# US 9,750,815 B2 · Composition comprising shellac and/or a salt thereof and sodium starch glycolate > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,815 B2 - Document ID: US9750815B2 - Status: Granted - Kind: B2 - Application number: 13/812,465 - Filed: 2011-06-30 - Published: 2013-05-30 - Granted: 2017-09-05 - Earliest claimed: 2010-07-26 - Assignees: Gnosis S.p.A. - Applicants: Daniele Giovannone; Carlo De Angelis - Inventors: Daniele Giovannone; Carlo De Angelis - Web page: https://patentgrep.com/patent/US9750815B2 ## CPC - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61K 9/282: {Organic compounds, e.g. fats} - A61K 9/286: {Polysaccharides, e.g. gums; Cyclodextrin} - A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)} - A61K 9/4816: {Wall or shell material} - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61K 9/5015: {Organic compounds, e.g. fats, sugars} - A61K 9/5036: {Polysaccharides, e.g. gums, alginate; Cyclodextrin} - A61K 9/5078: {with drug-free core} - A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)} - A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) - A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61K 9/1611: {Inorganic compounds} - A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules} - A61K 9/485: {Inorganic compounds} - A61K 9/4858: {Organic compounds} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The object of the present invention is a composition comprising shellac and/or a salt thereof and sodium starch glycolate and at least one physiologically acceptable excipient and a process for obtaining it. ## Claims ### Claim 1 A composition which is a gastroresistant coating composition comprising a suspension or a powder to be reconstituted in water of a shellac basic amino acid salt and sodium starch glycolate and at least one physiologically acceptable excipient. ### Claim 2 (depends on 1) The composition according to claim 1, characterised in that the sodium starch glycolate is sodium starch glycolate of type A or type B and/or a mixture thereof. ### Claim 3 (depends on 1) The composition according to claim 1, characterised in that said composition is a coating composition for solid oral formulations in the form of tablets, capsules, pellets, granules and/or microgranules. ### Claim 4 (depends on 1) The composition according to claim 1, characterised in that said composition is in the form of an aqueous suspension. ### Claim 5 (depends on 1) The composition according to claim 1 wherein the coating composition is in the form of a spray suspension. ### Claim 6 (depends on 1) The composition according to claim 1, characterised in that said basic amino acid is selected from among arginine, lysine, ornithine and/or a mixture thereof. ### Claim 7 (depends on 6) The composition according to claim 6, characterised in that said basic amino acid is arginine. ### Claim 8 (depends on 1) The composition according to claim 1, characterised in that sodium starch glycolate is in form of powder with a granulometry comprised between 0.5 and 200 micron. ### Claim 9 (depends on 8) The composition according to claim 8, characterised in that sodium starch glycolate is in form of powder with a granulometry comprised between 10 and 50 micron. ### Claim 10 (depends on 1) The composition according to claim 1, characterised in that the shellac basic amino acid salt is contained in an amount between 1 and 99% by weight with respect to the total weight. ### Claim 11 (depends on 10) The composition according to claim 10, characterised in that the shellac basic amino acid salt and sodium starch glycolate are present in equal amounts. ### Claim 12 (depends on 10) The composition according to claim 10, characterised in that shellac basic amino acid salt thereof is contained in an amount between 50 and 95% by weight with respect to the total weight. ### Claim 13 (depends on 1) The composition according to claim 1, characterised in that sodium starch glycolate is contained in an amount between 0.05 and 70% by weight with respect to the total weight. ### Claim 14 (depends on 13) The composition according to claim 13, characterised in that sodium starch glycolate is contained in an amount 0.1% and 50% by weight with respect to the total weight. ### Claim 15 (depends on 1) The composition according to claim 1, characterised in that at least one additional physiologically acceptable excipient is selected from among plasticizers, suspension agents or glidants and/or dilutants. ### Claim 16 (depends on 15) The composition according to claim 15, characterised in that said suspension agents or glidants are selected from among precipitated silica, talc and/or a mixture thereof. ### Claim 17 (depends on 15) The composition according to claim 15, characterised in that said dilutants are selected from among talc, titanium dioxide and/or a mixture thereof. ### Claim 18 (depends on 15) The composition according to claim 15, characterised in that said plasticizers are selected from among triethyl citrate, polyethylene glycol, polypropylene glycol, glycerol monostearate, polyols, glycerine, vegetable oils and/or a mixture thereof. ### Claim 19 (depends on 18) The composition according to claim 18, characterised in that said plasticizers are contained in an amount between 2 and 50% by weight with respect to the total weight. ### Claim 20 (depends on 1) The composition of claim 1, wherein said composition is a coating of a coated solid oral formulation. ### Claim 21 (depends on 20) The composition according to claim 20, wherein said coated solid oral formulation is in the form of tablets, capsules, pellets, granules and/or microgranules. ### Claim 22 (depends on 10) The composition according to claim 10, wherein said coated solid oral formulation contains at least one active ingredient and/or nutraceutical, dietetic or food supplement and at least one physiologically acceptable adjuvant. ### Claim 23 (depends on 22) The composition according to claim 22, characterised in that said at least one active ingredient and/or nutraceutical, dietetic or food supplement of said coated solid oral formulation is selected from among SAMe (S-adenosyl methionine) and/or physiologically acceptable salts thereof, lansoprazole, pantoprazole, ibuprofen, lactic ferments, NADH, SOD, nattokinase. ### Claim 24 (depends on 22) The composition according to claim 22, characterised in that said at least one active ingredient and/or nutraceutical, dietetic or food supplement of said coated solid oral formulation is selected from SAMe and/or physiologically acceptable salts thereof. ### Claim 25 A process for preparing a coating composition, said process comprising the steps of: a) preparing a solution of shellac basic amino acid salt thereof, solution A; b) preparing an aqueous suspension of sodium starch glycolate, suspension B; c) mixing solution A and suspension B. ### Claim 26 (depends on 25) The process according to claim 25, characterised in that in step a) said shellac and/or a salt thereof is dissolved in a polar solvent comprising a C1-C4 alcohol, water, and/or in a mixture thereof. ### Claim 27 (depends on 25) The process according to claim 25, characterised in that in step a) said shellac basic amino acid salt thereof is dissolved in a polar solvent. ### Claim 28 (depends on 27) The process according to claim 27, characterised in that said polar solvent is water. ### Claim 29 (depends on 25) The process according to claim 25, characterised in that said process is carried out at a temperature comprised between 50 and 100° C. ### Claim 30 (depends on 29) The process according to claim 29, characterised in that said process is carried out at a temperature comprised between 50 and 80° C.