[Improving the quality of compounded medicines through self-assessment: proof of concept]. / Améliorer la qualité des préparations magistrates par l'autocontrôle: proof of concept.

A systematic quality control of compounded medicines, and an associated guidance of community pharmacists, was identified as a complementary opportunity to improve and guarantee the quality of compounded medicines. Before implementing this on a national scale, a pilot project was organized. Fifty pharmacies prepared the same formula and had it checked regarding labelling, preparation reports and analytical parameters. This proof of concept demonstrated that the organisation of quality control of compounded medicines by the professional body itself is feasible. Such audits fit well in de quality assurance systems in place in community pharmacy, where any corrective measures are properly documented and implemented. This form of self-regulation has a preventive character for detecting defects and contributes to improving the quality of the preparations and thus to the patient safety.

Anthranoid-containing medicines and food supplements on the Belgian market: a comparative study.

Medicines and food supplements containing anthranoid herbal drug preparations were verified on identity of the herbal substance, content of total hydroxyanthracene glycosides and microbiological quality. All examined medicines complied with the fixed requirements whereas all food supplements deviated from 1 or more of the criteria. The food supplements showed a large variability in quality and content.

[Glucosamine preparations on the Belgian market: a comparative study]. / Préparations à base de glucosamine sur le marché belge -- une étude comparative.

Fourteen food supplements and one medicine containing glucosamine and formulated as film-coated tablets and capsules, were evaluated with different tests, including uniformity of mass and dosage units, disintegration, identification and assay of glucosamine with a validated HPLC-ELSD method. The medicinal product fulfilled all the fixed requirements whereas three food supplements didn't comply with regard to disintegration (product 7) and content of glucosamine (product 11 and 13).

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.

Automatic screening of obstructive sleep apnea from the ECG based on empirical mode decomposition and wavelet analysis.

This study analyses two different methods to detect obstructive sleep apnea (OSA) during sleep time based only on the ECG signal. OSA is a common sleep disorder caused by repetitive occlusions of the upper airways, which produces a characteristic pattern on the ECG. ECG features, such as the heart rate variability (HRV) and the QRS peak area, contain information suitable for making a fast, non-invasive and simple screening of sleep apnea. Fifty recordings freely available on Physionet have been included in this analysis, subdivided in a training and in a testing set. We investigated the possibility of using the recently proposed method of empirical mode decomposition (EMD) for this application, comparing the results with the ones obtained through the well-established wavelet analysis (WA). By these decomposition techniques, several features have been extracted from the ECG signal and complemented with a series of standard HRV time domain measures. The best performing feature subset, selected through a sequential feature selection (SFS) method, was used as the input of linear and quadratic discriminant classifiers. In this way we were able to classify the signals on a minute-by-minute basis as apneic or nonapneic with different best-subset sizes, obtaining an accuracy up to 89% with WA and 85% with EMD. Furthermore, 100% correct discrimination of apneic patients from normal subjects was achieved independently of the feature extractor. Finally, the same procedure was repeated by pooling features from standard HRV time domain, EMD and WA together in order to investigate if the two decomposition techniques could provide complementary features. The obtained accuracy was 89%, similarly to the one achieved using only Wavelet analysis as the feature extractor; however, some complementary features in EMD and WA are evident.

Dextromethorphan hydrobromide preparations on the Belgian market--a comparative study.

Liquid preparations for oral use containing dextromethorphan hydrobromide were verified on identity, content and microbiological quality. The assay method was previously validated according to international guidelines. All examined products complied with the postulated requirements.

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.

Automatic screening of Obstructive Sleep Apnea from the ECG based on Empirical Mode Decomposition and wavelet analysis.

This study proposes three different methods to evaluate Obstructive Sleep Apnea (OSA) during sleep time solely based on the ECG signal. OSA is a common sleep disorder produced by repetitive occlusions of the upper airways, which produces a characteristic pattern on the ECG. Extraction of ECG characteristics as the heart rate variability and the QRS peak area offer alternative measures for cheap, non-invasive and reliable pre-diagnosis of sleep apnea. 50 of the 70 recordings from the database of the Computers in Cardiology Challenge 2000, freely available on Physionet, have been used in this analysis, subdivided in a training and a testing set. We investigated the possibilities concerning the use of the recently proposed method Empirical Mode Decomposition in this application and compared it with the established Wavelet Analysis. From the results of these decompositions the eventual features were extracted, complemented with a series of standard HRV time domain measures and three extra non-linear measures. Of all features smoothed versions were calculated. From the obtained feature set, the best performing feature subset was used as the input of a Linear Discriminant Classifier. In this way we were able to classify the signal on a minute-by-minute basis as apneic or non-apneic with an accuracy of around 90% and to perfectly separate between apneic and normal patients, using around 20 to 40 features and with the possibility to do this in three alternative ways.

