Skoner D.P.,Allegheny General Hospital |
LaForce C.F.,North Carolina Clinical Research |
Nathan R.A.,and Research Center |
Urdaneta E.R.,McNeil Consumer Healthcare |
And 4 more authors.
Allergy and Asthma Proceedings | Year: 2014
The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that COPY particular condition. This study evaluated the effect of cetirizine on symptom severity and health-related QOL, using a disease-specific instrument, in adults with PAR. This randomized, double-blind, placebo-controlled study was conducted at 15 U.S. centers outside the pollen allergy season. After a 1-week placebo run-in period, qualified subjects aged 18-65 years with PAR were randomized to once-daily cetirizine 10 mg (n=158) or placebo (n=163) for 4 weeks. Change from baseline in total symptom severity complex (TSSC) and overall Rhinitis Quality of Life Questionnaire (RQLQ) scores were primary efficacy end points. Cetirizine produced significantly greater improvements in mean TSSC for each treatment week (p < 0.05) and for the entire 4-week treatment period (p=0.005) compared with placebo. After 4 weeks, cetirizine-treated subjects reported significantly greater overall improvement in RQLQ scores compared with placebo-treated subjects (p=0.004). After 1 week, cetirizine produced significant improvements in the nasal symptoms, practical problems, and activities RQLQ domain scores compared with placebo (p < 0.05). After 4 weeks, cetirizine-treated subjects reported significant reductions in these RQLQ domain scores and in emotion domain scores compared with placebo-treated subjects (p < 0.05). Cetirizine 10 mg daily produced significant improvements in symptom severity and allergic rhinitis-related QOL compared with placebo in adults with PAR. Copyright © 2014, OceanSide Publications, Inc.
News Article | December 6, 2016
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced the appointment of Dr. Joseph (Joe) Reo to the role of Director of Global Scientific Affairs. In his new post, Dr. Reo will be responsible for Catalent’s internal scientific affairs to evolve the company’s scientific offerings, including generation of scientific content, integration of scientific communications, managing industry, private and academic relationships, and serving as co-chair of the Catalent Applied Drug Delivery Institute. In addition, he will lead Catalent’s competitive technical intelligence function, its assessment of new growth opportunities, and will drive early-phase development of new technology platforms through collaboration with the Institute, Catalent’s internal scientific community and its scientific advisory boards. Dr. Reo brings to Catalent over 35 years of experience in the pharmaceutical industry, specializing in modified release technologies, polymer engineering and science, solids, liquids, semi-solids, nasal delivery, and the switch from prescription to over-the-counter medications. He joins Catalent from Bayer HealthCare, where he was Director, Rx-to-OTC Switch Science, and was responsible for leading the science disciplines and project team for the development of prescription to non-prescription classification change. Prior to this, Dr. Reo worked in Rx-to-OTC roles both at Bayer, and previously, with Merck Consumer Healthcare. Dr. Reo began his career as Principal Scientist with McNeil Consumer Healthcare, before going on to work in senior scientific positions with Pfizer and Schering-Plough Healthcare, where he specialized in formulation design and development. A graduate of Temple University in Philadelphia, he holds a doctorate in pharmaceutical sciences, and, for the past year, has chaired the Formulation Design & Development Section of the American Association of Pharmaceutical Scientists (AAPS). “We welcome Joe to Catalent in his new role, leading our scientific affairs team,” commented Julien Meissonnier, Vice President Science and Technology. “His proven expertise in drug delivery and experience in scientific partnerships will certainly be an asset to continue Catalent’s strategy of engaging with the external scientific community. Joe will play a key role in enhancing and evolving Catalent’s scientific offerings to deliver better outcomes to patients.” About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,500 people, including over 1,400 scientists, more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
Qi D.S.,McNeil Consumer Healthcare |
May L.G.,Consultant |
Zimmerman B.,Johnson and Johnson Consumer Products U.S. |
Peng P.,Johnson and Johnson Consumer Products U.S. |
And 3 more authors.
