Patent application EP17176138A (EP), filed 2017-06-14
Publication number: EP3257516A1
Title: PHARMACEUTICAL COMPOSITION COMPRISING CETRARIA ISLANDICA ACH., SODIUM HYALURONATE AND A SALINE SOLUTION FOR TREATING AILMENTS OF THE RESPIRATORY SYSTEM
Abstract: The present invention relates to a composition comprising a mixture which comprises or, alternatively, consists of  Cetraria islandica Ach. , sodium hyaluronate and a saline solution with an osmolarity such as to ensure that the finished product has an osmolarity greater than or equal to 300 mOsm/l, for use as a medicament, preferably for adolescents and subjects of paediatric age. In particular, the present invention relates to said composition for use in the treatment of respiratory tract disorders selected from among rhinitis, sinusitis, asthma, pharyngitis (pharyngotonsillitis), epiglottitis, laryngitis, bronchiolitis, cystic fibrosis and bronchiectasis, in particular for adolescents and subjects of paediatric age. Finally, the present invention relates in particular to said composition for use in the treatment of respiratory tract pathologies associated with mucus hypersecretion, preferably for adolescents and subjects of paediatric age.
IPC codes: A61K  31/   728            A I
A61K  33/    14            A I
A61K  36/    09            A I
A61K   9/    12            A I
A61P  11/    00            A I
Claims: number: 1
text: A pharmaceutical composition comprising:
number: 2
text: The composition according to claim 1, wherein theCetraria islandica Ach. is present as a fluid, dry or glyceric extract; preferably, theCetraria islandica Ach. is present in a concentration by weight comprised from 0.001% to 10%, preferably in a concentration by weight comprised from 0.1% to 5%, and even more preferably in a concentration by weight comprised from 0.1% to 2.5%, relative to the total weight of the composition.
number: 3
text: The composition according to claim 1 or 2, wherein the sodium hyaluronate is present in a concentration by weight comprised from 0.01% to 5%, preferably in a concentration by weight comprised from 0.05% to 2.5%, or from 0.3% to 2.5%, and even more preferably in a concentration by weight comprised from 0.1 % to 1% or from 0.5% to 1%, relative to the finished product/final composition.
number: 4
text: The composition according to any one of claims 1-3, wherein the average molecular weight of the sodium hyaluronate used together with theCetraria islandica Ach. is comprised from 100 kDa to 3000 kDa; preferably, the average molecular weight of the sodium hyaluronate is comprised from 200 kDa to 1500 kDa; even more preferably, the average molecular weight of the sodium hyaluronate is comprised from 300 kDa to 1000 kDa.
number: 5
text: The composition according to any one of claims 1-4, wherein the saline solution is based on an osmotically active salt, preferably sodium chloride, in an amount such as to ensure that said composition has an osmolarity greater than or equal to 300 mOsm/l, preferably comprised from 300 mOsm/l to 10000 mOsm/l or from 300 mOsm/l to 2000 mOsm/l; even more preferably, it has an osmolarity comprised from 300 mOsm/l to 3000 mOsm/l or from 400 mOsm/l to 1000 mOsm/l, for example 360, 500, 600, 700, 800, 900, 1000, 1220, 1660, 2100, 2380 or 2900 mOsm/l.
number: 6
text: The composition according to any one of claims 1-5, wherein said composition is for use in the treatment of adolescents and subjects of paediatric age.
number: 7
text: The composition according to any one of claims 1-6, wherein said composition is for use in the treatment of the respiratory tract pathologies associated with mucus hypersecretion, preferably in adolescents and subjects of paediatric age.
number: 8
text: The composition according to any one of claims 1-7, wherein said composition is for oral, nasal or inhalatory use, by spray or aerosol application/administration.
number: 9
text: The composition according to any one of claims 1-8, wherein said composition is administered by nebulization with a special device, such as a pneumatic or ultrasonic nebulizer, or by using a spray, or by direct nasal instillation.
Office action: search_report, dated 2017-12-20
Rejection reasons: inventive_step_epc_56
Prior art cited: ref_id: DE202006011920U1
ref_type: patent
severity: background
ref_id: DE202013000445U1
ref_type: patent
severity: background
ref_id: WO2015082356A1
ref_type: patent
severity: background
ref_id: EP2664330A1
ref_type: patent
severity: background
ref_id: - "EMA/HMPC/36866/2014", 6 May 2014, article MARIE  HEROUTOVA ET AL: "Assessment report on Cetraria islandica (L.) Acharius s.l., thallus", XP055349638
ref_type: npl
severity: background
ref_id: DE202006011920U
ref_type: patent
severity: background
ref_id: DE202013000445U
ref_type: patent
severity: background
ref_id: EP2664330
ref_type: patent
severity: obviousness
ref_id: WO2015082356
ref_type: patent
severity: obviousness
ref_id: - Marie Heroutova ET AL, "Assessment report on Cetraria islandica (L.) Acharius s.l., thallus", EMA/HMPC/36866/2014, (20140506), XP055349638 [Y] 1-9 * page  4  - page  10 * * page  14  - page  18 * * page  22; tables 5,6 *
ref_type: npl
severity: obviousness
Final disposition: pending (2017-12-20)