Evaluation of Bioequivalence Between the New Procaterol Hydrochloride Hydrate Dry Powder

903 views 5 replies
Reply to Topic
freemexy

Age: 2023
Total Posts: 0
Points: 10

Location:
,
Procaterol hydrochloride hydrate (procaterol) is a ß2-adrenergic receptor agonist that induces a strong bronchodilatory effect. The
procaterol dry powder inhaler (DPI) has been frequently used in patients
with bronchial asthma or chronic obstructive pulmonary disease. We
evaluated the bioequivalence and safety between the new procaterol DPI
(new DPI) and the approved procaterol DPI (approved DPI). This study was
a randomized, double-blind, double-dummy, crossover comparison to
evaluate the pharmacodynamic equivalence of the new DPI and the approved
DPI in patients with bronchial asthma. Primary efficacy variables were
area under the concentration-time curve (AUC) forced expiratory volume
in the first second (FEV1)/h and maximum FEV1 during the 480-minute
measurement period. Patients were divided into 2 groups, New-DPI-First
(n = 8) and Approved-DPI-First (n = 8), according to the investigational
medical product that was administered first. Patients inhaled 20 µg of
procaterol in each period. FEV1 was measured by a spirometer at predose
and at 15, 30, 60, 90, 120, 180, 240, 360, and 480 minutes after each
investigational medical product administration. Equivalence was
evaluated by confirming that the 2-sided 90%CIs for the difference
between the new and the approved DPI in means of AUC (FEV1)/h and
maximum FEV1 were within the acceptance criteria of –0.15 to 0.15 L. The
difference in means of AUC (FEV1)/h and maximum FEV1 was 0.041 L and
0.033 L, respectively, and the 90%CI was 0.004 to 0.078 L and –0.008 to
0.074 L, respectively. These CIs were both within the acceptance
criteria. The new DPI was assessed as being bioequivalent to the
approved DPI.Procaterol HCl powder
Inhaled drugs are the most common and effective therapy in the management of bronchial asthma or chronic obstructive pulmonary disease
(COPD). Short-acting ß2-agonists are known as rescue or relief
medications for asthma or COPD symptoms. Procaterol hydrochloride
hydrate
(8-hydroxy-5-{(1RS,2SR)-1-hydroxy-2-[(1-methylethyl)amino]butyl}quinolin-2(1H)-one
monohydrochloride hemihydrate) is a ß2-adrenergic receptor agonist
synthesized by Otsuka Pharmaceutical Co, Ltd, in 1973. It binds highly
selectively to ß2-adrenergic receptors in bronchial smooth muscle cells,
and a small dose of this drug induces a strong bronchodilatory
effect.1, 2 A variety of formulations have been developed for this drug
since the first launch of its tablet formulation in 1980. Currently
marketed formulations including dry powder inhaler (DPI) and pressurized
metered dose inhaler (pMDI) have been clinically useful, mainly in
Asia. The effects of these inhalants are immediate, providing a good
adaptation for sudden or new symptoms of asthma or COPD.
DPIs are easier to use than pMDIs because there is no need to coordinate actuation and inhalation. In addition, because DPIs do not
contain environmentally unfriendly propellants,3 it is thought that DPIs
are adaptive to future global environmental regulations. However, DPIs
are available in many different designs, and DPIs that require many
operational steps may mislead patients to inadequate inhalation of the
drug. It is obvious that incorrect usage of inhaler devices has a
considerable influence on the clinical effectiveness of the delivered
drug.3 Clickhaler® (an approved DPI device) has hallmarked the effective
uniformity and consistency of the delivered dose and fine particle
fraction over a range of inspiratory flow rates4; however, patients are
required to perform several steps to inhale the drug. To improve this, a
new DPI, Swinghaler® (a new DPI device) was designed that requires no
shaking to dispense the correct volume of powder into the measuring cups
prior to inhalation, thus reducing the operational steps, and is easier
to use.5, 6 In addition, the powder inhaler and storage container of
the new DPI device are integrated, making it a smaller device, which
greatly improves the portability of the drug. These features are
considered to be beneficial to patients, and Meptin®Swinghaler® (new
DPI) is expected to ease patients’ treatment. The new DPI was granted
approval in 2014 in Japan and is currently the only DPI of short-acting
ß2-agonists launched in Japan.6
The bioequivalence between the new DPI and the approved DPI in patients was unknown. Although there are no standardized methods to
demonstrate in vivo bioequivalence of inhaled bronchodilators, the most
practical method of showing therapeutic equivalence in vivo is by
estimating their relative potencies in clinical efficacy studies using
adequate methodology of comparing their bronchodilator actions.7 Hence,
this study was conducted to evaluate the bioequivalence and safety
between the new DPI (Otsuka Pharmaceutical Co, Ltd, Tokushima, Japan)
and the approved DPI (Otsuka Pharmaceutical Co, Ltd, Tokushima, Japan)
in patients with bronchial asthma.
Posted 24 Oct 2019

