Smart bio-
nanotechnology
1. CANNABINOIDS AND THE PROBLEM OF ABSORPTION
The absorption and bioavailability of drugs are determined, among other things, by the physiochemical properties, preparation and dosage form of the drug. Different formulations of the same active ingredients result in differences in bioavailability that can have significant clinical implications.
Due to their high lipophilicity, cannabinoids are almost insoluble in water. In order to be effectively absorbed via the oral or intestinal mucosa, they must be processed in such a way that they can first penetrate through the aqueous mucosa and then enter the bloodstream through the lipophilic mucosa.
These two barriers must be passed in order to achieve high bioavailability.
OILY CANNABINOID FORMULATIONS FOR ORAL INTAKE:
Cannabinoids in oily formulation taken orally interact with the glycoprotein-containing mucus of the oral or intestinal mucosa. This leads to a confluence of oily droplets into large drops (coalescence). These coalescences exceed a diameter of 400 nm, the absorption limit of the oral and to a large extent also the intestinal mucosa, resulting in inefficient absorption.
ETHANOLIC CANNABINOID FORMULATIONS FOR ORAL USE:
Cannabinoids dissolved in ethanol and consequently applied to the oral cavity precipitate through the reaction with water and form large agglomerates. Equivalent to oily coalescences, most of these agglomerates exceed the absorption limit of the oral mucosa of 400 nm and thus are only absorbed via the intestinal mucosa.
Fig.: Due to the large particle sizes of their agglomerates, both oily (above) and ethanolic (below) preparations are insufficiently absorbed through mucous membranes (particles larger than 400 nm or 20µm can’t be absorbed via the oral mucosa or the intestinal mucosa, respectively).
2. SMARTLIPID CANNABINOID FORMULATION AS NANODISPERSION:
With the innovative and globally patented manufacturing process PuranoTec®, poorly water-soluble cannabinoids can be solved in an aqueous nanodispersion. As such, they are enclosed in a biocompatible carrier that is surrounded by a water-soluble shell, the smart coating. As so-called SmartLipids, they remain physically stable in an aqueous environment (no coalescence or agglomerate formation) and can be effectively absorbed directly through the oral mucosa due to their particle size of <300nm.
Fig.: Lipophilic active ingredient core, enclosed in a biocompatible carrier, covered by a water-soluble shell (smart coating) Manufacturing process: PuranoTec®
Fig.: Due to the particle size of <300nm and the Smart Coating, SmartLipids can be effectively absorbed via the oral mucosa.
3. BETTER BIOAVAILABILITY
In order to evaluate the absorption, safety and tolerability of the Apurano SmartLipid active ingredient formulation, pharmacokinetics and the occurrence of side effects were examined in a clinical phase-I study (SELECT I). In a post-hoc analysis, plasma concentrations were compared with literature values of other cannabinoid preparations. (Lorenzl et al., Med Cannabis Cannabinoids. 2022; 5(1): 9–19.) 12 healthy cannabis-naïve subjects received a single dose of 3.96 mg ∆-9-THC – prepared as a nanodispersion in an aqueous solution (SmartLipid AP701) and applied as an oromucosal spray. Pharmacokinetic parameters and tolerability were evaluated over a period of 30 hours.
Compared to the literature for other cannabinoid preparations, up to 70% lower doses are required to achieve the same plasma concentrations of ∆-9-THC.
Fig.: The results from the SELECT study were compared with published data of other cannabinoid compounds by normalizing the AUC0-t values to a dose of 3.96 mg ∆-9-THC.
4. NO PSYCHOTROPIC SIDE EFFECTS WITH APURANO CANNABINOID SMARTLIPIDS:
At a clinically relevant dose of 3.96 mg ∆-9-THC, the SmartLipid AP701 showed good tolerability without the occurrence of psychotropic side effects. A possible reason for the lack of psychotropic side effects is the direct absorption via the oral mucosa into the blood. This circumvents the first pass metabolism of the liver, resulting in less conversion of delta-9-THC to the (psycho-)active metabolite 11-OH-THC. Since the PuranoTec® manufacturing process does not use any chemical solvents or alcohol, it does not cause irritations of the oral mucosa.
Fig.: Development of psychotropic and other side effects over the first 8 hours after ingestion of 3.96 mg THC prepared as a nanodispersion in aqueous solution (SmartLipid AP701).
