Forskning ved Københavns Universitet - Københavns Universitet

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Anette Müllertz

Anette Müllertz

Professor

  • Pharmaceutical Design and Drug Delivery

    13, Bygning: 13-3-305

    2100 København Ø

    Telefon: +45 35 33 64 40Mobil: +45 20 62 01 54

Area of Research

 Oral delivery of small molecules. Innovative pharmaceutical formulations, including lipid drug delivery systems. Impact of excipients. Dissolution and solubilization mechanisms for poorly soluble drug compounds. Development of media, simulating the gastro intestinal (GI) fluids. Development of digestion models and elucidating the mechanisms of solubilization and generated colloid phases in the GI tract. Absorption mechanisms for poorly soluble drugs in simulated GI fluids, using cell cultures and excised tissue. Bioavailability studies in humans and animals in order to develop predicative in vitro models.

Teaching and Supervision:

Teaching / supervising / assessing experiences

Lecturer at several Undergraduate and PhD courses, 1998 – present. Responsible for:  Advanced Drug Delivery (7.5 ECTS), Elective course. Responsible since 2004.  PhD course: Human Digestion and Absorption: Understanding oral Drug Absorption. Master students: Supervisor for a total of 40+ master thesis during employment at SUND and FARMA, and 9 during employment at Novo Nordisk A/S. In the last case these were both from FARMA and DTU.

Assessment experience: Assessor at the Nutrition course at DTU / The Royal Veterinary and Agricultural University of Denmark (KVL) (2002-present) Assessor for approx. 30 Bachelor and Master thesis at The Technical University of Denmark; LIFE, KU, and Århus University. (2001-present) In the assessment committee for 7 PhD students at (former)FARMA, DTU, LIFE, Uppsala University, Sweden, Goethe University, Germany, University of Marseilles, France and University of Otago, New Zealand.

PhD students, Supervisor (Total of 23; 9 ongoing):

  • Zangenberg, NH, 1996-2000; Solubilization of poorly soluble drug during in vitro Lipolysis. Funded by the Royal Danish School of Pharmacy. Presently: Takeda / Nycomed A/S, DK
  • Bondeskov Nielsen, P, 1997- 2000; Vitamin E as a vehicle for poorly soluble drugs. Co-funded by AlPharma A/S. Presently: Research scientist, Nycomed A/S, DK
  • De Ilardia-Arana, D, 1997- 2003; Biorelevant characterization of poorly soluble drugs. Selffunded Presently: Business developer, Pamplona University, Spain.
  • Holm, R. 1998 – 2001; Lymphatic transport of poorly soluble drugs Presently: Divisional director at H. Lundbeck A/S, DK
  • Hovgaard Sunesen, V, 1999 – 2003; Biorelevant dissolution media to simulate in vivo dissolution of poorly soluble drugs. Funded by the Danish University of Pharmaceutical Sciences, DK Presently: Research Scientist, Leo Pharma, DK.
  • Christensen, JØ, 1999-2004; Use of the Dynamic Lipolysis Model as a predictive tool for drug absorption. Co-funded by H. Lundbeck A/S Presently: Regulatory affairs, H. Lundbeck A/S, DK.
  • Karpf, DM, 2001 – 2005; Lymphatic transport of poorly soluble drugs Funded by Danish University of Pharmaceutical Sciences, DK Presently: Research Scientist, Novo Nordisk A/S, DK.
  • Grove, M, 2001-2006; Delivery of poorly soluble drugs Funded by Leo PHARMA Presently: Research Scientist, Novo Nordisk A/S, DK.
  • Nielsen, FS, 2001 – 2009; Lipid and Surfactant Based Formulations: Design, Characterization and In Vitro – In Vivo Relations for SEDDS Funded by The Øresund Contract Presently: Research Scientist, Novo Nordisk A/S, DK.
  • Ladegaard Lind, M, 2004 – 2009; Mechanisms for Oral Absorption of Poorly Water-soluble Compounds. Funded by Danish University of Pharmaceutical Sciences, DK Presently: Research Scientist, Leo Pharma, DK.
  • Larsen, A, 2007- 2013; Lipid based drug delivery systems; characterization and elucidation of mechanisms Co-funded by AstraZeneca, Se. Presently: Team Leader, Novo Nordisk A/S, DK
  • Tønsberg, H, 2007-2011; Effect of bile on the oral absorption of poorly water-soluble drugs in rats Co-funded by H. Lundbeck A/S. Presently: Pharmacovigilance, Coloplast A/S, DK.
  • Hagner Nielsen, L, 2009-2013; Micro-containers for delivery of poorly soluble drugs Funded by Namec (A Villum Kann Rasmussen Center of Excellence) . Presently: post doc, Namec consortium, Dept. Pharmacy, UCPH and Nanotech, DTU.
  • Lau Christiansen, M, 2010- ?; Predictive digestion methods for lipid based drug delivery systems. Funded by the Innovation Consortium Predicting Drug Absorption (PDA).
  • Madelung, P, 2010 - ?; Understanding the mechanisms behind surfactants induced bioavailability increase. Co-funded by Nycomed PHARMA.
  • Bertelsen, R, 2010 - ?; Predictive dissolution methods for oral solid dosage forms Funded by PDA. (Maternity leave in 2011)
  • Pedersen, PB, 2010-2013. Direct Visualization and Characterization of Oral Drug Delivery systems in the Fasted Human Stomach. Funded by PDA. Presently: Clinical Trials, Novo Nordisk A/S
  • Li, P, 2010-2014; Micro-containers for delivery of peptides and proteins. Funded by Namec.
  • Grøn Jensen, L, 2011-?; Gastric precipitation of poorly soluble drugs. Co-funded by AstraZeneca.
  • Sassene, PJ, 2013-? Predictive in vitro lipolysis models. Funded by the EU IMI Consortium Oral Biopharmaceutics Tools (OrBiTo).
  • Michaelsen, MH, 2013-?; Absorption Mechanism for Poorly soluble Drugs, dosed in Lipid-based Drug Delivery Systems Funded by the collaboration with University of British Columbia.
  • Madsen, C, 2013-?; Miniaturized methods for API Characterization. Funded by IMI OrBiTo.
  • Vieira da Silva Siqueira, SD, 2014-?; Nanoemulsion formulations for improved oral delivery of amphotericin B Funded by CAPES, Brazil.

 

Co-supervisor, PhD students (total of 7 (1 ongoing))
Hedeman, H, 1993-1996 Pedersen, BL, 1995-2000 Zimmerman, A, 2004–2008 Koradia, V, 2007-2011 Thomas, N 2009-2012 Bøtker, JP, 2010-2013 Jensen, KT, 2012-?

Post docs, supervisor:
Fatouros, D, 2004-06; Ren, S; 2008-11; Gordon, SC, 2010-2012; Jain, D, 2010-11. Thomas, N, 2012-2013.

Management, Funding and Administration:

Management experience Head of Center, Bioneer:FARMA – Danish Drug Development Center, based at Dept. of Pharmacy, University of Copenhagen, 2007-present. Group Leader for the Research Group for Rational Oral Drug Delivery (The RODD group), Dept. of Pharmacy, University of Copenhagen, 2002-present. Project coordinator at Novo Nordisk (1994-1998)

Grant Applications (2013): SFR: Human Upper Gastro Intestinal Simulations (HUGITS). Main applicant: AMu. Co.applicant: A/Prof Dennis S Nielsen, Food Science, SCIENCE. Status: Rejected in Phase 2.

NIH application, sponsored by FDA: Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide. Main applicant: AMU. Co-applicant: Prof. James Polli, Uni Mayland, US. Status: Pending.

Grundforsknings fonden: Intelligent oral Drug delivery Using Nano and microfabricated containers. Main applicant: Prof. Anja Boisen, DTU. Co-applicant: AMu. Status: Pending.

SIMCYP Grant and Partnership Scheme 2013: PBPK modelling of lipid based drug delivery systems, including lymphatic transport.  Main applicant: AMu. Status: Rejected.

Ormstrup Foundation: PhD stipend application: Elucidating Mechanisms of Drug Absorption in the Human Gastro-intestinal Tract: Effects of Mucoadhesion, Solubilization, Supersaturation and Precipitation. Main applicant: AMU. Co-applicant: Prof. Peter Villman, University Hospital, Herlev. Status: Rejected.

Phospholipid Research Center, Heidelberg: Elucidating the use of lyso-phospholipids in oral self-nanoemulsifying drug delivery systems. Main applicant: AMu. Status: Granted €75.000.

Swedish Research Council: LEVELS – an in vitro drug screening platform. Main applicant: Maria Tenje, Uni Lund, Se. Co-applicant: AMu. Status: Pending.

Finnish Research Council: Label-free coherent Raman imaging of intestinal drug absorption. Main Applicant: A/prof Clare Strachan, Uni Helsinki. Co-applicant: Amu. Status: Granted €148.000 in December 2013.

