BRIEFING

 Vinyl Alcohol and Vinyl Acetate (75:25) Copolymer 50000. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed.

 The US FDA Inactive Ingredient Database (IID) and GSRS databases include multiple UNII and CAS numbers for polyvinyl alcohol. These are based on the differences related to the degree of hydrolysis and average molecular weight of the said material. In the Excipient Nomenclature Guidelines, Vinyl Alcohol and Vinyl Acetate Copolymer has been documented and discussed in 4.4 Nomenclature of Synthetic Polymers.

 Vinyl Alcohol and Vinyl Acetate (75:25) Copolymer 50000 is typically produced through the polymerization of vinyl acetate. It is a type of polyvinyl alcohol with partially hydrolyzed ester groups of the starting material, vinyl acetate. The degree of hydrolysis influences the water solubility and hydrophilic properties. This copolymer is often used in controlled-release formulations as a film-forming agent or for adhesive applications in transdermal drug delivery systems.

 (CE: D. Chavan)

 Case ID—SUB-1371, SUB-2007