[Formulation and stability study of sucred solutions for a clinical trial in neonates]. / Fabrication et étude de stabilité de solutions sucrées pour un essai clinique chez le nouveau-né

A randomized, double blind clinical trial have been initiated in the neonatology unit of CHRU in Lille to compare the analgesic effect of two oral solutions (25% dextrose and 30% glucose) after heel prick sampling. As part of this trial, the pharmacy was asked to perform the preparation and the randomization. In agreement with good clinical practices and good manufacturing practices, we have valided manufacturing processes, and performed microbiological tests, chromatography control and polarimetric dosage. The stability study of solutions (six months), allows preparation of only one batch in accordance with good manufacturing practice for 25% sucrose and 30% glucose. The participation of hospital pharmacist in the preparation of investigational products is becoming more and more frequent. This enhances his involvement in the quality control of clinical trials.

[Pharmaceutical contribution to the non specific challenge in bronchial provocation tests]. / Contribution pharmaceutique a l'exploration de l'hyperréactivité bronchique non spécifique.

Aerosols of methacholine chloride are used in inhalation tests to measure non-specific bronchial responsiveness. Inhalation challenge solutions are not commercially available neither by pharmaceutical industry nor in France by the PCH-APHP. To reply to doctor's request, dilute concentrations of methacholine must be prepared properly in order to protect the patient and to assure doctor of test reproductibility. Osmolarity, pH and degradation of different dilute concentration of methacholine chloride have been compared with two diluents. This study allowed us to validate our preparation of solutions.

[Camptothecin and derivatives: a new class of antitumor agents]. / Camptothécine et dérivés: une nouvelle classe d'agents antitumoraux.

Camptothecin (CPT), an alkaloid isolated from the stem wood and bark of Camptotheca acuminata native to China, was discovered in the early 60's after a systematic screening of natural products by the National Cancer Institute (NCI). This new anticancer agent displays an unique mechanism of action as it inhibits intranuclear enzyme topoisomerase 1, involved in DNA replication. CPT is poorly water soluble and causes severe and unpredictable toxicities such as haemorrhagic cystitis and diarrhea; for therefore reason, a number of analogues have been synthetized in a attempt to define the features of the molecule that are essential for cytotoxicity and to produce derivatives with increased solubility. Clinical trials of several soluble molecules are in progress in the different countries: irinotecan, topotecan, 9-AC. Encouraging results are observed against solid tumors. Irinotecan was recently commercialized in France. It is a prodrug; the active metabolite SN-38 showed a good activity in metastatic colorectal adenocarcinoma; the limiting toxicities are myelotoxicity and essentially late diarrhea. However, new studies are needed for state precisely the optimal schedule of administration and association with other chemotherapeutic agents.

[Stability control of a copper histidinate solution]. / Contrôle de la stabilité d'une solution d'histidinate de cuivre.

Some authors have suggested the administration subcutaneous of copper histidinate for the treatment of the Menkes disease. The purpose of this study was to control the complex formation of Cu (II)-L-Histidine in molar ratio 1/2 and to verify the stability in some conditions of determination and validation production.

[Quality evaluation of Harpagophyton capsules]. / Etude de la qualité de gélules d'Harpagophyton.

Six samples of capsules Harpagophytum procumbens of different commercial origin have been examined by methods of the french Pharmacopoeia and measurement of the harpagoside by HPLC. The study showed variability of the quality of not pharmaceutical products.

[Comparative study of absorbent dressings]. / Etude comparative de pansements absorbants.

The quality of six absorbent dressings of fluffy padding has been compared. The study show one variability of the quality of products which can influence on scarred up the wounds. The part of hospital pharmacist in the choice of this articles is very important.