Center/Consortia involvements:

IMI EU consortium: Biopharmaceutical Tools for Oral Drug Delivery (OrBiTo) (10 big Pharma companies, 10 European universities and 2 SMEs. €10.6 mio, 2012-2017; €0.75 mio at UCPH

Villum Kann Rasmussen Centre of Excellence “NanoMechanical Sensors” (Namec) in collaboration with DTU Nanotech. 28 mio DKK, 2009-14; 6 mio DKK at UCPH.

Lipid Formulation Classification System Consortium (LFCS) (funded by Capsugel, Merck Serono, Gattefossé, Sanofi, BMS, Roche, Nicox, Actelion) collaboration with Monash University, Aus. €300.000 in 2010-2013; €140.000 at UCPH.

Food & Drug Administration (FDA), USA: Predictive In Vitro Methods, 2009-2011. $250.000 at UCPH.

Innovation Consortium: Predicting Drug Absorption (PDA). (Fertin, AstraZeneca, Lundbeck, Veloxis (LifeCyclePharma)). 2008-2012; 16.8 mio DKK at UCPH.

The Danish Medical Research Council: Mechanisms of solubilization and absorption of poorly water soluble drug compounds in the gastro-intestinal tract; impact of lipid based pharmaceutical formulations. (Granted 1.260.000DKK in November 2006).

The Danish Medical Research Council. Application: Development and characterization of lipid-based drug formulations for lipophilic drugs. Main Applicant: Prof. Jan Skov Pedersen, Århus Universitet. 271-05-0236 (Granted 1.260.000DKK over 3 years in December 2005).

The Danish Health Research Council: Lipid based formulations of poorly soluble drugs: Development and Characterization of formulations with a high and reproducible bioavailability. 22-04-0287. (Granted 720.000DKK over 2 years in December 2004).

Center contract: Methods for efficient development of drug candidates in small and medium-sized companies – exemplified by development of chalcones to anti-malariadrugs (Malaria Project) (2001-2006) (involved from 2003).

Øresund Contract (Swedish Vinnova and the Danish Research Council): Innovative drug formulations (2001-2004).

Center for Drug Design and Transport (1998-2001).

Private Funding (2003 to present, only grants > 100.000DKK): Carlsberg foundation: 200.000DKK, 2005 Augustinus Foundation: 200.000DKK, 2005 Hørslev Foundation: 206.700DKK, 2005 Frode Nygaards and wife’s foundation: 100.000DKK, 2004 Leo Pharma Reseach Foundation: 100.000DKK, 2003

Company collaborations (2004-2007 (start of Bioneer:FARMA)): Ferring A/S, (DK): Biopharmaceutical characterization of poorly soluble compounds (2007-2008). Actavis A/S (Icel): Examine and Evaluate cyclosporine formulations (2006-2008). Novo Nordisk A/S (DK): Biorelevant dissolution and IVIVC (2004-2007). Action Pharma (DK): Preformulation of 3 novel drug compounds. Derivatives of ME-10 393 (3 month 2006-2007). Novozymes A/S (DK): Absorption of proteolysed feed protein (6 months, 2006-2007). Gattefossé (Fr): In vitro lipolysis of macrogol glyceride surfactants and its impact on the solubility of a BCS class II drug (12 month; 2005-2006). Action Pharma (DK): Preformulation of a novel drug compound (4 months; 2005).

Prizes: 2005 American Association of Pharmaceutical Scientist’s Lipid-Based Drug Delivery Award 2009 FARMA prize for raising most funding

Miscellaneous (Internally at FARMA, KU, DK. From 2012: SUND, KU, DK) • Member of the Extended Group Leader Committee (2012-present) • Member of the Research committee (2006-2007 and 2009-2011) • Member of the Group leader Group 2006-2012 • Member of the Fusion Group at the Department of Pharmaceutics & Analytical Chemistry, 2006. Facilitating the fusion of two departments (Pharmaceutics and Analytical Chemistry) • Member of the Research Council, The Department of Pharmaceutics & Analytical Chemistry (2006-present) • Member of the Local collaboration council (LSU) at the Department of Pharmaceutics & Analytical Chemistry, DFU (2005-2007). • Member of the Research Council, the Department of Pharmaceutics (2002-2005) • Safety representative, the Department of Pharmaceutics (2002-2004)

Miscellaneous (Externally): • Chairman for the QbD and Product Performance in AAPS (2010-2013) http://www.aaps.org/inside/focus_groups/QBDPP/index.asp • Chairman for the Lipid Based Drug Delivery Focus Group (LBDD FG) in The American Association for Pharmaceutical Scientists (AAPS) (2010-2012) http://www.aapspharmaceutica.com/inside/focus_groups/Lipid/index.asp • Vice-chair for the QbD and Product Performance in AAPS (2010-2013) • Chair-elect for the LBDDS FG (2008-2010). • Participation and poster presentation (2-5 posters/year) at the Annual Meeting of the AAPS (1999-present) • Participation and presentations at the Annual Meeting of the Controlled Release Society (CRS) (2003, 2005, 2009, 2010, 2011, 2012, 2013 (2-3 poster presentations pr time and oral presentation in 2005 and 2013) • Organizer and participant in the European Drug Absorption Network (EDAN) annual meeting (2003- present) • Participating in the EDAN Public-Private Partnership to characterize Caco-2 cells with regards to transporters in 5 companies and 5 Universities in Europe. • Member of the Phospholipid Network, Medicon Valley 2003-2010 www.foodpluspharma.org • Participation and poster presentation in numerous European Drug Delivery conferences, organized by EUFEPS, APV or APGI (1998-present).

Reviewer: • European Journal of Pharmaceutical Science • Pharmaceutical Research • Journal of Pharmaceutical Sciences • Molecular Pharmaceutics • Journal of Nutrition • International Journal of Pharmaceutics • Journal of Controlled Release

Editorial Advisory Board: • Journal of Pharmaceutical Sciences (2004-present). • Journal of Drug Delivery • Therapeutic Delivery

Organization and Presentations at Meetings:

Organizing of Symposia/Workshops: • Symposium: Translational Pharmaceutics: Connecting Preclinical and Clinical Enabled Formulations. AAPS Annual Meeting, San Antonio, USA, November 2013. • 2-day Workshop: Developing a Biopharmaceutic Risk Assessment Roadmap. Prior to the AAPS Annual Meeting, San Antonio, USA, November 2013. • CRS Educational Workshop: Oral Delivery of Bioactives using Lipid-based Drug Delivery Systems, Honolulu, USA, July 2013. • The AAPS Workshop: Lipid-based Delivery for Improving Drug Absorption – Mechanistic Understanding and Practical Approaches. Baltimore, USA, April 2012. • Symposium: Supersaturable dosage forms. AAPS Annual meeting, Washington, USA, October 2011. • 2-day symposium: Application of Quality-by-Design for Development of Pediatric Dosage Forms and Formulations. CRS Annual Meeting, Washington, USA, August 2011. • Seminar: Optimising API Synthesis and Formulation Development, Marcus Evans seminar, Frankfurt, DE, May 2011.  • AAPS Oral Delivery Strategies Workshop, Baltimore, USA; April 2011. • CRS Product Development Forum on Poorly Soluble Drugs, Miami, USA, January 2011. • Hot Topic Discussion: Translational Biopharmaceutics: Facilitating Drug Development from the Lab to Patient. AAPS Annual Meeting, New Orleans, 2010. • Educational workshop: In vivo dissolution - is it a reality? Can it be correlated to in vitro or in silico dissolution? CRS Annual Meeting, Copenhagen, July 2009 • AAPS Workshop on Lipid-based Drug Delivery systems, Baltimore, USA, March 2009. • Sunrise session: Understanding Solubilization and Absorption of Poorly Soluble Drugs. AAPS Annual Meeting, San Antonio, November 2006.

Invited lectures (Conferences & Meetings; 2004-present):

