- Patent Number:
10736,855
- Appl. No:
16/078343
- Application Filed:
February 13, 2017
- نبذة مختصرة :
A composition suitable for forming a viscous suspension upon admixing with an aqueous medium, methods for its production and use thereof are provided. The composition includes a plurality of units, each unit having a core containing a proton pump inhibitor and an outer coating containing a gel-forming agent.
- Inventors:
DEXCEL PHARMA TECHNOLOGIES LTD. (Or-Akiva, IL)
- Assignees:
DEXCEL PHARMA TECHNOLOGIES LTD. (Or-Akiva, IL)
- Claim:
1. A composition suitable for forming a viscous suspension upon admixing with an aqueous medium, the composition comprising a plurality of swellable units, wherein each unit of said plurality of swellable units comprises: i) a core comprising a proton pump inhibitor; ii) an enteric coating layer over the core; and iii) a swellable outer coating comprising a gel-forming agent over the enteric coating layer, wherein each of said plurality of swellable units is coated with said swellable outer coating such that it is designed to swell upon imbibition of the aqueous medium by at least 50% of its initial volume.
- Claim:
2. The composition of claim 1 , wherein the plurality of swellable units swells upon imbibition of the aqueous medium by at least 100% of its initial volume.
- Claim:
3. The composition of claim 2 , wherein the plurality of swellable units swells upon imbibition of the aqueous medium by at least 150% of its initial volume.
- Claim:
4. The composition of claim 1 , wherein the proton pump inhibitor comprises at least one of omeprazole, lansoprazole, pantoprazole, rabeprazole, tenatoprazole, and pharmaceutically acceptable salts thereof.
- Claim:
5. The composition of claim 4 , wherein the proton pump inhibitor comprises s-omeprazole magnesium.
- Claim:
6. The composition of claim 1 , wherein the core comprises an inert seed coated with a drug layer comprising a proton pump inhibitor.
- Claim:
7. The composition of claim 1 , wherein the enteric coating comprises at least one polymer selected from the group consisting of cellulose acetate phthalate (CAP), hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polyvinyl acetate phthalate, cellulose acetate trimellitate, shellac, polymethacrylic acid, polymethyl methacrylate, polyethyl methacrylate, polyethyl acrylate, and mixtures thereof.
- Claim:
8. The composition of claim 1 , wherein the gel-forming agent comprises at least one of polysaccharide, acrylic or methacrylic polymer, cellulose derivative, polyethylene glycol, alginic acid, sodium alginate, carbomer, gelatin, magnesium aluminum silicate, poloxamer, polyvinyl alcohol, and naturally occurring or synthetic gum.
- Claim:
9. The composition of claim 8 , wherein the naturally occurring or synthetic gum is selected from the group consisting of xanthan gum, gum arabic, guar gum, locust bean gum, and gellan gum.
- Claim:
10. The composition of claim 9 , wherein the naturally occurring or synthetic gum comprises xanthan gum.
- Claim:
11. The composition of claim 1 , wherein each unit further comprises a pharmaceutically acceptable excipient.
- Claim:
12. The composition of claim 11 , wherein the pharmaceutically acceptable excipient comprises at least one of a binder, a filler, a surfactant, an anti-tacking agent, a plasticizer, a lubricant, a glidant, a disintegrant, an alkaline substance, a diluent, a tonicity enhancing agent, a wetting agent, a buffering substance, a colorant, a preservative, and any combination thereof.
- Claim:
13. The composition of claim 1 further comprising a plurality of particles.
- Claim:
14. The composition of claim 13 , wherein the plurality of particles is selected from granules, inert pellets, beads, powder, and mixtures thereof.
- Claim:
15. The composition of claim 14 , wherein the plurality of particles comprises a gel-forming agent.
- Claim:
16. The composition of claim 15 , wherein the gel-forming agent comprises at least one of polysaccharide, acrylic or methacrylic polymer, cellulose derivative; polyethylene glycol, alginic acid, sodium alginate, carbomer, gelatin, magnesium aluminum silicate, poloxamer, polyvinyl alcohol, and naturally occurring or synthetic gum.
- Claim:
17. The composition of claim 16 , wherein the naturally occurring or synthetic gum is selected from the group consisting of xanthan gum, gum arabic, guar gum, locust bean gum, and gellan gum.
- Claim:
18. The composition of claim 17 , wherein the naturally occurring or synthetic gum comprises xanthan gum.
- Claim:
19. The composition of claim 15 , wherein the plurality of particles further comprises a pharmaceutically acceptable excipient.
- Claim:
20. The composition of claim 19 , wherein the pharmaceutically acceptable excipient comprises at least one of a binder, a filler, a surfactant, an anti-tacking agent, a plasticizer, a lubricant, a glidant, a disintegrant, an alkaline substance, a diluent, a tonicity enhancing agent, a wetting agent, a buffering substance, a colorant, a preservative, and any combination thereof.