Gurgaon escorts is another up and coming satellite town, close New Delhi, framing the National Capital Region of India, alongside Delhi and Ghaziabad. The National Capital Territory of Delhi is likewise called the National Capital Region and alludes to New Delhi, Delhi Cantonment and Delhi rustic region, alongside 59 enumeration towns and 165 towns. Gurgaon actually implies the town of the Guru or the instructor. Concurring folklore expresses that the town was called Gurgaon escorts as the residents made exceptionally pleasant jaggery, from sugarcane. Escorts in Gurgaon has had a land blast and has seen marvel land cost increment. This was generally a farming area region providing sustenance corps and vegetable to the Delhi populace. 
Call girls in gurgaon
Call girls gurgaon
gurgaon Call girls
Escorts in Gurgaon
Call girls in Gurgaon
Call girls gurgaon
gurgaon Call girls
Escorts in Gurgaon
Call girls in Haridwar
Call girls in Dehradun
Call girls in Gurgaon
Call girls Gurgaon
Call girls in gurgaon
Escorts in Gurgaon
Call girls in jaipur
models girls in dehradun
Call girls in Noida
Call girls in Inudaipur
Call girl in Mumbai
CP ESCORTS SERVICE
Call Girls in CP
Free ads Posting
Free Business Listing
Free local business listing 
Free listing
Call girls in mumbai
Call girls in gurgaon
Call girls in indirapuram
Lawyer in Noida
Best Lawyer in Noida
Advocate Noida
Best Advocate Noida
Advocate in India
Best Advocate in India
Best Lawyer In India
Lawyer In India
Call girls in gurgaon
Call Girls in Agra
Call Girls in pune
Call Girls in noida
Call Girls in mumbai
Call Girls in jaipur
Call Girls in haridwar
Call Girls in delhi
Call Girls in dehradun
Call Girls in bengaluru
Posted 18 Mar 2020

