PubMed · 10596151
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H Virtanen. 1996. [Recurrent cough].. https://pubmed.ncbi.nlm.nih.gov/10596151/
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The purpose of this study was to apply the attractive technique of the supercritical fluid to the preparation of solvent-free solid dispersions. In particular, the gas antisolvent crystallisation technique (GAS), using supercritical carbon dioxide as processing medium, has been considered to prepare an enhanced release dosage form for of the poorly soluble carbamazepine, employing PEG 4000 as a hydrophilic carrier. The physical characterisation of the systems using laser granulometer, powder X-ray diffraction, thermal analyses, and scanning electron microscopy was carried out in order to understand the influence of this technological process on the physical status of the drug. The results of the physical characterisation attested a substantial correspondence of the solid state of the drug before and after treatment with GAS technique, whereas a pronounced change in size and morphology of the drug crystals was noticed. The dramatic reduction of the dimensions and the better crystal shape, together with the presence of the hydrophilic polymer determined a remarkable enhancement of the in vitro drug dissolution rate.
The major progress made in the understanding of the genetic basis of inter-individual variation in drug response, alongside the rapid advances in technology, provides major new opportunities to ensure the safe introduction of a new chemical entity into clinical practice. In essence, the aim is to get the right drug into the right patient using knowledge of factors that influence both benefit and risk. The stage of the drug development process at which genetic analysis needs to be undertaken is dependent on the frequency of the event, and the availability of clinical samples. Thus, common adverse events, or assessment of efficacy, will be feasible for testing in phases I-III. However, when a rare event is being studied, for example idiosyncratic toxicity, prospective analysis becomes impossible. Thus, retrospective studies using available drugs is important as it may provide paradigms for future drug development. Additionally, prospective collection of samples will be important so that rare adverse events identified during phase IV can then be analysed using toxicogenetic approaches. Ultimately, information obtained from toxicogenetics must be included in the Specific Product Characteristics (SPC) and thus formally translated into clinical practice in order to contraindicate the drug in specific patients with a genetically determined susceptibility to drug toxicity.
Therapeutic drug monitoring of carbamazepine (CBZ), a widely used antiepileptic drug, is required for optimization of pharmacotherapy with this drug and for assessment of the patient's compliance to therapy. The suitability of employing micellar electrokinetic capillary chromatography (MEKC) in the absence of electroosmosis for the determination of CBZ and its main metabolite carbamazepine-10,11-epoxide (CBZE) in extracts of human serum and plasma is reported. Using micelles formed by dodecyl sulfate, analyses performed in untreated fused-silica capillaries at acidic pH and in commercially available coated capillaries under application of reversed polarity are compared. Uncoated and polyvinyl alcohol coated capillaries proved to be unsuitable for this purpose, whereas capillaries coated with linear polyacrylamide and N-acryloylaminoethoxyethanol and operated at pH 7.6 are shown to provide high-quality and reliable data on a short time scale. Assay performance is discussed via statistical analysis of the data produced from a set of quality control sera that contain up to 14 different drugs and via analysis of patient samples. Intraday and interday imprecision data for concentrations between 4.0 and 84 microM are demonstrated to be < 10%. Run times are shown to be < 50% compared to those observed in conventional MEKC at alkaline pH (i.e., in the presence of electroosmosis).