Butalbital

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Gwendolyn A Mcmillin - One of the best experts on this subject based on the ideXlab platform.

  • quantitation of cocaine and metabolites phencyclidine Butalbital and phenobarbital in meconium by liquid chromatography tandem mass spectrometry
    Journal of Analytical Toxicology, 2018
    Co-Authors: Triniti L Scroggin, Gwendolyn A Mcmillin
    Abstract:

    In this study, a quantitative polarity switching liquid chromatography coupled with a tandem mass spectrometer (LC-MS/MS) method was developed to detect and quantify cocaine and metabolites (cocaethylene, benzoylecgonine and meta-hydroxybenzoylecgonine), phencyclidine (PCP) and barbiturates (phenobarbital and Butalbital) in meconium. Accuracy and precision samples at 0.0125% and 75% of the upper limit of quantitation (ULOQ) were analyzed in triplicate over 5 days with accuracy above 84% and average %CV values below 11%. Within-run (n = 15) and between-run (n = 15) %CV values were ≤5%. Analytical measurement ranges were reproducible and linear (R ≥ 0.995) for cocaine and metabolites (20-2,000 ng/g), PCP (10-1,000 ng/g) and barbiturates (50-5,000 ng/g). Accuracy of 100 ± 20% was observed at (the limits of detection) 10 ng/g for cocaine and metabolites, 2.5 ng/g for PCP and 25 ng/g for barbiturates. No carryover was observed at 2X ULOQ and no interfering substances were identified. Sample preparation recoveries were 53-83%. Fifty-one authentic patient samples previously characterized correlated with the newly developed test having R2 values ≥0.996. This combined method allows accurate quantitation of the targeted drugs in a complex matrix while decreasing sample preparation and analysis time with reduced sample volume. Clinical data and positivity rates were similar to previously published positivity rates. Validation data and positivity rate agreement signifies a reliable and robust assay.

Mark Adams - One of the best experts on this subject based on the ideXlab platform.

Stephen D Silberstein - One of the best experts on this subject based on the ideXlab platform.

  • sumatriptan naproxen and Butalbital a double blind placebo controlled crossover study
    Headache, 2012
    Co-Authors: Frederick J Derosier, Stephen D Silberstein, Fred D Sheftell, Roger Cady, Gary E Ruoff, Alok Krishen, Margaret Peykamian
    Abstract:

    Objectives.— The primary objective was to compare the efficacy of a sumatriptan and naproxen combination medication (SumaRT/Nap—85 mg sumatriptan and 500 mg naproxen sodium), a Butalbital-containing combination medication (BCM—50 mg Butalbital, 325 mg acetaminophen, 40 mg caffeine), and placebo when used to treat moderate to severe migraine headache pain in subjects who used BCMs in the past. Background.— Despite the lack of Food and Drug Administration approval and the absence of placebo-controlled trials to demonstrate efficacy, Butalbital-containing medications are among the most commonly prescribed acute migraine treatments in the United States. Butalbital-containing medications are associated with serious and undesirable side effects, and have been linked to the chronification of migraine and development of medication-overuse headaches. This study compares the relative efficacy, safety, and tolerability of a fixed dose SumaRT/Nap versus a BCM and placebo. Methods.— Enrolled subjects were required to have treated at least 1 migraine with a Butalbital medication in the past. Enrolled subjects treated 3 moderate to severe migraines using each of the 3 study treatments once in a randomized sequence. The primary endpoint compared SumaRT/Nap versus BCM for sustained pain freedom at 2-24 hours without the use of any rescue medication. This study combines data from 2 identical outpatient, randomized, multicenter, double-blind, double-dummy, 3 attack crossover studies in adult migraineurs (International Classification of Headache Disorders, 2nd edition). Results.— A total of 442 subjects treated at least 1 attack with study medication. The majority of the treated subjects were female (88%) with a mean age 43 years, who reported that their migraines had a severe impact on their lives (78% with Headache Impact Test-6 of >59). At screening, 88% of subjects reported current Butalbital use; 68% had used Butalbital for more than 6 weeks; and 82% reported satisfaction with Butalbital. Across treatment groups, 28-29% of subjects took study medication within 15 minutes of migraine onset, 34-37% of subjects took study medication >15 minutes to 2 hours after onset, and 32-36% of subjects took study medication more than 2 hours after onset. This study did not detect a difference at the nominal 0.05 level in percent sustained pain-free between SumaRT/Nap (8%), BCM (6%), and placebo (3%). SumaRT/Nap was superior to BCM for pain free at 2, 4, 6, 8, 24, 48 hours (P ≤ .044); pain relief (mild or no pain) at 2, 4, 6, 8, 24, 48 hours (P ≤ .01); sustained pain relief 2-24 hours (P < .001); migraine free (pain free with no nausea, photophobia, or phonophobia) at 4, 6, 8, 24, 48 hours (P ≤ .046); and complete symptom free (migraine free with no neck/sinus pain) at 4, 6, 8, 48 hours (P ≤ .031). Adverse event incidence was similar for all treatments (10%, 12%, and 9% for placebo, SumaRT/Nap, and BCM, respectively). Nausea was the most frequent adverse event (2%, 2%, and <1% for placebo, SumaRT/Nap, and BCM, respectively). Five serious adverse events were reported by 3 subjects: viral meningitis and colon neoplasm (placebo); chest pain and hypertension 17 days postdose (SumaRT/Nap); and breast cancer (BCM). Investigators judged no serious adverse events related to study medication. Conclusions.— This study primarily included subjects whose migraines significantly impacted their lives. Before the study, these subjects used Butalbital-containing medications as part of their current migraine treatment regimen and were satisfied with it, suggesting they were Butalbital responders who had found a workable treatment strategy for themselves. When treated with SumaRT/Nap versus BCM in this study, however, a significant proportion of subjects reported better treatment outcomes for themselves for both migraine pain and associated symptoms. Use of SumaRT/Nap was also associated with less rescue medication use and a longer time before use of rescue medication compared with both BCM and placebo.