Clinical Therapeutics | Year: 2012
Background: Although acetaminophen is one of the oldest and most widely used of all analgesic drugs, the incremental benefit of the 1000-mg dose compared with the 650-mg dose has been questioned. Objective: The aim of this study was to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a 6-hour period in patients experiencing at least moderate postsurgical dental pain. Methods: This single-center, randomized, doubleblind, placebo-controlled, single-dose study enrolled patients aged 16 to 50 years who experienced at least moderate pain after surgical removal of impacted third molars. Each patient received either acetaminophen 1000 mg (n = 239), acetaminophen 650 mg (n = 241), or placebo (n = 60) when they had at least moderate pain and a score≤50 on the 100-mm Visual Analog Scale (VAS) postsurgically. Pain intensity and pain relief were measured over 6 hours (VAS 0-100 mm). Results: All 540 patients (52% female; age range, 16-30 years; 95% white) were included in the efficacy analysis. For the primary efficacy endpoint (weighted sum of the pain intensity difference from baseline [PID] and pain relief [PAR] scores over 6 hours [SPRID6]), acetaminophen 1000 mg demonstrated a 24% improvement compared with acetaminophen 650 mg (529.4 vs 427.3; P = 0.001). In addition, acetaminophen 650 mg was significantly superior compared with placebo (P < 0.001). The weighted sum of PID over 6 hours (SPID6), the weighted total pain relief over 6 hours (TOTPAR6), and the percentage of patients with >50% of the maximum possible TOTPAR6 score were significantly greater for patients treated with acetaminophen 1000 mg compared with those receiving acetaminophen 650 mg (P ≤ 0.006) or placebo (P <0.001) and for patients treated with acetaminophen 650 mg compared with placebo (P < 0.001). Time to rescue, rescue rates through 4 and 6 hours, and patient global assessment demonstrated similar findings. Patients treated with acetaminophen 1000 mg or 650 mg had a significantly different distribution in times to confirmed perceptible and meaningful pain relief compared with those receiving placebo (P < 0.001). Adverse events were reported by 18.5% of patients, with no clinically important difference between active treatment groups and placebo. Conclusions: Acetaminophen 1000 mg provided clinically meaningful and statistically significantly greater efficacy in treating postsurgical dental pain compared with acetaminophen 650 mg and placebo. The outcomes of this study are limited to the single-dose design of this study. © 2012 Elsevier HS Journals, Inc..
News Article | February 17, 2017
This report studies Consumer Healthcare in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with capacity, production, price, revenue and market share for each manufacturer, covering Johnson & Johnson Bayer Healthcare GlaxoSmithKline Sanofi Pfizer Boehringer Ingelheim Merck Mitsubishi Tanabe Pharma Nestle Novartis Danone Abbott Laboratories Amway Eisai Herbalife McNeil Consumer Healthcare The Himalaya Drug Procter & Gamble Sun Pharma Taisho Pharmaceuticals Takeda Pharmaceuticals Vida Laboratories Omega Pharma Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Consumer Healthcare in these regions, from 2011 to 2021 (forecast), like North America Europe China Japan Southeast Asia India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into OTC Pharmaceuticals Dietary Supplements Split by application, this report focuses on consumption, market share and growth rate of Consumer Healthcare in each application, can be divided into Hospital Drugstore At any Query @ https://www.wiseguyreports.com/enquiry/974944-global-consumer-healthcare-market-research-report-2017 Table of Contents Global Consumer Healthcare Market Research Report 2017 1 Consumer Healthcare Market Overview 1.1 Product Overview and Scope of Consumer Healthcare 1.2 Consumer Healthcare Segment by Type 1.2.1 Global Production Market Share of Consumer Healthcare by Type in 2015 1.2.2 OTC Pharmaceuticals 1.2.3 Dietary Supplements 1.3 Consumer Healthcare Segment by Application 1.3.1 Consumer Healthcare Consumption Market Share by Application in 2015 1.3.2 Hospital 1.3.3 Drugstore 1.4 Consumer Healthcare Market by Region 1.4.1 North America Status and Prospect (2012-2022) 1.4.2 Europe Status and Prospect (2012-2022) 1.4.3 China Status and Prospect (2012-2022) 1.4.4 Japan Status and Prospect (2012-2022) 1.4.5 Southeast Asia Status and Prospect (2012-2022) 1.4.6 India Status and Prospect (2012-2022) 1.5 Global Market Size (Value) of Consumer Healthcare (2012-2022) 7 Global Consumer Healthcare Manufacturers Profiles/Analysis 7.1 Johnson & Johnson 7.1.1 