Cicatrisation cutanée et oxygénothérapie hyperbare

AIX-MARSEILLE2-BU Pharmacie (130552105) / SudocSudocFranceF

Approche pharmacoéconomique de deux protocoles de chimiothérapie de référence dans le cancer bronchopulmonaire non à petites cellules

AIX-MARSEILLE2-BU Pharmacie (130552105) / SudocSudocFranceF

Prise en charge du cancer du sein métastatique en 2006

AIX-MARSEILLE2-BU Pharmacie (130552105) / SudocSudocFranceF

Beyond-Use Dates Assignment for Pharmaceutical Preparations: Example of Low-Dose Amiodarone Capsules.

Background: Beyond-use dates (BUDs) in compounding practice are assigned from stability studies. The United States Pharmacopoeia (USP 42 NF 37) suggested to assign a 6 months BUD for dry oral forms. A new pediatric formula of amiodarone capsules was implemented in our hospital, with 3 dosages (5 mg, 20 mg, and 50 mg). Objective: BUD of these new formulas had to be determined by stability study. Methods: The method for the determination of amiodarone content was validated to be stability indicating, and a stability study was performed. Different excipients commonly used for capsule compounding were compared. Results: We found that, with microcrystalline cellulose as excipient, 50 mg amiodarone capsules were stable for 1 year, whereas 5 mg and 20 mg capsules were not. This difference was studied, and lactose or mannitol were found to be better excipients for 5 mg amiodarone capsules, despite their potential side effects. A potential drug-excipient interaction between microcrystalline cellulose and amiodarone hydrochloride is described. Conclusion: Amiodarone hydrochloride/microcrystalline cellulose capsules have a BUD of 1 month for 5 mg capsules, 6 months for 20 mg, and 1 year for 50 mg

Implementing medication reconciliation led to decrease the cumulative exposure to sedative and anticholinergic drugs at discharge of elderly hospitalized in an orthopaedic unit

International audienc

Comparison of rituximab originator (MabThera ® ) to biosimilar (Truxima ® ) in patients with multiple sclerosis

International audienceBackground: Rituximab’s originator MabThera ® or Rituxan ® has demonstrated high efficacy in multiple sclerosis (MS). Because of the patent expiration, rituximab biosimilars have been developed. However, because a biosimilar is not the exact copy of the originator, the efficacy and safety of a biosimilar may significantly differ. Objectives: To compare the efficacy and safety of the biosimilar Truxima ® and the originator MabThera ® in MS. Methods: Consecutive MS patients receiving MabThera ® or Truxima ® were prospectively followed during 1 year after treatment introduction. Allocation to each treatment depended on the period of introduction and not the physician’s choice. Lymphocyte count, clinical and magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS), and adverse events were compared. Results: In total, 105 and 40 patients received MabThera ® and Truxima ® , respectively. The two groups did not differ in baseline characteristics. Effect on CD19+ lymphocytes and disease activity were similar during follow-up. EDSS remained stable, with no difference between groups. Adverse events were similar between groups. Conclusion: The efficacy and safety of the rituximab biosimilar Truxima ® seem equivalent to the originator MabThera ® in MS patients. Truxima ® could represent a relatively cheap and safe therapeutic alternative to MabThera ® and could improve access to highly efficient therapy for MS in low- or middle-income countries

Low-dose erythromycin in pediatrics: Formulation and stability of 20 mg hard gelatin capsules.

ObjectiveErythromycin is a macrolide antibiotic that is also prescribed off-label in premature neonates as a prokinetic agent. There is no oral formulation with dosage and/or excipients adapted for these high-risk patients.MethodsClinical studies of erythromycin as a prokinetic agent were reviewed. Capsules of 20 milligrams of erythromycin were compounded with microcrystalline cellulose. Erythromycin capsules were analyzed using the chromatographic method described in the United States Pharmacopoeia which was found to be stability-indicating. The stability of 20 mg erythromycin capsules stored protected from light at room temperature was studied for one year.Results20 mg erythromycin capsules have a beyond use date not lower than one year.Conclusion20 milligrams erythromycin capsules can be compounded in batches of 300 unities in hospital pharmacy with a beyond-use-date of one year at ambient temperature protected from light

Pre-formulation and Stability Study of 20-mcg Clonidine Hydrochloride Pediatric Capsules

International audienceOBJECTIVE Clonidine hydrochloride is an antihypertensive, centrally acting α2 adrenergic agonist with various pediatric indications. For pediatric patients, 20-mcg clonidine hydrochloride capsules can be compounded from commercial tablets or from a pre-compounded titrated powder. These methods should be compared to ensure the best quality for the high-risk patients, and a beyond-use date should be established. METHODS Eight experimental batches were made from commercial tablets and 8 were made from microcrystalline cellulose (MCC)–based titrated powders. Quality controls were performed to determine the best compounding protocol. Stability study was conducted on capsules compounded with the best method. RESULTS Of 8 batches manufactured from commercial tablets, 7 were compliant for both clonidine mean content and content uniformity, whereas 7 of 8 batches manufactured from titrated powders were not. A clonidine loss during compounding was evidenced by surface sampling analyses. Clonidine hydrochloride 20-mcg capsules' mean content remained higher than 90% of initial content for 1 year when stored at 25°C with 60% relative humidity and protected from light. CONCLUSIONS Commercial tablets should be preferred to 1% clonidine hydrochloride and MCC titrated powder made from the active pharmaceutical ingredient. Twenty-microgram clonidine hydrochloride capsules made from commercial tablets are stable for 1 year when stored under managed ambient storage condition