Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation

摘要

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.

主权项

1. A coating agent comprising a polyethylene glycol having an average molecular weight of 950 to 25,000 and a swelling clay, wherein the mass percent of said polyethylene glycol and said swelling clay is 20:80 to 60:40, wherein the mass percent of the swelling clay in the film formed thereby is not less than 20, a sum of the polyethylene glycol and the swelling clay occupies not less than 70% mass percent of a film formed from the coating agent, the mass percent of the polyethylene glycol in a film formed by the coating agent is not less than 20%, the swelling clay is in a swollen state, and the agent does not comprise polyvinyl alcohol and wherein the coating agent, when coated on a solid preparation, disintegrates in a dissolution test at 37° C. using a paddle method at 50 rounds/min in 900 ml of water within 10 minutes in case of a size of 1 cm×2 cm and a thickness of 60 μm.