  • Simulating In Vivo Dissolution – and Dosage Form Behavior - by use of the Dynamic Gastric Model (DGM). AAPS annual meeting, San Antonio, USA, November 2013.
  • In Vitro Gastric and Intestinal Lipolysis Models to assess Lipid-based Drug Delivery Systems. AAPS annual meeting, San Antonio, USA, November 2013.
  • Lipid-based Drug Delivery – Increasing Bioavailability via Supersaturation Principles. AAPS annual meeting, San Antonio, USA, November 2013.
  • In Vitro Gastric and Intestinal Lipolysis Models to assess Lipid-based Drug Delivery Systems. Lorentz Workshop on Biophysics, Biochemistry and Physiology of Fat Digestion, Leiden, NL, September 2013.
  • Tuning of SNEDDS: Focus on drug load and in vitro digestion. CRS Educational Workshop, Honolulu, US, July 2013. 
  • Quality by Design (QbD): Systematic Development of Pharmaceutical Products. Case: SNEDDS. CRS Annual Meeting, Honolulu, US, July 2013.
  • Academic Aspects on Drug Dissolution. 5th World Conference in Drug Absorption Transport and Delivery, Uppsala, Sweden, June 2013.
  • Towards More Realistic Models Studying Fate of Lipids in the Gastro-Intestinal Tract. Annual Meeting of the Pharmaceutical Solid State Research Cluster, Lille, Fr, June, 2013
  • New Perspectives on Lipid and Surfactant based DDS for Oral Delivery of Poorly Soluble Drugs. The 6th International Symposium on Solid Oral Dosage Forms, Malmø, April 2013.
  • Solubilisation of Poorly Soluble Compounds – by use of Lipid-based Drug Delivery Systems. Successful Early Stage Development of Pharmaceuticals. APV Meeting, Frankfurt am Main, De, March 2013.
  • Increasing Oral Bioavailability by Self Nano-Emulsifying Drug Delivery Systems - effect of Drug Load – from unsaturated to supersaturated, Drug Delivery Australia 2012, Melbourne, Australia, November, 2012.
  • Solid state characterization in lipid dosage forms. Globalization of Pharmaceutics Education Network (GPEN) 9th Biennial Meeting, Melbourne, Australia, November 28-December 1, 2012.
  • Lipid-based Drug Delivery Systems – as a means to increase exposure of poorly soluble drugs. Pharmaceutical Solid State Research Cluster (PSSRC), Lisbon, August 2012.
  • Supersaturating Drug Delivery Systems for Poorly Water Soluble Drugs. Advanced Solid State Analysis (ASSA) International Conference, Barcelona, June, 2012.
  • Emerging Technologies for the Development of Lipid-based Drug Delivery System. Drug Delivery Seminar, FARMA, Copenhagen, June 2012.
  • Predictive In Vitro Models to Assess Performance of Lipid-based Drug Delivery Systems. AAPS Lipid workshop, Baltimore, April 2012.
  • Lipid formulations for poorly water soluble drugs. 8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Istanbul, Turkey, March 2012.
  • In-vitro methods to predict the in vivo performance of enabling formulations. Capsugel Seminar: De-risking Drug Development from Candidate Selection though to Clinical PoC. Medicon Valley Alliance, Copenhagen, February 2012
  • Lipid based drug delivery systems - as facilitator of GI supersaturation and amorphous precipitation. AAPS annual meeting, Washington, October 2011.
  • Improving Solubility, 5th PSSRC Symposium, Helsinki, September 2011.
  • Integrating lessons from nature and food into dosage form design and technology - Learning from food absorption. PharmSciFair, Prague, June 2011.
  • In Vitro Tools for Predicting Solubilization and Absorption of Poorly Soluble Drugs, CRS Product Development Forum, Miami, January 2011.
  • Translational Biopharmaceutics: Facilitating Drug Development from the Lab to Patients. Hot Topic at the AAPS AM, New Orleans, USA, November 2010.
  • Precipitation of poorly soluble drugs from self-emulsifying drug delivery systems during in vitro lipolysis. 2nd Conference Innovation in Drug Delivery APGI, Aix-en-Provence, France, October 2010.
  • Strategic development of lipid based drug delivery systems. Meeting Poorly soluble Drugs organized by the Swedish Medical Academy, Stockholm, Se, September 2010.
  • Oral Lipid Based Formulations - Design, Development & Characterization. TNO Symposium, Zeist, NL, June 2010
  • Oral Lipid Based Formulations, - Design, Development & Characterization. RP Scherer symposium, Frankfurt, De, June 2010.
  • Dissolution and predictive in vitro release testing – past, present & future. Yearly Meeting of the Pharmaceutical Analysis Science Group, Milton Keynes, UK, May 2010.
  • Characterization of SMEDDS by In Vitro lipolysis and XRPD. 7th European Drug Absorption Network Meeting, Leuven, Be, March 2010.
  • Characterization of SMEDDS containing cinnarizine - by In Vitro lipolysis and XRPD. APV World Pharmaceutical Conference, Malta, March 2010.
  • Characterization of Lipid Assemblies - and Development of Lipolysis Models. Workshop on Lipid based Drug Delivery Systems, Baltimore, USA, March 2009.
  • Rational development of Oral Nano-sized Self-Emulsifying Drug Delivery Systems. APV meeting on Poorly soluble Drugs, Basel, Ch, November 2008.
  • Rational development of Oral Nano-sized Self-Emulsifying Drug Delivery Systems. NanoMedicines, Patras, Gr, September 2008.
  • Lipid digestion. APS Biopharmaceutics & Drug Delivery 2007, the Academy of Pharmaceutical Sciences of Great Britain, London, UK, December 2007.
  • Characterization of prototype self-nanoemulsifying formulations of lipophilic compounds – and their digestion. Danish Colloid Sciences Symposium, Århus, DK, August, 2007.
  • Physiologic considerations in dissolution development. BE, BCS and beyond. American Association of Pharmaceutical Science Workshop, Bethesda, MD, USA, May 2007.
  • The use of biorelevant in vitro methods to predict bioavailability of poorly soluble drug compounds. American Association of Pharmaceutical Scientists, San Antonio, Tx, USA, November 2006.
  • Visualization of the digestion of self-nano-emulsifying drug delivery systems in fed/asted state by Cryo-TEM. American Association of Pharmaceutical Scientists, San Antonio, Tx, USA, November 2006.
  • Relating dissolution in biorelevant media with bioavailability for a poorly soluble compound. Danish Technical Chemistry Meeting II, The Technical University of Denmark, Lyngby, Denmark, June 2006.
  • Development of in vitro Methods for the Evaluation of Formulation Performance. Academie des Alpilles, Gattefossé, Frankrig, June 2005.
  • Solubilization of poorly soluble drugs in biorelevant media: Impact of bile salt and lipolysis products. Controlled Release Society Congress 2005, Miami, USA, July 2005.
  • Solubility studies of poorly soluble drugs: Effect of bile salts & lipolysis products. 3rd European Drug absorption Network meeting, Leuven, Belgium, March 2005.
  • Predicative in vitro models for poorly soluble drugs in lipid based formulations - problems and possibilities. Drug delivery – new routes to innovative formulations, ELF symposium, Malmö, Sweden, November 2004.
  • Achieving IVIVC: Choosing Biorelevant Media and Simulating Food. Dissolution testing, Bioequivalence and Bioavailability Studies Conference, Bruxelles, Belgium, November 2004.
  • ”Dissolution methods” for lipid based formulations. 2nd European Drug Absorption Network meeting, Leuven, Belgium, March 2004.
  • Biorelevant dissolution and solubilisation methods for poorly soluble drugs and lipid-based formulations of these. Dissolution, Bioequivalence and Bioavailability Conference, Philadelphia, USA, January 2004.

 

Invited lectures (Academia & Industry; 2004-present):

  • Solubilisation of Poorly Soluble Compounds – by use of Lipid-based Drug Delivery Systems Merck Millipore & Merck Serono, Darmstadt, De, March 2013.
  • In-vitro methods to predict the in vivo performance of enabling formulations. Webinar. Catalent, June 2012
  • Gastric in vitro models – and characterization of drug precipitation during in vitro digestion. AstraZeneca, Mölndal SE, September 2011.
  • Drug Delivery. PhD course, In vivo PhD school. LIFE, Frederiksberg, DK, June 2011, 2012.
  • Emerging In Vitro Models to Predict the Performance of Oral Lipid-based Systems. Leo Pharma, May 2011.
  • Development and Characterization of Self Micro-Emulsifying Drug Delivery Systems (SMEDDS) for oral delivery of poorly soluble drugs. University of Uppsala, Uppsala, October, 2010.
  • Developing biorelevant in vitro methods to predict absorption of poorly soluble drugs. FDA, Rockville, USA, November 2008.
  • Rational development of Oral Nano-sized Self-Emulsifying Drug Delivery Systems. University of Kentucky, USA, November 2008.
  • Rational development of Oral Lipid-Based Drug Delivery Systems, Astra-Zeneca, Macclesfield, UK, August 2008.
  • Use of Physiologically Relevant In Vitro Methods to Predict the Solubilization and Absorption of Poorly Soluble Drug Compounds. FDA, Rockville, USA, November 2007.
  • Lymphatic Transport of Poorly Soluble Drugs: In Vivo and In Vitro Assessment. Roche, Basel, Switzerland, August 2007.
  • Use of Physiologically Relevant In Vitro Methods to Predict the Solubilization and Absorption of Poorly Soluble Drug Compounds, BioEnCap Innovation Consortium, Værløse, DK, December 2006.
  • Understanding solubilization and absorption of poorly soluble drugs; Can we use In vitro methods? Novartis, Basel, Switzerland, November 2006.
  • Elucidation of dissolution, solubilization and absorption mechanisms for poorly soluble drug compounds. INRA-Laboratoire pharmacologie toxicologie, Toulouse, France, November 2006.
  • The Dynamic Lipolysis Model - a tool in the strategic development of lipid based formulations. Schering AG, Berlin, Germany, March 2006.
  • Development of biorelevant in vitro methods to predict bioavailability of poorly soluble drug compounds. Mercer University, Atlanta, GA, USA, February 2006.
  • SEDDS and SMEDDS:  Interactions with biorelevant dissolution media Lipolysis and IVIVC. Bristol-Myers-Squibb, Princeton, NJ, USA, February 2005
  • The Lipolysis model – A useful tool in drug characterization and formulation development. Pfizer, Groton, CT, USA, February 2005.
  • Solubility of poorly soluble drugs in biorelevant media - establishment of in vivo in vitro correlations. University of Georgia, Athens, GA, USA, February 2005.
  •  

