Nicotine Science Center 2015

Ativities and News

The high level of activity in the Nicotine Science Centre (NSC) has continued in 2015. NSC employees, led by Program Manager Kent Albin Nielsen, PhD, have participated in six major international conferences, organized four internal Fertin Pharma (Fertin) conferences, given eight presentations, seven poster presentations and completed eleven publications. In 2015 the Scientific Advisory Board (ASB) conducted two meetings, and launched three research projects in collaboration with Aalborg University, University of Southern Denmark and the University of Copenhagen.

The Scientific Advisory Board

The two SAB meetings in 2015 featured presentations on smoking cessation, NRT-products, oral drug delivery systems and buccal absorption.

The SAB meetings have primarily focused on expanding Fertin’s fundamental understanding of nicotine by covering topics such as absorption of nicotine, in-depth understanding of oral mucosal, evaluation of new delivery systems, understanding the fundamental mechanisms behind nicotine absorption, addressing the relevant factors that might lead to further optimization of existing products and finally on opportunities for new and improved NRT products.

The SAB has made important scientific progress, narrowing down the essential requirements to be achieved for the next generation of Nicotine Replacement Therapy (NRT) products.

Fertin conferences

Four Fertin conferences took place in 2015. The focus of the conferences was to increase the scientific knowledge of NRT and expand the competence of the specialists in the R&D department of Fertin.

Presenters at the Fertin conferences have been carefully chosen among external as well as internal experts. The topics presented were highly relevant to the further scientific development of existing and new NRT products.

Several of NSC’s collaborators have been invited to share their latest discoveries. This has ensured an effective tech transfer between involved parties and a smooth knowledge transfer between university researchers and specialists from Fertin’s R&D department.

A number of highly skilled experts have also been invited to present new areas of interest for NSC. In this way NSC is expanding its network to new external partners and at the same time scouting for new NRT products.

International Conferences

The NSC has participated in six conferences in 2015

1: 4th Annual NordForsk FPTP Network Meeting in Copenhagen, Denmark, January 21 - 23.

2: APV workshop on ODx and MBx - Orodispersible and Mucoadhesive Buccal Formulations, Innsbruck, Austria, January 29 - 30.

3: Annual meeting of the Society for Research on Nicotine and Tobacco (SRNT) in Philadelphia, USA, February 25 - 28.

4: Global Drug Delivery & Formulation Summit, Düsseldorf, Germany, February 9 - 11.

5: Controlled Release Society (CRS), Edinburg, Scotland, July 26 - 29.

6: American Association of Pharmaceutical Sciences (AAPS) Annual Meeting and Exposition in Orlando, Florida, October 25 - 29.

Presentations

The NSC have given eight oral and seven poster presentations in 2015

Oral presentations:

1: Effect of freeze protectants on integrity of permeability barriers in porcine buccal mucosa, presented at 4th Annual Nordforsk FPTP Network Meeting in
     Copenhagen, January 21 - 23.
2: Innovative compressed bi-layer chewing gum technology for delivery of active pharmaceutical ingredients presented at Global Drug Delivery & Formulation
     Summit, Düsseldorf, Germany, February 9 - 11.

3: Intra-oral nicotine provoked pain, sensory and vasomotor responses: A dose-response study, presented at European Pain Federation EFIC®, Vienna, Austria
     September 2 - 5.
4: Drug delivery to the oral mucosa – possibilities and limitations, presented at the International Association for Dental Research/Continental European Division
     Congress in Antalya, Turkey, October 16.
5: Elucidation of oromucosal absorption barriers to nicotine and strategies for absorption enhancement - Mucus as a permeability barrier, presented at Rational Oral
     Drug Deliver (RODD) group day at University of Copenhagen, Denmark, November 13.
6: Medicated chewing gum, presented at University of Copenhagen, Denmark, November 30.
7: Presentation of the Nicotine Science Center and Fertin Pharma A/S at University of Copenhagen, Denmark, November 5.
8: Presentation of the Nicotine Science Center and Fertin Pharma A/S at Aarhus University, Denmark, November 23.

Poster presentations:
1: Intra-oral psychophysical and physiologic responses to menthol and nicotine: presented at Annual meeting of the SRNT in Philadelphia, USA, February 25 - 28.
2: Can freeze protectants preserve the integrity of permeability barriers in porcine buccal mucosa?: presented at PhD day for students enrolled at the Graduate School
     of Health and Medical Sciences, University of Copenhagen, Denmark, May 21.
3: Can freeze protectants preserve the integrity of permeability barriers in porcine buccal mucosa?: presented at ULLA Summer School in Paris with PhD students from
     8 European universities working in Pharmaceutical Sciences, France, July 6 - 10.
4: Chewing Gum with a Built-in Trigger Mechanism for Drug Delivery presented at Controlled Release Society (CRS), Edinburg, Scotland, July 26 - 29.
5: Nicotine-induced irritation and pain are attenuated by eucalyptus presented at European Pain Federation EFIC®, Vienna, Austria, September 2 - 5.
6: Intraoral Psychophysical and Physiologic Responses to Cinnamaldehyde and Nicotine presented at European Pain Federation EFIC®, Vienna, Austria September 2 - 5.
7: Do Freeze Protectants Affect the Integrity of Permeability Barriers in Porcine Buccal Mucosa presented at American Association of Pharmaceutical Sciences (AAPS)
     Annual Meeting and Exposition in Orlando, Florida, USA, October 25 - 29.

