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( 12 ) United States Patent US009775814B2 (12 ) United States Patent (10 ) Patent No. : US 9 , 775 ,814 B2 Teles et al. (45 ) Date of Patent: Oct . 3 , 2017 ( 54 ) ENTERIC SOFT CAPSULE COMPOSITIONS 2007/ 0196463 AL 8 / 2007 Podili et al . 2012 /0301546 Al * 11/ 2012 Hassan . .. .. A61K 31/ 00 424 /465 ( 71 ) Applicant: PATHEON SOFTGELS INC , High 2013/ 0034605 A1 * 2 /2013 Kshirsagar .. .. .. A61K 9 / 2886 Point, NC (US ) 424 /472 ( 72 ) Inventors : Helena Maria de Albuquerque 2014 /0348879 AL 11 / 2014 Hassan et al. Ferreira Teles , Breda (NL ) ; Henricus FOREIGN PATENT DOCUMENTS Marinus Gerardus Maria van Duijnhoven , den Bosch (NL ) ; Mélanie DE 3222476 A1 12 / 1983 Françoise Géraldine Bayarri, Tilburg EP 0092908 A2 3 / 1983 EP 1184033 A1 3 / 2002 (NL ) wo 9850019 A1 11/ 1998 WO 0067723 A2 11/ 2000 ( 73 ) Assignee : PATHEON SOFTGELS INC . , High WO 0124780 A2 4 / 2001 Point, NC (US ) wo WO 02 / 49637 A1 6 / 2002 WO 2004012701 A2 2 /2004 @( * ) Notice : Subject to any disclaimer, the term of this WO 2004030658 A1 4 /2004 patent is extended or adjusted under 35 U . S . C . 154 (b ) by 0 days . OTHER PUBLICATIONS Eudragit NE 30D [ retrieved from on - line website : http :/ /eudragit . ( 21) Appl . No. : 14 /744 ,057 evonik . com /product /eudragit /en /products - services / eudragit - prod ucts / sustained - release - formulations/ ne -30 - d /pages / default. aspx , ( 22 ) Filed : Jun . 19 , 2015 last visit Mar. 31 , 2016 ] ). * Eudragit L 100 — [ retrived from on - line website : http :/ / eudragit. (65 ) Prior Publication Data evonik . com /product / eudragit /en /products -services / eudragit- prod US 2015 / 0366815 A1 Dec. 24 , 2015 ucts/ enteric - formulations/ 1 - 100 /Pages /default . aspx , last visit Mar. 31, 2016 ]. * Eudragit FS 30D [ retrieved from on - line website : http : / / eudragit . Related U . S . Application Data evonik . com /product / eudragit /en /products -services / eudragit- prod (60 ) Provisional application No . 62 /015 ,063 , filed on Jun . ucts /enteric -formulations / fs - 30 - d /pages /default .aspx , last visit Mar. 31 , 2016 ). * 20 , 2014 . Waybackmachine ( Eudragit NE 30D [ retrieved from on - line web site : https :/ /web .archive . org /web / * /http : // eudragit .evonik .com / (51 ) Int. Ci. product / eudragit / en / products -services / eudragit - products / sustained A61K 9 / 48 ( 2006 . 01 ) release - formulations/ ne - 30 - d / pages/ default .aspx , last visit Mar . 31 , A61K 9 /40 ( 2006 .01 ) 2016 ] ) . * Waybackmachine (Eudragit L100 : [ retrieved from on - line website : ( 52 ) U . S . CI. https: / /web .archive . org /web / 20160328193204 / http : // eudragit . CPC . .. .. .. .. .. A61K 9 / 4866 ( 2013 .01 ) ; A61K 9 /485 evonik . com /product / eudragit / en /products - services /eudragit -prod (2013 .01 ) ; A61K 9 / 4808 ( 2013 .01 ) ; A61K ucts / enteric - formulations/ 1 - 100 / pages /default . aspx , last visit Mar. 9 /4825 ( 2013 .01 ) ; A61K 9 /4833 (2013 .01 ) ; 31, 2016 ]) . * A61K 9 /4858 (2013 .01 ) Waybackmachine ( Eudragit FS 3D ; [ retrieved from on - line website : ( 58 ) Field of Classification Search https: // web . archive. org /web / * /http : / / eudragit . evonik . com / product / None eudragit/ en / products - services /eudragit -products / enteric - formula tions/ fs - 30 - d /pages /default .aspx , last visit Mar . 