Patent application EP17169102A (EP), filed 2017-05-02
Publication number: EP3241549A1
Title: SPRINKLE COMPOSITION OF CINACALCET
Abstract: The present invention relates to a sprinkle composition of cinacalcet which provides a dissolution profile which is comparable to the currently marketed tablet dosage form.
IPC codes: A61K  31/   137            A I
A61K   9/    48            A I
A61K   9/    50            A I
Claims: number: 1
text: A capsule composition comprising a coated core of cinacalcet wherein the said composition releases at least about 60 % of cinacalcet in 60 minutes in 900 mL of 0.05 N hydrochloric acid in USP II apparatus at 100 rpm and said coated cores are taste masked.
number: 2
text: The capsule composition according to claim 1 wherein the composition further releases at least about 40 % of cinacalcet in 30 minutes in 900 mL of 0.05 N hydrochloric acid in USP II apparatus at 100 rpm.
number: 3
text: The capsule composition according to claim 1 wherein the coated cores are selected from the group consisting of plurality of granules, beads, pellets and minitablets.
number: 4
text: The capsule composition according to claim 3 wherein the coated cores have the particle size d<90> of less than or equal to 800 µm.
number: 5
text: The capsule composition according to claim 1 wherein the coated core comprises
number: 6
text: The capsule composition according to claim 5 wherein the weight ratio of cinacalcet to inert core is from about 1:0.1 to about 1:4.
number: 7
text: The capsule composition according to claim 5 wherein the taste mask coating may comprise one or more sweetener, taste mask polymers and coating additives.
number: 8
text: The capsule composition according to claim 5 wherein the taste mask coating is present in an amount from about 2% to about 40% w/w of the total weight of the composition.
number: 9
text: The capsule composition according to claim 5, wherein the composition further comprises one or more pharmaceutically acceptable excipients selected form the group comprising binder, disintegrant, diluents, surfactant, sweetener, antioxidants, glidants, and lubricants.
number: 10
text: The capsule composition according to claim 9, wherein the binder is present in an amount from about 8% to about 50% of the total weight of the composition.
number: 11
text: The capsule composition according to claim 9, wherein the disintegrant is present extra granularly.
number: 12
text: A capsule composition of cinacalcet comprising coated cores, wherein the coated cores comprise:
number: 13
text: A capsule composition of cinacalcet comprising coated cores in the form of
number: 14
text: The capsule composition according to claim 13, wherein the coated cores can be sprinkled on soft food.
number: 15
text: A pharmaceutically acceptable capsule containing a drug coated core composition comprising: a plurality of coated cores and a lubricant, wherein each coated core comprises
number: 16
text: The pharmaceutically acceptable capsule of claim 15, wherein the capsule releases at least about 40 % of cinacalcet in 30 minutes when placed in 900 mL of 0.05 N hydrochloric acid in USP II apparatus at 100 rpm.
number: 17
text: The pharmaceutically acceptable capsule according to claim 15 wherein the drug layer comprises cinacalcet hydrochloride and the weight ratio of cinacalcet hydrochloride to inert core is from about 1.25:1 to about 2:1.
number: 18
text: The pharmaceutically acceptable capsule of claim 15, wherein the taste mask layer comprises hypromellose and a sweetener.
number: 19
text: The pharmaceutically acceptable capsule of claim 15, wherein the drug layer further comprises hypromellose.
number: 20
text: The pharmaceutically acceptable capsule of claim 15, further comprising a disintegrant and glidant, wherein the ratio of lubricant: disintegrant: glidant is from about 0.5:0.5:1.0 to 2:2:2.5.
number: 21
text: The pharmaceutically acceptable capsult of claim 20, wherein the disintegrant is croscarmellose sodium, the lubricant is magnesium stearate, and the glidant is silicon dioxide.
Office action: search_report, dated 2017-11-08
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: WO2012071535A2
ref_type: patent
severity: background
ref_id: WO2008064202A2
ref_type: patent
severity: background
ref_id: EP2614816A1
ref_type: patent
severity: background
ref_id: WO2012071535A2
ref_type: patent
severity: background
ref_id: US2008260813A1
ref_type: patent
severity: background
ref_id: WO2008064202
ref_type: patent
severity: novelty_destroying
ref_id: US2008260813
ref_type: patent
severity: obviousness
ref_id: WO2012071535
ref_type: patent
severity: obviousness
ref_id: EP2614816
ref_type: patent
severity: novelty_destroying
Final disposition: pending (2017-11-08)