[Bisacodyl as laxative in Belgian pharmacy]. / Le laxalif bisacodyl dans les pharmacies belges.

Obstipation is a common complaint in pharmacies and one of the treatment strategies is the delivery of enteric coated bisacodyL tablets. This article reviews the different aspects that are important for pharmacists to guarantee patient safety: whether medical treatment is required or not, which advice should be given on how to use the drug, and to conclude what is the analytical quality of the commercial products on the Belgian market.

Ethinylestradiol and levonorgestrel preparations on the Belgian market: a comparative study.

Preparations formulated as coated or film-coated tablets, containing levonorgestrel and the combination ethinylestradiol/levonorgestrel, were evaluated in a comparative study. This study comprised in vitro dissolution, assay and content uniformity. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements.

Langerhans cell histiocytosis: two case reports in adults and review of the literature.

Langerhans Cell histiocytosis is a rare proliferative histiocytic disorder in which pathologic Langerhans cells accumulate in a variety of organs. The clinical presentation, evolution and therapeutic options are highly variable. Because of its relative rarity and the broad clinical spectrum, the diagnosis of Langerhans cell histiocytosis is often delayed or missed. At present, many questions with respect to aetiology, pathogenesis and treatment remain unanswered. In the present article we want to raise the awareness of this rare disease in adults and its diversity by the means of two case reports. In addition, the clinical manifestations, diagnosis and the current management are reviewed.

Nifedipine preparations on the Belgian market: a comparative study.

Nifedipine preparations formulated as immediate-release capsules and prolonged-release tablets were evaluated with different tests, including in vitro dissolution, assay and content uniformity, and determination of related compounds. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements but the dissolution test for prolonged-release tablets showed that these products cannot be interchanged.

Lisinopril and lisinopril/hydrochlorothiazide preparations on the Belgian market: a comparative study.

Preparations containing lisinopril and the combination lisinopril/hydrochlorothiazide, and formulated as tablets were evaluated with different tests, including in vitro dissolution, assay and content uniformity, and determination of related compounds. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements.

Propranolol preparations on the Belgian market: a comparative study.

Propranolol preparations formulated as immediate-release tablets and prolonged-release capsules were evaluated with different tests, including in vitro dissolution and assay with previously validated methods according to the guideline of the European network of Official Medicines Control Laboratories (OMCLs). All examined products complied with our requirements and those described in the European, British and the US Pharmacopoeia and consequently they can be considered as pharmaceutically equivalent.

Fluconazole preparations on the Belgian market: a comparative study.

Fluconazole preparations formulated as capsules were evaluated with different tests, including in vitro dissolution and assay with previously validated methods according to the guideline of the European network of Official Medicines Control Laboratories (OMCLs). All examined products complied with our requirements and those described in the European and the US Pharmacopoeia and consequently they can be considered as pharmaceutically equivalent.

Piracetam preparations on the Belgian market: a comparative study.

Piracetam preparations formulated as capsules, tablets and granules were evaluated with different tests including in vitro dissolution and assay with previously validated methods according to the guideline of the European network of official medicines control laboratories (OMCLs). All examined products complied with the requirements as described here and in the European Pharmacopoeia except for the dissolution test where 3 products did not meet the USP acceptance criteria applied on the established specification.

Ranitidine preparations on the Belgian market: a comparative study.

Ranitidine preparations formulated as tablets and granules were evaluated with different tests including in vitro dissolution and assay. Previously the analytical methods of these tests were validated according to the guidelines of the European network of Official Medicines Control Laboratories (OMCLs). All examined products complied to the requirements as described in the European, the British and the US Pharmacopoeia and consequently they can be considered as pharmaceutically equivalent.

Application of several modified peak purity assays to real complex multicomponent mixtures by high-performance liquid chromatography with diode-array detection.

Simple to use interactive self-modelling mixture analysis (SIMPLISMA), orthogonal projection (OPA) and Needle Search (NS) approaches have been applied to the determination of a number of compounds present in a complex multicomponent system. None of these three approaches succeeded completely when they were tested using the whole data matrix. When OPA and NS were applied to three simpler submatrices, obtained by dividing the total data matrix, and where a smaller number of compounds were present, better performance was achieved.

Nested designs in ruggedness testing.

Nested designs were performed in order to execute a ruggedness test according to the United States Pharmacopeia definition for ruggedness, in which mainly non-procedure related factors are examined. Several nested designs have been executed on a high performance liquid chromatography assay to determine tetracycline and related substances in bulk samples of tetracycline. Factors such as different laboratories, analysts, instruments, columns, days and batches were examined. The interpretation methods described in the literature were found to cause problems. In these methods the variances of the examined factors are estimated from the calculated mean square values and from the equation for the expected mean squares. Very frequently, negative variance estimates were obtained. Their absolute values were found to be dependent on the influence of the factor examined below it in the design, on the examined response. Therefore an alternative interpretation method for nested designs, based on pooled variances, was proposed and found to be appropriate to use for ruggedness testing purposes. Both approaches, the one from the literature and the one proposed here, were tested on simulated data coming from a nested design with four factors and on the experimentally measured data.