Category: Formulation and Quality
Purpose: The main objective of the study was to evaluate the effect of critical process parameters during fluid bed coating on the physical characteristics (apperance) and release profile of a model drug.
Methods: The process involves wet granulation by high shear granulation, drying, blending, compression and coating using Surelease E-7-19040 in GPCG 15 using 9” Wurster column .
Batches were manufactured using a wet granulation process (Vector high shear granulator) with commonly used excipients (binder, diluent). The dry granules were blended with extragranular excipients such as glidant and lubricant, followed by compression. The compressed mini-tablets were coated in 9” Wurster coating pan. A partial factorial design was used to develop design space and determine control strategy for Drug X enteric coating process. The critical parameters studied were air volume (A1), spray rate (A2), and product temperature versus agglomerates (B1) and dissolution (B2) as responses. The minitablets were coated in wurster and characterized for percent yield, assay, dissolution, and appearance.
Results: For fluid bed coating, air volume, spray rate and product temperature were optimized to obtain desired drug release profile of drug X. The optimized parameters for enteric coating of Drug X for batch size of 4.0 kg using Surelease E-7-19040 were spray rate 40 g/min, air volume 170 cfm and product temperature of 44.0 °C. The desired dissolution profile of the Surelease E-7-19040 coated minitablets was greater than 80% within 8 hours which was achieved by optimized coating parameters obtained by design of experiments.
Conclusion: These studies demonstrated that a promising coating process as well as controlled strategy was successfully designed using DOE approach.
Bruhalkumar Shah– Whippany, New Jersey
Deep Patel– Sr. Formulation Scientist, Halo Pharmaceutical Inc d/b/a Cambrex, Whippany, Whippany, New Jersey
Bhavik Patel– Whippany, New Jersey
Satish Shetty– Whippany, New Jersey
Anthony Qu– Whippany, New Jersey