Process for manufacturing chewable dosage forms for drug delivery and products thereof

摘要

A palatable, edible soft chewable medication vehicle for delivery of a pharmaceutically acceptable active ingredient, such as a drug, to an animal or human subject. The edible soft chews contain only food grade or better inactive ingredients, and preferably do not contain ingredients of animal origin. Processes for manufacturing the edible soft chews do not require the use of heat or the addition of water during mixing of active and inactive ingredients, provide stable concentrations of the active ingredient, and produce chews of consistent weight and texture.

主权项

1. A process for manufacturing an edible soft chewable medication comprising:
(a) blending an active ingredient with an oil and dry inactive ingredients including a flavoring, a binder, a bulking agent, a humectant and an excipient, wherein blending is performed at no more than about 10 °C. above room temperature; (b) blending an anti-sticking agent selected from the group consisting of polyethylene glycol and paraffin wax with the blended ingredients of step (a) to form an edible soft chew mixture having a cookie dough-like texture; and (c) molding the edible soft chew mixture into individual dosage units of the edible soft chewable medication without use of extrusion wherein the dosage units so formed are of consistent weight and active content from unit to unit.