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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.
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    ABSTRACT: Batch digestion experiments were conducted to determine the effects of inoculums/substrate ratio of three different ratios (ISRs) 0.3, 0.5 and 1. The substrate chosen in this study was slaughterhouse waste from Adrar city (south west of Algeria). The inoculation was made by sludge issued from wastewater treatment plant. During this study, several parameters of anaerobic digestion were measured, such as pH, VFA, AT and volume of the produced biogas. pH variation and VFA/TA values have shown high stability of anaerobic digestion process.
    Energy Procedia 01/2014; 50:57–63.
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    ABSTRACT: Currently, there is no consensus on endpoint measures to assess clinical outcome for pediatric UC. This study reviewed the endpoints used in the registration trials of approved drugs for pediatric UC. The primary efficacy endpoints of all registration trials completed from 1950 - 2008 that led to FDA approval for indications in pediatric and adult UC were reviewed. Colazal and Remicade have been approved for pediatric UC indication, and clinical response was used as a primary endpoint in these registration trials. The clinical response in the adult Colazal trials was defined as a reduction of rectal bleeding and improvement in at least one of the other assessed symptoms (stool frequency, patient functional assessment, abdominal pain, sigmoidoscopic grade, and physician's global assessment) assessed by the Sutherland UC Activity Index. The pediatric Colazal trial defined clinical response using the Modified Sutherland UC Activity Index, which excluded abdominal pain and functional assessment. Both adult and pediatric Remicade trials used clinical response defined by the Mayo score as the primary endpoint. The Pediatric Ulcerative Colitis Activity Index (PUCAI) was used to measure various secondary endpoints in the pediatric Remicade trial. Pediatric-specific endpoints were used, but outcome measures and definition of clinical response was not consistent in pediatric UC trials. Consensus on definition of successful treatment outcome (clinical response and/or remission) and collaboration in the development of well-defined and reliable measures of signs and symptoms for use in conjunction with endoscopic parameters of mucosal healing will facilitate pediatric drug development.
    Journal of pediatric gastroenterology and nutrition 10/2013;


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    Route de l'Observatoire, Bouzareah, 16340, Algiers, Algeria
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    Noureddine YASSAA
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