First in man bioavailability and tolerability studies of a silica-lipid hybrid (Lipoceramic) formulation: a Phase I study with ibuprofen

Drug Delivery and Translational Research
Angel TanClive A Prestidge

Abstract

Clinical trials addressing the viability of lipid and nanoparticle-based solid dosage forms for the oral delivery of poorly water-soluble drugs are limited to date. This Phase I study aimed to assess the comparative tolerability and oral pharmacokinetics of a novel silica nanoparticle-lipid hybrid formulation encapsulating ibuprofen (i.e., Lipoceramic-IBU) with reference to a commercial tablet (i.e., Nurofen®). The test (Lipoceramic-IBU) and reference (Nurofen®) ibuprofen formulations were characterised for physicochemical properties and in vitro solubilisation performance prior to the clinical study. A randomised, double-blinded, one-period single oral dose (20 mg ibuprofen) study was performed in 16 healthy male subjects under fasting conditions. Encapsulation of ibuprofen in a molecularly dispersed form in the Lipoceramic nanostructured silica-lipid matrices was shown to produce superior drug solubilisation in comparison to Nurofen® and the pure drug during a two-step dissolution (or solubilisation) study in aqueous buffers of pH 1.2 followed by pH 6.5. Pharmacokinetic profiles revealed an approximately 1.95-fold increased bioavailability (p=0.02) and a 1.5-fold higher maximum plasma concentration (p=0.14) for Lipoceramic-IB...Continue Reading

References

Jun 16, 2004·International Journal of Pharmaceutics·Alf LamprechtJean-Pierre Benoit
Sep 2, 2005·Journal of Pharmaceutical Sciences·H PotthastD M Barends
Sep 7, 2005·Journal of Pharmaceutical and Biomedical Analysis·Romána ZelkóKároly Süvegh
Jun 17, 2006·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Dong-Jin JangChong-Kook Kim
Mar 3, 2007·Nature Reviews. Drug Discovery·Christopher J H PorterWilliam N Charman
Jul 10, 2007·Advanced Drug Delivery Reviews·David J Hauss
Nov 30, 2007·Advanced Drug Delivery Reviews·V JanninD Marchaud
Jun 14, 2008·International Journal of Pharmaceutics·Ganesh P Sanganwar, Ram B Gupta
Jul 8, 2008·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Tao YiXiangliang Yang
Nov 18, 2008·Journal of Controlled Release : Official Journal of the Controlled Release Society·Angel TanClive A Prestidge
Aug 25, 2009·International Journal of Pharmaceutics·Zhiyuan WangZhonggui He
Jan 19, 2010·Journal of Controlled Release : Official Journal of the Controlled Release Society·Spomenka SimovicClive A Prestidge
Jan 8, 2011·Expert Opinion on Drug Delivery·Dali ShuklaBrahmeshwar Mishra
Jan 13, 2011·Expert Opinion on Drug Delivery·Ali NokhodchiClaudia S Leopold
Apr 1, 2011·Drug Development and Industrial Pharmacy·Christina M HentzschelClaudia S Leopold
Apr 12, 2011·Drug Development and Industrial Pharmacy·Myung Joo KangSang-Cheol Chi
Oct 27, 2011·International Journal of Pharmaceutics·Laurent PergePhilippe Legrand
May 29, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·M C HamoudiA Bochot
Aug 17, 2012·Journal of Microencapsulation·Karthik Y JangaPrabhakar Reddy Veerareddy
Jan 29, 2013·Journal of Controlled Release : Official Journal of the Controlled Release Society·Tri-Hung NguyenBen J Boyd

❮ Previous
Next ❯

Citations

May 24, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Shasha RaoClive A Prestidge
Jan 27, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Tahnee J DeningClive A Prestidge
Mar 10, 2016·Colloids and Surfaces. B, Biointerfaces·Paul JoyceClive A Prestidge
Apr 20, 2016·Advanced Drug Delivery Reviews·Orlagh M FeeneyChristopher J H Porter
May 11, 2016·Expert Review of Vaccines·Gabriela Navarro-TovarSergio Rosales-Mendoza
Aug 15, 2014·ACS Applied Materials & Interfaces·Angel TanClive A Prestidge
Oct 13, 2017·Drug Development and Industrial Pharmacy·Jake IrvineNazrul Islam
Dec 8, 2017·Expert Opinion on Pharmacotherapy·Kevin H ManiarC Thomas Vangsness
Apr 3, 2020·Pharmaceutical Research·Hayley B SchultzClive A Prestidge
Dec 16, 2018·The Journal of Pharmacology and Experimental Therapeutics·Hayley B SchultzClive A Prestidge
Jan 25, 2021·Advanced Drug Delivery Reviews·Taskeen Iqbal JanjuaAmirali Popat
Jul 2, 2019·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Maja PreskarMirjana Gašperlin
Dec 10, 2016·ACS Applied Materials & Interfaces·Tahnee J DeningClive A Prestidge
Sep 18, 2021·International Journal of Pharmaceutics·Tahlia R MeolaClive A Prestidge

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.