Pharmaceutical tablet coatings are commonly based on hydroxypropyl methyl cellulose, poly (vinyl alcohol), and acrylic polymers. Currently available tablet coating technology includes spraying of a dilute polymer solution over the tablets, and a time-consuming drying process. Amphoteric latex coating materials contain weak acid and strong base stabilizing moieties on the latex surfaces, and exist as a low-viscosity dispersions at high solids at mildly acidic pH. An increase in pH deprotonates the carboxylic acid group and leads to its ionic linkage with the quaternary ammonium groups also present. This ionic coacervation mechanism enables the coating to set quickly. This study focuses on the evaluation of amphoteric polyacrylate latex-based film forming materials for tablet coatings. A series of amphoteric latexes was prepared from monomers already used in the synthesis of FDA-approved polyacrylate polymers. Polymer composition was systematically varied in order to understand the effects on polymer film formation temperature, setting efficiency as a function of pH, and film properties such as tack, puncture, gloss, optical clarity, water permeability, etc. Latex films made from these suspensions showed equal or superior performance compared with commercially-used cellulosic and poly (vinyl alcohol) tablet coatings. Several requirements for tablet coatings have been achieved, including high solids (~40 wt %); good optical properties (clarity &gt; 90%, transmission &gt; 93%, and haze &lt; 6%); no tackiness, and low permeability (water vapor permeability &lt; 2 x 10<sup>-7</sup> g / Pa s m).

Progress in the development of high-solids, quick-set pharmaceutical tablet coatings

2019 Spring National Meeting

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