  • Butalbital in the treatment of headache history pharmacology and efficacy
    Headache, 2001
    Co-Authors: Stephen D Silberstein, Douglas C Mccrory
    Abstract:

    Analgesics containing Butalbital compounded with aspirin, acetaminophen, and/or caffeine are widely used for the treatment of migraine and tension-type headache. The Butalbital-containing compounds are efficacious in placebo-controlled trials among patients with episodic tension-type headaches. Despite their frequent clinical use for migraine, they have not been studied in placebo-controlled trials among patients with migraine. Barbiturates can produce intoxication, hangover, tolerance, dependence, and toxicity. Butalbital can result in intoxication that is clinically indistinguishable from that produced by alcohol. Butalbital-containing analgesics can produce drug-induced headache in addition to tolerance and dependence. Higher doses can produce withdrawal syndromes after discontinuation. Butalbital-containing analgesics may be effective as backup medications or when other medications are ineffective or cannot be used. Because of concerns about overuse, medication-overuse headache, and withdrawal, their use should be limited and carefully monitored.

  • practice parameter evidence based guidelines for migraine headache an evidence based review report of the quality standards subcommittee of the american academy of neurology
    Neurology, 2000
    Co-Authors: Stephen D Silberstein
    Abstract:

    Mission statement. The Quality Standards Subcommittee (QSS) of the American Academy of Neurology (AAN) is charged with developing practice parameters for physicians. This practice parameter summarizes the results from the four evidence-based reviews on the management of patients with migraine: specifically, acute, preventive, and nonpharmacologic treatments for migraine, and the role of neuroimaging in patients with headache. The full papers for these treatment guidelines are published elsewhere,1-6⇓⇓⇓⇓⇓ and only the specific treatment recommendations are summarized below. Migraine is a very common disorder. An estimated 18% of women and 6% of men experience migraine, but many go undiagnosed and undertreated.7 There have been a number of advances in the diagnosis and treatment of migraine as well as great strides in understanding its pathogenesis, making it one of the best understood of the neurologic disorders. Migraine is characterized by enhanced sensitivity of the nervous system. The attack is associated with activation of the trigeminal-vascular system. In June 1998, Duke University’s Center for Clinical Health Policy Research, in collaboration with the AAN, completed four Technical Reviews on migraine sponsored by the Agency for Health Care Policy and Research. These reviews covered self-administered drug treatments for acute migraine8; parenteral drug treatments for acute migraine9; drug treatments for the prevention of migraine10; and behavioral and physical treatments for migraine.11 The Education and Research Foundation of the AAN later funded additional reports on diagnostic testing for headache patients, an update on sumatriptan and other 5-HT1 agonists, and a report on Butalbital-containing compounds for migraine and tension-type headache, using the same methodology that was used in the original Technical Reviews . A multidisciplinary panel of professional organizations (The US Headache Consortium) produced four treatment guidelines, each related to a distinct set of …

Michael G. Bartlett - One of the best experts on this subject based on the ideXlab platform.

