Talc-free polyvinyl alcohol composition

Abstract

The present invention provides a talc-free composition characterizable as non-tacky and having an average water vapor permeability of at most 5.0 times 10 −7 grams per Pascal-hour-meter and having a capability of forming a non-tacky film having an average water vapor permeability of at most 5.0 times 10 −7 grams per Pascal-hour-meter. Also provided are the non-tacky film, a method of coating a dosage form with the composition, and a manufactured article comprising the composition.

1 . A talc-free composition characterizable as non-tacky and having an average water permeability of at most 5.0 times 10 −7  grams per Pascal-hour-meter and having a capability of forming a non-tacky film having an average water vapor permeability of at most 5.0 times 10 −7  grams per Pascal-hour-meter. 
     
     
         2 . The talc-free composition of  claim 1  further characterizable as having at least a normalized film clarity of at least 500 percent per millimeter of film thickness. 
     
     
         3 . The talc-free composition of  claim 1  further characterizable as having a film haze of at most 13 percent. 
     
     
         4 . The talc-free composition of  claim 1  consisting essentially of a low viscosity polyvinyl alcohol and a tack-reducing organic adjuvant, wherein the weight/weight ratio of the low viscosity polyvinyl alcohol to tack-reducing organic adjuvant in the composition is from ≧60:40 to ≦95:5. 
     
     
         5 . The talc-free composition of  claim 4 , wherein the tack-reducing organic adjuvant is a carboxymethylcellulose, poly(ethylene glycol), hydroxypropyl methyl cellulose, maltodextrin, methylcellulose, or polyvinylpyrrolidone, or a combination thereof. 
     
     
         6 . The talc-free composition of  claim 5 , wherein the tack-reducing organic adjuvant is a carboxymethylcellulose. 
     
     
         7 . The talc-free composition of  claim 1  further consisting essentially of a non-canceling amount of at least one secondary organic adjuvant that is a plasticizer, surfactant, or removable dispersant. 
     
     
         8 . The talc-free composition of  claim 7 , wherein the secondary organic adjuvant is poly(ethylene glycol), polysorbate, water; or a combination of poly(ethylene glycol), polysorbate, and, optionally, water. 
     
     
         9 . A method of preparing a coated solid dosage form, the method comprising contacting a coating-effective amount of the talc-free composition of one of the preceding claims with a solid health formulation comprising an active ingredient, the contacting being performed in such a way so as to coat the solid health formulation to give a coated solid dosage form comprising a non-tacky film comprising the talc-free composition in coating operative contact with the solid health formulation. 
     
     
         10 . A manufactured article comprising the talc-free composition of  claim 1 . 
     
     
         11 . The manufactured article of  claim 10  comprising a coated solid dosage form comprising a non-tacky film comprising the talc-free composition, the non-tacky film being in coating operative contact with the solid health formulation and having an average water permeability of at most 5.0 times 10 −7  grams per Pascal-hour-meter. 
     
     
         12 . A non-tacky film comprising the talc-free composition of  claim 1 .