31, 2016 ] ) . * See application file for complete search history . Nikam et al ., “ Eudragit a versatile polymer: a review ” , Pharmacologyonline 1 : 152 - 164 ( 2011, pp . 152 - 164 ) . * ( 56 ) References Cited International Search Report for PCT /US2015 /036539 , mailed Sep . 25 , 2015 . U . S . PATENT DOCUMENTS Zu , Y ., et al. , “ Effect of neutralization of poly (methacrylic acid - co 3 ,826 ,666 A 7 / 1974 Hirai et al . ethyl acrylate ) on drug release from enteric -coated pellets upon 3 , 959 , 540 A 5 / 1976 Leiberich et al . accelerated storage ” , Drug Development and Industrial Pharmacy , 4 , 138 ,013 A 2 / 1979 Okajima vol. 33 ( 2007 ) , pp . 457 -473 . 4 ,500 ,453 A 2 / 1985 Shank 4 , 790 , 881 A 12 / 1988 Wittwer et al. * cited by examiner 4 , 816 , 259 A 3 / 1989 Matthews et al. 5 , 146 , 730 A 9 / 1992 Sadek et al . 5 , 194 , 464 A 3 / 1993 Itoh et al . Primary Examiner — Ernst V Arnold 5 , 459 , 983 A 10 / 1995 Sadek et al . Assistant Examiner — Kyung Sook Chang 6 , 193 , 999 B1 2 / 2001 Gennadios (74 ) Attorney , Agent, or Firm — Brinks Gilson & Lione 6 , 331 , 316 B1 12 / 2001 Ullah et al. 6 ,482 , 516 B1 11 / 2002 Sadek et al . 8 , 685, 445 B2 4 / 2014 Hassan et al. (57 ) ABSTRACT 2001 /0051188 A1 12 / 2001 Ullah et al. Described herein are enteric soft capsules comprising gastric 2005 / 0095285 A1 5 / 2005 Rao et al . 2006 /0115527 Al 6 / 2006 Hassan et al . resistant polymers and gelatin and methods for manufactur 2006 / 0165778 Al 7 / 2006 Hassan et al. ing the same. The enteric soft capsules described herein have 2007 / 0082046 A1 * 4 / 2007 Chidambaram .. A61K 9 /4816 enhanced enteric and elastic properties and are simpler to 424 /456 manufacture and produce . 2007/ 0098786 A1* 5 / 2007 Chidambaram .. A61K 9 / 4816 424 /456 22 Claims, No Drawings US 9 , 775 , 814 B2 ENTERIC SOFT CAPSULE COMPOSITIONS addition , these enteric soft capsules present unexpectedly enhanced enteric properties and require the use of less CROSS REFERENCE TO RELATED plasticizing agents . The gel mass is simpler and safer to APPLICATIONS manufacture because the use of volatile alkali agents is not 5 required . Furthermore , the enteric soft capsules described This application claims priority to U . S . Provisional Patent herein have an increased compatibility with alkali - labile Application No . 62/ 015 ,063 , filed Jun . 20 , 2014 , which is active drug substances . incorporated by reference herein in its entirety . This appli cation is related to International Patent Application No . SUMMARY PCT /US2015 / 36539 , filed on Jun . 19 , 2015 , which is incor - 10 porated by reference herein in its entirety . One embodiment described herein is an oral enteric soft capsule shell formed from a gel mass composition compris TECHNICAL FIELD ing : ( a ) at least one or more film - forming polymers ; ( b ) at least one or more acid - insoluble polymers ; ( c ) at least one or Described herein are enteric soft capsules comprising 15 more plasticizers ; ( d ) a solvent ; and ( e ) optionally , an alkali gastric resistant polymers and gelatin and methods for neutralizing agent. In one aspect described herein , the one or manufacturing the same. more film - forming polymers comprises about 10 % to about 40 % of the total gel mass . In another aspect described BACKGROUND herein , the one or more film - forming polymers comprises 20 gelatin , hydroxypropylmethylcellulose (HPMC ) , or carra The use and manufacture of enteric dosage forms are geenan . In one aspect described herein , the