Tablets & Capsules


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Tablets & Capsules January/February 2021 39 anhydrous lactose produced by the new roller dryer are considered. Methods Umetrics Simca-P 16 software was used to generate a PCA model based on the available quality anal- ysis data. Parameters considered were absorbance at 210, 270, and 400 nm, total moisture content by Karl Fisher, loss on drying (LOD), acidity, beta content, bulk density, tapped density, specific rotation, and national Pharmaceutical Excipients Council (IPEC) [18]. Validation with three batches showed no difference between the new roller dryer and the existing one, with a 95 percent con- fidence acceptance range based on 5 years of historical data. This study expands the evaluation using PCA. More than 150 batches of anhydrous lactose produced between January 2017 and August 2020 by the existing roller dryer are considered. Twenty-three batches of univariate analyses. It can be used to investigate batch-to-batch vari- ation and allows identification of batches with maximum variation. Many authors have used MVA to improve understanding of specific functional excipients, like ethylcel- lulose [9], lactose monohydrate [10] and microcrystalline cellulose [4]. Van Snick et al. (2018) also used PCA to reveal similarities and dis- similarities between pharmaceutical raw materials [11]. The understand- ing of excipient variation obtained by these types of evaluations can reduce the number of experimental studies required during drug prod- uct development [12]. Several studies have compared batch-to-batch variability from one manufacturing site with variation over multiple sources [13-17]. It was generally recognized that batch-to- batch variability from a sole man- ufacturing site was less important than differences between multiple sources. Without understanding the intrinsic variation and poten- tial functional differences, sourcing from two locations can be a risk. A thorough evaluation and under- standing of the differences between p r o d u c t i o n l o c a t i o n s c a n h e l p to overcome these concerns and de-risk the use of material from a second source. The following study evaluated the equivalence of a pharmaceutical grade of anhydrous lactose from two different production lines. The study uses PCA to understand batch-to- batch differences and to evaluate the impact of excipient variation from the two production lines on product properties and functionality. Study approach DFE Pharma installed and qual- ified a new roller dryer for the production of anhydrous lactose (SuperTab 21AN) in quarter 1 of 2020. The new line is identical to an existing line in terms of scale and equipment type. Production of anhy- drous lactose with this additional roller dryer is classified as a not-sig- nificant (type 1) change accord- ing to guidelines set by the Inter- QUALICAPS NEW FP-40 EASIFILL SUPERIOR BENEFITS: • Economical • User friendly • Compact in size • Easy cleaning • Quick changeover • Capable of filling up to 40,000 capsules per hr FULLY-AUTOMATIC POWDER/PELLET CAPSULE FILLER

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