Delving into the Latest Updates on Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Cipro XR, Ciprofloxacin, Ciprofloxacin ER

Target

Bacterial DNA gyrase x Topoisomerase IV

Action

inhibitors, modulators

Mechanism

Bacterial DNA gyrase inhibitors(Bacterial DNA gyrase inhibitors), Bacterial top IV modulators(Bacterial topoisomerase IV modulators)

Therapeutic Areas

Infectious DiseasesUrogenital Diseases

Active Indication

Complicated urinary tract infectionUrinary Tract Infections

Inactive Indication

Staphylococcal Infections

Originator Organization

Bayer AG

Active Organization

Bayer Pharma AG

Inactive Organization

Bayer HealthCare Pharmaceuticals, Inc.

Bayer AG

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (13 Dec 2002),

Infectious DiseasesStaphylococcal InfectionsUrinary Tract Infections

RegulationOrphan Drug (European Union)

Login to view timeline

Structure/Sequence

Molecular FormulaC22H29FN4O5

InChIKeyFQIZHAJJHVXXBP-UHFFFAOYSA-N

CAS Registry229976-67-4

View All Structures (2)

The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

Start Date01 Jul 2010

Sponsor / Collaborator

Bayer AG

NCT00961038

/ CompletedPhase 1

Randomized, Single-Blinded, Placebo-Controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLD II - III), Following Inhalation of Ciprofloxacin PulmoSphere® Inhalation Powder

Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with moderate to severe COPD (stage II-III according to GOLD Criteria)

Start Date01 Aug 2009

Sponsor / Collaborator

Bayer AG

[+1]

NCT01670435

/ CompletedNot Applicable

Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

Start Date01 May 2007

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride

Login to view more data

100 Translational Medicine associated with Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride

Login to view more data

100 Patents (Medical) associated with Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride

Login to view more data

7

Literatures (Medical) associated with Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride

01 Nov 2020·European Journal of Pharmaceutics and BiopharmaceuticsQ2 · MEDICINE

Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV

Q2 · MEDICINE

Article

Author: Rosenblatt, Karin ; Etherson, Kelly ; Hanley, Sarah ; Winge, Fredrik ; Williams, James ; Brown, Jonathan ; Smith, Kieran Lewis ; Miyaji, Yoshihiro ; Karkossa, Frank ; Schäfer, Kerstin Julia ; Klein, Sandra ; Reppas, Christos ; Dressman, Jennifer ; Andreas, Cord J ; Karlsson, Eva ; Tomaszewska, Irena ; Maier, Gerd-Michael ; Mistry, Nena ; Vertzoni, Maria ; Vrettos, Napoleon-Nikolaos ; McAllister, Mark

During the OrBiTo project, our knowledge on the gastrointestinal environment has improved substantially and biorelevant media composition have been refined. The aim of this study was to propose optimized biorelevant testing conditions for modified release products, to evaluate the reproducibility of the optimized compendial apparatus III (USP apparatus III) and compendial apparatus IV (USP apparatus IV, open-loop mode) dissolution methods and to evaluate the usefulness of these methods to forecast the direction of food effects, if any, based on the results of two «ring» studies and by using two model modified release (MR) products, Ciproxin / Cipro XR and COREG CR. Six OrBiTo partners participated in each of the ring studies. All laboratories were provided with standard protocols, pure drug substance, and dose units. For the USP apparatus III, the dissolution methods applied to Ciproxin / Cipro XR, a monolithic MR product of an active pharmaceutical ingredient (API) with moderate aqueous solubility, were robust with low intra- and inter-laboratory data variability. Data from all partners were in line on a qualitative basis with food effect data in humans. For the USP apparatus IV, the dissolution methods applied to COREG CR, a multiparticulate, pH dependent, MR product of an API with low and pH dependent solubility led to high intra- and inter- laboratory data variability. Data from all partners were in line, on a qualitative basis, with the previously observed food effects in humans.