one or more known in the art. Such dosage forms are described in film - forming polymers comprises Type A gelatin or Type B Remington ' s Pharmaceutical Sciences, 18th ed ., Mack Pub gelatin . In another aspect described herein , the Type A lishing Co . , Easton , Pa . ( 1990 ) . Enteric dosage forms are gelatin comprises acid bone, pig skin , poultry , fish , gelatin useful for protecting the contents of the dosage form from 25 hydrolysate , or acid hide ; and the Type B gelatin comprises the gastric conditions of the stomach and / or to protect lime bone gelatin . In another aspect described herein , the gastric tissue from an irritant material contained in the Type A gelatin has a Bloom strength of about 150 grams to dosage form . A further use for enteric dosages is prevention about 200 grams and the Type B gelatin has a Bloom of a lasting , unacceptable mouth odor resulting from inges - strength of about 130 grams to about 170 grams. In another tion of substances like garlic or fish oil . Enteric dosage 30 aspect described herein , the Type A gelatin or Type B gelatin forms are also used to provide slow , controlled , or delayed comprises about 20 % to about 32 % of the total gel mass . In release of a substance . one aspect described herein , the one or more acid - insoluble Enteric - coated dosage forms are typically produced by a polymers comprises about 5 % to about 20 % of the total gel film coating process , where a thin film layer of an acid - mass . In another aspect described herein , the one or more insoluble ( enteric ) polymer is applied to the surface of a 35 acid - insoluble polymers comprises acrylic and methacrylate pre -manufactured dosage form , such as a tablet, and to a acid copolymers , cellulose acetate phthalate (CAP ) , cellu lesser extent hard and soft capsules . The enteric coating lose acetate butyrate , hydroxypropylmethylcellulose phtha method involves spraying an aqueous or organic solution or late (HPMCP ) , sodium alginate , pectin , or potassium alg suspension of one or more enteric polymers onto tumbling inate . In another aspect described herein , the one or more or moving tablets or capsules, followed by drying at elevated 40 acrylic and methacrylate acid copolymers comprises: ( a ) temperatures . poly (methacylic acid - co -ethyl acrylate) 1 : 1 ; or ( b ) poly Enteric soft capsules are described in U . S . Pat. No . (methacylic acid - co - ethyl acrylate ) 1 : 1 and poly ( ethyl acry 8 ,685 , 445 , where an acid - insoluble polymer is combined late -co -methyl methacrylate ) 21; or (c ) poly (methacylic with a water soluble film forming polymer in the presence of acid - co - ethyl acrylate ) 1 : 1 and poly (methyl acrylate - co an alkaline aqueous solvent. This formulation resulted in 45 methyl methacrylate -co -methacrylic acid ) 7 : 3 : 1 ; or ( d ) poly acid resistant capsule shells where the enteric polymer was (methacylic acid - co - ethyl acrylate ) 1 : 1 , poly ( ethyl acrylate integrated into the capsule shell . This approach eliminated co -methyl methacrylate ) 2 : 1 , and poly (methyl acrylate - co problems associated with enteric coatings, such as the pres - methyl methacrylate -co -methacrylic acid ) 7 : 3 : 1 . In one ence of " orange peel” surface formation , also known as aspect described herein , the weight ratio of poly (methacylic surface roughness, mottling , or lack of surface homogeneity .
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