Publications:

Book chapters:

  • Fatouros DG, Müllertz A. Development of Self-Emulsifying Drug Delivery Systems (SEDDS) for Oral Bioavailability Enhancement of Poorly Soluble Drugs. In Drug Delivery Strategies for Poorly Water-Soluble Drugs, A. Fahr (ed) Wiley, 2012
  • Boyd BJ, Nguyen TH, Müllertz A, Lipids in Oral Controlled Release Drug Delivery  Controlled Release in Oral Drug Delivery, 299-327, 2011
  • Müllertz A. Food effects on Drug Absorption and Dosage Form Performance. In: Drug Absorption, Prediction and assessment. Dressman, J., Reppas, C. (eds) Informa Healthcare, 2010
  • Pedersen BL, Müllertz A. In vitro Dissolution. In: Molecular Biopharmaceutics. Aspects of Drug Characterization, Drug Delivery and dosage Form Evaluation. Steffansen, B., Nielsen, C.U., Brodin, B. (eds.). Pharmaceutical Press, 2010.
  • Müllertz A. Bio-relevant dissolution Media. In: Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics. Augustijns, P. (Ed.). Vol. 6 in the AAPS Biotechnology: Pharmaceutical Aspects Series. 2007.
  • Fatouros D., Müllertz A. Using in vitro dynamic lipolysis modeling as a tool for exploring IVIVC relationships for oral lipid-based formulations. In:  Lipid-Based Formulations for Oral Drug Delivery. Hauss, D. (Ed.). Taylor & Francis, New York. 2007.
  • Grove M., Müllertz A. Self-emulsifying systems for oral delivery of poorly soluble drugs. In:  Lipid-Based Formulations for Oral Drug Delivery. Hauss, D. (Ed.). Taylor & Francis, New York. 2007.
  • Nielsen FS, Müllertz A. Development of in vitro Methods for the Evaluation of Formulation Performance. In: Drug Candidate Optimization and Early Development, Pouton, C. (ed.). Bulletin Technique Gattefossé, France. 2005.

International, peer-reviewed Journals (*: Corresponding author):

