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G Vergote

Publications and source records attributed to G Vergote.

7 recordsLinked to original sources

The quality of essential antimicrobial and antimalarial drugs marketed in Rwanda and Tanzania: influence of tropical storage conditions on in vitro dissolution.

OBJECTIVE: The quality of 33 formulations of essential antimicrobial and antimalarial drugs (amoxicillin capsules, metronidazole tablets, sulfamethoxazole/trimethoprim tablets, quinine tablets and sulphadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed and the influence of tropical storage conditions on potency and in vitro dissolution investigated. METHODS: Drug content and in vitro dissolution were determined immediately after purchase and during 6-month storage under simulated tropical conditions (75% relative humidity, 40 degrees C) using the methods described in the USP 24 monographs on the drugs concerned. RESULTS AND DISCUSSION: At the time of purchase, the drug content of all the formulations was within the limits recommended by the USP 24, but after 6-month storage, the drug content of one sulfamethoxazole/trimethoprim and one quinine formulation were found to be substandard. Immediately after purchase, four formulations (three sulfamethoxazole/trimethoprim and one sulphadoxine/pyrimethamine combination) failed the USP 24 dissolution test. Except for three metronidazole and one quinine formulations, dissolution tests performed after 6 months of storage under simulated tropical conditions showed that drug release remained within the USP 24 recommended values. CONCLUSION: In both countries, essential drug formulations met pharmacopoeial potency requirements, but some had a poor in vitro drug release profiles. Some of the formulations tested were not stable upon storage under simulated tropical conditions.

Anti-Infective Agents↗

Drug formulations intended for the global market should be tested for stability under tropical climatic conditions.

RATIONALE OBJECTIVE: The quality of drugs imported into developing countries having a tropical climate may be adversely affected if their formulations have not been optimized for stability under these conditions. The present study investigated the influence of tropical climate conditions (class IV: 40 degrees C, 75% relative humidity) on the drug content, in vitro dissolution and oral bioavailability of different formulations of two essential drugs marketed in Tanzania: diclofenac sodium and ciprofloxacin tablets. METHODS: Before and after 3 and 6 months storage under class IV conditions the drug content and in vitro dissolution were evaluated using United States Pharmacopoeia (USP) 24 methods. Following a randomized four-period cross-over study, the pharmacokinetic parameters of drug formulations stored for 3 months under class IV conditions were compared with those stored at ambient conditions. RESULTS: Drug content and drug release from all tested ciprofloxacin formulations were within USP-24 requirements and remained stable during storage at simulated tropical conditions. Oral bioavailability was also not influenced by tropical conditions. The dissolution rate of two diclofenac formulations (Diclo 50 manufactured by Camden and Dicloflame 50 manufactured by Intas) reduced significantly during storage under class IV conditions. After oral administration Camden tablets stored for 3 months under class IV conditions showed a reduction in C(max) (90% CI of C(max) ratio: 0.59 - 0.76). This reduction was smaller than expected based on the in vitro tests. CONCLUSIONS: Some drug formulations imported into Tanzania are not optimized for stability in a tropical climate. Manufacturers and regulatory authorities should pay more attention to the WHO recommendations for testing the stability of drugs under tropical climate conditions. Efforts should be made to improve the in vitro tests to better predict the bioavailability.

Administration, Oral↗

Esophageal metastasis from breast carcinoma.

A case of esophageal metastasis from a breast carcinoma is presented. Location was, as usual, midesophageal. The interval of time between breast carcinoma and the onset of esophageal symptoms was rather long. Barium swallow examination enabled correct diagnosis, whereas several series of superficial endoscopical biopsies were negative. Diagnosis was confirmed by deep endoscopical biopsy.

Breast Neoplasms↗

The reversal sign.

We report a 36-year-old woman with a bacterial meningitis. CT after resuscitation showed a striking "reversal sign." Opinions on the pathogenesis of this sign are discussed; it indicates serious brain damage and carries a poor prognosis.

Adult↗

Forensic determination of pregnancy hormones in human bloodstains.

When different bloodstains are encountered at the scene of crime, it is possible to discriminate those from a pregnant woman from others. Human chorionic gonadotrophin, human placental lactogen, total oestriol and progesterone in the stains may be determined with radioimmunoassay techniques using commercial kits. Only 1 cm2 of bloodstain is needed for the determination of all four parameters, which gives information about the state of pregnancy. More than 100 stains of blood from women in all stages of pregnancy, normal menstruating women, menopausal and post-menopausal women and male subjects, and of menstrual blood were analysed. Bloodstains from pregnant women were easy to evaluate with the four determinations, only very early pregnancies being undetected. Stains from non-pregnant women were negative or below the cut-off level. Two case examples are also described.

Adolescent↗