The Secondary Drying and the Fate of Organic Solvents for Spray Dried Dispersion Drug Product

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• 作者：Daniel S. Hsieh (1)
  Hongfei Yue (2)
  Sarah J. Nicholson (3)
  Daniel Roberts (1)
  Richard Schild (4)
  John F. Gamble (3)
  Mark Lindrud (4)
  
  1. Drug Product Science & Technology ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; New Jersey ; 08903 ; USA
  2. Analytical and Bioanalytical Development ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; New Jersey ; 08903 ; USA
  3. Drug Product Science & Technology ; Bristol-Myers Squibb Company ; Reeds Lane ; Moreton ; Merseyside ; CH46 1QW ; UK
  4. Chemical Development ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; NJ ; 08903 ; USA
  
• 关键词：amorphous ; Fickian diffusion ; modeling ; secondary drying ; spray dried dispersion
• 刊名：Pharmaceutical Research
• 出版年：2015
• 出版时间：May 2015
• 年：2015
• 卷：32
• 期：5
• 页码：1804-1816
• 全文大小：2,392 KB
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• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  Pharmacy
  Biochemistry
  Medical Law
  Biomedical Engineering
  
• 出版者：Springer Netherlands
• ISSN：1573-904X

文摘

Purpose To understand the mechanisms of secondary drying of spray-dried dispersion (SDD) drug product and establish a model to describe the fate of organic solvents in such a product. Methods The experimental approach includes characterization of the SDD particles, drying studies of SDD using an integrated weighing balance and mass spectrometer, and the subsequent generation of the drying curve. The theoretical approach includes the establishment of a Fickian diffusion model. Results The kinetics of solvent removal during secondary drying from the lab scale to a bench scale follows Fickian diffusion model. Excellent agreement is obtained between the experimental data and the prediction from the modeling. Conclusions The diffusion process is dependent upon temperature. The key to a successful scale up of the secondary drying is to control the drying temperature. The fate of primary solvents including methanol and acetone, and their potential impurity such as benzene can be described by the Fickian diffusion model. A mathematical relationship based upon the ratio of diffusion coefficient was established to predict the benzene concentration from the fate of the primary solvent during the secondary drying process.