Product description

NanoStat™ is Medlab's patented NanoCelle® delivery platform (buccal spray) for the treatment of elevated cholesterol. Atorvastatin (as calcium) belongs to the class of medicines known as “statins”, more specifically called HMG-CoA reductase inhibitors. HMG-CoA reductase is an enzyme involved in regulating cholesterol levels in your body. Statins are used along with changes to exercise and diet to help control the amount of cholesterol produced by the body. 
CLINICAL TRIAL: 
single dose, blinded, balanced, randomised, two-treatment, two period, two sequence, two-way crossover pilot study comparing the pharmacokinetics of 1 x 8 mg atorvastatin oral spray (Medlab Clinical, Australia) with 1 x 20 mg Lipitor® capsule (Pfizer, Australia) in healthy subjects under fasting conditions.  
FORMULATION: 
NanoStat™ is an investigative new sub-micron spray delivering 8 mg Atorvastatin in four actuations of the pump applied to the oro-buccal membrane.
DATE of HREC approval: 4 July 2017
HREC: Southern Health and Disability Ethics Committees, Wellington 6011 NZ
HREC Approval ID: 17/STH/106
CTN: CT-2015-CTN–0180-0-v1
ANZCTR: ACTRN12618000208202
STUDY SITE: Zenith Technology Corp. Ltd - 156 Frederick Street, PO Box 1777, Dunedin, NZ
STATUS: Completed

IP RIGHTSPatent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: AustraliaApplication number: 2016226280Filing Date: 2nd March 16 Status: Accepted

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: CanadaApplication number: 2978179Filing Date: 2nd March 16 Status: Filed

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: EuropeApplication number: 16759418.3Filing Date: 2nd March 16 Status: Under examination

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: New ZealandApplication number: 735138Filing Date:  2nd March 2016 Status: Examination Requested

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: SingaporeApplication number: 11201707068XFiling Date: 2nd March 2016 Status: Under examination

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: United StatesApplication number: 15/555038 Filing Date: 2nd March 2016Status: Under examination

Patent Title: Transmucosal and transdermal delivery systems// NanoCelleJurisdiction: Hong KongApplication number: 18103321.4Filing Date: 2nd March 2016Status: Filed
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Specifications

Categories Pharmaceutical Machinery & TechnologyBioavailability enhancement; Pharmaceutical PackagingDrug Delivery Systems; Finished Dosage Forms
Sales markets Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia)
Supplied from Australia

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