Fast-dispersing dosage forms containing fish gelatin
View Patent ↗The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is fish gelatin and the composition is a fast-dispersing dosage form designed to release the active ingredient rapidly on contact with a fluid. In one embodiment, the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity on contact with saliva. The fish gelatin can be obtained from cold water fish sources and is preferably the non-gelling, non-hydrolyzed form. A process for preparing such a composition and a method of using fish gelatin in a fast dispersing dosage form are also provided.
1. A pharmaceutical composition in an oral solid molded fast-dispersing dosage form comprising an active ingredient and a non-hydrolyzed, non-gelling fish gelatin carrier which releases the active ingredient, wherein said composition disintegrates within 1 to 60 seconds of being placed in contact with fluid, and wherein said dosage form comprises a network of the active ingredient and the non-hydrolyzed, non-gelling fish gelatin carrier prepared by the process of subliming solvent from an admixture in the solid state in which the admixture comprises the active ingredient, the non-hydrolyzed, non-gelling fish gelatin carrier and a solvent.
2. The pharmaceutical composition according to claim 1 , wherein the active ingredient is present in an amount ranging from about 0.2% to about 95% by weight of the composition in dried dosage form.
3. The pharmaceutical composition according to claim 2 , wherein the active ingredient is present in an amount ranging from about 1% to about 20% by weight of the composition in dried dosage form.
4. The pharmaceutical composition according to claim 1 , wherein the non-hydrolyzed, non-gelling fish gelatin is spray-dried non-hydrolyzed, non-gelling fish gelatin.
5. The pharmaceutical composition according to claim 1 further comprising an additional ingredient selected from the group consisting of matrix forming agents, sugars, cyclic sugars, amino acids, preservatives, surfactants, viscosity enhancers, coloring agents, flavoring agents, pH modifiers, sweeteners, taste-masking agents, and combinations thereof.