Company Basic Information, Manufacturing Base and Its Competitors 7.1.2 Consumer Healthcare Product Type, Application and Specification 220.127.116.11 Product A 18.104.22.168 Product B 7.1.3 Johnson & Johnson Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.1.4 Main Business/Business Overview 7.2 Bayer Healthcare 7.2.1 Company Basic Information, Manufacturing Base and Its Competitors 7.2.2 Consumer Healthcare Product Type, Application and Specification 22.214.171.124 Product A 126.96.36.199 Product B 7.2.3 Bayer Healthcare Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.2.4 Main Business/Business Overview 7.3 GlaxoSmithKline 7.3.1 Company Basic Information, Manufacturing Base and Its Competitors 7.3.2 Consumer Healthcare Product Type, Application and Specification 188.8.131.52 Product A 184.108.40.206 Product B 7.3.3 GlaxoSmithKline Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.3.4 Main Business/Business Overview 7.4 Sanofi 7.4.1 Company Basic Information, Manufacturing Base and Its Competitors 7.4.2 Consumer Healthcare Product Type, Application and Specification 220.127.116.11 Product A 18.104.22.168 Product B 7.4.3 Sanofi Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.4.4 Main Business/Business Overview 7.5 Pfizer 7.5.1 Company Basic Information, Manufacturing Base and Its Competitors 7.5.2 Consumer Healthcare Product Type, Application and Specification 22.214.171.124 Product A 126.96.36.199 Product B 7.5.3 Pfizer Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.5.4 Main Business/Business Overview 7.6 Boehringer Ingelheim 7.6.1 Company Basic Information, Manufacturing Base and Its Competitors 7.6.2 Consumer Healthcare Product Type, Application and Specification 188.8.131.52 Product A 184.108.40.206 Product B 7.6.3 Boehringer Ingelheim Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.6.4 Main Business/Business Overview 7.7 Merck 7.7.1 Company Basic Information, Manufacturing Base and Its Competitors 7.7.2 Consumer Healthcare Product Type, Application and Specification 220.127.116.11 Product A 18.104.22.168 Product B 7.7.3 Merck Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.7.4 Main Business/Business Overview 7.8 Mitsubishi Tanabe Pharma 7.8.1 Company Basic Information, Manufacturing Base and Its Competitors 7.8.2 Consumer Healthcare Product Type, Application and Specification 22.214.171.124 Product A 126.96.36.199 Product B 7.8.3 Mitsubishi Tanabe Pharma Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.8.4 Main Business/Business Overview 7.9 Nestle 7.9.1 Company Basic Information, Manufacturing Base and Its Competitors 7.9.2 Consumer Healthcare Product Type, Application and Specification 188.8.131.52 Product A 184.108.40.206 Product B 7.9.3 Nestle Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.9.4 Main Business/Business Overview 7.10 Novartis 7.10.1 Company Basic Information, Manufacturing Base and Its Competitors 7.10.2 Consumer Healthcare Product Type, Application and Specification 220.127.116.11 Product A 18.104.22.168 Product B 7.10.3 Novartis Consumer Healthcare Production, Revenue, Price and Gross Margin (2015 and 2016) 7.10.4 Main Business/Business Overview 7.11 Danone 7.12 Abbott Laboratories 7.13 Amway 7.14 Eisai 7.15 Herbalife 7.16 McNeil Consumer Healthcare 7.17 The Himalaya Drug 7.18 Procter & Gamble 7.19 Sun Pharma 7.20 Taisho Pharmaceuticals 7.21 Takeda Pharmaceuticals 7.22 Vida Laboratories 7.23 Omega Pharma For more information, please visit https://www.wiseguyreports.com/sample-request/974944-global-consumer-healthcare-market-research-report-2017
Huang J.-T.,Cordis Analytical R and D |
Li H.-Q.,Cordis Analytical R and D |
Szyszka R.,Drexel University |
Veselov V.,Cordis Analytical R and D |
And 5 more authors.
Journal of Mass Spectrometry | Year: 2012
A molecular imaging application was developed to characterize the drug distribution on CYPHER ® and NEVO ™ Drug-eluting Stents using MALDI Qq-ToF analytical methodology. The coating matrix, laser energy, laser frequency, spatial resolution (related to rastering speed) and mass spectrometer parameters were optimized to analyze drug distribution in both durable and biodegradable polymer matrices. The developed method was extended to generate data from stents explanted from porcine coronary arteries. Due to the method's intrinsic specificity, it offers a significant advantage over other techniques in that it allows low-level detection of the target molecule without biological interferences from the blood or tissue. The method is also capable of detecting drug-related degradation products both from the finished stent product and from explanted stents. © 2012 John Wiley & Sons, Ltd.
