CY1121570T1 - NICOTINE PREPARATION - Google Patents

NICOTINE PREPARATION

Info

Publication number
CY1121570T1
CY1121570T1 CY20191100419T CY191100419T CY1121570T1 CY 1121570 T1 CY1121570 T1 CY 1121570T1 CY 20191100419 T CY20191100419 T CY 20191100419T CY 191100419 T CY191100419 T CY 191100419T CY 1121570 T1 CY1121570 T1 CY 1121570T1
Authority
CY
Cyprus
Prior art keywords
solution
nicotine
film
weight
average
Prior art date
Application number
CY20191100419T
Other languages
Greek (el)
Inventor
Fredrik Hübinette
Original Assignee
Nicoccino Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from EP13712730.4A external-priority patent/EP2830589B1/en
Application filed by Nicoccino Ab filed Critical Nicoccino Ab
Publication of CY1121570T1 publication Critical patent/CY1121570T1/en

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Μέθοδος βιομηχανικής κατασκευής ενός βλεννοπροσφυτικού υμενίου που περιέχει νικοτίνη, με την παρασκευή ενός υδατικού διαλύματος σε ένα pΗ από 9,5 έως 13, με το διάλυμα να περιλαμβάνει (i) ένα άλας νικοτίνης, (ii) έναν αλκαλικό παράγοντα ρύθμισης του pΗ, και (iii) έναν παράγοντα σχηματισμού υμενίου που περιλαμβάνει ένα αλγινικό άλας μονοσθενούς κατιόντος ή ένα μίγμα αλγινικών αλάτων μονοσθενών κατιόντων, με τον παράγοντα σχηματισμού υμενίου να έχει μια μέση περιεκτικότητα γουλουρονικού (G) από 50 έως 85% κατά βάρος, μια μέση περιεκτικότητα μαννουρονικού (Μ) από 15 έως 50% κατά βάρος, ένα μέσο μοριακό βάρος από 30.000 g/mol έως 90.000 g/mol και είναι τέτοιος που ένα υδατικό διάλυμα του 10% σε μια θερμοκρασία 20°C έχει ένα ιξώδες 100-1000 mPas, όπως μετριέται σε ένα ρυθμό διάτμησης 20 σαλ με τη χρήση ενός ιξωδόμετρου Brookfield με αξονίσκο No. 2, κατανέμοντας το διάλυμα επάνω σε μια στερεή επιφάνεια και επιτρέποντας στο διάλυμα να ξηρανθεί επάνω στην επιφάνεια. Βλεννοπροσφυτικό υμένιο που περιέχει νικοτίνη.Process for the manufacture of a nicotine-containing mucosal adhesive film, by preparing an aqueous solution at a pH of 9.5 to 13, wherein the solution comprises (i) a nicotine salt, (ii) an alkaline pH adjusting agent, and ( (iii) a film-forming agent comprising a monovalent cation alginate or a mixture of monovalent cation alginates, with the film-forming agent having an average guluronic acid (G) content of 50 to 85% by weight, an average mannuronic acid (M) content from 15 to 50% by weight, an average molecular weight of 30,000 g / mol to 90,000 g / mol and is such that a 10% aqueous solution at a temperature of 20 ° C has a viscosity of 100-1000 mPas, as measured in a shear rate of 20 rpm using a Brookfield viscometer with no. 2, distributing the solution on a solid surface and allowing the solution to dry on the surface. Mucosal adhesive film containing nicotine.

CY20191100419T 2012-03-27 2019-04-16 NICOTINE PREPARATION CY1121570T1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261615997P 2012-03-27 2012-03-27
EP12161483 2012-03-27
EP13712730.4A EP2830589B1 (en) 2012-03-27 2013-03-15 Nicotine formulation
PCT/EP2013/055456 WO2013143891A1 (en) 2012-03-27 2013-03-15 Nicotine formulation

Publications (1)

Publication Number Publication Date
CY1121570T1 true CY1121570T1 (en) 2020-05-29

Family

ID=66248907

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191100419T CY1121570T1 (en) 2012-03-27 2019-04-16 NICOTINE PREPARATION

Country Status (10)

Country Link
CY (1) CY1121570T1 (en)
DK (1) DK2830589T3 (en)
ES (1) ES2720488T3 (en)
HR (1) HRP20190598T1 (en)
HU (1) HUE043009T2 (en)
IL (1) IL234771B (en)
LT (1) LT2830589T (en)
ME (1) ME03456B (en)
PT (1) PT2830589T (en)
TR (1) TR201905664T4 (en)

Also Published As

Publication number Publication date
TR201905664T4 (en) 2019-05-21
ME03456B (en) 2020-01-20
DK2830589T3 (en) 2019-04-29
IL234771A0 (en) 2014-11-30
IL234771B (en) 2019-10-31
LT2830589T (en) 2019-05-27
HUE043009T2 (en) 2019-07-29
PT2830589T (en) 2019-05-20
ES2720488T3 (en) 2019-07-22
HRP20190598T1 (en) 2019-06-14

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