Suitability of differently formulated dry powder Newcastle disease vaccines for mass vaccination of poultry

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• 作者：Katrien Huyge^a ; Kristien Van Reeth^b ; Thomas De Beer^c ; Wil J.M. Landman^d ; ^e ; Jo H.H. van Eck^d ; Jean Paul Remon^a ; Chris Vervaet^a ; ^{Chris.Vervaet@UGent.be}
• 关键词：BSA ; bovine serum albumin ; DPBS ; Dulbecco&rsquo ; s phosphate buffered saline ; DSC ; differential scanning calorimetry ; EID50 ; 50%egg infectious dose ; ND ; Newcastle disease ; PVP ; polyvinylpyrrolidone ; RH ; relative humidity ; SEM ; scanning electron microscopy
• 刊名：European Journal of Pharmaceutics and Biopharmaceutics
• 出版年：2012
• 期刊代码：16_09396411
• 类别：pha
• 出版时间：April, 2012
• 卷：80
• 期：3
• 页码：649-656
• 文件大小：482 K

摘要

Dry powders containing a live-attenuated Newcastle disease vaccine (LZ58 strain) and intended for mass vaccination of poultry were prepared by spray drying using mannitol in combination with trehalose or inositol, polyvinylpyrrolidone (PVP) and/or bovine serum albumin (BSA) as stabilizers. These powders were evaluated for vaccine stabilizing capacity during production and storage (at 6 掳C and 25 掳C), moisture content, hygroscopicity and dry powder dispersibility. A mixture design, varying the ratio of mannitol, inositol and BSA, was used to select the stabilizer combination which resulted in the desired powder properties (i.e. good vaccine stability during production and storage, low moisture content and hygroscopicity and good dry dispersibility). Inositol-containing powders had the same vaccine stabilizing capacity as trehalose powders, but were less hygroscopic. Incorporation of BSA enhanced the vaccine stability in the powders compared to PVP-containing formulations. However, increasing the BSA concentration increased the hygroscopicity and reduced the dry dispersibility of the powder. No valid mathematical model could be calculated for vaccine stability during production or storage, but the individual experiments indicated that a formulation combining mannitol, inositol and BSA in a ratio of 73.3:13.3:13.3 (wt/wt) resulted in the lowest vaccine titre loss during production (1.6-2.0 log₁₀ 50%egg infectious dose (EID₅₀) and storage at 6 掳C (max. 0.8 log₁₀ EID₅₀ after 6 months) in combination with a low moisture content (1.1-1.4%), low hygroscopicity (1.9-2.1%water uptake at 60%relative humidity) and good dry dispersibility properties.