CHALLENGES TO IMPROVE THE STABILITY AND EFFICACY OF AN INTRAVESICAL BCG PRODUCT

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HOZOURI HAMIDREZA; NOROUZIAN DARIUSH; NAFISSI VARCHEH NASTARAN; ABOOFAZELI REZA

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Journal Paper

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Journal: Iranian Journal of Pharmaceutical Research Year:2014 | Volume:13 | Issue:SUPPL Page(s): 143-150

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Title

CHALLENGES TO IMPROVE THE STABILITY AND EFFICACY OF AN INTRAVESICAL BCG PRODUCT

Author(s)

HOZOURI HAMIDREZA | NOROUZIAN DARIUSH | NAFISSI VARCHEH NASTARAN | ABOOFAZELI REZA | Issue Writer Certificate

Keywords

BACILLUS CALMETTE-GUERIN

BCG

INTRAVESICAL

LYOPHILIZATION

TREHALOSE

MYCOBACTERIUM BOVIS

Abstract

The aim of this investigation was to improve the storage stability and survival rate of an INTRAVESICAL BCG product, manufactured with an attenuated strain of MYCOBACTERIUM BOVIS (Pasteur strain 1173P2 of BCG) in the presence of sodium glutamate. Formulations with various concentrations of TREHALOSE (a known protectant) were developed as liquid and lyophilized forms. Formulations were evaluated by different methods, including optical density measurement, safety assessment, skin reaction test, moisture content determination, viability assay, bacterial and fungal contaminations and the results were compared with those obtained for sodium glutamate-containing formulations. The stability tests were also carried out in various storage durations and different temperatures. To develop the LYOPHILIZATION protocol, glass transition temperatures in the presence of both stabilizers were determined using differential scanning calorimetry. In general, results showed that TREHALOSE could considerably increase the stability of the product against freezing and drying processes, increase the survival rate even in the liquid formulations, as well as the production of an acceptable cake. However, further studies are required to optimize the product characteristics.

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APA: Copy

HOZOURI, HAMIDREZA, NOROUZIAN, DARIUSH, NAFISSI VARCHEH, NASTARAN, & ABOOFAZELI, REZA. (2014). CHALLENGES TO IMPROVE THE STABILITY AND EFFICACY OF AN INTRAVESICAL BCG PRODUCT. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 13(SUPPL), 143-150. SID. https://sid.ir/paper/288422/en

Vancouver: Copy

HOZOURI HAMIDREZA, NOROUZIAN DARIUSH, NAFISSI VARCHEH NASTARAN, ABOOFAZELI REZA. CHALLENGES TO IMPROVE THE STABILITY AND EFFICACY OF AN INTRAVESICAL BCG PRODUCT. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2014;13(SUPPL):143-150. Available from: https://sid.ir/paper/288422/en

IEEE: Copy

HAMIDREZA HOZOURI, DARIUSH NOROUZIAN, NASTARAN NAFISSI VARCHEH, and REZA ABOOFAZELI, “CHALLENGES TO IMPROVE THE STABILITY AND EFFICACY OF AN INTRAVESICAL BCG PRODUCT,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 13, no. SUPPL, pp. 143–150, 2014, [Online]. Available: https://sid.ir/paper/288422/en

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