5 research outputs found

    Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use

    Get PDF
    BACKGROUND: Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. METHOD: UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET) following the European pharmacopoeia standards. RESULTS: Four different preservatives were identified namely methylparahydroxybenzoate (MP), propylparahydroxybenzoate (PP), benzoic acid and sorbic acid. MP and PP were identified in Artesiane(® )(artemether 300 mg/100 ml), Alaxin(® )(dihydroartemisinin 160 mg/80 ml) andGvither (® )(artemether 300 mg/100 ml) respectively. Sorbic acid was presentin Artenam(® )(artemether 180 mg/60 ml) while benzoic acid was identified in Santecxin(® )(dihydroartemisinin 160 mg/80 ml) andArtexin(® )(dihydroartemisinin 160 mg/80 ml) respectively. Cotecxin(® )(dihydroartemisinin 160 mg/80 ml) did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6) of the products did not completely dissolve and the PET results revealed that only Artenam(® )and Gvither(® )met the requirements for antimicrobial efficacy. The other products did not conform. CONCLUSION: These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both the active ingredient and the preservative, including the efficacy of the latter

    Aspects galéniques des shampooings médicinaux: mise à jour (Pharmacy compounding of medicinal shampoos: an update)

    Full text link
    Delivery of magistral (extemporaneous) preparations must comply with quality standards, as described in the "Guide to Good Officinal Pharmaceutical Practice" and the pharmacy's Quality Manual (Royal Decree of 21 January 2009). In this study, the shampoo Simplex Herdewijn, prepared with Texapon NSO, is compared with commercially available basic shampoos (Shampoo Fagron and Shampoo Simplex Conforma) with respect to its composition as well as its physicochemical properties. These basic shampoos were used to develop medicinal shampoos. The active compounds of these shampoos were: 0.5% hexachlorophene, 1% ichtammol, 1% cade oil or 2% liquor carbonis detergens. The necessary concentration of Cetomacrogol 1000, required to solubilise the active compounds was determined, as well as the amount of sodium chloride needed to adjust the viscosity of the shampoo. The viscosity of the basic and medicinal shampoos was determined by means of rheograms and by calculating their apparent viscosity. Additionally, a number of fundamental aspects of the formulation of shampoos are discussed in this paper. The results can be useful to pharmacists as guidelines for the preparation of medicinal shampoos. Beside patient instruction and pharmaceutical care, the intrinsic quality of magistral preparations is a prerequisite for therapeutic activity
    corecore