In the prototype development and manufacture of Liquid Filled Gelatin Capsules, numerous capsule defects are encountered such as leaking, softening, body-shape deformation, among others. Encountering these defects during product development and on storage stability require additional batch manufacturing and longer development time. As a result, the potential product launch will be delayed and the cost for correcting these issues will be substantial for the company.<br/>In order to better understand the cause and ultimate mitigation of these defects, we have collaborated with National Institute of Standards and Technology (NIST) to perform systematic studies of gelatin composition variations with the attendant polymer structure variations as probed by small angle neutron scattering (SANS). This will help us better understand and clarify the protein structural changes which occurs leading to the capsule defects cited above. With the knowledge of the product performance and gelatin structure on the molecular level, we can then modify the gelatin composition to favorably design capsules which are resistant to defects that have been historically observed. The detailed experimental designs, technologies used, and experimental results will be presented and discussed.

Small angle neutron scattering studies of gelatin as applied to liquid filled gelatin capsules

255th National Meeting (2018)

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