Publications

The NSC have published obtained eleven publications in 2015
1: Nicotine-induced burning and pain in the oral tissues are attenuated by eucalyptus oil when co-released in chewing gum; bachelor project, Aalborg University, 2015.
2: Functional Electrospun Nanostructures and Microstructures for Food and Bioengineering Applications – FENAMI (File No: 10-093456, J.nr.; 0603-00383B) Final
     Qualitative Report.
3: Psychophysical and vasomotor responses of the oral tissues: a nicotine dose-response and menthol interaction study, Arendt Nielsen, Thomas; Nielsen, Bruno 
     Provstgaard; Wang, Kelun; Arendt-Nielsen, Lars; Boudreau, Shellie, Nicotine & Tobacco Research, 2016. E-pub ahead of print.

4: Intraoral Psychophysical and Physiologic Responses to Cinnamaldehyde and Nicotine, Andersen M, Jensen T, Nielsen, KA, Arendt-Nielsen L, Boudreau (2015) Journal
    of Neurophysiology,
Submitted.

5: Intra-oral psychophysical and physiologic responses to menthol and nicotine, Arendt-Nielsen T, Wang, K, Arendt-Nielsen L, Boudreau SA, Nielsen KA, Nielsen BP,
     (2015) SRNT, PO No. 164.
6: Chewing Gum with a Built-in Trigger Mechanism for Drug Delivery, Nielsen KA, Nielsen BP, Stahl M-LL,Andersen, BH (2015) Controlled Release Society, CRS, PO No.
     285.
7: Nicotine-induced irritation and pain are attenuated by eucalyptus oil. / Hoeck E, Jensen AB, Marker JB, Dong N, Hansen E, Arendt-Nielsen L, Boudreau S (2015) 9th
    Congress of the European Pain Federation, EFIC, s. PO32a No. 545; EFIC5-1281.
8: Intra-oral psychophysical and physiologic responses to cinnamaldehyde and nicotine, Jensen T, Kim AM, Wang K, Provstgaard BP, Boudreau S (2015) 9th Congress
    of the European Pain Federation, EFIC, 2015, s. PO13 No. 147; EFIC5-0432.
9: Can the integrity of porcine buccal mucosa be preserved at sub-zero storage; Master thesis by Mary Carlos Axelsen, University of Copenhagen, March 2.

10: Correlation between ex vivo bovine and porcine buccal permeability – Studies of nicotine and diazepam; Master thesis by Sana Riyad Jabbar, University of
       Copenhagen, August 6.
11: A study of ex vivo permeability of nicotine – can porcine buccal mucosa be saturated? Development of a LC/MS/MS method for quantification of nicotine; Master
       thesis by Trung Tin Le Dinh, University of Copenhagen, September 3.

New Projects

On September 1. 2015, a new PhD-project was launched within the NSC, in collaboration with the University of Southern Denmark. The hypothesis of the project is to investigate the binding mechanisms/kinetics between Nicotine and selected ion-exchange resins in order to reveal the possible impact of formulation designs on the thermodynamic mechanisms governing the respective equilibrium constant. Also, loading- and release-profiles will be investigated. It is expected that the obtained data will elucidate parameters relevant when optimizing such sustained release formulations in an attempt to produce an adequate kinetic profile of a given API, together with a predictable and reproducible formulation design with respect to loading-dose and dissolution/solubility profile of the drug-substance. The project is led by cand. scient. Philipp A- Elvang, a native of Denmark and a graduate of the Department of Physics, Chemistry and Pharmacy from the University of Southern Denmark.

On February 14. 2015, a new bachelor project was launched within the NSC in collaboration with Aalborg University. The aim of this study was to investigate the modulatory effects of eucalyptus oil on nicotine-induced burning and pain when administered by chewing gum to the oral tissue. Furthermore, the effects of an interrupted chewing regime were investigated.

September 2015, a new master project was launched within the NSC, in collaboration with the University of Copenhagen. The hypothesis of the project is: development of ex vivo and in vitro models to assess the barrier properties of mucus on buccal mucosa. The project is led by Mette and Eva Marxen form Department Pharmacy from the University of Copenhagen.

Finalized Projects

1: FENAMI (Functional nano-microstructures for food and bioengineering applications): The objectives of this research consortium were to generate the scientific and technological basis to: (i) develop new nano-microcarrier systems for bioactive compounds using electrospun nano-microstructures for their immobilization, (ii) develop new nano-micro delivery systems utilizing enzyme functionality and molecular imprinted polymers for controlled delivery/release of bioactives, (iii) study the structural and functional properties of nano-microstructures (NMS) as novel components of food and bioengineered products, (iv) evaluate their bioavailability and degradation/digestion in-vitro and in-vivo. The overall aim is to create new functional systems that have a potential usage in foods/healthy foods, as nutritional supplements, as pharmaceutical products and for a range of other bioengineering applications.

2: Nicotine-induced burning and pain sensations in the oral tissue are reduced by eucalyptus oil when co-released in chewing gum; Nhung Dong, Eva Ørsnæs Hansen, Emil Østergaard Hoeck, Annemarie Brusen Jensen and Jens Broch Marker; a bachelor project conducted at Aalborg University in collaboration with Fertin.

Outlook for 2016:

The level of activity is going to remain high in 2016. At the moment, participation in four conferences is planned: BioBarriers 2016 - 11th Conference and Workshop on Biological Barriers, 10th world meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (PBP), the Society for Research on Nicotine and Tobacco (SRNT) Europe Annual Meeting 2016, and 18th International Pharmaceutical Technology Symposium-IPTS 2016.

Furthermore, three new project launches are planned for February, May and June, and two articles (from research projects with the University of Aalborg and University of Copenhagen and Copenhagen University), are going to be submitted for publication.