Near-infrared analytical control of pharmaceuticals. A single calibration model from mixed phase to coated tablets

Abstract

A new method for analysis of the active compound in a commercial pharmaceutical formulation in different steps of the production cycle, based on near-infrared diffuse reflectance spectroscopy, is proposed. The analysis includes three different steps of the production cycle: granules ready for compression (mixed phase), cores (intermediate) and coated tablets (final product). Satisfactory predictive results for production samples, independently of its origin in the production cycle, require calibration with laboratory-made samples covering the concentration range involved in the manufacturing process, and also production samples from various production batches and different steps, which introduce the variation sources inherent in such a process. A global and sole model was found to determine the active compound during the production cycle, with errors of prediction less than 1.8% in all cases. Tablets can be individually analysed with high accuracy and precision, so a content uniformity analysis may be performed.

Simultaneous non-destructive determination of two components of combined paracetamol and amantadine hydrochloride in tablets and powder by NIR spectroscopy and artificial neural networks

“…Near-infrared (NIR) spectroscopy has proved to be a powerful analytical tool for analyzing a wide variety of samples used in the agricultural, nutritional, petrochemical, textile and pharmaceutical industries [1][2][3][4][5][6][7][8][9][10][11][12], especially the use of NIR spectroscopy for the quantitative analysis of pharmaceutical samples has been significantly increased during the last decade. According to current quantitative methods, pharmaceutical samples are mainly analyzed in solution after extraction from a dosage form.…”

Near Infrared Spectroscopy in Drug Discovery and Development Processes

“…The results of the validation with reference and NIR predicted data are displayed in Figure 9.15c, and the statistics of the method in Figure 9.15d [116 ]. An increasing number of papers are published about the use of NIRS for the follow-up of the tablet production process, from the raw materials to the final product, with tablets being coated or not or packaged or not [74,106,117,118]. Successful implementation during early stage formulation development was also presented by Li [119].…”

Predictive and correlative techniques for the design, optimisation and manufacture of solid dosage forms

“…NIR has also displayed great potential in predicting the properties of the ® nal dosage form. In addition to tablet hardness and ® lm-coat thickness, NIR has been used to predict the dissolution rate of dosage forms (Kirsch & Drennen 1995), drug content (Blanco et al 1998a(Blanco et al , 2000Chen et al 2001) and quantifying the decomposition of acetylsalicylic acid into salicylic acid in aspirin tablets (Drennen & Lodder 1990). Many models can be combined and a series of tablet properties can be predicted from a single spectrum (Kirsch & Drennen 1995).…”