(621d) Near Infrared Hyperspectral Imaging to Monitor Drug Content and Coating Thickness Uniformity of Oral Disintegrating Films during a Continuous Manufacturing Process

Authors: 
Pavurala, N., Office of Testing and Research, U.S. Food and Drug Administration
Mazumder, S., Office of Testing and Research, U.S. Food and Drug Administration
Krull, S. M., Office of Testing and Research, U. S. Food and Drug Administration
Yazdanpanah, N., U.S. Food and Drug Administration
Xu, X., Office of Testing and Research, U.S. Food and Drug Administration
Yang, X., U.S. Food and Drug Administration
Taylor, C., U.S. Food and Drug Administration
O'Connor, T., U.S. Food and Drug Administration
Ashraf, M., Office of Testing and Research, U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
Continuous manufacturing of oral disintegrating films (ODF) involves several unit operations such as mixing of raw materials such as active pharmaceutical ingredient (API), film forming polymer, plasticizer and other excipients to form a uniform mixture/slurry, coating the mixture followed by drying, die cutting to desired shape and size and packaging. Coat thickness and drug content uniformity are two critical in-process variables which directly impact the critical quality attribute (CQA) of ODF such as drug assay. Non-uniformity in the coating thickness or drug content can lead to deviation from target drug load, which in turn may affect the in vivo drug delivery rate. Hyperspectral Imaging using near infrared spectroscopy (NIRS) is a potential technology that integrates spectroscopy and conventional imaging to obtain both spectral and spatial information of a material while it is in motion. Objective is to develop and validate the use of Near Infra-red (NIR) hyperspectral imaging for its ability to monitor drug content and coat thickness uniformity of ODF. Hyperspectral Imaging system equipped with a full range (1000-2500 nm) short wavelength infrared (SWIR) camera was employed for this study. ODF samples of varying coating thickness and drug content were prepared and divided into training and test sets to develop and validate the chemometric model for coat thickness and drug content. The results and findings of this study will be presented.