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This study demonstrates the capabilities of NIR imaging as an effective tool for characterization of pharmaceutical powder blends. The powder system used in this small-scale powder blending study consists of acetaminophen (APAP, the model API), microcrystalline cellulose (MCC) and lactose monohydrate. Mixtures of these components were blended for different times for a total of ten time points (ten blending trials). Images collected from multiple locations of the blends were used to generate a qualitative description of the components' blending dynamics and a quantitative determination of both the blending end point and the distribution variability of the components. Multivariate analyses, including pure-component PCA and discriminate PLS, were used to treat the imaging data. A good correlation was observed between imaging results and a UV-Vis monitoring method for determining blend homogeneity. Score images indicated general trends of the distribution of blending constituents for all ten blending trials. The API distribution pattern throughout blending was detected and the API domain size for different blending trials was compared. Blending insights obtained from this study may be transferable to large scale powder blending. Blending process understanding obtained from this study has the potential to facilitate the optimization of blending process control in the future.
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PMID:Characterization of pharmaceutical powder blends by NIR chemical imaging. 1794 13

A new approach for testing batch "similarity" through comparison of drug dissolution profiles, based on principal component analysis with the establishment of a confidence region (PCA-CR), is presented. The dissolution curves corresponding to three brands each of Furosemide and Acetaminophen tablets, taken as model drugs, were prepared by dissolution measurements at multiple pre-specified time points. Reference and test data were simultaneously subjected to PCA and pairwise comparisons between the dissolution characteristics of lots of the same and different brands were carried out. The comparisons involved plotting the weighed scores of the first two principal components of reference and test lots, while decision about "similarity" was made by checking for inclusion of more than 80% of the tablets of the test lot in the 95% confidence ellipse of the reference samples. Two published datasets were also analyzed in the same fashion and all the results were compared with information provided by the difference (f1) and similarity (f2) factor tests. Unlike the f2 criterion, the proposed method reflects variability within the individual dissolution curves, being also highly sensitive to profile (shape and size) variations. Comparison between the area enclosed by the confidence ellipses of the weighed scores plot and the region obtained from the bootstrap-calculated acceptable values of the corresponding f2 tests suggested that PCA-CR represents, in general, a more discriminating standard.
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PMID:A new principal component analysis-based approach for testing "similarity" of drug dissolution profiles. 1839 69

In this study, postoperative analgesic effects of intravenous paracetamol administration in lumbar discectomy patients were evaluated. After the approval of ethic committee, 90 patients undergoing lumbar disc hernia operation randomly divided into 3 groups. After standart general anesthesia, patients in group I received 1 gr i.v. paracetamol infusion 15 minutes before the induction, patients in group II received i.v. Paracetamol infusion started 15 minutes before the end of surgery. i.v morphine via PCA is used for postoperative analgesia maintenance and patients pain scores were assessed with VAS at 0., 1., 2., 3., 6., 12. and 24. hours. First analgesic requirement time, total morphine consumption and side effects were recorded. In group I and II, VAS scores, 24 h morphine consumption and first morphine requirement times were significantly different comparing to group III. As a result, we think that in lumbar discectomy cases preoperative administration of 1 gr paracetamol has no preemptive analgesic effect.
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PMID:[Does iv paracetamol have preemptive analgesic effect on lumber disc surgeries?]. 1902 Oct 6

Fentanyl is the most commonly used opioid analgesic in intravenous patient-controlled analgesia (IV PCA) in Korea. IV oxycodone was approved for postoperative IV PCA by the Ministry of Food and Drug Safety of Korea in 2013. The approved dosage regimen for postoperative pain relief with IV oxycodone is IV bolus loading of 2 mg followed by PCA composed of demand boluses of 1 mg and no background infusion with an oxycodone concentration of 1 mg/ml. However, a simulation study indicated that the minimum effective analgesic concentration (MEAC, as indicated by relief of pain by administering rescue analgesics) of oxycodone was reached most quickly with a higher loading dose of 0.1 mg/kg and IV PCA with background infusion. Oxycodone is a therapeutic option as an analgesic for postoperative pain management. It is necessary to reduce the analgesic dose of oxycodone in elderly patients because metabolic clearance decreases with age.
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PMID:A new therapeutic option for postoperative pain management with oxycodone HCI injection. 2727 64

In this study, the 1H HRMAS-NMR (High-resolution Magic Angle Spinning-Nuclear Magnetic Resonance) spectra of 52 cheese samples obtained from the South Korean dairy farms were evaluated for their metabolic profiling and intensities associating with the sensory qualities. The NMR profiles displayed a broad range of compounds comprising amino acids, carbohydrates, organic acids, and phospholipids. Afterwards, the cheese samples were categorized into three groups (more likeness - G1, moderate likeness - G2, less likeness - G3), in relating to their sensory scores. The NMR data of the samples were later investigated through multivariate statistical tools to define the variations in metabolic fingerprints of every cheese sample and their intensities hailing in individual sensory groups. The unsupervised PCA employing all cheese samples unveiled the uniqueness in metabolite profiles of the brown and cheddar type cheeses (outliers). Moreover, Gouda and other types of cheeses displayed samples positioning in respective of their metabolite profiles. The pairwise comparison of sensory groups in the supervised models perceived better separation in OPLS-DA than PLS-DA. The corresponding VIP (PLS-DA) and loading (OPLS-DA) plots revealed amino acids and organic acids (lactate, citrate) as significant variables. The discrimination of G 1 Gouda type of cheeses against G 2 and G 3 was highly associated with their citrate levels. Further investigation using heatmaps displayed clear differentiation between each sensory group in terms of the levels of amino acids, lactate, citrate, phospholipids, and glycerol, conveying these variations are likely due to proteolytic and metabolic processes in cheese ripening. This study concluded that 1H HRMAS-NMR metabolite profile of the Korean cheeses is consistence with their sensory qualities. Further, the candidate metabolites identified in this study confers their potential application as biomarkers in cheese industries for faster and effective validation of sensory characteristics.
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PMID:1H HRMAS-NMR based metabolic fingerprints for discrimination of cheeses based on sensory qualities. 3248 80