Gabapentin Bioequivalence Study: Quantification By Liquid Chromatography Coupled To Mass Spectrometry

The study was performed to compare the bioavailability of two gabapentin 400 mg capsule formulation (Gabapentin from Arrow Farmacêutica S/A as test formulation and Neurontin ® from Pfizer, Brazil, as reference formulation) in 26 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a one week wash out period. Plasma samples were obtained over a 48 hour interval. The gabapentin was analyzed by LC/MS/MS, in the presence of pracetamole as internal standard. With plasma concentration vs. time curves, data obtained from this metabolite, the following pharmacokinetics parameters were obtained: AUC 0-t, AUC 0-inf and C max. Geometric mean of gabapentin/Neurontin ® 400 mg individual percent ratio was 100.58% AUC 0-t, 101.35% for AUC 0-inf and 97.76% for C max. The 90% confidence intervals were 92.00 - 109.95%, 93.00 - 110.44%, 88.41 - 108.10%, respectively. Since the 90% confidence intervals for C max, AUC 0-t and AUC 0 -inf were within the 80 - 125% interval proposed by Food and Drug Administration, it was concluded that gabapentin 400 mg capsule was bioequivalent to Neurontin ® 400 mg capsule according to both the rate and extent of absorption. © 2011 Junior EA, et al.38187190Wattananat, T., Akarawut, W., Validated LC-MS-MS Method for the Determination of Gabapentin in Human Plasma: Application to a Bioequivalence Study (2009) J Chromatogr Sci, 47, pp. 868-871Stewart, B.H., Kagler, A.R., Thompson, P.R., Bockbrader, H.N., A saturable transport mechanism in the intestinal absorption of gabapentin is the underlying cause of the lack of proportionality between increasing dose and drug levels in plasma (1993) Pharma Res, 10, pp. 276-281McLean, M.J., Gabapentin in the management of convulsive disorders (1999) Epilepsia, 40, pp. 39-50Goa, K.L., Sorkin, E.M., Gabapentin: A review of its pharmacological properties and clinical potential in epilepsy (1993) Drugs, 46, pp. 409-427Zhu, Z., Neirinck, L., High-performance liquid chromatographic method for the determination of gabapentin in human plasma (2002) J Chromatogr B Analyt Technol Biomed Life Sci, 779, pp. 307-312Sagirli, O., Cetin, S.M., Determination of gabapentin in human plasma and urine by high-performance liquid chromatography with UV-vis detection (2006) J Pharm Biomed Anal, 42, pp. 618-624Jalalizadeh, H., Souri, E., Tehrani, M.B., Jahangiri, A., Validated HPLC method for the determination of gabapentin in human plasma using precolumn derivatization with 1-fluoro-2,4-dinitrobenzene and its application to a pharmacokinetic study (2007) J Chromatogr B Analyt Technol Biomed Life Sci, 854, pp. 43-47Forrest, G., Sills, G.J., Leach, J.P., Brodie, M.J., Determination of gabapentin in plasma by high-performance liquid chromatography (1996) J Chromatogr B Analyt Technol Biomed Life Sci, 681, pp. 421-425Tang, P.H., Miles, M.V., Glauser, T.A., Degrauw, T., Automated microanalysis of gabapentin in human serum by high-performance liquid chromatography with fluorometric detection (1999) J Chromatogr B Analyt Technol Biomed Life Sci, 727, pp. 125-129Hassan, E.M., Belal, F., Al-Deeb, O.A., Khalil, N.Y., Spectrofluorimetric determination of vigabatrin and gabapentin in dosage forms and spiked plasma samples through derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (2001) J. AOAC Int., 84, pp. 1017-1024Gauthier, D., Gupta, R., Determination of gabapentin in plasma by liquid chromatography with fluorescence detection after solid-phase extraction with a C18 column (2002) Clin Chem, 48, pp. 2259-2261Chung, T.C., Tai, C.T., Wu, H.L., Simple and sensitive liquid chromatographic method with fluorimetric detection for the analysis of gabapentin in human plasma (2006) J Chromatogr A, 119, pp. 294-298Bahrami, G., Kiani, A., Sensitive high-performance liquid chromatographic quantitation of gabapentin in human serum using liquid-liquid extraction and pre-column derivatization with 9-fluorenylmethyl chloroformate (2006) J Chromatogr B Analyt Technol Biomed Life Sci, 835, pp. 123-126Krivanek, P., Koppatz, K., Turnheim, K., Simultaneous isocratic HPLC determination of vigabatrin and gabapentin in human plasma by dansyl derivatization (2003) Ther Drug Monit, 25, pp. 374-377Chang, S.Y., Wang, F.Y., Simple and sensitive liquid chromatographic method with fluorimetric detection for the analysis of gabapentin in human plasma (2004) J Chromatogr B Analyt Technol Biomed Life Sci, 799, pp. 265-270Wolf, C.E., Saady, J.J., Poklis, A., Determination of gabapentin in serum using solid phase extraction and gas-liquid chromatography (1996) J Anal Toxicol, 20, pp. 498-501Kushnir, M.M., Cossett, J., Brown, P.I., Urry, F.M., Analysis of gabapentin in serum and plasma by solid-phase extraction and gas chromatography-mass spectrometry for therapeutic drug monitoring (1999) J Anal Toxicol, 23, pp. 1-6Borrey, D.C., Godderis, K.O., Engelrelst, V.I., Bernard, D.R., Langlois, M.R., Quantitative determination of vigabatrin and gabapentin in human serum by gas chromatography-mass spectrometry (2005) Clin Chim Acta, 354, pp. 147-151Gambelunghe, C., Mariucci, G., Tantucci, M., Ambrosini, M.V., Gas chromatography-tandemmass spectrometry analysis of gabapentin in serum (2005) Biomed Chromatogr, 19, pp. 63-67Matar, K.M., Abdel-Hamid, M.E., Rapid tandem mass spectrometric method for determination of gabapentin in human plasma (2005) Chromatographia, 61, pp. 499-504Ramakrishna, N.V.S., Vishwottam, K.N., Koteshwara, M., Maroj, S., Santosh, M., Rapid quantification of gabapentin in human plasma by liquid chromatography/tandemmass spectrometry (2006) J Pharm Biomed Anal, 40, pp. 360-368Ifa, D.R., Falci, M., Moraes, M.E., Bezerra, F.A., Moraes, M.O., Gabapentin quantification in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Application to bioequivalence study (2001) J Mass Spectrom, 36, pp. 188-194Ji, H.Y., Jeong, D.W., Kim, Y.H., Kim, H.H., Yoon, Y.S., Determination of gabapentin in human plasma using hydrophilic interaction liquid chromatography with tandem mass spectrometry (2006) Rapid Commun Mass Spectrom, 20, pp. 2127-2132Carlsson, K.C., Reubsaet, J.L., Sample preparation and determination of gabapentin in venous and capillary blood using liquid chromatography-tandem mass spectrometry (2004) J Pharm Biomed Anal, 34, pp. 415-423Park, J.H., Jhee, O.H., Park, S.H., Lee, J.S., Lee, M.H., Validated LC-MS/ MS method for quantification of gabapentin in human plasma: Application to pharmacokinetic and bioequivalence studies in Korean volunteers (2007) Biomed Chromatogr, 21, pp. 829-83