  • capillary electrophoresis determination of Butalbital from serum using solid phase extraction spe and ultraviolet detection
    Journal of Liquid Chromatography & Related Technologies, 2000
    Co-Authors: Karthik Srinivasan, Michael G. Bartlett
    Abstract:

    Butalbital is a sedative hypnotic that is used mainly in combination with analgesics in the treatment of tension headaches. This paper develops and validates a rapid and sensitive method for the determination of Butalbital in serum using capillary electrophoresis (CE) and ultraviolet detection. The internal standard chosen for this assay was aprobarbital because it showed similar chemical structure, identical chromatographic/SPE characteristics, and was commercially available. The CE run buffer contained 50 mM sodium dihydrogen phosphate buffer at pH 9.0 containing 20 mM hydroxypropyl-β-cyclodextrin as a capillary zone electrophoresis (CZE) buffer additive. An SPE method, using C[18] Bond-Elut cartridges, was developed to recover the drug and internal standard from serum. The CE system consists of a 75 micron I.D., 52 cm length fused silica capillary maintained at a run voltage of 15 kV with sample detection performed at 254 nm. The limit of detection for Butalbital was

  • Supercritical fluid extraction and negative ion electrospray liquid chromatography tandem mass spectrometry analysis of phenobarbital, Butalbital, pentobarbital and thiopental in human serum
    Rapid Communications in Mass Spectrometry, 1998
    Co-Authors: J. Christopher Spell, Karthik Srinivasan, James T. Stewart, Michael G. Bartlett
    Abstract:

    Four commonly used barbiturates (phenobarbital, Butalbital, pentobarbital and thiopental) were analyzed in human serum using supercritical fluid extraction (SFE) and negative ionization LC/ESI-MS/MS. Barbital was used as the internal standard. Carbon dioxide SFE was performed at 40 degrees C and 500 atm, with a total extraction time of 35 min. The analytes were collected off-line in a liquid trap containing absolute methanol. Samples were then concentrated by vacuum centrifugation. The high performance liquid chromatography separation utilized gradient elution with a total analysis time of 21 min. The precursor and major product ions for the four barbiturates were monitored on a triple quadrupole mass spectrometer with negative ion electrospray ionization (ESI) in the multiple reaction monitoring mode as follows: (1) thiopental (m/z 241.20-->58.00), (2) phenobarbital (m/z 231.10-->188.0), (3) pentobarbital (m/z 225.10-->181.90) and (4) Butalbital (m/z 222.80-->179.90). In the case of phenobarbital, pentobarbital and Butalbital, the most abundant product ion arises from the loss of 43 u (HCNO loss). However, in the case of thiopental, the most abundant product ion was observed at m/z 58.0 (the [M-183]-ion, or NCS-). Mechanisms for the formation of the collision induced dissociation reaction products of these barbiturates are proposed.

James T. Stewart - One of the best experts on this subject based on the ideXlab platform.

  • assay for the simultaneous determination of acetaminophen caffeine Butalbital in human serum using a monolithic column
    Journal of Pharmaceutical and Biomedical Analysis, 2004
    Co-Authors: C Pistos, James T. Stewart
    Abstract:

    Abstract A fast and sensitive high performance liquid chromatography (HPLC) assay was developed on a C18 monolithic column for the simultaneous determination of acetaminophen–caffeine–Butalbital in human serum. Serum samples were treated with a solid phase extraction procedure. The analytes were separated using a mobile phase of 95:5 (v/v) 0.1 M potassium phosphate monobasic (pH 2.41)–acetonitrile on the C18 monolithic column with detection at 220 nm. Benzoic acid was used as the internal standard (IS). The method was validated over the range of 1.25–100 μg/ml for each drug and found to be linear ( r > 0.995, n = 12) with RSD less than 8.3%. The method proved to be accurate (percent bias for all calibration samples varied from −14.6 to −1.3%) and precise (ranged from 2.9 to 13.4%). The mean percent absolute recoveries from serum were 89.7 ± 3.6 for acetaminophen, 95.5 ± 4.5 for caffeine, 99 ± 5.2 for Butalbital and 83.4 ± 3.9% for the internal standard.

