Villafañe García, Sachel M.

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    Evaluation of blend homogeneity with large differences in particle sizes using Near Infrared Spectroscopy (NIRS)
    (2005) Villafañe García, Sachel M.; Romañach, Rodolfo J.; College of Arts and Sciencies - Sciences; Patrón, Francis; Velázquez, Carlos; Department of Chemistry; Perales, Oscar
    Solid dosage forms are the most commonly prescribed pharmaceutical formulations. They consist of a homogeneous mixture of ingredients that provide desired characteristics. The process of blending during manufacturing processes is important to assure the quality of the product and it may be assessed by blend uniformity analysis. The sampling process is, also, very important and has been widely studied since it has been demonstrated that the sample thieves, the most common sampling method used in the pharmaceutical industry, introduce errors in the process. Some of these sampling errors are segregation, weight variability and product adulteration. Sample thieves do not follow Allen “golden rules” of sampling that state that a powder should always be sampled when in motion. Near Infrared Spectroscopy (NIRS) and stream sampling are alternative sampling techniques to evaluate blend homogeneity. In this work, lactose granules were prepared to obtain large differences in particle size, creating a blend difficult to sample and evaluate. Three sampling techniques: a pocket thief, Bellamy’s thief and stream sampling were used with a 20% (m/m) ibuprofen – granules blend. Sample weight variation and Relative Standard Deviation (RSD), for ibuprofen content, between 10 and 13 % (m/m) were observed. Also, the distribution of ibuprofen by particle size of granules was determined and its concentration was found to vary with particle sizes: as the particle size increases the ibuprofen concentration decreases. Also, a NIR Blend Monitor with wireless connection was evaluated as a tool for the in-line determination of blend homogeneity. Granules of different particle sizes were sieved and placed in a V-blender to observe the blend homogeneity from a physical point of view. The spectra showed differences in baseline and absorption due to the differences in particle sizes when multiplicative scattering correction (MSC) was applied to original data. Small particles showed less absorption and baseline than larger particles. Different approaches such as mean square of differences, moving block standard deviation and absorbance at 1542 nm were evaluated to analyze changes in spectra.