  • Madelung P, Østergaard J, Bertelsen P, Jørgensen EV, Jacobsen J, Müllertz A*. Impact of sodium dodecyl sulphate on the dissolution of poorly soluble drug into biorelevant medium from drug-surfactant discs. Int J Pharm (accepted)
  • Pedersen PB, Bar-Shalom D, Baldursdottir S, Vilmann P, Müllertz A*. Feasibility of capsule endoscopy for direct imaring of drug delivery systems in the fasted upper-gastrointestinal tract. Pharm Res (In Press).
  • Meng-Lund E, Jacobsen J, Janfelt J, Holm R, Müllertz A, Nicolazzo JA. Azone® decreases the buccal mucosal permeation of diazepam in a concentration-dependent manner via a reservoir effect. J Pharm Sci (In Press)
  • Raijada D, Müllertz A, Cornett C, Munk, T, Sonnergaard J, Rantanen J. Miniaturized Approach for Excipient Selection During the Development of Oral Solid Dosage Form. J Pharm Sci (In Press).
  • Borkar N, Xia D, Holm R, Gan Y, Müllertz A, Yang M, Mu H. Investigating the correlation between in vivo absorption and in vitro release of fenofibrate from lipid matrix particles in biorelevant medium. Eur J Pharm Sci. 23; 51:204-10, 2014.
  • M. Boegh, S.G. Baldursdottir, A. Müllertz, H.M. Nielsen, Property profiling of biosimilar mucus in a novel mucus-containing in vitro model for assessment of intestinal drug absorption Eur J Pharm Biopharm (In Press).
  • Christiansen ML, Holm R, Kristensen J, Kreilgaard M, Jacobsen J, Abrahamsson B, Müllertz A*. Cinnarizine food-effects in beagle dogs can be avoided by administration in a Self Nano Emulsifying Drug Delivery System (SNEDDS). Eur J Pharm Sci. (In Press)
  • Nielsen LH, Gordon S, Holm R, Selen A, Rades T, Müllertz A*. Preparation of an amorphous sodium furosemide salt improves solubility and dissolution rate and leads to a faster Tmax after oral dosing to rats. Eur. J Pharm Biopharm 85 (3), 942-951. 2013.
  • Marizza P, Keller SS, Müllertz A, Boisen A. Polymer-filled microcontainers for oral delivery loaded using supercritical impregnation. J Contr Rel 10 (173) 1-9, 2014
  • Christophersen PC, Christiansen ML, Holm R, Kristensen J, Jacobsen J, Abrahamsson B, Müllertz A. Fed and fasted state gastro-intestinal in vitro lipolysis: In vitro in vivo relations of a conventional tablet, a SNEDDS and a solidified SNEDDS. Eur J Pharm Sci. 2013 (In Press).
  • Lennernäs H, Aarons L, Augustijns P, Beato S, Bolger M, Box K, Brewster M, Butler J, Dressman J, Holm R, Julia Frank K, Kendall R, Langguth P, Sydor J, Lindahl A, McAllister M, Muenster U, Müllertz A, Ojala K, Pepin X, Reppas C, Rostami-Hodjegan A, Verwei M, Weitschies W, Wilson C, Karlsson C, Abrahamsson B. Oral biopharmaceutics tools - Time for a new initiative - An introduction to the IMI project OrBiTo. Eur J Pharm Sci. 2013 (In Press).
  • Bergström CA, Holm R, Jørgensen SA, Andersson SB, Artursson P, Beato S, Borde A, Box K, Brewster M, Dressman J, Feng KI, Halbert G, Kostewicz E, McAllister M, Muenster U, Thinnes J, Taylor R, Mullertz A. Early pharmaceutical profiling to predict oral drug absorption: Current status and unmet needs. Eur J Pharm Sci. 2013 (In Press)
  • Nielsen LH, Gordon s, Pajander JP, Østergaard J, Rades T, Müllertz, A. Biorelevant characterisation of amorphous furosemide salt exhibits conversion to a furosemide hydrate during dissolution. Int J Pharm. 457 (1), 14-24, 2013.
  • Larsen AT, Åkesson P, Juréus A, Saaby L, Abu-Rmaileh R, Abrahamsson B, Østergaard J, Müllertz A*. Bioavailability of Cinnarizine in Dogs: Effect of SNEDDS Loading Level and Correlation with Cinnarizine Solubilization During In Vitro Lipolysis. Pharm Res 30 (12), 3101-3113, 2013.
  • Kostewicz ES, Abrahamsson B, Brewster B, Brouwers J, Butler J, Calert S, Dickinson PA, Dressman J, Holm R, Klein S, Mann J, McAllister M, Minekus M, Muenster U, Müllertz A, Verwei M, Vertzoni M, Weitschies W, Augustijns P. In vitro models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci (In Press)
  • Müllertz A, Fatouros DG, Vertzoni M, Reppas C. Unravelling the ultrastructure of ascending colon fluids from patients with ulcerative colitis by cryogenic transmission electron microscopy. J Pharm Pharmacol (Accepted)
  • Christophersen PC, Zhang L, Yang M, Nielsen HM, Müllertz A, Mu H. Solid lipid particles for oral delivery of peptide and protein drugs I - Elucidating the release mechanism of lysozyme during lipolysis. Eur J Pharm Biopharm. 85 (3), 473-480, 2013.
  • M. Boegh, S.G. Baldursdottir, M.H. Nielsen, A. Müllertz, H.M. Nielsen, Development and rheological profiling of biosimilar mucus. Ann Transactions Nordic Rheology Soc. 21, 233-240, 2013
  • Nielsen LH, Keller SS, Boisen A, Müllertz A, Rades T. A slow cooling rate of indomethacin melt spatially confined in microcontainers increases the physical stability of the amorphous drug without influencing its biorelevant dissolution behaviour. Drug Deliv Translat Res 1-7, 2013.
  • Thomas N, Rades T, Müllertz A*. Recent developments in oral lipid-based drug delivery. J. Drug Del. Sci. Tech. 23 (4) 375-382, 2013
  • Boegh M, Foged C, Müllertz A, Nielsen HM. Mucosal drug delivery: barriers, in vitro models and formulation strategies. J. Drug Del. Sci. Tech. 23 (4) 383-391, 2013.
  • Li P, Nielsen HM, Fano M, Müllertz A. Preparation and characterization of insulin-surfactant complexes for loading into lipid-based drug delivery systems. J Pharm Sci. 102(8):2689-98, 2013.
  • Pedersen PB, Vilmann P, Bar-Shalom D, Müllertz A, Baldursdottir S. Characterization of fasted human gastric fluid for relevant rheological parameters and gastric lipase activities, Eur J Pharm Sci. S0939-6411 (13) 00193-8, 2013
  • Williams HD, Sassene P, Kleberg K, Calderone M, Igonin A, Jule E, Vertommen J, Blundell R, Benameur H, Müllertz A, Pouton CW, Porter CJ; on behalf of the LFCS Consortium. Toward the Establishment of Standardized In Vitro Tests for Lipid-Based Formulations, Part 3: Understanding Supersaturation Versus Precipitation Potential During the In Vitro Digestion of Type I, II, IIIA, IIIB and IV Lipid-Based Formulations. Pharm Res. 30 (12):3059-761, 2013.
  • Nielsen, LH, Rades T, Müllertz A. Characterisation during storage and dissolution of solid dispersions containing furosemide and hydroxypropyl methylcellulose. J Drug Deliv Sci Tech 2013
  • Pedersen PB, Pajander J, Müllertz A, Vilmann P, Jørgensen L, Baldursdottir S. Towards understanding of complex fluids in pharmaceutical sciences. J Drug Deliv Sci Tech 2013
  • Holm R, Müllertz A, Mu H. Bile salts and their importance for drug absorption. Int J Pharm. 453(1):44-55, 2013.
  • Mu H, Holm R, Müllertz A. Lipid-based formulations for oral administration of poorly water-soluble drugs. Int J Pharm. 453(1):215-24, 2013.
  • Boetker JP, Rantanen J, Rades T, Müllertz A, Ostergaard J, Jensen H. A New Approach to Dissolution Testing by UV Imaging and Finite Element Simulations. Pharm Res. 30(5):1328-, 2013. doi: 10.1007/s11095-013-0972-0
  • Larsen AT, Ohlsson AG, Polentarutti B, Barker RA, Phillips AR, Abu-Rmaileh R, Dickinson PA, Abrahamsson B, Ostergaard J, Müllertz A*. Oral bioavailability of cinnarizine in dogs: Relation to SNEDDS droplet size, drug solubility and in vitro precipitation. Eur J Pharm Sci. 48, 339-50. 2013. doi: 10.1016/j.ejps.2012
  • Devraj R, Williams HD, Warren DB, Müllertz A, Porter CJ, Pouton CW. In vitro digestion testing of lipid-based delivery systems: Calcium ions combine with fatty acids liberated from triglyceride rich lipid solutions to form soaps and reduce the solubilization capacity of colloidal digestion products. Int J Pharm. 441, 323-33. 2013. doi: 10.1016/j.ijpharm.20122012
  • Larsen AT, Ogbonna A, Abu-Rmaileh R, Abrahamsson B, Østergaard J, Müllertz A. SNEDDS Containing Poorly Water Soluble Cinnarizine; Development and in Vitro Characterization of Dispersion, Digestion and Solubilization. Pharmaceutics 4 (4), 641-665, 2012.
  • Gordon S, Naelapää K, Rantanen J, Selen A, Müllertz A, Ostergaard J. Real-time dissolution behavior of furosemide in biorelevant media as determined by UV imaging. Pharm Dev Technol. 11, 1-10, 2012
  • Hywel D Williams, Mette U Anby, Philip Sassene, Karen Kleberg, Jean-Claude Bakala-N’Goma, Marilyn Calderone, Vincent Jannin, Annabel Igonin, Anette Partheil, Delphine Marchaud, Eduardo Jule, Jan Vertommen, Mario Maio, Ross Blundell, Hassan Benameur, Frédéric Carrière, Anette Müllertz, Colin W Pouton, Christopher JH Porter. Toward the Establishment of Standardized in Vitro Tests for Lipid-Based Formulations. 2. The Effect of Bile Salt Concentration and Drug Loading on the Performance of Type I, II, IIIA, IIIB, and IV Formulations during in Vitro Digestion. Mol Pharm, 9, 11, 3286-3300, 2012
  • Thomas N, Holm R, Rades T, Müllertz A. Characterizing Lipid Lipolysis and Its Implication in Lipid-Based Formulation Development. AAPS J. 14, 8, 60-71. 2012.    doi: 10.1208/s12248-012-9398-6
  • Thomas, N, Holm, R, Garmer, M, Karlsson, JJ, Müllertz, A*, Rades, T. Supersaturated self-nanoemulsifying drug delivery systems (super-SNEDDS) enhance the bioavailability of the poorly water-soluble drug simvastatin in dogs. AAPS J. 15, 219-27, 2013
  • Parmentier J, Thomas N, Müllertz A, Fricker G, Rades T, Exploring the fate of liposomes in the intestine by dynamic in vitro lipolysis. Int J Pharm, 1;437(1-2):253-63, 2012.
  • Ren S, Mu H, Alchaer F, Chtatou A, Müllertz A. Optimization of self nanoemulsifying drug delivery system for poorly water-soluble drug using response surface methodology. Drug Dev Ind Pharm. 39, 799-806, 2012