  • rapid method for analysis of aspirin Butalbital in serum utilizing a monolithic c18 column
    Journal of Liquid Chromatography & Related Technologies, 2003
    Co-Authors: C Pistos, James T. Stewart
    Abstract:

    Abstract A fast and sensitive high performance liquid chromatography (HPLC) assay was developed for the simultaneous determination of aspirin–Butalbital in human serum. Serum samples were treated with a solid phase extraction procedure. The analytes were separated using a mobile phase of 90:10 (v/v) 0.1 M aqueous potassium phosphate monobasic (pH 4)‐acetonitrile on a monolithic C18 column with UV detection at 220 nm. Benzoic acid was used as the internal standard (IS). The method was validated over the range of 0.5–100 µg mL−1 for each drug. The method proved to be accurate (percent bias for all calibration samples varied from −13 to 6.6%) and precise (range from 0.1% to 10%). The mean percent absolute recoveries were 104 ± 6.3 for aspirin, 92.6 ± 5.5 for Butalbital and 106 ± 6.9 for the internal standard. The assay should be applicable for use in pharmacokinetic studies and routine serum monitoring of these drugs.

  • hplc methods for aspirin caffeine Butalbital and acetaminophen caffeine Butalbital mixtures in tablet dosage forms using non porous octadecylsilane columns
    Journal of Liquid Chromatography & Related Technologies, 2000
    Co-Authors: James T. Stewart
    Abstract:

    High performance liquid chromatography procedures using non-porous ODS columns were developed for the assay of aspirin-caffeine-Butalbital (mixture 1) and acetaminophen-caffeine-Butalbital (mixture 2). The separation and quantitation of Mixture 1 were achieved on a 3.0 μm non-porous silica ODS column at ambient temperature using a mobile phase of 98:2 v/v 50 mM phosphate buffer pH 3.0-acetonitrile at a flow rate of 1.5 mL/min with detection at 220 nm. The method showed linearity for aspirin-caffeine-Butalbital in the 325–6500, 40–800, and 50–1000 ng/mL ranges, respectively. Intra- and inter-day RSD values were 0.19–1.72% and 1.30–1.49% for aspirin, 0.08–1.17% and 0.06–1.09% for caffeine, and 0.09–1.55% and 0.07–2.10% for Butalbital, respectively. Accuracy of intra and inter-day were in the 0.70–1.27% and 0.20–1.13% for aspirin, 0.05–0.06% and 0.004–0.09% for caffeine, and 0.02–0.09 and 0.02–0.05% for Butalbital, respectively. The limits of detection for aspirin, caffeine, and Butalbital were 5, 5, and 10 ...

  • simultaneous determination of codeine caffeine Butalbital and aspirin by free solution capillary electrophoresis
    Journal of Liquid Chromatography & Related Technologies, 1999
    Co-Authors: Ahsanul Haque, James T. Stewart
    Abstract:

    A free solution capillary electrophoresis method was developed to separate and quantitate codeine (CD), caffeine (CF), Butalbital (BB), and aspirin (AP) in a mixture. The mixture was injected hydrodynamically for 5s at the anodic end and separation was performed on a fused silica capillary (72 cm × 50 μm i.d; 50cm to detector) at an applied voltage of 20 kV with 0.05 M phosphate run buffer pH 8. Separation was performed at ambient temperature and the total run time for analysis was 14 min. Detection was set at 220 nm. Calibration curves were prepared for CD, CF, BB, and AP with methyl p-hydroxy benzoate as internal standard. For each analyte, the correlation coefficients was greater than 0.999 (n=4). The RSDs % of ten replicate injections for each analyte were less than 1.4 %. The method was applied to the quantitation of CF, BB, and AP in a commercial tablet. Recoveries of the drug components were in the 96–104 % range.

  • determination of acetaminophen caffeine and Butalbital in a commercial tablet dosage form by micellar electrokinetic chromatography
    Journal of Liquid Chromatography & Related Technologies, 1999
    Co-Authors: Ahsanul Haque, James T. Stewart
    Abstract:

    A micellar electrokinetic chromatography (MEKC) method was developed to analyze acetaminophen (AP),caffeine (CF), and Butalbital (BB) simultaneously in a commercial tablet dosage form. Uncoated fused silica capillary (70 cm × 50 μm i.d, 50 cm to detector) was used for the separation at an applied voltage of 20 kV. A phosphate run buffer (pH 9, 0.05 M) containing 0.05 M sodium dodecyl sulphate was used for analysis. Separations of the analytes were achieved within 12 min at ambient temperature with detection set at 220 nm. Calibration curves were prepared for AP (260-520 μg/mL), CF (30–64 μg/mL) and BB (40–80 μg/mL) by the internal standard method with methyl–p–hydroxybenzoate as internal standard. Correlation coefficients of calibration curves were greater than 0.990. A five second hydrodynamic injection was used for analysis. Tablet powder equivalent to one tablet weight was extracted with absolute methanol in an ultrasonic bath for 30 min. The methanol extract was diluted with water and injected into th...

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