The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.

Start Date01 Aug 2008

Sponsor / Collaborator

Associacao Beneficente Siria

[+1]

100 Clinical Results associated with Medley Pharmaceuticals Ltd.

0 Patents (Medical) associated with Medley Pharmaceuticals Ltd.

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12 Nov 2022·Research Journal of Pharmaceutical Dosage Forms and Technology

Formulation Optimization and Evaluation of Taste Masked Oro-dispersible Tablet of Levocetrizine Dihydrochloride by Ion Exchange Resin

Author: Ashwini V, Pati ; Nasir, Mohd. ; Swati P, Patil ; S. D., Barhate ; M. M., Bari

The aim of this study was to prepare ODT of taste masked levocetrizine dihydrochloride by using ion exchange resin. Levocetrizine Dihydrochloride is bitter in taste, Kyron T-134 a weak cationic exchange resin was used to mask the bitter taste of the drug. The ODTs were prepared by using drug-resin (DRC) complex using batch process. Compression of ODTs was done by using direct compression method with the technique of addition of superdisintegrants. Central composite design (CCD) was applied as an optimization technique. FTIR and DSC studies indicated drug and excipients were compatible with each other. The prepared orodispersible tablet blend and tablets were evaluated for various pre-compression and post-compression parameters. The Batch LH3 was given as optimized batch by central composite design. This optimized batch LH3 was passed all the pre-compression and post- compression parameters. The prepared ODTS showed successfully rapid onset of action with decrease in disintegration time 26 sec and %drug released was found to be 98.26%. It was concluded that levocetrizine dihydrochloride ODTs were prepared successfully by taste masking method using Kyron T-134 ion exchange resin and croscarmellose sodium as Superdisintegrant using CCD. AS per CDER guidelines, it shows DT within 5-30 sec.

10 Aug 2022·Asian Journal of Pharmacy and Technology

Formulation Optimization and Evaluation of Push Pull Osmotic Pump Tablet of Vildagliptin

Author: Nasir, Mohd. ; M. M., Bari ; R. J., Ubhale ; S. D., Barhate ; V. Patil, Ashwini

Purpose- The present study was to develop an oral push-pull osmotic pump tablet of vildagliptin, DPP-IV inhibitor drug; which is BCS class I drug. Method- The tablets were prepared by the wet granulation method using polyox and osmotic agent NaCl. The granules were compressed into bilayered tablet by conventional compression machine. The bilayered core osmotic tablets were coated with cellulose acetate in a conventional pan coating. In-vitro dissolution was evaluated using USP dissolution apparatus II in 0.1 N HCl pH 1.2 buffers for 2 hrs and phosphate buffer pH 7.5 for 22 hrs respectively. The formulated optimized batch VP1 were kept to stability studies for 3 months. Result- The formulated optimized batch VP1 of PPOP tablet shows 2hrs lag time with zero order release kinetic. In –vitro drug release was obtained 91.45 % up to 22hrs respectively. Polyox in push-pull layer along with osmotic agent and cellulose acetate controlled the drug release pattern from formulated PPOP tablet. No significant changes were observed upto the period of 3 months of storage during stability study. Conclusion- The PPOP tablet of vildagliptin was able to deliver the drug in controlled pattern over a long period of time by the process of osmosis. Conventional compression and pan coating method can be used to prepare PPOP tablet successfully.

01 Mar 2012·Journal of the Indian Medical Association

Evaluation of efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery.