01 Feb 2018·Drug Delivery and Translational ResearchQ3 · MEDICINE

Urinary excretion of ciprofloxacin after administration of extended release tablets in healthy volunteers. Swellable drug-polyelectrolyte matrix versus bilayer tablets

Q3 · MEDICINE

Article

Author: Luciani Giacobbe, L C ; Olivera, María Eugenia ; Battistini, F D ; Jimenez-Kairuz, A F ; Alovero, F L ; Sanchez, M F ; Romañuk, C B ; Guzmán, M L ; Alarcón-Ramirez, L P ; Manzo, R H

This paper builds on a previous paper in which new ciprofloxacin extended-release tablets were developed based on a ciprofloxacin-based swellable drug polyelectrolyte matrix (SDPM-CIP). The matrix contains a molecular dispersion of ciprofloxacin ionically bonded to the acidic groups of carbomer, forming the polyelectrolyte-drug complex CB-CIP. This formulation showed that the release profile of the ciprofloxacin bilayer tablets currently commercialised can be achieved with a simpler strategy. Thus, since ciprofloxacin urine concentrations are associated with the clinical cure of urinary tract infections, the goal of this work was to compare the urinary excretion of SDPM-CIP tablets with those of the CIPRO XR® bilayer tablets. A batch of SDPM-CIP tablets was manufactured by the wet granulation method and the CB-CIP ionic complex was obtained in situ. Fasted healthy volunteers received a single oral dose of 500 mg ciprofloxacin of either formulation in a randomised crossover study. Urinary concentrations were assessed by HPLC at intervals up to 36 h. Pharmacokinetic parameters (rate of urinary excretion, maximum urine excretion rate, t_max, area under the curve, amount and percentage of the ciprofloxacin dose excreted in urine) showed no statistical differences between both formulations at any of the time intervals of collection. The processing conditions to obtain SDPM-CIP tablets are easy to scale up since they involve technology currently employed in the pharmaceutical industry and the process is less challenging to implement. In addition, SDPM-CIP tablets met pharmacopoeial quality specifications.

01 Dec 2009·Journal of ChemotherapyQ4 · MEDICINE

Efficacy and Safety of Ciprofloxacin XR 1000 mg Once Daily Versus Ciprofloxacin 500 mg Twice Daily in the Treatment of Complicated Urinary Tract infections

Q4 · MEDICINE

Article

Author: Mirone, V. ; Verze, P. ; Di Vito, C. ; Lotti, T. ; Imbimbo, C. ; Fusco, F. ; Tagliatatela, D.

The aim of this trial was to compare the efficacy and safety of extended-release ciprofloxacin (CIPRO XR) versus the immediate-release formulation (CIPRO IR) in the treatment of complicated urinary tract infections (UTIs). 212 patients were randomized to CIPRO XR 1,000 mg tablet once daily or CIPROXIN IR 500 mg tablet twice daily. Treatment efficacy was evaluated by bacteriological outcome. Safety was measured by recording adverse events. The rate of bacteriological eradication was 83% in the CIPRO XR group and 75% in the CIPRO IR. the overall incidence of adverse events reported was higher in the CIPRO IR group. The authors conclude that CIPRO XR is a safe and effective treatment for complicated UTIs. Although the limited data available do not consent to support a statistically superior efficacy or safety compared to CIPRO IR, a trend in favor of CIPRO XR is clearly evident in all efficacy and safety variables. CIPRO XR is associated with reduced frequencies of drug-related adverse events compared to CIPRO IR.

100 Deals associated with Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01MA02	DB00537

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Complicated urinary tract infection	United States	Bayer Pharma AG	28 Aug 2003
Urinary Tract Infections	United States	Bayer Pharma AG	28 Aug 2003

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infectious Diseases	Phase 1	United States	Bayer HealthCare Pharmaceuticals, Inc.	13 Dec 2002

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2007	Not Applicable	-	46	Topical Ciprofloxacin 0.3%	(ewxzvswxbm) = The bacteria most commonly isolated was coagulase negative Staphylococcus (66.7%) tluxerszhn (udowsmlcnb )	-	01 May 2007
				Topical Ciprofloxacin 0.3% (Control (No Antibiotics))