Solid -state characterization and impurities determination of Fluconazol generic products

in Journal of Pharmaceutical Analysis (2012)

In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These ... [more ▼]

In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid- state characterization of the three samples was realized with different physicochemical methods as: X- ray powder diffraction, Fourier- transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the recrystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. [less ▲]

Solid lipid microparticles containing the sunscreen agent, octyl-dimethylaminobenzoate: Effect of the vehicle

in European Journal of Pharmaceutics & Biopharmaceutics (2007), 66(3), 483-487

Solid lipid microparticles (SLMs) loaded with the sunscreen agent, octyl-dimethyl amino benzoate (ODAB), were prepared in order to achieve enhanced sunscreen photostability. The microparticles were ... [more ▼]

Solid lipid microparticles (SLMs) loaded with the sunscreen agent, octyl-dimethyl amino benzoate (ODAB), were prepared in order to achieve enhanced sunscreen photostability. The microparticles were produced by the melt dispersion technique using glyceryl behenate as lipidic material and poloxamer 188 as the emulsifier. The obtained SLMs showed proper features in terms of morphology, size distribution (1.67-15.81 mu m) and ODAB loading (16.15 +/- 0.11%, w/w). The sunscreen release from the SLMs was slower than its dissolution rate and the photodecomposition of ODAB was markedly decreased (> 51.3%) by encapsulation into the lipid microparticles. The efficacy of the SLM carrier system was also evaluated after their introduction in model topical formulations (i.e., hydrogel and oil-in-water emulsion). Further in vitro release measurements, performed using Franz diffusion cells with polycarbonate membranes, indicated that the retention capacity of the microparticles was lost after their incorporation into the emulsion, whereas it was retained in the hydrogel. Moreover, the SLMs achieved a reduction of the sunscreen photodegradation in the hydrogel vehicle (the ODAB loss decreased from 87.4% to 59.1%), whereas no significant photoprotective effect was observed in the emulsion. Therefore, the efficacy of the ODAB-loaded SLMs was markedly affected by the vehicle. (c) 2007 Elsevier B.V. All rights reserved. [less ▲]

Solid lipid Nanoparticles for administration by inhalation : Optimisation of manufacturing parameters

Conference (2004)

Solid lipid Nanoparticles for drug Pumonary Administration

in Proceedings of 30th International Symposium on Controlled Release of Bioactive Materials (2003)

Solid phase extraction : An alternative to the use of rotary evaporators for solvent removal in the rapid formulation of PET radiopharmaceuticals

in Journal of Labelled Compounds & Radiopharmaceuticals (1999), 42(1), 63-75

Solid phase extraction (SPE) was used for the formulation of several radiopharmaceuticals. The method involves dilution of the previously purified HPLC compound with water, trapping of the activity on an ... [more ▼]

Solid phase extraction (SPE) was used for the formulation of several radiopharmaceuticals. The method involves dilution of the previously purified HPLC compound with water, trapping of the activity on an SPE bed, washing off the support, elution of the radiopharmaceutical with a small volume of ethanol (<1 mL) and dilution with sterile isotonic saline solution. Recovery of the radiopharmaceuticals was always higher than 97%. Two different methods of automation were developed for the formulation of [11C] and [18F]radiopharmaceuticals. In all cases, organic solvent levels in the injectable solution were below the recommended limits. This fast (3-6 min.) and easy to automate process can be considered as an alternative to the conventional methods (rotary evaporators). Copyright © 1999 John Wiley [less ▲]

Solid state synthesis and crystal chemistry of new fillowite-type phosphates

Poster (2006)

Solid-state fermentation of xylanase from Penicillium canescens 10-10c in a multi-layer packed bed reactor

in Applied Biochemistry and Biotechnology (2008), 145

Solid-state fermentation of xylanase from Penicillium canescens 10/10c in a multi packed bed reactor (MPBR)

Conference (2007, May 29)

Solid-state NMR study of modified clay and polymer/clay nanocomposites

in Clay Minerals (2006), 41

Solid-state nuclear magnetic resonance studies of the transformation of the zeolite Y catalyst in the course of hydrochlorination of 1-methylcyclohexene by thionyl chloride

in Applied Catalysis A : General (1993), 98(1), 71-79

1-Methylcyclohexene was hydrochlorinated with SOCl2 to 1-chloro-1-methylcyclohexane at room temperature in CH2Cl2 as the solvent and in presence of the faujasitic zeolite ZF520 catalyst. 4-Coordinated ... [more ▼]

1-Methylcyclohexene was hydrochlorinated with SOCl2 to 1-chloro-1-methylcyclohexane at room temperature in CH2Cl2 as the solvent and in presence of the faujasitic zeolite ZF520 catalyst. 4-Coordinated framework aluminium in the parent sample coexisting with a small amount of immobile extra-framework aluminium at ca. -1 ppm is completely removed after just one reaction run and transformed into two distinct 6-coordinated species resonating at 0.2 and -3.1 ppm. The former line is assigned to Al(H2O)63+ cations, the latter is likely to come from a species with mixed solvation shells, probably Al(Cl-)(H2O)52+ and Al(OH-)(H2O)52+. Crystallinity of the catalyst is seriously affected by the reaction. The spectra confirm that before reaction the zeolite contains Si(3Si,1OH) and Si(2Si,2OH) groups. During the reaction most hydroxyl groups created by dealumination are removed, although some Si(3Si,1OH) remain. MAS NMR spectra are fully consistent with the proposed reaction mechanism. [less ▲]