Posted 30 Apr 2020

vraiel says
audiobookkeeper.rucottagenet.rueyesvision.rueyesvisions.comfactoringfee.rufilmzones.rugadwall.rugaffertape.rugageboard.rugagrule.rugallduct.rugalvanometric.rugangforeman.rugangwayplatform.ru
garbagechute.rugardeningleave.rugascautery.rugashbucket.rugasreturn.rugatedsweep.rugaugemodel.rugaussianfilter.rugearpitchdiameter.rugeartreating.rugeneralizedanalysis.rugeneralprovisions.rugeophysicalprobe.rugeriatricnurse.ru
getintoaflap.rugetthebounce.ruhabeascorpus.ruhabituate.ruhackedbolt.ruhackworker.ruhadronicannihilation.ruhaemagglutinin.ruhailsquall.ruhairysphere.ruhalforderfringe.ruhalfsiblings.ruhallofresidence.ruhaltstate.ru
handcoding.ruhandportedhead.ruhandradar.ruhandsfreetelephone.ruhangonpart.ruhaphazardwinding.ruhardalloyteeth.ruhardasiron.ruhardenedconcrete.ruharmonicinteraction.ruhartlaubgoose.ruhatchholddown.ruhaveafinetime.ruhazardousatmosphere.ru
headregulator.ruheartofgold.ruheatageingresistance.ruheatinggas.ruheavydutymetalcutting.rujacketedwall.rujapanesecedar.rujibtypecrane.rujobabandonment.rujobstress.rujogformation.rujointcapsule.rujointsealingmaterial.rujournallubricator.ru
juicecatcher.rujunctionofchannels.rujusticiablehomicide.rujuxtapositiontwin.rukaposidisease.rukeepagoodoffing.rukeepsmthinhand.rukentishglory.rukerbweight.rukerrrotation.rukeymanassurance.rukeyserum.rukickplate.rukillthefattedcalf.ru
kilowattsecond.rukingweakfish.rukinozones.rukleinbottle.rukneejoint.ruknifesethouse.ruknockonatom.ruknowledgestate.rukondoferromagnet.rulabeledgraph.rulaborracket.rulabourearnings.rulabourleasing.rulaburnumtree.ru
lacingcourse.rulacrimalpoint.rulactogenicfactor.rulacunarycoefficient.ruladletreatediron.rulaggingload.rulaissezaller.rulambdatransition.rulaminatedmaterial.rulammasshoot.rulamphouse.rulancecorporal.rulancingdie.rulandingdoor.ru
landmarksensor.rulandreform.rulanduseratio.rulanguagelaboratory.rulargeheart.rulasercalibration.rulaserlens.rulaserpulse.rulaterevent.rulatrinesergeant.rulayabout.ruleadcoating.ruleadingfirm.rulearningcurve.ru
leaveword.rumachinesensible.rumagneticequator.rumagnetotelluricfield.rumailinghouse.rumajorconcern.rumammasdarling.rumanagerialstaff.rumanipulatinghand.rumanualchoke.rumedinfobooks.rump3lists.runameresolution.runaphtheneseries.ru
narrowmouthed.runationalcensus.runaturalfunctor.runavelseed.runeatplaster.runecroticcaries.runegativefibration.runeighbouringrights.ruobjectmodule.ruobservationballoon.ruobstructivepatent.ruoceanmining.ruoctupolephonon.ruofflinesystem.ru
offsetholder.ruolibanumresinoid.ruonesticket.rupackedspheres.rupagingterminal.rupalatinebones.rupalmberry.rupapercoating.ruparaconvexgroup.ruparasolmonoplane.ruparkingbrake.rupartfamily.rupartialmajorant.ruquadrupleworm.ru
qualitybooster.ruquasimoney.ruquenchedspark.ruquodrecuperet.rurabbetledge.ruradialchaser.ruradiationestimator.rurailwaybridge.rurandomcoloration.rurapidgrowth.rurattlesnakemaster.rureachthroughregion.rureadingmagnifier.rurearchain.ru
recessioncone.rurecordedassignment.rurectifiersubstation.ruredemptionvalue.rureducingflange.rureferenceantigen.ruregeneratedprotein.rureinvestmentplan.rusafedrilling.rusagprofile.rusalestypelease.rusamplinginterval.rusatellitehydrology.ruscarcecommodity.ru
scrapermat.ruscrewingunit.ruseawaterpump.rusecondaryblock.rusecularclergy.ruseismicefficiency.ruselectivediffuser.rusemiasphalticflux.rusemifinishmachining.ruspicetrade.ruspysale.rustungun.rutacticaldiameter.rutailstockcenter.ru
tamecurve.rutapecorrection.rutappingchuck.rutaskreasoning.rutechnicalgrade.rutelangiectaticlipoma.rutelescopicdamper.rutemperateclimate.rutemperedmeasure.rutenementbuilding.ruultramaficrock.ruultraviolettesting.ru
Posted 17 May 2020

Posted 01 Jul 2020

Posted 01 Aug 2020

Reply to Topic