Article

Author: Joshi, Chandrakant ; Faruqui, Arif A

Acute diarrhoea in adults is one of the most commonly encountered medical emergency in general practice and is responsible for considerable morbidity around the world. To evaluate the efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery, a study was carried out among 290 patients, age group from 18 to 65 years suffering from diarrhoea, dysentery, gastro-enteritis. Study drug infusion O2, (Medley Pharmaceutical, Mumbai) containing ofloxacin 200 mg + ornidazole 500 mg was administrated twice daily for a duration of 5 days. Number of soft or watery stool, body temperature, nausea, abdominal pain, gas and flatulence were recorded at baseline and at the end of the study. Tolerability and efficacy was evaluated based on the global assessment by the investigator based on a 3-point scale marked as excellent/good/poor. Two hundred and fifty-six-patients (160 male and 96 female) were included for final analysis, 34 patients lost to follow-up. Mean number of watery stool per day was reduced from 9.273 +/- 0.4537 to 1.375 +/- 0.07001 (p < 0.0001) by infusion O2. Body temperature was significantly reduced from 38.055 +/- 0.045 degrees C to 36.778 +/- 0.016 degrees C (p < 0.0001) at the end of the study. Pretreatment symptom nausea was significantly reduced in 90.34% of patients. Improvement in vomiting symptoms was reported in 72.35% of patients after administration of anti-emetic drug; 96.84% and 77.25% of patients reported improvement in abdominal pain and gas/flatulence respectively at the end of the trial by infusion O2. As per investigators' assessment about efficacy of trial drug, 98.43% of patients reported good to excellent and 1.56% reported poor efficacy. As per investigators' assessment about tolerability 98.43% of patients reported good to excellent and 1.17% reported poor tolerability. Minor incidences of nausea, gastritis, metallic taste were reported in 7.42%, 7.14%, and 5.85% of patients respectively. No serious adverse events were reported which led to withdrawal of patient from the study. Result of this study shows that, combination of ofloxacin with ornidazole infusion (infusion O2) significantly reduces number of watery stool and associated symptoms like nausea, abdominal pain, flatulence/gas with excellent tolerability.

News (Medical) associated with Medley Pharmaceuticals Ltd.

31 Jan 2023

·www.prnewswire.com

Europe Small Molecule Contract Development and Manufacturing Organization (CDMO) Markets 2022-2031: Increasing Demand for Small Molecule Medicines and Therapies & Rising Demand for Cost Control

DUBLIN, Jan. 31, 2023 /PRNewswire/ -- The "Europe Small Molecule Contract Development and Manufacturing Organization Market 2021-2031 by Product Type, Service Type, Customer Type, Therapeutic Area, and Country: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering. Europe small molecule contract development and manufacturing organization (CDMO) market was valued at $ 17,340.6 million in 2021 and will grow by 6.2% annually over 2021-2031. The market is driven by the increasing demand for small molecule medicines and therapies, a rising demand for cost control in drug development, the increasing incidence of disease, and rising healthcare expenditures. Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2019-2021 and provides forecast from 2022 till 2031 with 2021 as the base year. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.) The trend and outlook of Europe market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19 and Russia-Ukraine conflict. The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players. Selected Key Players: Boehringer Ingelheim Cambrex Corporation Catalent Cipla Covance Inc. Lonza Group Ltd. Medley Pharmaceuticals NatcoPharma Patheon (Thermo Fisher Scientific, Inc.) Piramal Pharma Solutions RedHillBiopharma Siegfried Holding AG STA Pharmaceutical Sun Pharmaceutical Teva In-depth qualitative analyses include identification and investigation of the following aspects: Market Structure Growth Drivers Restraints and Challenges Emerging Product Trends & Market Opportunities Porter's Fiver Forces Scope of the Report Active Pharmaceutical Ingredients (API) Branded Drugs Generic Drugs Finished Dosage Formulations (FDF) Oral Solid Drugs Injectable Drugs Semi-solid or Liquid Drugs Other FDFs Based on Service Type Preclinical Use Clinical Use Phase I Phase II Phase III Phase IV Commercial Use By Customer Type Pharmaceutical Firms Biotechnology Firms By Therapeutic Area Infectious Diseases Oncology Ophthalmology Cardiovascular Disorders Central Nervous System Respiratory Disorders Metabolic Diseases Other Therapeutic Areas Geographically, the following national/local markets are fully investigated: Germany UK France Spain Italy Netherlands Rest of Europe (further segmented into Russia, Switzerland, Poland, Sweden, Belgium, Austria, Ireland, Norway, Denmark, and Finland) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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