Claims for Patent: 10,688,047

Summary for Patent: 10,688,047

Title:	Physically and chemically stable oral suspensions of givinostat
Abstract:	Physically and chemically stable oral liquid formulations of Givinostat (Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride) are disclosed, together with methods for the preparation thereof. Such oral formulations are in the form of aqueous suspensions and contain Givinostat and/or pharmaceutically acceptable salts and/or derivatives thereof, at least a wetting agent and/or at least a density-imparting agent. Such formulations are suitable for oral administration for systemic therapeutic action.
Inventor(s):	Colombo Giuseppe, Artico Roberta, Mascagni Paolo, Monzani Maria Valmen, Puccianti Silvia
Assignee:	ITALFARMACO SPA
Application Number:	US15770443
Patent Claims:	2. The suspension according to claim 1 , characterized in that Givinostat and/or a pharmaceutically acceptable salt thereof is present in amounts between 0.1% w/v and 20% w/v.3. The suspension according to claim 1 , characterized in that Givinostat and/or pharmaceutically acceptable salt thereof is present in particle form having an average particle size lower than 200 μm.4. The suspension according to claim 1 , characterized in that said wetting agent is a polyoxyethylene sorbitan fatty acid ester.5. The suspension according to claim 1 , characterized in that said wetting agent is present in amounts between 0.00025% w/v and 2% w/v.6. The suspension according to claim 1 , characterized in that said density-imparting agent is present in amounts between 5% w/v and 70% w/v.7. The suspension according to claim 1 , characterized in that said buffering agent is tartrate buffer.8. The suspension according to claim 1 , characterized in that said buffering agent is present in amounts between 0.05% w/v and 5% w/v.9. The suspension according to claim 1 , characterized in that said suspending agent is present in amounts between 0.01% w/v and 5% w/v.10. The suspension according to claim 1 , characterized in that said suspending agent is tragacanth gum.11. A method for treating a disease responding to histone deacetylase inhibitors selected from the group consisting of: neurological and psychiatric diseases claim 1 , cancer claim 1 , inflammatory diseases claim 1 , HIV/AIDS claim 1 , and spinal muscular atrophy; comprising the step of administering the suspension according to to a subject in need thereof.12. The method according to claim 11 , which treats disease responding to Givinostat selected from the group consisting of systemic juvenile idiopathic arthritis claim 11 , polycythaemia vera claim 11 , essential thrombocythemia claim 11 , leukemias claim 11 , myelomas claim 11 , myelofibrosis claim 11 , Duchenne muscular dystrophy claim 11 , Becker muscular dystrophy and other forms of muscular dystrophy.13. The method according to claim 12 , characterized in that it is administered orally.14. A method for preparing the suspension according to claim 1 , comprising the steps of:a) preparing a dispersing vehicle comprising water, the density-imparting agent, the suspending agent and the buffering agent;b) pre-dispersing Givinostat into an aqueous solution comprising the wetting agent; andc) adding said pre-dispersion to said dispersing vehicle in order to obtain a suspension.15. The suspension according to claim 1 , characterized in that said polyoxyethylene sorbitan fatty acid ester is polysorbate 20 or polysorbate 80.16. The suspension according to claim 1 , characterized in that said density-imparting agent is sorbitol.17. The suspension according to claim 1 , wherein the wetting agent is a polyoxyethylene sorbitan fatty acid ester claim 1 , the density-imparting agent is sorbitol claim 1 , the buffer agent is a tartrate buffer claim 1 , and the suspending agent is tragacanth gum.