# US 2013/0156829 A1 · Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156829 A1 - Document ID: US20130156829A1 - Status: Published application - Kind: A1 - Application number: 13/819,523 - Filed: 2011-08-31 - Published: 2013-06-20 - Earliest claimed: 2010-08-31 - Assignees: Toray Industries, Inc. - Inventors: Yuki Fujisaki; Ryoji Yoshii; Suguru Takaki - Web page: https://patentgrep.com/patent/US20130156829A1 ## CPC - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 9/2813: {Inorganic compounds} - A61K 9/2853: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)} - A61K 47/02: Inorganic 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 A coating agent for a pharmaceutical solid preparation imparts an unpackaged pharmaceutical solid preparation with excellent barrier properties equivalent to those of a PTP sheet without affecting the disintegration properties of the pharmaceutical solid preparation. The coating agent for a pharmaceutical solid preparation includes a polyethylene glycol having an average molecular weight of 950 to 25,000 and a swelling clay, wherein the mass ratio of the polyethylene glycol and the swelling clay is 2:8 to 6:4. ## Claims ### Claim 1 A coating agent tor a pharmaceutical solid preparation comprising a polyethylene glycol having an average molecular weight of 950 to 25,000 and a swelling clay, wherein the mass ratio of said polyethylene glycol and said swelling clay is 2:8 to 6:4. ### Claim 2 (depends on 1) The coating agent according to claim 1, wherein said swelling clay is bentonite or aluminum magnesium silicate. ### Claim 3 (depends on 1) The coating agent according to claim 1, further comprising a sugar alcohol derivative surfactant in an amount of 0.5 to 30%. ### Claim 4 (depends on 3) The coating agent according to claim 3, wherein said sugar alcohol derivative surfactant is a sorbitan fatty acid ester. ### Claim 5 (depends on 1) A pharmaceutical film formulation comprising the coating agent according to claim 1, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 6 (depends on 1) A coated pharmaceutical solid preparation coated with the coating agent according to claim 1, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 7 A pharmaceutical film formulation comprising a polyethylene glycol having an average molecular weight of 950 to 25,000 and a swelling clay, wherein a mass ratio of said polyethylene glycol and said swelling clay is 2:8 to 6:4 and water vapor permeability at a room temperature of 40° C. and a relative humidity of 75% is less than 1.0×10−4 g·mm/cm2·24 hr·atm. ### Claim 8 A coated pharmaceutical solid preparation comprising a coating layer, said coating layer comprising a polyethylene glycol having an average molecular weight of 950 to 25,000 and a swelling day, in which coating layer a mass ratio of said polyethylene glycol and said swelling clay is 2:8 to 5:4 and water vapor permeability at a room temperature of 40° C. and a relative humidity of 75% is less than 1.0×10−4 g·mm/cm2·24 hr·atm. ### Claim 9 (depends on 2) The coating agent according to claim 2, further comprising a sugar alcohol derivative surfactant in an amount of 0.5 to 30%. ### Claim 10 (depends on 9) The coating agent according to claim 9, wherein said sugar alcohol derivative surfactant is a sorbitan fatty acid ester. ### Claim 11 (depends on 2) A pharmaceutical film formulation comprising the coating agent according to claim 2, having a water vapor permeability of less than 1.0×10 −4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 12 (depends on 3) A pharmaceutical film formulation comprising the coating agent according to claim 3, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 13 (depends on 4) A pharmaceutical film formulation comprising the coating agent according to claim 4, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 14 (depends on 9) A pharmaceutical film formulation comprising the coating agent according to claim 9, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 15 (depends on 10) A pharmaceutical film formulation comprising the coating agent according to claim 10, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 16 (depends on 2) A coated pharmaceutical solid preparation coated with the coating agent according to claim 2, haying a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 17 (depends on 3) A coated pharmaceutical solid preparation coated with the coating agent according to claim 3, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 18 (depends on 4) A coated pharmaceutical solid preparation coated with the coating agent according to claim 4, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 19 (depends on 9) A coated pharmaceutical solid preparation coated with the coating agent according to claim 9, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%. ### Claim 20 (depends on 10) A coated pharmaceutical solid preparation coated with the coating agent according to claim 10, having a water vapor permeability of less than 1.0×10−4 g·mm/cm2·24 hr·atm at a room temperature of 40° C. and a relative humidity of 75%.