Josep R. Ticó Grau

SeDeM Diagram: A New Expert System for the Formulation of Drugs in Solid Form

The SeDeM expert system is a methodology which is applied in preformulation and formulation studies of medicines specifically in solid dosage forms. This system informs on the physical profile of powdered substances (APIs and excipients) used to formulate drugs (Sune et al, 2005; Garcia et al, 2010; Aguilar et al, 2009). By determining whether powders (API or excipient) are suitable for direct compression, the SeDeM profile will inform about the advantages and gaps of those powdered substance to be used in direct compression, so the system informs on whether the direct compression method is appropriate (e.g.. wet granulation should be applied before compression). The characterization of powdered substances by SeDeM facilitates the identification of the characteristics that require amendment in order to obtain tablets by direct compression. This system thus provides information that will ensure the robust design of the formulation in the final product. This new method is based on the selection and application of several parameters that the formulation must fulfill to ensure a successful tablet elaborated by direct compression. The following criteria are applied: a. The formulation must be representative and appropriate for the requirements of compression technology. b. The execution of the experimental methodology and calculus must be readily applicable.

SeDeM Diagram: an expert system for preformation, characterization and optimization of tablets obtained by direct compression

Abstract: SeDeM expert system is an innovative tool which allows characterization of a powdered substance. This information is used to identify strengths and weaknesses for development of tablets by direct compression. The tool allows successful design of tablets, avoiding unnecessary studies and trials, and reducing the lead time of development. In addition, SeDeM expert system provides a mathematical formula to obtain the final formulation of tablets by direct compression in an easy way containing the minimum excipient (one) with a minimum test. The information provided is categorised as dimension, compressibility, flowability/powder flow, lubricity/ stability, and lubricity/dosage—this can be provided in graphical form, the SeDeM Diagram. The methodology information can be used in further studies using Quality by Design. In this chapter, the methodology is described along with some examples. It has been widely demonstrated in pharmaceutical labs that this is a robust tool. This tool was developed at the University of Barcelona.

Selección de emulsiones lipídicas en nutrición parenteral: parámetros bioquímicos y hematológicos

INTRODUCTION Lipid emulsions (LE) are a component of parenteral nutrition (PN) and its fatty acid (FA) profile determines various physiological responses. OBJECTIVES To assess the adequacy of a clinical not restricted protocol in the choice of LE by studying complementary biochemical and hematological parameters (BHP) at the beginning of the PN. METHODS A 4-year retrospective observational study of LE administered to patients with PN. Demographic, clinical, nutritional and analytical variables at the beginning of the PN were collected. Univariate and multivariate analyses were performed to study the correlation between the initial clinical and biochemical parameters and the LE profile used. RESULTS Four hundred and sixty patients (29.5%) out of 1,558 had BHP at the beginning of PN and used mainly the LE combinations soybean (SO) + medium-chain triglycerides (MCT) + olive (OO) + fish (FO) (37.4%) and SO + MCT + OO (35.6%). Statistically significant differences on the LE pattern were observed between patients with and those without initial BHP (44.8% vs39.5% received FO, respectively). Conditions regularly associated with elevated C-reactive protein (CRP) were associated with increased use of FO LE: SO+OO+FO (OR: 4.52 [95% CI: 1.43-13.91]) and SO+MCT+OO+FO (OR: 3.34 [95% CI: 2.10-5.33]). In those complex conditions related with the critical patient MCT were used: hepatic failure (SO+MCT OR: 2.42 [95% CI: 1.03-5.68]) and renal failure (SO+MCT+FO OR: 3.34 [95% CI: 1.12-9.99]). CONCLUSIONS The use of BHP at the beginning of PN treatment allows complementing the clinical and metabolic criteria in LE selection.