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(12) Patent Application Publication (10) Pub. No.: US 2015/0024048A1 Hemmingsen Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2015/0024048A1 Hemmingsen Et Al US 2015.0024048A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0024048A1 Hemmingsen et al. (43) Pub. Date: Jan. 22, 2015 (54) CONTROLLED RELEASE (52) U.S. Cl. PHARMACEUTICAL COMPOSITIONS FOR CPC ............. A61K9/2086 (2013.01); A61 K9/2853 PROLONGED EFFECT (2013.01); A61 K3I/573 (2013.01); A61 K 3 1/167 (2013.01); A61 K31/485 (2013.01) (71) Applicant: Egalet Ltd., London (GB) USPC ............ 424/472: 514/179; 514/630; 514/282 (72) Inventors: Pernille Hoyrup Hemmingsen, (57) ABSTRACT Bagsvaerd (DK); Anders Vagno Pedersen, Virum (DK); Daniel Layered pharmaceutical composition Suitable for oral use in Bar-Shalom, Kokkedal (DK) the treatment of diseases where absorption takes place over a large part of the gastrointestinal tract. The composition com (21) Appl. No.: 14/446,234 prising A) a solid inner layer comprising i) an active substance, and (22) Filed: Jul. 29, 2014 ii) one or more disintegrants/exploding agents, one of more effervescent agents or a mixture thereof. Related U.S. Application Data the solid inner layer being sandwiched between two outer (63) Continuation of application No. 12/602.953, filed on layers B1) and B2), each outer layer comprising Jun. 7, 2010, now Pat. No. 8,821,928, filed as applica iii) a substantially water soluble and/or crystalline polymer or tion No. PCT/EP2008/056910 on Jun. 4, 2008. a mixture of substantially water soluble and/or crystalline polymers, the polymer being a polyglycol in the form of one (60) Provisional application No. 60/941,848, filed on Jun. ofa) a homopolymer having a MW of at least about 100,000 4, 2007. daltons, and b) a copolymer having a MW of at least about (30) Foreign Application Priority Data 2,000 daltons, or a mixture thereof, and iv) an active Substance, which is the same as in said solidinner Jun. 4, 2007 (DK) ........................... PA 2007 OO816 layer A), and layer A being different from layer B. Publication Classification the layered composition being coated with a coating C) that has at least one opening exposing at least one Surface of said (51) Int. Cl. outer layer, the coating being Substantially insoluble in and A6 IK9/20 (2006.01) impermeable to fluids and comprising a polymer, and the A6 IK3I/485 (2006.01) composition having a cylindrical form optionally with one or A6 IK3I/67 (2006.01) more tapered ends, wherein the ratio between the surface area A6 IK 9/28 (2006.01) of one end surface of the cylinder and the length of the A 6LX3/573 (2006.01) cylinder is in a range of from 0.02 to 45 mm. Patent Application Publication Jan. 22, 2015 Sheet 1 of 24 US 2015/0024048A1 Second burst matrix (A) First burst matrix Delay plug (B) Shell (C) Fig. 1 Patent Application Publication Jan. 22, 2015 Sheet 2 of 24 US 2015/0024048A1 Active plug (B) Active plug (A) Shell (C) Fig. 2 Patent Application Publication Jan. 22, 2015 Sheet 3 of 24 US 2015/0024048A1 1OO Š -- 80 --S. Burst-Hydrocodone 'Na' S i --&- Controlled - Morphine g 60 sŠS as s 3. Š SS 40 s s is O 2 4. 6 8 10 12 14 16 18 Time (h) Fig. 3 Patent Application Publication Jan. 22, 2015 Sheet 4 of 24 US 2015/0024048A1 --&-Morphine 6 O or Sr. OxyCodone 40 - 20 p. o: O 5 10 15 20 Time (h) Fig. 4 Patent Application Publication Jan. 22, 2015 Sheet 5 of 24 US 2015/0024048A1 A delay.plug - B / / ) \ Center plug Shell \ (A) / \ , ? Ys -l |- ^ N - - end plug (AVB) Fig. 5 Patent Application Publication Jan. 22, 2015 Sheet 6 of 24 US 2015/0024048A1 1OO – 8O 6O – 40 - --buffer 7.2 2O -H buffer 6.8 -o-0.1 NHCl O r r O 50 1OO 15O 2OO 250 3OO Time (min) Fig. 6 Patent Application Publication Jan. 22, 2015 Sheet 7 of 24 US 2015/0024048A1 Shell (C) End Plug(B) Center plug (A) Fig. 7 Patent Application Publication Jan. 22, 2015 Sheet 8 of 24 US 2015/0024048A1 100,0 ... --o-o-o-o----- *** I i 80, O – i i 60,0- s s : ?: -o-' SS 40.0 - * - s - 20,0- - - - s s O,O (s O 1 2 3 4 5 6 7 8 9 10 Time (h) Fig. 8 Patent Application Publication Jan. 22, 2015 Sheet 9 of 24 US 2015/0024048A1 .xerx-8* ...x-x-8**.-- ...x-8-8-"*** c 80 - - f 60 i s 40 i 2O - | a x O s.