  • Li P, Mørck Nielsen H, Müllertz A*. Oral Delivery of Peptides and Proteins using Lipid-based Drug Delivery Systems.  Expert Opin Drug Deliv, 9, 1289-304. 2012
  • Holm R, Hesselkilde JZ, Jørgensen EB, Müllertz A. Using resin to generate a non-invasive intestinal bile-depleted rat model was unsuccessful. Eur. J. Pharm. Sci. 23, 347-351, 2012
  • Nielsen LH, Keller SS, Gordon KC, Boisen A, Rades T, Müllertz A*. Spatial confinement can lead to increased stability of amorphous indomethacin. Eur J Pharm Biopharm. 81, 418-25, 2012
  • Thomas N, Holm R, Müllertz A*, Rades T. In vitro and in vivo performance of novel supersaturated self-nanoemulsifying drug delivery systems (super-SNEDDS). J Control Release 160, 25-32, 2012
  • Williams HD, Sassene P, Kleberg K, Bakala-N'goma JC, Calderone M, Jannin V, Igonin A, Partheil A, Marchaud D, Jule E, Vertommen J, Maio M, Blundell R, Benameur H, Carrière F, Müllertz A, Porter CJ, Pouton CW. Toward the establishment of standardized in vitro tests for lipid-based formulations, part 1: Method parameterization and comparison of in vitro digestion profiles across a range of representative formulations. J Pharm Sci. 101, 3360-80, 2012
  • Thomas N, Müllertz A, Graf A, Rades T. Influence of lipid composition and drug load on the in vitro performance of self-nanoemulsifying drug delivery systems. J Pharm Sci. 101, 1721-31. 2012
  • Müllertz A, Fatouros DG, Smith JR, Vertzoni M, Reppas C. Insights into intermediate phases of human intestinal fluids visualised by atomic force microscopy and cryo -transmission electron microscopy ex vivo. Mol Pharm. (2):237-47, 2012.
  • Witzleb R, Müllertz A, Kanikanti VR, Hamann HJ, Kleinebudde P. Dissolution of solid lipid extrudates in biorelevant media. Int J Pharm. 422(1-2):116-24, 2012.
  • Boetker JP, Savolainen M, Koradia V, Tian F, Rades T, Müllertz A, Cornett C, Rantanen J, Østergaard J. Insights into the early dissolution events of amlodipine using UV imaging and Raman spectroscopy. Mol Pharm. 8(4):1372-80, 2011.
  • Tønsberg H, Holm R, Mu H, Boll JB, Jacobsen J, Müllertz A. Effect of bile on the oral absorption of halofantrine in polyethylene glycol 400 and polysorbate 80 formulations dosed to bile duct cannulated rats. J Pharm Pharmacol. 2011 Jun;63(6):817-24, 2011.
  • Larsen, A, Sassene, P, Müllertz A*. In Vitro Lipolysis Models as a Tool for the Characterization of Oral Lipid and Surfactant Based Drug Delivery Systems. Int J Pharm. 417(1-2):245-55, 2011.
  • Koradia V, Fontelonga de Lemos AF, Allesø M, Lopez de Diego H, Ringkjøbing-Elema M, Müllertz A, Rantanen J. Phase transformations of amlodipine besylate solid forms. J.  Pharm Sci. 100, 2896-910, 2011.
  •  Holm R, Jørgensen EB, Harborg M, Larsen R, Holm P, Müllertz A, Jacobsen J. A novel excipient, 1-perfluorohexyloctane shows limited utility for the oral delivery of poorly water-soluble drugs. Eur J Pharm Sci. 42, 416-22. 2011
  • Müllertz A*, Ogbonna A, Ren S, Rades T. Review: New Perspectives on Lipid and Surfactant based Drug Delivery Systems for Oral Delivery of Poorly Soluble Drugs. J Pharm Pharmacol, 62, 1622-36, 2010.
  • Kleberg, K, Jacobsen, J, Müllertz, A*. Review: Characterising the behaviour of poorly water soluble drugs in the intestine: Application of biorelevant media for solubility, dissolution and transport studies. J Pharm Pharmacol, 62, 1656-68, 2010.
  • Tønsberg H, Holm R, Bjerregaard TG, Boll JB, Jacobsen J, Müllertz A. An updated and simplified method for bile duct cannulation of rats. Lab Anim. 44, 373-6, 2010
  • Sassene PJ, Knopp MM, Hesselkilde JZ, Koradia V, Larsen A, Rades T, Müllertz A*. Precipitation of a poorly soluble model drug during in vitro lipolysis: Characterization and dissolution of the precipitate. J Pharm Sci, 99, 4982-91, 2010.
  • Selen A, Cruañes MT, Müllertz A, Dickinson PA, Cook JA, Polli JE, Kesisoglou F, Crison J, Johnson KC, Muirhead GT, Schofield T, Tsong Y. Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit. AAPS J, 12, 465-72, 2010.
  • Bakandritsos A, Zboril R, Bouropoulos N, Kallinteri P, Favretto ME, Parker TL, Müllertz A, Fatouros DG. The preparation of magnetically guided lipid based nanoemulsions using self-emulsifying technology. Nanotech. 5;21(5):55104, 2010.
  • Tønsberg H, Jacobsen, J, Müllertz, A, Holm, R. Effects of polysorbate 80 on the in vitro precipitation and oral bioavailability of halofantrine from polyethylene glycol 400 formulations in rats. J Pharm Pharmacol, 62, 63-70, 2010.
  • Kleberg, K, Jacobsen,F, Fatouros, D, Müllertz, A*. Biorelevant media simulating fed state intestinal fluids: Colloid phase characterization and impact on solubilization capacity, J Pharm Sci, 99, 3522-32, 2010.   
  • Fatouros DG, Walrand I, Bergenstahl B, Müllertz, A. Physicochemical Characterization of Simulated Intestinal Fed-State Fluids Containing Lyso-Phosphatidylcholine and Cholesterol. Diss Tech. 16, 3, 47-50, 2009.
  • Zimmermann A, Millqvist-Fureby A, Elema MR, Hansen T, Müllertz A, Hovgaard L., Adsorption of pharmaceutical excipients onto microcrystals of siramesine hydrochloride: Effects on physicochemical properties. Eur J Pharm Biopharm. 71, 109-16, 2009.
  • Fatouros DG, Walrand I, Bergenstahl B, Müllertz A*. Colloidal Structures in Media Simulating Intestinal Fed State Conditions with and Without Lipolysis Products.Pharm Res. 26, 361-74, 2009.
  • Hayeshi R, Hilgendorf C, Artursson P, Augustijns P, Brodin B, Dehertogh P, Fisher K, Fossati L, Hovenkamp E, Korjamo T, Masungi C, Maubon N, Mols R, Müllertz A, Mönkkönen J, O'Driscoll C, Oppers-Tiemissen HM, Ragnarsson EG, Rooseboom M, Ungell AL. Comparison of drug transporter gene expression and functionality in Caco-2 cells from 10 different laboratories. Eur J Pharm Sci. 18, 35, 383-96, 2008.
  • Thybo P, Pedersen BL, Hovgaard L, Holm R, Müllertz A. Characterization and physical stability of spray dried solid dispersions of probucol and PVP-K30. Pharm Dev Technol. 13, 375-86, 2008.
  • Zimmermann A, Tian F, Lopez de Diego H, Ringkjøbing Elema M, Rantanen J, Müllertz A, Hovgaard L. Influence of the Solid Form of Siramesine Hydrochloride on its Behavior in Aqueous Environments. Pharm Res, 26, 846-54, 2008
  • Fatouros, D.G., Nielsen, F.S., Douroumis, D., Hadjileontiadis, L.J., Mullertz, A. In vitro – in vivo correlations of self emulsifying drug delivery systems combining the dynamic lipolysis model and Neuro-fuzzy networks, Eur J Pharm Biopharm, 69, 887-98, 2008.
  • Lind ML, Jacobsen J, Holm R, Müllertz A*. Intestinal lymphatic transport of halofantrine in rats assessed using a chylomicron flow blocking approach: The influence of polysorbate 60 and 80. Eur J Pharm Sci, 35, 211-218, 2008.
  • Larsen A, Holm R, Pedersen ML, Müllertz A*. Lipid-based Formulations for Danazol Containing a Digestible Surfactant, Labrafil M2125CS: In Vivo Bioavailability and Dynamic In Vitro Lipolysis. Pharm Res, 69, 553-562, 2008.
  • Lue, B-M., Nielsen, F.S., Magnussen, T.L., Schou, H.M., Kristensen, K., Jacobsen, L.O., Müllertz, A*. Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound. Eur J Pharm Biopharm, 69, 648-57, 2008.
  • Fatouros, D.G., Müllertz, A. vitro lipid digestion models in design of drug delivery systems for enhancing oral bioavailability. Expert Opin Drug Metab Toxicol. 4, 1, 65-76, 2008.
  • Nielsen, F.S., Petersen, K.B., Müllertz, A*. Bioavailability of Probucol from Lipid and Surfactant Based Formulations in Minipigs: Influence of Particle Size and Dietary State. Eur J Pharm Biopharm, 69, 553-62, 2008.
  • Fatouros, D.G., Karpf, D.M., Nielsen, F.N., Müllertz, A., Clinical Studies with Oral Lipid Based Formulations of Poorly Soluble Compounds. Review. Ther Clin Risk Manag. 3(4): 591-604, 2007.
  • Lind, M.L., Jacobsen, J., Holm, R., Müllertz, A*. Development of simulated intestinal fluids, containing nutrients, as transport media, in the Caco-2 cell culture model: Viability, transport of a poorly aqueous soluble drug and a substrate of efflux mechanisms. Eur J Pharm Sci, 32, 261-70, 2007.
  • Zimmermann A, Elema MR, Hansen T, Müllertz A, Hovgaard L. Determination of surface-adsorbed excipients of various types on drug particles prepared by antisolvent precipitation using HPLC with evaporative light scattering detection. J Pharm Biomed Anal, 15; 44, 874-80, 2007.
  • Fatouros, D.G., Deen, G.R., Arleth, L., Bergenstahl, B., Nielsen, F.S., Skov Pedersen, J. Müllertz, A*. Structural development of self nano emulsifying drug delivery systems (SNEDDS) during in vitro lipid digestion monitored by Small-Angle X-ray Scattering. Pharm Res, 24, 1844-53, 2007.
  • Fatouros, D.G., Bergenstahl, B., Müllertz, A*. Morphological observations on a lipid based drug delivery system during in vitro digestion. Eur J Pharm Sci, 31, 85-94, 2007.
  • Nielsen, F.S., Gibault, E., Ljusberg-Wahren, H., Arleth, A., Pedersen, J.S., Müllertz, A*. Characterization of prototype self-nanoemulsifying formulations of lipophilic compounds. J Pharm Sci, 96, 876-92, 2007.
  • Grove M., Müllertz A., Pedersen G.P., Nielsen J.L. Bioavailability of seocalcitol III: Administration of lipid-based formulations to minipigs in the fasted and fed state. Eur J Pharm Sci. 31, 8-15, 2007.
  • Grove, M., Nielsen, J.L., Pedersen, G.P., Müllertz, A*. Bioavailability of Seocalcitol IV: Evaluation of Lymphatic Transport in Conscious Rats. Pharm. Res. 23, 2681-8, 2006. 