About US
ABOUT US
Apurano Pharmaceuticals GmbH is a vertically integrated pharmaceutical company focused on the development, manufacturing and clinical development of smart bio-nanotechnology drugs for chronic pain and psychiatric indications. The basis of Apurano is its worldwide patented nanotechnology PuranoTec®, which allows poorly water-soluble active ingredients from natural materials such as plants, fungi or cyanobacteria to be better absorbed as a nanodispersion applied sublingually via a spray. This has been shown by phase 1 studies (Lorenzl S et al., Medical Cannabis and Cannabinoids 2021).
Apurano conducts clinical phase 1 studies in its own clinical trial center in cooperation with a teaching hospital of the Ludwig Maximilian University of Munich. Phase 2 and 3 studies are designed and carried out with the leading university clinics and other clinical centers in Germany and Austria. In the last years Apurano has set up a team of specialists in clinical development, medical and regulatory affairs in order to design and conduct studies efficiently, in accordance with the latest regulatory requirements and with innovative IT methods and tools. In the meantime, Apurano has built up a stable network of leading university clinics and clinical as well as medical centers in Germany and Austria.
OUR MISSION
With the help of scientific knowledge & nanotechnology of natural active ingredients, we want to develop new therapies against chronic pain & psychiatric indications and thus give many patients a better quality of life.
With our fundamental research and manufacturing technology PuranoTec®, we want to improve the health of many people worldwide by using the full potential of natural active ingredients through PuranoTec® to improve chronic pain and psychiatric disorders. We are driven by our belief in scientific principles, innovation and passion.
Apurano combines decades of experience, expertise and basic research of world-leading scientists and clinicians in the field of chronic pain and psychiatric indications with the efficiency, precision and inventiveness of a highly motivated team. By this we want to improve the lives of many people in the long term.
With Smart Bio-Nanotechnology against chronic pain
Our company has the worldwide patented manufacturing technology PuranoTec®, which transfers natural active ingredients into a liquid nanoparticulate formulation so that they can be absorbed through the oral mucosa.
Leader in the field of nanoparticulate natural active ingredients
With its smart bio-nanotechnology PuranoTec®, Apurano has developed two active ingredients in two major indication areas, Adezunap as an active ingredient in the investigational drug AP707 for chronic pain and AP703 for psychiatric indications.
We’re tackling one of the world’s greatest health challenges
1.7 billion people worldwide suffer from chronic pain. 78% of patients affected by chronic pain are not satisfied with their current therapy because it does not sufficiently reduce their pain. At the same time, chronic pain is the leading cause of long-term disability and accounts for more than US$1 trillion in annual costs worldwide. This is more than cancer, heart disease and diabetes combined.
MANAGEMENT TEAM
Apurano Pharmaceuticals is led by a team of seasoned industry executives who collectively bring decades of productiontechnology, product development, clinical development and regulatory affairs experience to the company. The team not only shares an unparalleled determination and passion to help patients, but they also have a history of working together to successfully build companies and bring novel and effective therapies to market
Dr. Werner Brand
Managing Director
- Founder and Managing Director of Apurano Pharmaceuticals
- Entrepreneur since 2007: Founder of five pharmaceutical companies
- Inventor of five patent families and of the PuranoTec manufacturing process
- Many years of experience in management positions in companies in the automotive, process engineering and management consulting
- Studied aerospace engineering at the Technical University of Munich, The University Manchester (UK) and Northwestern University (USA), PhD at the University of Sheffield (UK)
Stefan Gähler-Brand
Chief Operating Officer
- Many years of experience in the operational area and quality management in the pharmaceutical industry
- 15 years of experience in supply chain management and quality management in various industries
- Studied economic geography at the Ludwig Maximilian University in Munich
Dr. Mathias Schmidt
Head of regulatory Affairs and Qualified Person
- Qualified Person at Apurano Pharmaceuticals GmbH since 2016
- Study of pharmacy and PhD at the Pharmaceutical Institute of the Eberhard Karls University of Tübingen
- Many years of experience as head of medical-scientific departments in the pharmaceutical industry with a focus on phytopharmaceuticals
- Since 2003 self-employed in the field of drug development and approval
- Processing of quality, toxicology, pharmacovigilance and clinical projects
- Expertise in phased plan and safety assessment procedures for herbal medicinal products
- Qualification as “Qualified Person Pharmacovigilance” and “Qualified Person” in the GMP area including quality management
- Extensive publication activity in the field of herbal medicinal products
- Chairman of the scientific board of trustees of the Society for Phytotherapy and member of the scientific committee of the ESCOP
- Focus on medicinal plants with effects against anxiety and depression, as well as endocrine applications and gastrointestinal diseases
- Deployment as an expert for the EU and the countries of Oceania for the quality and safety of use of kava (Piper methysticum)
SCIENTIFIC ADVISORY BOARD
Apurano Pharmaceuticals is also advised by a Scientific Board with considerable chronic pain, neurology and psychiatry research and development experience.
