients is essential step in the preformulation stage of early development of new finished dosage form. Thermal analysis and vibrational spectroscopy are complementary techniques that play a pivotal role to assess the solid-state compatibility of API with excipients. Their coupling and combination with multivariate analysis, provide valuable quantitative aspect to reveal the potential interactions. The impetus of this work was aimed to fully elucidate the solid-state compatibility of ibuprofen and magnesium stearate in binary mixtures comprising pharmaceutically acceptable amounts of magnesium stearate (0.25-5% w/w). Binary mixtures were analyzed before and after exposure at strictly controlled stress conditions (25 °C/60% relative humidity and 40 °C/75% relative humidity). Interaction between ibuprofen and magnesium stearate was unambiguously confirmed. The product of their interaction was synthetized separately, characterized by means of FTIR spectroscopy, DSC, TG/DTG and XRPD for the first time and identified as diibuprofen magnesium. The induced solid-state pseudopolymorphic transition of this product to diibuprofen magnesium tetrahydrate was also studied and discussed.

Authors+Show Affiliations

Research and Development, Alkaloid AD, Skopje, Republic of North Macedonia.Faculty of Pharmacy, Institute of Pharmaceutical Technology, University of Ss. Cyril and Methodius, Skopje, Republic of North Macedonia.Research and Development, Alkaloid AD, Skopje, Republic of North Macedonia. Faculty of Natural Sciences and Mathematics, Institute of Chemistry, Ss. Cyril and Methodius University, Skopje, Republic of North Macedonia.Research and Development, Alkaloid AD, Skopje, Republic of North Macedonia.Research and Development, Alkaloid AD, Skopje, Republic of North Macedonia.Research and Development, Alkaloid AD, Skopje, Republic of North Macedonia.Faculty of Natural Sciences and Mathematics, Institute of Chemistry, Ss. Cyril and Methodius University, Skopje, Republic of North Macedonia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32597246

Citation

Stojanovska Pecova, Monika, et al. "Solid-state Interaction of Ibuprofen With Magnesium Stearate and Product Characterization Thereof." Drug Development and Industrial Pharmacy, vol. 46, no. 8, 2020, pp. 1308-1317.
Stojanovska Pecova M, Geskovski N, Petrushevski G, et al. Solid-state interaction of ibuprofen with magnesium stearate and product characterization thereof. Drug Dev Ind Pharm. 2020;46(8):1308-1317.
Stojanovska Pecova, M., Geskovski, N., Petrushevski, G., Chachorovska, M., Krsteska, L., Ugarkovic, S., & Makreski, P. (2020). Solid-state interaction of ibuprofen with magnesium stearate and product characterization thereof. Drug Development and Industrial Pharmacy, 46(8), 1308-1317. https://doi.org/10.1080/03639045.2020.1788067
Stojanovska Pecova M, et al. Solid-state Interaction of Ibuprofen With Magnesium Stearate and Product Characterization Thereof. Drug Dev Ind Pharm. 2020;46(8):1308-1317. PubMed PMID: 32597246.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Solid-state interaction of ibuprofen with magnesium stearate and product characterization thereof. AU - Stojanovska Pecova,Monika, AU - Geskovski,Nikola, AU - Petrushevski,Gjorgji, AU - Chachorovska,Marina, AU - Krsteska,Liljana, AU - Ugarkovic,Sonja, AU - Makreski,Petre, Y1 - 2020/07/08/ PY - 2020/7/1/pubmed PY - 2020/7/1/medline PY - 2020/6/30/entrez KW - Ibuprofen KW - compatibility KW - diibuprofen magnesium tetrahydrate KW - magnesium stearate KW - mechanosynthesis KW - solid-state interaction SP - 1308 EP - 1317 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 46 IS - 8 N2 - Solid-state compatibility of API with excipients is essential step in the preformulation stage of early development of new finished dosage form. Thermal analysis and vibrational spectroscopy are complementary techniques that play a pivotal role to assess the solid-state compatibility of API with excipients. Their coupling and combination with multivariate analysis, provide valuable quantitative aspect to reveal the potential interactions. The impetus of this work was aimed to fully elucidate the solid-state compatibility of ibuprofen and magnesium stearate in binary mixtures comprising pharmaceutically acceptable amounts of magnesium stearate (0.25-5% w/w). Binary mixtures were analyzed before and after exposure at strictly controlled stress conditions (25 °C/60% relative humidity and 40 °C/75% relative humidity). Interaction between ibuprofen and magnesium stearate was unambiguously confirmed. The product of their interaction was synthetized separately, characterized by means of FTIR spectroscopy, DSC, TG/DTG and XRPD for the first time and identified as diibuprofen magnesium. The induced solid-state pseudopolymorphic transition of this product to diibuprofen magnesium tetrahydrate was also studied and discussed. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/32597246/Solid-state_interaction_of_ibuprofen_with_magnesium_stearate_and_product_characterization_thereof L2 - http://www.tandfonline.com/doi/full/10.1080/03639045.2020.1788067 DB - PRIME DP - Unbound Medicine ER -
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