Corticosteroid containing orally disintegrating tablet compositions for eosinophilic esophagitis

A method of manufacturing a batch of orally disintegrating tablets, each orally disintegrating tablet comprising drug particles comprising:

• a. fluticasone propionate adsorbed onto a pharmaceutically acceptable carrier;
• and
• b at least one disintegrant;
• wherein each orally disintegrating tablet comprises about 1.5 mg to about 3 mg of fluticasone propionate, and the fluticasone propionate has a mean particle size of ranging from about 100 nm to about 100 μm;
• wherein the batch of orally disintegrating tablets has a content uniformity ranging from about 93.2 to about 100.4;
• and
• wherein each orally disintegrating tablet disintegrates within 60 seconds when tested using the USP <701>method for disintegration time;
• the method comprising:
• (a) preparing a preblend 1 by blending (i) the pharmaceutically acceptable carrier, (ii) the fluticasone propionate, and (iii) a glidant;
• (b) passing preblend 1 through a comminuting mill;
• (c) blending the preblend 1 of step (b), the at least one disintegrant, and one or more pharmaceutically acceptable excipients to provide a preblend 2;
• (d) blending the preblend 2, the at least one disintegrant, and one or more excipients to provide a final blend;
• and
• (e) compressing the final blend to form a batch of orally disintegrating tablets.