In situ, liquid-activated film coated tablets and a process for making the same
View Patent ↗Tablets and other objects are film coated by including in the tablet a film-forming polymer that is activated upon contact with an activating amount of liquid. The film-forming polymer, e.g., a cellulosic ether, is homogeneously mixed with the other ingredients of the tablet, shaped into any desirable form, loaded into a conventional coating apparatus, and sprayed or foamed with an activating amount of fluid, e.g., water, alcohol, etc., and dried. This coating process eliminates potential problems such as spray nozzle clogging, inappropriate coating fluid viscosity, and the inability to properly atomize the coating fluid. This coating process does not impart any appreciable weight or thickness gain to the tablet.
1. A process of making a dosage form product that comprises a core and a film-coating, the process comprising the steps of
preparing a core from a pharmaceutically active ingredient and a material comprising a water-soluble, film-forming polymer with a weight average molecular weight of at least 12,000, wherein the film-forming polymer is a cellulose ester or a cellulose ether,
compressing the core into a desired size and shape, and
then coating the core by activating the film-forming polymer in the core by contacting the core with a sufficient amount of liquid activating fluid containing a surface tension lowering agent and at least 90 percent by weight water to hydrate the film-forming polymer into a film coating on the core,
wherein no film-forming polymer is contained in the activating fluid, and wherein the core and film coating each have a chemical composition that is essentially the same as the other.
2. The process of claim 1 in which the film-forming polymer is a cellulose ether.
3. The process of claim 1 in which the film-forming polymer is homogeneously dispersed throughout the dosage form product.
4. The process of claim 1 in which the film forming polymer is methyl cellulose.
5. The process of claim 1 in which the film forming polymer is hydroxypropyl methylcellulose.
6. The process of claim 1 in which the surface tension lowering agent is sodium lauryl sulfate.