International journal of pharmaceutics
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Although bacterial nanocellulose (BNC) may serve as an ideal wound dressing, it exhibits no antibacterial properties by itself. Therefore, in the present study BNC was functionalized with the antiseptic drug octenidine. Drug loading and release, mechanical characteristics, biocompatibility, and antimicrobial efficacy were investigated. ⋯ In biological assays, drug-loaded BNC demonstrated high biocompatibility in human keratinocytes and antimicrobial activity against Staphylococcus aureus. In a long-term storage test, the octenidine loaded in BNC was found to be stable, releasable, and biologically active over a period of 6 months without changes. In conclusion, octenidine loaded BNC presents a ready-to-use wound dressing for the treatment of infected wounds that can be stored over 6 months without losing its antibacterial activity.
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Review
Progress review of the European Paediatric Regulatory Framework after six years of implementation.
The EU regulation (EU 1901/2006 Paediatric Regulation) that entered into force in 2007 has changed the field of medicinal drug development for children in the EU. Five years after its implementation a large number changes due to this regulation have been incorporated by Pharmaceutical Industry considering the development of new candidate drug. This report is a review of changes already implemented and the aspects of paediatric drug development, which still needs to be addressed in future working in the fields to provide better medicines for children.
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The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines. One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. ⋯ A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.
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Encapsulated local anesthetics extend postoperative analgesic effect following site-directed nerve injection; potentially reducing postoperative complications. Our study aim was to investigate efficacy of our improved extended duration formulation - 15% bupivacaine in poly(DL-lactic acid co castor oil) 3:7 synthesized by ring opening polymerization. In vitro, around 70% of bupivacaine was released from the p(DLLA-CO) 3:7 after 10 days. ⋯ Following surgery, motor block was observed for 48 h following administration of bupivacaine-polymer formulation and rearing was reduced (returning to baseline after 48 h). No significant differences in mechanical nociceptive response were observed. The optimized bupivacaine-polymer formulation prolonged duration of local anesthesia effect in our animal model up to at least 48 h.
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Tablets are frequently subdivided to lower the dose, to facilitate swallowing by e.g. children or older people or to save costs. Splitting devices are commonly used when hand breaking is difficult or painful. ⋯ Health care professionals should realize that tablet splitting may result in inaccurate dosing. Authorities should undertake appropriate measures to assure good function of tablet splitters and, where feasible, to reduce the need for their use.