The team’s combined expertise in neurological research, clinical development, production and company building are critical for delivering on the promise of bringing innovative therapies to market to provide relief and hope for the millions of patients affected by neurological and psychiatric conditions.
Prof. Dr. med. Dr. h.c.
Walter Zieglgänsberger
Chairman, chronic pain
- Emeritus Professor of Clinical Neuropharmacology at the Max Planck Institute for Psychiatry in Munich
- Leading scientist in pain and addiction research
- Winner of the Federal Cross of Merit, 1st class
- Twice laureate of the German Pain Prize
- Founding member of various professional societies
- Reviewer and member of the editorial boards of numerous international journals, including Reviewing Editor for Science
Univ.-Prof. Dr. med. Dr. rer. nat.
Thomas R. Tölle
Chronic pain, neurology
- Head of the center for interdisciplinary pain medicine at the Klinikum Rechts der Isar of the Technical University of Munich and head of the clinical-experimental pain research group
- Head of the office of the German Research Association for Neuropathic Pain project of the BMBF and consortium leader of the Rise-uP project of the Innovation Fund of the G-BA.
- Member of the editorial boards of various specialist journals, tutor for the Alexander von Humboldt Foundation and reviewer for national and international research sponsors
Prof. Dr. pharm.
Rudolf Brenneisen
Pharmacology/Pharmacy
- Professor Emeritus University of Bern for Pharmacy
- 40 years of experience in cannabinoid pharmacology
- Board member of the Swiss Society for Medicinal Cannabis and Cannabinoids
- Secretary General of the Swiss Academy of Pharmaceutical Sciences
- Editor-in-Chief of the journal “Medical Cannabis and Cannabinoids”
Prof. Dr. med.
Dan Ziegler
Diabetic polyneuropathy
- Deputy Director of the German Diabetes Center
- Specialist in diabetic neuropathic pain
- Member of expert committees for the development of guidelines of national diabetes societies: DDG: Diabetic Neuropathy and ADA: Consensus Report on Diabetic Neuropathy
Prof. Dr. med.
Stefan Lorenzl
Spasticity, Palliative Care, Parkinson’s Disease
- Head of department neurology and palliative care hospital Agatharied (Ludwig Maximilian University Munich)
- Professor for palliative care at the Paracelsus University in Salzburg
- Focus TOP physician for Parkinson’s disease
- Author of over 100 scientific publications
- More than 200 scientific lectures in the last 5 years
- Member of several professional societies
- Head of the working group on palliative care in the German Society for Neurology together with Prof. Rolke
Prof. Dr. med.
Borwin Bandelow
Anxiety Disorders
- Professor Emeritus Neurology and Psychiatry University of Göttingen
- Author of numerous publications and books
- 2019 Focus TOP physician for Anxiety Disorders
- Founder and Honorary Chairman of the Society for Anxiety Research e.V.
- Listed by the magazine Cicero as one of the most important German-speaking intellectuals
Federal State Pharmacy Director a.D.
