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    ABSTRACT: Particulate growth in parenteral product frequently results in product recalls causing drug shortages. While this is mostly attributed to quality issues in a firm, particulates growth could also be due to inadequate product, process, or environmental understanding. Therefore, the objective of this study was to use indomethacin sodium trihydrate (drug) as a model drug for lyophilization and evaluates short-term stability with respect to particulate growth at different storage temperatures. Under aseptic condition, each vial filled with filtered drug solution was lyophilized, and stoppered in LyoStar3. Crimped vials were kept at 5 °C, 15 °C, 25 °C, 25 °C/60%RH, and 40 °C/75%RH. At predefined time interval, samples were characterized using X-ray powder diffraction (XRPD), thermal, and spectroscopic method. Lyophilized formulation showed four thermal events: 60–90 °C demonstrating glass transition, 110–160 °C showing recrystallization exotherm,170–220 °C exhibiting endotherm of potential polymorph, and 250 °C showing melting endotherm. XRPD of the lyophilized powder demonstrated peak at 2θ 11.10. Spectroscopic studies of lyophilized powder indicated alteration in symmetric and asymmetric carboxylate peaks over time indicating initiation of crystallization and crystal growth. Reconstitution studies indicated higher reconstitution time after six weeks for sample stored at 40 °C/75%RH. Furthermore, reconstituted solution showed presence of particulates after 8 weeks storage. These studies suggest that particulate growth can stem from poorly developed formulation and not necessarily due to frequently ascribed filtration issues.
    International Journal of Pharmaceutics 10/2014; 473(1-2):545-551. DOI:10.1016/j.ijpharm.2014.07.035
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    ABSTRACT: Conference code: 106839, Export Date: 21 March 2015, Correspondence Address: Ghezloun, A.; Centre de Développement des Energies Renouvelables, CDER, Route de l'Observatoire, Bouzaréah, 16340, Algiers, Algeria; email: a.ghezloun@cder.dz, References: Chevalier, J.-M., (2005) L'Équation de Johannesburg, Med Énergie, N° 15, , Avril;
    International Conference on Technologies and Materials for Renewable Energy, Environment and Sustainability, TMREES 2014 - EUMISD, Beirut; 01/2014
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    ABSTRACT: Conference code: 106839, Export Date: 21 March 2015, References: Boudghene Stambouli, A., Khiat, Z., Flazi, S., Kitamura, Y., A review on the renewable energy development in Algeria: Current perspective, energy scenario and sustainability issues (2012) Renewable and Sustainable Energy Reviews, 16, pp. 4445-4460;
    International Conference on Technologies and Materials for Renewable Energy, Environment and Sustainability, TMREES 2014 - EUMISD, Beirut; 01/2014

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  • Address
    Route de l'Observatoire, Bouzareah, 16340, Algiers, Algeria
  • Head of Institution
    Noureddine YASSAA
  • Website
    http://www.cder.dz
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    +21321901503
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    +21321901560
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Solar Energy 09/2012; 91. DOI:10.1016/j.solener.2012.09.016
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