Patent application EP16171316A (EP), filed 2016-05-25
Publication number: EP3248594A1
Title: TABLET FOR MULTIPLE ORAL APPLICATIONS
Abstract: The present invention relates to a multi-application tablet, in particular to a tablet being designated as a dispersible tablet, oral dispersible tablet, peroral tablet and/or chewable table. Further, the invention relates to a multi-application tablet, wherein the tablet comprises a granulated inner excipient phase and an outer phase comprising the active pharmaceutical ingredient.
IPC codes: A61K   9/    16            A I
A61K   9/    20            A I
A61K   9/    46            A I
Claims: number: 1
text: Multi-application tablet comprising
number: 2
text: Multi-application tablet according to claim 1, wherein the tablet can be used in two, three or four different applications.
number: 3
text: Multi-application tablet according to claims 1 or 2, wherein the tablet is selected from water-dispersible tablets, oral dispersible tablets, peroral tablets and/or chewable tablets.
number: 4
text: Multi-application tablet according to any one of the preceding claims, wherein the granulated inner phase is obtainable by wet granulation.
number: 5
text: Multi-application tablet according to any one of the preceding claims, wherein the (e2) surfactant is a non-ionic amphiphilic compound having an HLB value of 9.5 to 19, or anionic or cationic amphiphilic compound having an HLB value of 8 to 80.
number: 6
text: Multi-application tablet according to any one of the preceding claims, wherein the tablet comprises 0.2 to 7 wt.% binder, based on the total weight of the tablet.
number: 7
text: Multi-application tablet according to any one of the preceding claims, wherein the active pharmaceutical ingredient being present in the outer phase is in form of coated particles.
number: 8
text: Multi-application tablet according to any one of the preceding claims, wherein the active pharmaceutical ingredient is selected from paracetamol, arpiprazole, ibuprofen, pseudoephedrine, a combination of ibuprofen and pseudoephedrine, ascorbic acid, doxylamine, in particular paracetamol.
number: 9
text: Multi-application tablet according to any one of the preceding claims, wherein the excipients comprise
number: 10
text: Multi-application tablet according to any one of the preceding claims, wherein the tablet has a total weight of 50 to 1500 mg.
number: 11
text: Multi-application tablet according to any one of the preceding claims, wherein the tablet has a hardness of 30 N to 200 N as measured according to Ph.Eur. 6.0, Chapter 2.9.8.
number: 12
text: Multi-application tablet according to any one of the preceding claims, wherein the disintegration time of the tablet in water at 37°C is from more than 15 seconds to 5 minutes as measured according to Ph. Eur., 6<th> edition, chapter 2.9.1.
number: 13
text: Multi-application tablet according to any one of the preceding claims, wherein the tablet shows a content release of 60 to 100% after 15 minutes, as measured according to USP with apparatus type II paddle, 900 ml test medium, 0.1 n HCl, at 37°C, 75 rpm.
number: 14
text: Method for preparing a multi-application tablet according to claims 1 to 13, comprising the step of
Office action: search_report, dated 2017-11-29
Rejection reasons: inventive_step_epc_56
Prior art cited: ref_id: US2007218129A1
ref_type: patent
severity: background
ref_id: US2011300216A1
ref_type: patent
severity: background
ref_id: - BAUER FROMMING FUHRER: "Lehrbuch der Pharmazeutischen Technologie", 2006, WISSENSCHAFTLICHE VERLAGSGESELLSCHAFT MBH, pages: 319
ref_type: npl
severity: background
ref_id: - "Ph. Eur."
ref_type: npl
severity: background
ref_id: US2012196909A1
ref_type: patent
severity: background
ref_id: US2007104785A1
ref_type: patent
severity: background
ref_id: US2012196909
ref_type: patent
severity: obviousness
ref_id: US2007104785
ref_type: patent
severity: obviousness
Final disposition: pending (2017-11-29)