  • Holm, R., Porsgaard, T., Porter, C.H.J., Høy, C.E.H., Edwards, G.A., Müllertz, A., Kristensen, H.G., Charman, W.N. Lymphatic fatty acids in canines dosed with pharmaceutical formulations containing structured triacylglycerols. Eur. J. Lipid Sci. Technol. 108, 714-722, 2006.
  • Grove M., Müllertz A., Nielsen J.L., Pedersen G.P. Bioavailability of seocalcitol II: development and characterisation of self-microemulsifying drug delivery systems (SMEDDS) for oral administration containing medium and long chain triglycerides. Eur J Pharm Sci. 28, 233-242, 2006.
  • Ilardia-Arana, D., Kristensen, H.G., Müllertz, A*. Biorelevant dissolution media: Aggregation of amphiphiles and solubility of estradiol. J. Pharm. Sci. 95, 248-55, 2006. 
  • Karpf, D.M., Holm, R., Garafalo, C., Levy, E., Jakobsen, J., Müllertz*, A. Effect of different surfactants in biorelevant media on the secretion of a lipophilic compound in lipoproteins using the Caco-2 cell culture. J. Pharm. Sci. 95, 45-55, 2006.
  • Ljusberg-Wahren, H., Nielsen, F.S., Brogård, M., Troedsson, E., Müllertz, A. Enzymatic Characterization of Lipid Based Drug Delivery Systems. Int. J. Pharm. 298, 2, 328-32, 2005.
  • Grove, M., Pedersen, G.P., Nielsen, J.L., Müllertz, A*. Bioavailability of seocalcitol I: Correlating solubility in biorelevant media with oral bioavailability in rats - effect of medium and long chain triglycerides. J. Pharm. Sci. 94, 8, 1830-8, 2005.
  • Sunesen, V.H., Pedersen, B.L.,  Kristensen, H.G., Müllertz, A*. In vivo In vitro correlations for a poorly soluble drug using the flow through dissolution method with biorelevan dissolution media. Eur. J. Pharm. Sci 24, 305-13, 2005.
  •  Sunesen, V.H., Vedelsdal, R., Kristensen, H.G., Christrup, L., Müllertz, A*. Effect of  liquid volume and food intake on the absolute bioavailability of a low soluble drug. Eur. J. Pharm. Sci. 24, 297-303, 2005.
  • Christensen, J.O., Schultz, K., Mollgaard, B., Kristensen, H.G., Müllertz, A*. Solubilisation of poorly water-soluble drugs during in vitro lipolysis of medium- and long-chain triacylglycerols. Eur. J. Pharm. Sci. 23, 3, 287-96, 2004.
  • Karpf, D.M., Holm, R., Kristensen, H.G., Müllertz, A*. Influence of the Type of Surfactant and the Degree of Dispersion on the Lymphatic Transport of Halofantrine in Conscious Rats. Pharm. Res. 21, 8, 1413-1418, 2004.
  • Holm, R., Porter, C.H.J., Edwards, G.A., Müllertz, A., Kristensen, H.G., Charman, W.N. Examination of oral absorption and lymphatic transport of halofantrine in a triple-cannulated canine model after administration in self-microemulsifying drug delivery systems (SMEDDS) containing structured triglycerides. Eur. J. Pharm. Sci. 20, 91-97, 2003.
  • Holm, R., Porter, C.H.J., Müllertz, A., Kristensen, H.G., Charman, W.N. Structured triglyceride vehicles for oral delivery of halofantrine: Examination of intestinal lymphatic transport and bioavailability conscious rats. Pharm. Res. 19, 9, 2002.
  • Holm, R., Müllertz, A., Christensen, E., Høy, C.-E.,  Kristensen, H.G. Comparison of total bioavailability and the lymphatic absorption of halofantrine from 3 different unsaturated triglycerides in lymph-cannulated conscious rats. Eur. J. Pharm. Sci. 14, 331-337, 2001.
  • Holm, R., Müllertz, A., Pedersen, G.P., Kristensen, H.G. Comparison of the lymphatic transport of halofantrine administered in disperse systems containing 3 different unsaturated fatty acids. Pharm. Res. 18(9), 1299-1304, 2001.
  • Zangenberg, N.H., Müllertz, A., Kristensen, H.G., Hovgaard, L. A dynamic lipolysis model: II: Evaluation of the model. Eur. J. Pharm. Sci. 14, 237-244, 2001.
  • Zangenberg, N.H., Müllertz, A., Kristensen, H.G., Hovgaard, L. A dynamic lipolysis model: I: Controlling the rate of lipolysis by continous addition of calcium. Eur. J. Pharm. Sci. 14, 115-122, 2001.
  • Nielsen, P.B., Müllertz, A., Norling, T., Kristensen, H.G. Comparison of the lymphatic transport of a lipophilic drug from vehicles containing alpha-tocopherol and/or triglyserides in rats. J. Pharm. Pharmacol. 53, 1439-1445, 2001.
  • Nielsen, P.B., Müllertz, A., Norling, T., Kristensen, H.G. The effect of alpha-tocopherol on the in vitro solubilisation of lipophilic drugs. Int. J. Pharm. 222, 217-224, 2001.
  • Pedersen, B.L., Müllertz, A., Brøndsted, H., Gjelstrup Kristensen, H. A comparison of the solubility of danazol in human and simulated gastrointestinal fluids. J. Pharm. Res.  17, 891-894, 2000.
  • Pedersen, B.L., Brøndsted, H., Müllertz, A., Norring Christensen, F., Lennernäs, H., Gjelstrup Kristensen, H. Dissolution of hydrocortisone in human and simulated intestinal fluids. Pharm. Res. 17, 183-189, 2000.
  • Hedeman, H., Brøndsted, H., Müllertz, A., Frokjaer, S. Fat emulsions based on structured lipids (1,3-specific triglycerides): An investgation of the in vivo fate. Pharm. Res., 13, 5, 725-728, 1996.
  • Søberg Christensen, M., Müllertz, A., Høy, C.-E. Absorption of triglycerides with defined or random structure by rats with biliary and pancreatic diversion. Lipids, 30, 1995.
  • Hultin, M., Müllertz, A., Zundell, M.A. et al. Metabolism of emulsions containing medium and long chain triglycerides or interesterified triglycerides. J. Lipid Res. 35, 1994.
  • Müllertz, A., Hølmer, G., Groendahl-Hansen, J. Increased concentration of plasmingen activator inhibitor type-1 in plasma after intake of fish oil. Fibrinolysis, 4, 86-88, 1990.
  • Müllertz, A., Schmedes, A., Hølmer, G. Separation and detection of phospholipid hydroperoxides in the low nanomolar range by HPLC/ironthiocyanate assay. Lipids, 25, 7, 1990.
  •  
  • Patents (Only maintained patents are mentioned):
  • 1. G Berge, PH Olesen, SO Hustvedt, A Müllertz, JEJ Klaveness. Compositions and preconcentrates comprising at least one salicylate and omega-3 fatty acid oil mixture       WO Patent App. PCT/IB2012/002,850. WO Patent 2,013,072,767
  • 2. Kofod; L.V., Kauppinen; M.S., Andersen; L.N., Clausen; I.G., Müllertz; A. Enzyme with galactanase activity. PCT/DK97/00092
  • 3. SO Hustvedt, PH Olesen, G Berge, A Müllertz. COMPOSITIONS COMPRISING A FATTY ACID OIL MIXTURE AND A FREE FATTY ACID, AND METHODS AND USES THEREOF. US Patent 20,120,232,141
  • 4. JEJ Klaveness, G Berge, SO Hustvedt, PH Olesen, A Müllertz. COATED CAPSULES AND TABLETS OF A FATTY ACID OIL MIXTURE. WO Patent 2,011,048,493. EP Patent 2,490,678
  • 5. SO Hustvedt, G Berge, PH Olesen, A MÜLLERTZ. Compositions comprising a fatty acid oil mixture, a free fatty acid, and a statin. EP Patent App. 20,110,823,132. WO Patent 2,012,032,417, WO Patent App. PCT/IB2011/002,755
  • 6. Müllertz, A., Jensen, L.B., Jensen, B.K. Animal feed additives. PCT/DK97/00172
  • 7. Hansen, P.K., Wagner, P., Müllertz, A., Knap, I.H. Animal feed additives comprising xylanase. PCT/DK96/00046, EP Patent 0,805,856
  • 8. Jakobsen, T.S., Heldt-Hansen, H.P., Kofod, L.V., Bagger, C.L., Müllertz, A. Processing plant material with xylanase. PCT/DK95/00082
  • 9. Kofod, L.V., Kauppinen, M.S., Christgau, S., Heldt-Hansen, H.P, Dalboege, H., Andersen; L. N., Si; J.Q., Jacobsen, T.S., Munk, N., Müllertz, A. Enzymes with xylanase activity from aspergillus aculeatus. PCT/DK94/00088
  • Assorted publications, non-peer-reviewed (2004-present).
  • homas N, Holm R, Rades T, Müllertz A. Overmætning i kapsler eller i tarmen (Supersaturation in capsules or in the gut). Lægemiddelformulering (Drug Research) 2012.
  • Meng-Lund E, Holm R, Müllertz A, Jacobsen J. Modelforsøg baner vejen: Effektiv optagelse af lægemidler gennem kindslimhinden (In vitro studies pave the way: Effective uptake of drugs through the buccal mucosa). Lægemiddelformulering (Drug Research) 2012.
  • Naelapää, K, Müllertz,A, Jacobsen, J, Rømsing, J, Bar-Shalom, D. Tablets with loose ends induces delayed release of drug. Drug Research (In Danish: Lægemiddelforskning) 2009.
  • Larsen A, Fatourous D, Jacobsen J, Müllertz A. Dynamisk model for fordøjelse af lipidbaserede lægemidler i tarmen. Dansk Kemi 89 (8), 30-33, 2008.
  • Lind, M.L., Jacobsen, J., Holm, R., Mullertz, A. Screening the capability of drug substances to permeate the intestinal wall. Drug Research (In Danish: Lægemiddelforskning) 2006.
  • Pedersen, B.L., Müllertz, A. Development of in vitro dissolution methods that can predict in vivo events. DFU Profile 2006
  • Jæpelt, R.B., Müllerz, A. NNCXZ. Dissolution in Biorelevant media. Confidential report to Novo Nordisk A/S, 2006.
  • Lue, B.M., Müllertz, A. NNCXX, hemiethylenediamine: Solubility & Dissolution in Crude Biorelevant Media. Confidential report to Novo Nordisk A/S, 2006.
  • Nielsen, M.T. Müllertz, A. NNCXY. Dissolution in Biorelevant media. Confidential report to Novo Nordisk A/S, 2006.
  • Larsen, A., Müllertz, A. In vitro lipolysis of macrogol glyceride surfactants and its impact on the solubility of a BCS class II drug, Confidential report to Gattefossé, 2006.
  • Nielsen, F.S., Müllertz, A., Preformulation of a novel drug compound. Confidential report, to Action Pharma (DK). 2005.
  • Nielsen, F.S., Müllertz, A., Preformulation of LC474 and LC1266. Report in the Malaria project, 2005.
  • Basse, L.H., Müllertz, A. Studies for the improvement of the bioavailability of chosen chalchones. Report in the Malaria Project 2004.
  • Karpf, D.M., Jacobsen, J., Müllertz, A. Chylomicron Secretion in CaCo-2 Cell Cultures - A Marker for the Lymphatic Transport of Lipophilic Drugs? DFU Profile 2004.

