Process for manufacturing chewable dosage forms for drug delivery and products thereof
AssigneeTriad Specialty Products, LLC
InventorsNeil Paulsen, Roland Johnson, Michael Coffee
Life of this patent
Estimating the term…
Abstract
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.
Claims7
A process for manufacturing a edible soft chewable medication vehicle, the method comprising:
- (a) forming an active suspension comprising a coated medicament comprising an active agent and an oil, wherein the medication active is one whose stability or potency can be adversely affected by temperatures typically generated during extrusion;
- (b) blending the active suspension formed in step (a) with dry inactive ingredients not of animal origin in a mixer having a mixing chamber and mixing shaft, wherein operation of the mixer causes a edible soft chew mixture to be formed having the active ingredient uniformly blended therein;
- (c) adding a water-soluble polyethylene glycol anti-sticking agent to the dry mixture and blending it therein to form a edible soft chewable mixture;
- (d) removing the edible soft chewable mixture from the mixer;
- and,
- (e) forming the edible soft chewable mixture into individual unit masses, wherein the unit masses so formed are of consistent weight from unit to unit,
- wherein no heat is generated by, or applied during, performance of any step of the method, and wherein further no water is added to the active agent during performance of the method.
A process for manufacturing a edible soft chewable medication vehicle, the method comprising:
- (a) forming an active suspension comprising a coated medicament comprising an active agent active and an oil, wherein the medication active is one whose stability or potency can be adversely affected by temperatures typically generated during extrusion;
- (b) blending the active suspension formed in step (a) with dry inactive ingredients not of animal origin in a mixer having a mixing chamber and mixing shaft, wherein operation of the mixer causes a edible soft chew mixture to be formed having the active ingredient uniformly blended therein;
- (c) adding a water-soluble polyethylene glycol anti-sticking agent to the dry mixture and blending it therein to form a edible soft chewable mixture;
- (d) removing the edible soft chewable mixture from the mixer;
- and,
- (e) forming the edible soft chewable mixture into individual unit masses, wherein the unit masses so formed are of consistent weight from unit to unit,
- wherein the edible soft chew mixture and the ingredients thereof are maintained at room temperature or +/−10° C. thereof during performance of any step of the method, and wherein further no water is added to the active agent during performance of the method.
Dependencies are inferred from the claim text.