Prior M.J.,McNeil Consumer Healthcare |
Harrison D.D.,Janssen Research and Development LLC |
Frustaci M.E.,Janssen Research and Development LLC
Current Medical Research and Opinion | Year: 2014
Objective: Determine efficacy and safety of acetaminophen extended release (ER) 1300mg given three times daily compared to placebo for relieving signs and symptoms of hip or knee osteoarthritis. Research design and methods: Sixty investigators at 58 private, ambulatory, primary care sites in the US enrolled 542 outpatient adults ≥40 years old with moderate to severe idiopathic osteoarthritis pain into a randomized, placebo-controlled, double-blind 12 week clinical trial. Patients were randomly assigned to treatment given three times daily of acetaminophen 1300mg (n=267) or placebo (n=275). Results: The three primary endpoints measured through week 12 favored acetaminophen ER as follows: least squares (LS) mean change from baseline for WOMAC physical function subscale score was significantly greater for acetaminophen ER than for placebo (P=0.011); LS mean patient's global assessment of response to therapy was significantly greater for acetaminophen ER than for placebo (P=0.010); and LS mean change from baseline for WOMAC pain subscale score was marginally greater for acetaminophen ER than for placebo (P=0.054). LS mean change from baseline for secondary endpoints through week 12 also favored acetaminophen ER compared with placebo: significantly for WOMAC stiffness subscale score (P=0.004), significantly for WOMAC total index score (P=0.013), and marginally for Nottingham Health Profile energy subscale score (P=0.057). The percentage of patients with any adverse event was similar for both treatment groups. Hepatic transaminases exceeded 3×ULN in seven acetaminophen ER patients and one placebo patient. Elevations were attributed to health conditions in three of seven acetaminophen ER patients; elevations in the remaining four patients returned to or toward normal. Conclusions: Acetaminophen ER 1300mg, a nonprescription drug, given three times daily, can provide effective relief of signs and symptoms of osteoarthritis of the hip or knee and was well tolerated. ClinicalTrials.gov registration number: NCT00240799. © 2014 Informa UK Ltd.
Temple A.R.,McNeil Consumer Healthcare |
Temple A.R.,University of Utah |
Temple B.R.,University of Chicago |
Kuffner E.K.,Healthcare Global
Clinical Therapeutics | Year: 2013
Background: A standardized approach to dosing acetaminophen in pediatric populations was published in 1983. That review proposed specific weight-related dosing for infants and children weighing 6 through 95 lb and an age-based schedule for children aged <4 months through 11 years. Subsequent clinical studies evaluating these and alternative doses of acetaminophen supported the recommended 10-15-mg/kg dose. Objective: This article reviewed published and unpublished pediatric antipyretic data to provide a critical assessment of the 10-15-mg/kg oral dose and the current pediatric oral dosing schedules for acetaminophen. Methods: Published literature and unpublished clinical trials that evaluated the antipyretic efficacy of acetaminophen in children were reviewed. The PubMed database was searched using the term acetaminophen or paracetamol, with study criteria limited to randomized, controlled trials; oral dosing; patient age <12 years; and publication between 1982 and August 2012. All of the sponsor's unpublished antipyretic clinical studies completed between 1980 and August 2012 and involving at least 1 oral-formulation acetaminophen-only treatment arm were identified. Data from published literature containing sufficient detail to verify doses; dosing frequency; and, when necessary, estimates from figures, and from acetaminophen arms of the unpublished studies were analyzed. Results: Thirteen unpublished trials enrolled 705 children to receive an oral dose of 10-15 mg/kg of acetaminophen. This dose resulted in a rapid onset of temperature reduction, with a maximum temperature decrement of ~3 hours following administration. Results from 40 published clinical trials in which 2332 children received oral acetaminophen for fever support these findings. The most common adverse events reported in any of the reported studies were gastrointestinal in nature and generally mild in intensity. Conclusions: Data support the recommended 10-15-mg/kg oral dose and demonstrate that the age and weight schedules for over-the-counter acetaminophen proposed in 1983 remain appropriate. © 2013.
Shah R.,University of the Sciences in Philadelphia |
Shah R.,McNeil Consumer Healthcare |
Blustein L.,University of the Sciences in Philadelphia |
Blustein L.,McNeil Consumer Healthcare |
And 2 more authors.