--S$SS Nrs O 1 2 3 4 Time (h) Fig. 9 Patent Application Publication Jan. 22, 2015 Sheet 10 of 24 US 2015/0024048A1 Shell (C) End plug(B) Pellets (A) Filler (A) Fig. 10 Patent Application Publication Jan. 22, 2015 Sheet 11 of 24 US 2015/0024048A1 80 - 6O - 4 O 20 10 15 20 Time (h) Fig.11 Patent Application Publication Jan. 22, 2015 Sheet 12 of 24 US 2015/0024048A1 100 - s a s O 80 - A A : N • & sixx &r & 40%O EtOH A -8. Phosphate-buffer is 60 - 4 f f & S. f 40 – g O O O,5 1 15 2 Time (h) Fig. 12 Patent Application Publication Jan. 22, 2015 Sheet 13 of 24 US 2015/0024048A1 120 100 re 8 O 6 O Fig. 13 Patent Application Publication Jan. 22, 2015 Sheet 14 of 24 US 2015/0024048A1 120 ; 1OO sa-Šasasasasa-Šarxvts 80 : W& 3. : S. 3 6o : s g & S. & 40 20 Patent Application Publication Jan. 22, 2015 Sheet 15 of 24 US 2015/0024048A1 Burst-lag-burst f Burst: 1 - 100% in less than 1h - Lag: less than 10% (5%) in a s duration of 1 to 10h Burst: 1 - 100% in less than 1 h Fig. 15 Patent Application Publication Jan. 22, 2015 Sheet 16 of 24 US 2015/0024048A1 ac Burst-controlled-burst $ Burst: 1 - 100% in eSS than 1 h Controlled: 0.1%/h - 30%/h (50 %/h) in a duration of 1 to 10h Burst: 1 - 100% in eSS than 1 h Fig. 16 Patent Application Publication Jan. 22, 2015 Sheet 17 of 24 US 2015/0024048A1 Burst-controlled Burst: 1 - 99% in less than 1 h econtrolled: 0.1%/h -30%/h (50 %/h) in a duration of 1 to 10h Fig. 17 Patent Application Publication Jan. 22, 2015 Sheet 18 of 24 US 2015/0024048A1 Controlled-burst Controlled: 0.1%/h - 30%/h (50%/h) in a duration of 1 to 10 h Burst: 1 - 100% in less than 1 h Fig. 18 Patent Application Publication Jan. 22, 2015 Sheet 19 of 24 US 2015/0024048A1 Lag-burst Lag: less than 10% (5%) in a duration of 1 to 10h Burst: 1 - 100% in leSS than 1h Lag-burst-lag-burst etc Fig. 19 Patent Application Publication Jan. 22, 2015 Sheet 20 of 24 US 2015/0024048A1 Controlled-controlled Controlled: 0.1%/h - 30%/h / (50%/h) in a duration of 1 to 10 a Controlled: 0.1%/h - 30%/h (50%/h) in a duration of 1 to 10 h Fig. 20 Patent Application Publication Jan. 22, 2015 Sheet 21 of 24 US 2015/0024048A1 Controlled-controlled oControlled: 0.1%/h - 30%/h (50%/h) in a duration of 1 to 10 h oControlled: 0.1%/h - 30%/h L1 (50%/h) in a duration of 1 to 10 Time h Fig. 21 Patent Application Publication Jan. 22, 2015 Sheet 22 of 24 US 2015/0024048A1 1 Active A 1 - 100% in less than 12h 2 ACtive B 1 - 100% in less than 12h Time Fig. 22 Patent Application Publication Jan. 22, 2015 Sheet 23 of 24 US 2015/0024048A1 1 Active A 1/ / 1 - 100% in less than 12h 2 Active B 0.1%/h - 30%/h (50%/h) in a duration of 1 to 12h 1 - 100% in less than 12h Fig. 23 Patent Application Publication Jan. 22, 2015 Sheet 24 of 24 US 2015/0024048A1 -aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa 1 Active A 1 - 100% in less than 12h 2 Active B 2 eless than 10% (5%) in a duration of 1 to 12 h 1 - 100% in less than 12h Fig. 24 US 2015/0024048 A1 Jan. 22, 2015 CONTROLLED RELEASE keeping” (intestinal peristalsis) might lead to anomalies in the PHARMACEUTICAL COMPOSITIONS FOR effect of solid oral dosage forms which might be compensated PROLONGED EFFECT by the formulation. 0005. Furthermore, the active substance may exert its CROSS-REFERENCE TO RELATED effect locally in the colon or other parts of the gastrointestinal APPLICATIONS system, Such as for treatment of cancer, inflammation, gas 0001. This application is a continuation of U.S. patent trointestinal diseases and treatment with anthelmintic agents. application Ser. No. 12/602.953, filed Jun. 7, 2010, which is a BRIEF DESCRIPTION OF THE DRAWINGS National Stage of International Application No. PCT/ EP2002/056910, filed Jun. 4, 2008, which claims the benefit 0006 FIG. 1, illustrate double burst unit, with a delay under 35 U.S.C. S 119(e) of U.S. Provisional Patent Applica between the two bursts. tion No. 60/941,848, filed Jun. 4, 2007, these applications are 0007 FIG. 2, illustrate simple combination formulation. incorporated herein by reference in their entireties. 0008 FIG.3, releases of Hydrocodone and Morphine with burst-controlled release behaviour see preparation 4. INTRODUCTION 0009 FIG. 4, releases of Oxycodone and Morphine with controlled-controlled release behaviour see preparation 5. 0002 The present invention relates to a technology that is (0010 FIG. 5, illustrate double burst unit, with a delay especially Suitable for designing oral pharmaceutical compo between the two bursts.
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