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.

[Omega-3 fatty acid preparations--a comparative study]. / Préparations d'acides gras omega-3: une étude comparative.

Fifteen food supplements and 1 medicine, formulated as soft capsules and containing omega-3 fatty acids, were evaluated with different tests, including desegregation, determination of the anisidine and peroxide values and assay of the omega-3 acids according to the European Pharmacopoeia. All the products contained purified fish oil rich in omega-3 fatty acids, mainly eicosapentaenoic acid (C20:5; EPA) and docosahexaenoic acid (C22:6; DHA), and available as triglycerides, ethyl esters or free fatty acids. The medicinal product complied with the fixed requirements whereas 7 of the 15 food supplements deviated from 1 or more of the criteria with regard to the peroxide value and the content of 1 or more of the fattty acids.

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.

Ginkgo biloba medicines and food supplements on the Belgian market: a comparative study.

Medicines and food supplements based on the dry extract of the leaves of Ginkgo biloba L. were evaluated by determination of the content of total flavonoids, rutin and terpene lactones by means of liquid chromatography. All examined medicines complied with the fixed requirements whereas all food supplements deviated from 1 or more of the criteria. It could also be demonstrated that some products contained extracts to which rutin was added.

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.

Antibacterial and molluscicidal phenolic acids from Spondias mombin.

Spondias mombin L. (Anacardiaceae), used in traditional medicine because of its antimicrobial properties, was found to contain a series of 6-alkenyl-salicylic acids. They were isolated from the ethanolic extract of leaves and stems of Spondias mombin by a combination of chromatographic methods. Their structure was determined by NMR and MS techniques as (17:3), (17:2) and (17:1) pelandjuaic acid [or 6-(8'Z,11'Z,14'Z-heptadecatrienyl)-salicylic acid, 6-(8'Z,11'Z-heptadecadienyl)-salicylic acid, and 6-(10'Z-heptadecenyl)-salicylic acid, respectively], 6-(12'Z-non-adecenyl)-salicylic acid, and 6-(15'Z-heneicosenyl)-salicylic acid, the two last compounds being new ones. These phenolic acids were shown to have a pronounced antibacterial effect against Bacillus cereus, Streptococcus pyogenes, and Mycobacterium fortuitum (minimal bactericidal concentration in a concentration range of 3-25 micrograms/ml), and a molluscicidal effect against the snail Biomphalaria glabrata, an intermediate host in the schistosome life cycle. Because of their high molluscicidal activity (LC90 down to 1-3 ppm), these long-chain salicylic acid derivatives may be important tools in the prevention of schistosomiasis.

Mass spectral characterization of C-glycosidic flavonoids isolated from a medicinal plant (Passiflora incarnata).

The four major C-glycosidic flavonoids isolated from Passiflora incarnata were identified as schaftoside, isoschaftoside, isovetexin-2''-O-glucopyranoside and isoorientin-2''-O-glucopyranoside on the basis of mass spectral and 13C NMR data. The daughter ion spectra of [M + H]+ ions of schaftoside and isoschaftoside showed differences for the [M + H - 104]+ ions, which could be rationalized by hydrogen bonding effects. In the negative-ion mode, pronounced differences were found for the [M - H - 90]- and [M - H - 120]- ions, formed by prevalent fragmentation in the C-6-linked sugar moiety. With respect to isovitexin-2''-O-beta-glucopyranoside and isoorientin-2''-O-beta-glucopyranoside, the daughter ion spectra of both the [M + H]+ and [M - H]- ions provided evidence for a 1----2 linkage in the diglucosidic moiety. Support for C-6 glucosylation was obtained by recording the daughter ion spectra of [M - H - 162]- ions, which were in good agreement with that obtained for [M - H]- ions of isovitexin.

Plant antiviral agents, VI. Isolation of antiviral phenolic glucosides from Populus cultivar Beaupre by droplet counter-current chromatography.

Bioassay-guided isolation of the 80% EtOH extract of the leaves of Populus cultivar Beaupré by means of dccc afforded four known phenolic glucosides. Salicin and salireposide were shown to be, at least partially, responsible for the antiviral activity of the extract against poliomyelitis and Semliki forest viruses.