 

Poster presentation (2011 – 2012):

  • LG Jensen, JX Wu, J Rantanen, T Rades, B Abrahamsson and A Müllertz, Polarized light microscopy as a method for analyzing API precipitation in simulated gastric media, Joint ASCEPT-APSA 2012 Conference, Sydney, Australia, December, 2012.
  • PB Pedersen, P Vilmann, D Bar-Shalom, SG Baldursdottir and A Müllertz, “Optimization of simulated gastric media (FaSSGF) based on rheological characterization of human gastric fluid” Joint ASCEPT-APSA 2012 Conference, Sydney, Australia, December, 2012.
  • PB Pedersen, P Vilmann, D Bar-Shalom, SG Baldursdottir and A Müllertz, “Rheological Characterization of Fasted Human Gastric Fluid”, Globalization of Pharmaceutics Education Network (GPEN) 9th Biennial Meeting, Melbourne, Australia, November 28-December 1, 2012
  • PB Pedersen, P Vilmann, SG Baldursdottir, D Bar-Shalom, and A Müllertz, “Rheological Behavior of Fasted State Human Gastric Aspirates compared to Existing Biorelevant Gastric Media”, Drug Delivery Australia 2012, Melbourne, Australia, November, 2012.

  • LG Jensen, JX Wu, J Rantanen, T Rades, B Abrahamsson and A Müllertz, Visualization of API precipitation in simulated gastric media by polarized light microscopy", Globalization of Pharmaceutics Education Network (GPEN) 9th Biennial Meeting, Melbourne, Australia, November 28-December 1, 2012
  • LG Jensen, JX Wu, J Rantanen, T Rades, B Abrahamsson and A Müllertz, Development of a Microscopy Based Method for Evaluating API Precipitation in Simulated Gastric Media, Drug Delivery Australia 2012, Melbourne, Australia, November 26-27, 2012.
  • LG Jensen, JX Wu, J Rantanen, T Rades, B Abrahamsson and A Müllertz, Visualization of API Precipitation in Simulated Gastric Media by Light Microscopy, 2012 AAPS Annual Meeting and Exposition, Chicago, IL, USA, October 14-18, 2012.
  • PB. Pedersen, P Vilmann, D Bar-Shalom, SG. Baldursdottir, and A Müllertz, “Optimization of simulated gastric media (FaSSGF) based on rheological characterization of human gastric fluid”, 2012 AAPS Annual Meeting and Exposition, Chicago, IL, USA, October 14-18, 2012.
  • HD Williams, P Sassene, D Birch, ML Christiansen, M Calderone, V Jannin, A Igonin, E Jule, J Vertommen, R Blundell, H Benameur, A Müllertz, CW Pouton and CJH Porter. The LFCS Consortium: 1 - Effect of saturation level of a neutral drug and a weakly acidic drug on the performance of lipid-based formulations during in vitro digestion. AAPS annual meeting and Exposition. October 14-18, 2012. Chicago, Il, USA.
  • HD Williams, P Sassene, D Birch, ML Christiansen, M Calderone, V Jannin, A Igonin, E Jule, J Vertommen, R Blundell, H Benameur, A Müllertz, CJH Porter and CW Pouton. The LFCS Consortium: 2 - Toward the development of a new performance-based lipid formulation classification system (LFPCS). AAPS annual meeting and Exposition. October 14-18, 2012. Chicago, Il, USA.
  • D Birch, P Sassene, ML Christiansen, HD Williams, M Calderone, V Jannin, A Igonin, E Jule, J Vertommen,  R Blundell, H Benameur, CJH Porter, CW Pouton and A Müllertz. The LFCS Consortium: 3 - Effect of saturation level of a highly lipophilic drug on the performance of lipid-based formulations during in vitro digestion. AAPS annual meeting and Exposition. October 14-18, 2012. Chicago, Il, USA. Poster ID. R6268.
  • ML Christiansen, P Sassene, D Birch, HD Williams, M Calderone, V Jannin,  A Igonin, E Jule, J Vertommen,  R Blundell, H Benameur, CJH Porter, CW Pouton and A Müllertz. The LFCS Consortium: 4 - Solubilisation of a weak base during in vitro digestion of 8 lipid-based formulations under 3 different conditions. AAPS annual meeting and Exposition. October 14-18, 2012. Chicago, Il, USA. Poster ID. R6269
  • P Li, HM Nielsen and A Müllertz. Impact of emulsion-based drug delivery systems on insulin’s intestinal transport. AAPS Annual Meeting and Exposition, Chicago, October 2012.ing Li, Hanne Mørck Nielsen, Mathias Fanø and Anette Müllertz. Preparation and characterization of surfactant-insulin complex for loading into lipid-based formulations. AAPS Annual Meeting and Exposition, Chicago, October 2012.
  • P Li, HM Nielsen and A Müllertz. Insulin loaded self-nanoemulsifying drug delivery systems (SNEDDS)-the influence of chain length of the oil on the of system. Drug research academy (DRA) summer school, Helsinge, August, 2012.
  • LG. Jensen, J Rantanen, T Rades, B Abrahamsson and A Müllertz,"Visualization of API precipitation in simulated gastric media by polarized light microscopy", DRA Summer Conference, Helsinge, Denmark, August, 2012.
  • PB Pedersen, AL Nielsen, P Vilmann, SG. Baldursdottir,  D Bar-Shalom, and A Müllertz, “Optimization of Simulated Gastric Media (FaSSGF) Based on Rheological Characterization of Human Gastric Fluid”, DRA Summer Conference, Helsinge, Denmark, August, 2012. 

  • L. Saaby, A Müllertz. Transepithelial drug transport in Calu-3 cells grown under LCC and AIC conditions: Impact of mucus on drug permeability. The 39th Annual Meeting & Exposition of the Controlled Release Society. Centre des Congrès de Québec, Québec City, Canada, July 2012.
  • N. Thomas, R. Holm, A. Müllertz, T. Rades. In vitro and in vivo performance of novel supersaturated self-nanoemulsifying drug delivery systems (super-SNEDDS). APV World Meeting, Istanbul, March 2012.
  • PB Pedersen, P Vilmann, D Bar-Shalom, and A Müllertz,  “Direct Visualization of Lipid Based Formulations Behaviour in the Upper-Gastrointestinal Tract”, APV World meeting 2012, Istanbul, Turkey, March, 2012
  • LG. Jensen, J Rantanen, T Rades, B Abrahamsson and A Müllertz, "Visualization of API precipitation in simulated gastric media by light microscopy", 14th Conference on Formulation and Delivery of Bioactives, Dunedin, New Zealand, February, 2012.
  • Ping Li, Hanne Mørck Nielsen and Anette Müllertz. Self-microemulsifying drug delivery systems (SMEDDS) for oral delivery of insulin - formulation design and characterization. Day of Research at the Faculty of Health and Medical Sciences, University of Copenhagen, January 2012.
  •  J Parmentier, N Thomas, A Müllertz, G Fricker, T Rades. Investigation of liposome stability by dynamic in vitro lipolysis. AAPS Annual meeting, Washington, October 2011.
  • L. Hagner Nielsen1, S. Sylvest Keller2, K. Gordon3, A. Boisen2, T. Rades4, A. Müllertz. Spatial confinement of amorphous indomethacin increases stability. AAPS Annual meeting, Washington, October 2011.
  • PB Pedersen, P Vilmann, D Bar-Shalom, A Müllertz. Direct Imaging of Dosage Form Behaviour in the Upper-Gastrointestinal tract. AAPS Annual meeting, Washington, October 2011.
  •  P Christophersen, ML Christiansen, R Holm, J Kristensen, J Jacobsen, B Abrahamsson, A Müllertz. IVIVR between solubilisation in a two step lipolysis model and bioavailability in dogs for a conventional tablet and a Self Micro Emulsifying Drug Delivery System (SMEDDS) containing cinnarizine.AAPS Annual meeting, Washington, October 2011.
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Primære forskningsområder

Drug delivery af small molecules
Innovative pharmaceutical formulations, including lipid drug delivery systems.
Impact of exhipients.
Dissolution and solubilization mechanisms for poorly soluble drug compounds.
Development of media, simulating the gastra intestinal (GI) fluids.
Development of digestion models and elucidating the mechanisms of solubilization and generated colloid phases in the GI tract.
Absorption mechanisms for poorly soluble drugs in simulated GI fluids, using cell cultures and excised tissue.
Bioavailability studies in humans and animals in order to develop predicative in vitro models.

ID: 1302503