Patent AU-2021416460-B2 (AU)
Title: Soft capsule shells and soft capsules
Inventor: CHEN JIEWEI
IPC: A61K9/48
Filed: 2021-12-28
Granted: 2023-11-09
Abstract: if N j 41-, 9JP)L i IN -Ef |EP $ l 
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(54) Title: SOFT CAPSULE SHELL AND SOFT CAPSULE 
= (5 4)&lZW 2 X ± 
(57) Abstract: A soft capsule shell prepared by a film-forming composition and a soft capsule comprising the soft capsule shell and 
a filler. The film-forming composition comprises 1.5 to 5 wt% of a first gelling agent, 30 to 40 wt% of a starch, 10 to 25 wt% of a 
plasticizer and 35 to 55 wt% ofwater. The first gelling agent is gellan gum which has the following properties: a gellan gum solution 
obtained by dissolving 1.5 wt% ofthe gellan gum in water at 90°C for 30 minutes has a viscosity within the range of 10 to 60 mPa.s 
as measured by a rotational viscometer. The soft capsule shell comprises 0 to 3 wt% of starch particles having an average particle size 
of 10 to 50 microns, and the soft capsule shell has enteric properties.  
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2/2
INTERNATIONAL SEARCH REPORT International application No.  
PCT/CN2021/142080 
A. CLASSIFICATION OF SUBJECT MATTER 
A6lK9/48(2006.01)i; A6lK47/36(2006.01)i; A23Pl0/30(2016.01)i 
According to International Patent Classification (IPC) or to both national classification and IPC 
B. FIELDS SEARCHED 
Minimum documentation searched (classification system followed by classification symbols) 
A61K; A23P 
Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched 
Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) 
VEN, DWPI, WPABS, CNTXT, WPABSC, CNKI, ELSEVIER SCIENCE DIRECT, ISI WEB OF SCICENCE, 
SPRINGERLINK, GOOGLE scholar, baidu scholar: aiushlar: h , , MAi, ), , %ith, soft, capsule, film, 
forming, gellan, gum, starch+, plasticizer+, enteric+ 
C. DOCUMENTS CONSIDERED TO BE RELEVANT 
Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.  
PX CN 113398088 A (SIRIO PHARMA CO., LTD.) 17 September 2021 (2021-09-17) 1-10 
entire document 
X US 2016136101 Al (SWISS CAPS RECHTE & LIZENZEN) 19 May 2016 (2016-05-19) 1, 3-4,6,8-10 
claims 21, 27-29, and 33-35, and description, paragraphs 1, 10-11, 15, 23-27 and31-45 
Y US 2016136101 Al (SWISS CAPS RECHTE & LIZENZEN) 19 May 2016 (2016-05-19) 2,5,7 
claims 21, 27-29, and 33-35, and description, paragraphs 1, 10-11, 15, 23-27, and 31-45 
Y WO 2019208668 Al (FUJI CAPSULE CO., LTD.) 31 October 2019 (2019-10-31) 2,5,7 
claims 1-2, and description, paragraphs 19 and 83 
Y CN 1663989 A (NATIONAL STARCH AND CHEMICAL INVESTMENT HOLDING 2 
CORPORATION) 07 September 2005 (2005-09-07) 
claims 1-3, embodiment 1, and description, p. 4, paragraph 2 
A JP 2009040716 A (OYO SEIKAGAKU KENKYUSHO et al.) 26 February 2009 (2009-02-26) 1-10 
entire document 
HFurther documents are listed in the continuation of Box C. / See patent family annex.  
* Special categories of cited documents: "T" later document published after the international filing date or priority 
"A" document defining the general state of the art which is not considered date and not in conflict with the application but cited to understand the 
to be of particular relevance principle or theory underlying the invention 
"E" earlier application or patent but published on or after the international " document of particular relevance; the claimed invention cannot be 
filing date considered novel or cannot be considered to involve an inventive step 
"L" document which may throw doubts on priority claims) or which is when the document is taken alone 
cited to establish the publication date of another citation or other " document of particular relevance; the claimed invention cannot be 
special reason (as specified) considered to involve an inventive step when the document is 
"O" document referring to an oral disclosure, use, exhibition or other combined with one or more other such documents, such combination 
means being obvious to a person skilled in the art 
"p" document published prior to the international filing date but later than " document member of the same patent family 
the priority date claimed 
Date of the actual completion of the international search Date of mailing of the international search report 
16 March 2022 30 March 2022 
Name and mailing address of the ISA/CN Authorized officer 
China National Intellectual Property Administration (ISA/ 
CN) 
No. 6, Xitucheng Road, Jimenqiao, Haidian District, Beijing 
100088, China 
Facsimile No. (86-10)62019451 Telephone No.  
Form PCT/TS A/710 (second sheel (niirv 701 5
INTERNATIONAL SEARCH REPORT International application No.  
PCT/CN2021/142080 
Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet) 
This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons: 
1. / Claims Nos.: 9 
because they relate to subject matter not required to be searched by this Authority, namely: 
[1] Claim 9 covers an application of a capsule shell or a soft capsule in a drug, relates to a process of 
treating a disease using a drug, belongs to a method for treating a disease, and falls within the case 
defined in PCT Rule 39.1(iv) for which no search is required. However, a search was conducted on a 
use of the capsule shell or the soft capsule in the preparation of a drug.  
2. Claims Nos.: 
because they relate to parts of the international application that do not comply with the prescribed requirements to such an 
extent that no meaningful international search can be carried out, specifically: 
3. Claims Nos.: 
because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).  
Form PCT/ISA/210 (continuation of first sheet) (January 2015)
INTERNATIONAL SEARCH REPORT International application No.  
Information on patent family members PCT/CN2021/142080 
Patent document Publication date Patent family members) Publication date 
cited in search report (day/month/year) (day/month/year) 
CN 113398088 A 17 September 2021 None 
US 2016136101 Al 19 May 2016 EP 2815744 Al 24 December 2014 
WO 2014202757 Al 24 December 2014 
EP 3010493 Al 27 April 2016 
EP 3010493 B1 07 August 2019 
AU 2014283167 Al 21 January 2016 
WO 2019208668 Al 31 October 2019 TW 201944985 A 01 December 2019 
JP WO2019208668 Al 30 April 2021 
SG 11202010239 U A 27 November 2020 
US 2021196641 Al 01 July 2021 
EP 3785707 Al 03 March 2021 
EP 3785707 A4 02 March 2022 
CN 1663989 A 07 September 2005 SI 1570843 T1 30 April 2012 
EP 1570843 Al 07 September 2005 
EP 1570843 B1 14 September 2011 
CN 100528950 C 19 August 2009 
KR 20060043253 A 15 May 2006 
KR 101239269 B1 06 March 2013 
ES 2373443 T3 03 February 2012 
AT 524164 T 15 September 2011 
JP 2005281687 A 13 October 2005 
JP 4959948 B2 27June2012 
PT 1570843 E 30 December 2011 
DK 1570843 T3 31 October 2011 
PL 1570843 T3 30 April 2012 
US 2005196436 Al 08 September 2005 
US 7494667 B2 24 February 2009 
JP 2009040716 A 26 February 2009 None 
Form PCT/ISA/210 (patent family annex) (January 2015)
PCT/CN2021/142080 
A. -J$ % 
A61K 9/48(2006.01)i; A61K 47/36(2006.01)i; A23P 10/30(2016.01)i 
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