Manejo da irrigação do feijoeiro considerando critérios técnicos e econômicos em ambiente de Cerrado.

bitstream/CPAC-2010/30265/1/bolpd-221.pd

Principles and philosophies for speech and language therapists working with people with primary progressive aphasia: An international expert consensus

Purpose: Primary progressive aphasia (PPA) is a language-led dementia associated with Alzheimer’s pathology and fronto-temporal lobar degeneration. Multiple tailored speech and language interventions have been developed for people with PPA. Speech and language therapists/speech-language pathologists (SLT/Ps) report lacking confidence in identifying the most pertinent interventions options relevant to their clients living with PPA during their illness trajectory. Materials and methods: The aim of this study was to establish a consensus amongst 15 clinical-academic SLT/Ps on best practice in selection and delivery of speech and language therapy interventions for people with PPA. An online nominal group technique (NGT) and consequent focus group session were held. NGT rankings were aggregated and focus groups video recorded, transcribed, and reflexive thematic analysis undertaken. Results: The results of the NGT identified 17 items. Two main themes and seven further subthemes were identified in the focus groups. The main themes comprised (1) philosophy of person-centredness and (2) complexity. The seven subthemes were knowing people deeply, preventing disasters, practical issues, professional development, connectedness, barriers and limitations, and peer support and mentoring towards a shared understanding. Conclusions: This study describes the philosophy of expert practice and outlines a set of best practice principles when working with people with PPA.Implications for rehabilitation Primary progressive aphasia (PPA) describes a group of language led dementias which deteriorate inexorably over time. Providing speech and language therapy for people with PPA is complex and must be person centred and bespoke. This study describes the philosophy of expert practice and outlines a set of best practice principles for speech and language therapists/pathologists working with people with people with PPA

Assessing the distribution of exotic egg parasitoids of Halyomorpha halys in Europe with a large-scale monitoring program

The brown marmorated stink bug Halyomorpha halys is an invasive agricultural pest with a worldwide distribution. Classical biological control has been identified as the most promising method to reduce the populations of H. halys. Adventive populations of two candidates for releases, Trissolcus japonicus and Trissolcus mitsukurii, have recently been detected in Europe. To assess their distribution and abundance, a large-scale survey was performed. From May to September 2019, a wide area covering northern Italy and parts of Switzerland was surveyed, highlighting the expanding distribution of both Tr. japonicus and Tr. mitsukurii. Within four years after their first detection in Europe, both species have rapidly spread into all types of habitats where H. halys is present, showing a wide distribution and continuous expansion. Both exotic Trissolcus showed high levels of parasitism rate towards H. halys, while parasitization of non-target species was a rare event. The generalist Anastatus bifasciatus was the predominant native parasitoid of H. halys, while the emergence of native scelionids from H. halys eggs was rarely observed. The presence of the hyperparasitoid Acroclisoides sinicus was also recorded. This study provided fundamental data that supported the development of the first inoculative release program of Tr. japonicus in Europe

Failure or success? Defensive strategies and piecemeal change among racial inequalities in the Brazilian banking sector

We analyze how Brazilian Black Movement organizations and banks deployed different mechanisms like cooperation, cooptation, and confrontation that generated affirmative action initiatives in the banking sector at the beginning of this century. Black movement organizations triggered an institutional change by connecting fields and exploring a constellation of strategies. However, Brazilian banks adopted defensive strategies aiming to accommodate their interests. We find that only piecemeal change occurred, as the field’s structures – resource distribution and power – remained unscratched. We conclude by noting how the success of social movement strategies can depend upon the framing and sense-giving work that social movements conduct in their continuous jockeying activity toward incumbents