The Experts below are selected from a list of 117 Experts worldwide ranked by ideXlab platform
Leslie Hendeles - One of the best experts on this subject based on the ideXlab platform.
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Over-the-Counter Oral Phenylephrine: A Placebo for Nasal Congestion
The journal of allergy and clinical immunology. In practice, 2015Co-Authors: Randy C. Hatton, Leslie HendelesAbstract:The category of over-the counter (OTC) [nonprescription] drugs was established in the United States in 1951 by the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act. The Kefauver-Harris Amendments to the Act required proof of efficacy for all drugs (prescription and nonprescription) approved after 1938. OTC drugs are marketed under regulations that established a monograph approval process, as well as the New Drug Application process. During the 1970s, the US Food and Drug Administration (FDA) convened panels of experts to review the efficacy and safety of OTC products on the market. The panel on Cough, Cold and Allergy Products determined that phenylephrine (PE) and pseudoephedrine were safe and effective for treating nasal congestion. A final OTC Nasal Decongestant Drugs Products monograph was published in 1994. Manufacturers can market the drugs listed in the monograph, alone or in combination, as long as the ingredients, dosage, and instructions for use list exactly what is required in the monograph. Even though phenylpropanolamine was effective, it was not included in the final monograph because of safety concerns about hemorrhagic strokes primarily when used as an OTC appetite suppressant. Because of the widespread use of pseudoephedrine to illegally make methamphetamine, Congress attached an amendment to the Patriot Act, the Combat Methamphetamine Epidemic Act, placing it “behind the counter” and requiring a photo identification and log of the transaction. This removed pseudoephedrine-containing products (Sudafed and others) from grocery and convenience stores, as well as from “in front of the counter” in pharmacies. The use of PE increased dramatically after 2004, presumably because it was the only “in front of the counter” OTC option. In 2005, we reviewed the existing evidence and questioned whether PE was effective at the FDA-approved dose of 10 mg. Subsequently, we undertook a meta-analysis
Evan R. Williams - One of the best experts on this subject based on the ideXlab platform.
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Direct standard-free quantitation of Tamiflu and other pharmaceutical tablets using clustering agents with electrospray ionization mass spectrometry.
Analytical chemistry, 2010Co-Authors: Tawnya G. Flick, Ryan D. Leib, Evan R. WilliamsAbstract:Accurate and rapid quantitation is advantageous to identify counterfeit and substandard pharmaceutical drugs. A standard-free electrospray ionization mass spectrometry method is used to directly determine the dosage in the prescription and over-the-counter drugs Tamiflu, Sudafed, and Dramamine. A tablet of each drug was dissolved in aqueous solution, filtered, and introduced into solutions containing a known concentration of l-tryptophan, l-phenylalanine, or prednisone as a clustering agent. The active ingredient(s) incorporates statistically into large clusters of the clustering agent where effects of differential ionization/detection are substantially reduced. From the abundances of large clusters, the dosages of the active ingredients in each of the tablets were determined to typically better than 20% accuracy even when the ionization/detection efficiency of the individual components differed by over 100×. Although this unorthodox method for quantitation is not as accurate as using conventional standar...
Sepehr Shakib - One of the best experts on this subject based on the ideXlab platform.
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A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza.
Clinical and experimental pharmacology & physiology, 2004Co-Authors: Jenny Latte, David Taverner, Peter Slobodian, Sepehr ShakibAbstract:1. The aim of the present study was to assess the efficacy of pseudoephedrine in coryza. 2. In a double-blind, randomized, placebo-controlled design, 48 adults with acute coryza received a single oral dose of 60 mg pseudoephedrine (Sudafed; Pfizer Consumer HealthCare Group, Caringbah, NSW, Australia) or matching placebo. Before and after dosing, nasal airway resistance (NAR), nasal volume, the minimum intranasal cross-sectional area (MCA) and the symptom of nasal congestion were measured. 3. Pseudoephedrine produced a significant decrease in NAR (P = 0.005; 95% confidence interval (CI) 0.073, 0.383). Nasal volume increased, but this did not reach significance (P = 0.07; 95% CI -0.842, 0.034). There was no change in MCA and symptoms. 4. In conclusion, pseudoephedrine has a moderate effect in decreasing objective measures of nasal congestion in coryza.