Hartmut Reinbold
Pharmacy
- Management of the central pharmacy of the LWL Klinik Dortmund for many years
- Long-standing technical chairman of the Drugs Commission of the Regional Association of Westphalia Lippe (LWL)
- Broad professional experience in pharmacology
- Numerous publications, lectures and author of 8 specialist books
- Lecturer for specialist training in psychiatry and geriatric pharmacy for many years
- Pharmacological training for doctors, pharmacists, nursing staff
- Nationwide implementation of clinical visits in psychiatric institutions
- Workshop management for “Meet the Expert”
- Expert for specific and complex pharmacological questions
Prof. Dr. Beat Lutz
Endocannabinoid System
- Director of the Institute for Physiological Chemistry at the Johannes Gutenberg University of Mainz
- World-renowned expert on the endocannabinoid system
- Author of numerous publications e.g. in Nature, Science and Neuroscience
- Chair of the Gordon Conference “Cannabinoid Functions in the CN: 2011
- Chairman of the DFG research area FOR926 (with Prof. A. Zimmer, Bonn): 2008-2014
PD Dr. Carsten Wotjak
Anxiety Disorders, Endocannabinoid System
- Director Preclinic at Boehringer-Ingelheim
- Expert in anxiety disorder and its pathogenesis
- Expert on the role of the endocannabinoid system in fear and anxiety
- Author of numerous publications in leading international scientific journals
- Previous group leader at the Max Planck Institute for Psychiatry, Stress Neurobiology & Neurogenetic
Prof. Dr. med. Kai G. Kahl
Anxiety Disorders, Affective Disorders
- Executive Senior Physician at the Clinic for Psychiatry, Social Psychiatry and Psychotherapy at the Hannover Medical School
- Medical management of the training institute for behavioral therapy and behavioral medicine (AVVM), supervisor
- Head of the research group “Brain, heart and mental disorders”
- Head of the AGNP working group “Polypharmacy”
- Clinical and scientific expertise in affective and personality disorders. Focus on borderline disorders
Prof. Dr. med. Michael Kellner
Anxiety and Obsessive–compulsive disorders
- Head of the speciality clinic for anxiety disorder, obsessive-compulsive disorder and post-traumatic stress disorder at the Klinikum rechts der Isar of the Technical University Munich
- Professor at the University Hospital Hamburg-Eppendorf
- Previous dead of department Psychiatry, Psychotherapy & Psychosomatic Medicine at the Herford Clinic (teaching hospital of the Ruhr University Bochum)
- Member of the S3 Guideline Commission for Anxiety Disorders
- 2011-2019 Focus Top Physician for Anxiety Disorder
- Development of the panic and anxiety outpatient clinic at the MPI in Munich
- Establishment of the first German special outpatient clinic for post-traumatic stress disorders in Hamburg
- Author of over 100 international peer-reviewed publications on panic and anxiety disorders, post-traumatic stress disorder, depression, obsessive-compulsive disorder; Focus on psychoneuroendocrinology, psychopharmacology and experimental psychopathology
- Indication areas: anxiety disorders, obsessive-compulsive disorder, post-traumatic stress disorder, depression
R&D GRANTS
Apurano Pharmaceuticals GmbH is focused on research and innovation. For this reason, our company was funded by the Bavarian State Ministry for Economics and Media, Energy and Technology with a very large research project in the first year after it was founded with a very large research project. In the following years, Apurano was funded four more times by the Bavarian State Ministry for Economics and Media, Energy and Technology and the Federal Ministry for Economics and Energy for various research projects in cooperation with well-known university partners. This underlines our innovative strength and the clear focus of our company on research and development.
Indications
INDICATIONS
1.7 billion people worldwide suffer from chronic pain. 78% of patients affected by chronic pain are not satisfied with their current therapy because it does not sufficiently reduce their pain. At the same time, chronic pain is the leading cause of long-term disability and accounts for more than US$1 trillion in annual costs worldwide. This is more than cancer, heart disease and diabetes combined.
Chronic pain is a very multifaceted and complex disease. It includes pain at the site of the event (so-called nociceptive pain) via the transmission of the spinal cord to various areas of the brain that are responsible for signal processing of the pain. In particular, these are limbic structures.
With Adezunap, Apurano has developed an active ingredient that attacks at various points in the chronic pain process. Adezunap is currently right before the pivotal study for chronic pain.
PRODUCT
PIPELINE
PIPELINE
Apurano Pharmaceuticals is in advanced clinical development with the investigational compound AP707 in the indications of chronic pain and MS spasticity.
In the first half of 2023, the phase-III studies DISCOVER conducted in four chronic pain indications will start in order to obtain generalized market approval for chronic pain.
Fig. Drug pipeline of Apurano Pharmaceuticals
Fachkreise
PROFESSIONAL GROUPS
INFORMATIONEN FOR MEDICAL PROFESSIONALS
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CAREER
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NEWS
NEWS
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 | E-mail info@apurano.de |  | Phone Order +49 8024 46869 80 Advice Hotline +49 8024 46869 70 Fax +49 8024 46869 99 |
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