- Claim:
21. The composition of claim 1 , adapted for preparing a single dose sachet.
- Claim:
22. The composition of claim 1 , adapted for administration via the oral route or a nasogastric tube.
- Claim:
23. A method of treating a disease or disorder selected from the group consisting of gastroesophageal reflux disease, gastritis, peptic ulcers (duodenal and gastric), and erosive esophagitis, the method comprising administering to a subject in need thereof the composition of claim 1 .
- Claim:
24. The composition of claim 1 , wherein the gel-forming agent is in an amount of about 10% to about 40% by weight of each unit.
- Patent References Cited:
4045563 August 1977 Berntsson et al.
4255431 March 1981 Junggren et al.
4359465 November 1982 Ruwart
4472409 September 1984 Senn-Bilfinger
4508905 April 1985 Junggren et al.
4628098 December 1986 Nohara et al.
4738975 April 1988 Nohara et al.
4786505 November 1988 Lovgren et al.
4853230 August 1989 Lovgren et al.
4882169 November 1989 Ventouras
5045321 September 1991 Makino et al.
5045552 September 1991 Souda et al.
5312824 May 1994 Sohda et al.
5690960 November 1997 Bengtsson et al.
5714504 February 1998 Lindberg et al.
5900424 May 1999 Kallstrom et al.
6147103 November 2000 Anousis et al.
6149942 November 2000 Scheiwe et al.
6166213 December 2000 Anousis et al.
6191148 February 2001 McManus et al.
6228400 May 2001 Lee et al.
6248355 June 2001 Seth
6316481 November 2001 Freehauf
6328993 December 2001 Linder et al.
6328994 December 2001 Shimizu et al.
6369085 April 2002 Cotton et al.
6391342 May 2002 Henriksen et al.
6428810 August 2002 Bergstrand et al.
6479075 November 2002 Odidi et al.
6551621 April 2003 Debregeas et al.
6576258 June 2003 Kofler et al.
6596315 July 2003 Boissier et al.
6605303 August 2003 Karehill et al.
6610323 August 2003 Lundberg et al.
6706285 March 2004 Woo
6780436 August 2004 López-Cabrera et al.
6780882 August 2004 Phillips
7041316 May 2006 Chen
7217429 May 2007 Garcia et al.
7276253 October 2007 Heese et al.
7419996 September 2008 Chow et al.
7732474 June 2010 Muskulus et al.
7906145 March 2011 Castan et al.
8530500 September 2013 Juvonen et al.
8968776 March 2015 Seth et al.
8993599 March 2015 Hall et al.
2001/0053387 December 2001 Hamied
2002/0039597 April 2002 Ukai et al.
2003/0091643 May 2003 Friesen et al.
2005/0031700 February 2005 Hall et al.
2005/0042277 February 2005 Srinivas
2005/0095285 May 2005 Rao et al.
2006/0093680 May 2006 Humar et al.
2006/0134210 June 2006 Persson
2006/0159756 July 2006 Sjoblom
2006/0165794 July 2006 Chenevier et al.
2007/0053981 March 2007 Blychert et al.
2007/0196486 August 2007 Vanderbist et al.
2008/0175917 July 2008 Glad et al.
2009/0068261 March 2009 Reher et al.
2009/0092658 April 2009 Hall et al.
2009/0291136 November 2009 Stanic Ljubin et al.
2010/0068291 March 2010 Caisse et al.
2011/0223244 September 2011 Liversidge et al.
2012/0128764 May 2012 Venkatesh et al.
2013/0202705 August 2013 Hamed
2013/0266658 October 2013 Weiß et al.
2014/0065232 March 2014 Shlieout et al.
2014/0255503 September 2014 Sangrà Perez et al.
2014/0377347 December 2014 Vivek et al.
2015/0044303 February 2015 Olmstead et al.
2015/0209432 July 2015 Konda et al.
1232746 August 2002
1949900 July 2008
WO-0078293 December 2000
WO 2004/004690 January 2004
WO 2005/105045 November 2005
WO 2006/068596 June 2006
WO 2012/017074 February 2012
WO 2015/082562 June 2015
WO 2015/108392 July 2015
WO 2015/166473 November 2015
- Other References:
Kollidon (https://industries.basf.com/bin/bws/docunnentDownload.en.8800483977685) BASF Mar. 2008, 9th revised edition, pp. 1-330 (Year: 2008). cited by examiner
Talukdar, M.M. et al. “Swelling and drug release behaviour of xanthan gum matrix tablets” International Journal of Pharmaceutics 120 (1995) 63-72 (Year: 1995). cited by examiner
Nargund, R. et al. “Synthesis, characterization and antiulcer study of pH-sensitive microspheres” Der Pharmacia Lettre, 2011, 3 (6):82-89 (Year: 2011). cited by examiner
International Search Report and Written Opinion issued for PCT application No. PCT/IL2017/050179 dated May 9, 2017, 8 pages. cited by applicant
- Primary Examiner:
Rosenthal, Andrew S
- Attorney, Agent or Firm:
Rothwell, Figg, Ernst & Manbeck, P.C.
- الرقم المعرف:
edspgr.10736855
Processing Request
No Comments.