J. Faour - One of the best experts on this subject based on the ideXlab platform.
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Osmotic pseudoephedrine tablet: In vitro/in vivo correlation study
Clinical Pharmacology & Therapeutics, 2005Co-Authors: M. Befumo, E. C. Feleder, M. A. Coppari, M. A. Ricci, J. FaourAbstract:Background A preliminary linear IVIVC was suggested from a previous bioavailability study of Pseudoephedrine osmotic tablets. Our objective was to develop and validate a full IVIVC and build a PK model to predict the entire time-course of plasma concentrations, in order to support adjustments of the PSE release profile. Methods Dissolution was carried out on 12 units (USP app. II 37°C, water, 100 rpm). A single dose of 3 osmotic tablets (PSE 240mg) with different release profiles and Children's Sudafed® (20 ml, 60mg PSE, Warner-Lambert) as IR reference were administered to 8 healthy subjects using a randomized William's crossover design. PSE (0–72hr) was assayed in plasma by GC-MS. Pharmacokinetic and statistical calculations were carried out in WinNonlin Pro 4.0. Results Relative bioavailability was 100.0%, 92.4 % and 94.5% (fast, medium and slow release rate respectively). 90%CIs were within 80.00%-125.00%. A linear IVIVC was observed, with slopes (±95%CI limits) 1.0239±0.0438, 1.0467±0.0470 and 1.0303±0.0498. Model internal prediction errors for Cmax and AUC were under 10%. Conclusions A linear 1:1 IVIVC was demonstrated for osmotic PSE tablets, which presented similar bioavailability to the reference IR product. The resulting pk model is able to predict the in vivo impact of eventual formulation changes. Clinical Pharmacology & Therapeutics (2005) 77, P83–P83; doi: 10.1016/j.clpt.2004.12.210
Randy C. Hatton - One of the best experts on this subject based on the ideXlab platform.
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Over-the-Counter Oral Phenylephrine: A Placebo for Nasal Congestion
The journal of allergy and clinical immunology. In practice, 2015Co-Authors: Randy C. Hatton, Leslie HendelesAbstract:The category of over-the counter (OTC) [nonprescription] drugs was established in the United States in 1951 by the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act. The Kefauver-Harris Amendments to the Act required proof of efficacy for all drugs (prescription and nonprescription) approved after 1938. OTC drugs are marketed under regulations that established a monograph approval process, as well as the New Drug Application process. During the 1970s, the US Food and Drug Administration (FDA) convened panels of experts to review the efficacy and safety of OTC products on the market. The panel on Cough, Cold and Allergy Products determined that phenylephrine (PE) and pseudoephedrine were safe and effective for treating nasal congestion. A final OTC Nasal Decongestant Drugs Products monograph was published in 1994. Manufacturers can market the drugs listed in the monograph, alone or in combination, as long as the ingredients, dosage, and instructions for use list exactly what is required in the monograph. Even though phenylpropanolamine was effective, it was not included in the final monograph because of safety concerns about hemorrhagic strokes primarily when used as an OTC appetite suppressant. Because of the widespread use of pseudoephedrine to illegally make methamphetamine, Congress attached an amendment to the Patriot Act, the Combat Methamphetamine Epidemic Act, placing it “behind the counter” and requiring a photo identification and log of the transaction. This removed pseudoephedrine-containing products (Sudafed and others) from grocery and convenience stores, as well as from “in front of the counter” in pharmacies. The use of PE increased dramatically after 2004, presumably because it was the only “in front of the counter” OTC option. In 2005, we reviewed the existing evidence and questioned whether PE was effective at the FDA-approved dose of 10 mg. Subsequently, we undertook a meta-analysis