Journal of Pediatrics | Year: 2014
Objective To identify and compare volumetric measures used by healthcare providers in communicating dosing instructions for pediatric liquid prescriptions to parents/caregivers. Study design Dosing instructions were retrospectively reviewed for the 10 most frequently prescribed liquid medications dispensed from 4 community pharmacies for patients aged ≤12 years during a 3-month period. Volumetric measures on original prescriptions (ie, milliliters, teaspoons) were compared with those utilized by the pharmacist on the pharmacy label dispensed to the parent/caregiver. Results Of 649 prescriptions and corresponding pharmacy labels evaluated, 68% of prescriptions and 62% of pharmacy labels communicated dosing in milliliters, 24% of prescriptions and 29% of pharmacy labels communicated dosing in teaspoonfuls, 7% of prescriptions and 0% of pharmacy labels communicated dosing in other measures (ie, milligrams, cubic centimeters, "dose"), and 25% of dispensed pharmacy labels did not reflect units as written in the prescription. Conclusion Volumetric measures utilized by healthcare professionals in dosing instructions for prescription pediatric oral liquid medications are not consistent. Healthcare professionals and parents/caregivers should be educated on safe dosing practices for liquid pediatric medications. Generalizability to the larger pediatric population may vary depending on pharmacy chain, location, and medications evaluated. © 2014 Mosby Inc.
Prior M.J.,McNeil Consumer Healthcare |
Lavins B.J.,McNeil Consumer Healthcare |
Lavins B.J.,Ironwood Pharmaceuticals |
Cooper K.,McNeil Consumer Healthcare
Clinical Journal of Pain | Year: 2012
Objective: To compare the efficacy of acetaminophen extended release (ER) caplets to placebo in treating muscle soreness after a marathon. Methods: This was a randomized, double-blind, placebo-controlled study of participants ≥18 years old, who completed a marathon and experienced muscle soreness rated at least 4 on a 0-to-10 numerical rating scale. The intent-to-treat efficacy analysis included 610 participants. Participants were screened for eligibility before the marathon, and reported to the study tent after the marathon. On confirming eligibility, participants were randomly assigned to 4 days of 3-times-daily treatment of either acetaminophen ER 1300 mg (n=307) or placebo (n=303). Results: Participants treated with acetaminophen ER reported a significantly (P<0.0001) greater decrease in the primary endpoint of average change from baseline in muscle soreness on the day of the marathon (day 1) (-0.79) than did placebo (-0.36). In addition, the adjusted mean average interference with sleep was significantly lower for acetaminophen ER (2.14) than for placebo (2.52, P=0.0046). The adjusted mean overall satisfaction with treatment was significantly higher for acetaminophen ER (5.38) than for placebo (4.64, P=0.0060). Adverse events were reported by 3.7% of participants, with no clinically important difference between treatment groups. No serious adverse events were reported. Conclusions: Acetaminophen ER 1300 mg, a nonprescription drug, was an effective treatment for post-race muscle soreness on the day of the marathon. In addition, acetaminophen ER provided benefit for interference with sleep and overall satisfaction with treatment, and was generally well tolerated. Copyright © 2012 by Lippincott Williams & Wilkins.
Method development and validation for the determination of 2,4,6-tribromoanisole, 2,4,6-tribromophenol, 2,4,6-trichloroanisole, and 2,4,6-trichlorophenol in various drug products using stir bar sorptive extraction and gas chromatography-tandem mass spectrometry detection
Huang J.-T.,Analytical Research and Development |
Alquier L.,Analytical Research and Development |
Kaisa J.P.,Analytical Research and Development |
Reed G.,McNeil Consumer Healthcare |
And 2 more authors.
Journal of Chromatography A | Year: 2012
Recently, haloanisoles and halophenols are associated with multiple product recall situations in the pharmaceutical industry. The majority of the recalls are associated with consumer complaints due to the presence of 2,4,6-tribromoanisole, as extremely low levels of this component can be easily detected by the human nose. As part of the root cause analysis to address the cause of the consumer complaints, a GC-MS/MS based analytical method combined with stir bar sorptive extraction (SBSE) sample preparation was developed for determination of halophenols and haloanisoles from various drug product formulations. The method also applies to the analysis of 2,4,6-tribromoanisole analysis in various packaging materials. The optimized MS/MS method is based on component-specific MRM transitions. The detection limit is component dependent and in the range of 1-100. pg/tablet for solid dosage formulations and 0.04-4. ng/L for water based solutions. Deuterated tribromoanisole was used as internal standard for quantitation. The paper also may provide guidance for performing trace level method validation in the regulated Pharmaceutical Industry. © 2012 Elsevier B.V.