Patent ID: 7972621
Filing Date: 2011-07-05
Classification: A61K

Abstract:
1. A process for preparing a pharmaceutical composition in a fast dispersing dosage form containing at least one active ingredient and at least one carrier comprising the steps of: selecting the at least one carrier based at least in part on the molecular weight profile of the carrier and a predetermined final total gelatin concentration between 3.5% and 6.0% w/w of the composition, wherein the at least one carrier is inert to the active ingredient and wherein the at least one carrier is a combination of high molecular weight fish gelatin and standard molecular weight fish gelatin, and wherein the ratio of high molecular weight fish gelatin to standard molecular weight fish gelatin is 50:50 to 10:90; forming a mixture of the at least one active ingredient and the at least one carrier in a suitable solvent to create a formulation; cooling the formulation to an intermediate formulation dosing temperature; dosing the formulation into discrete units at the intermediate formulation dosing temperature; solidifying the discrete units; and removing the solvent from the solid discrete units to form a network of the at least one active ingredient and the at least one carrier; wherein the formulation has a total viable count of less than 1000 cfu/ml; wherein the solid discrete units have an acceptable surface appearance; wherein the formulation exhibits a fairly constant viscosity over a period of about 48 hours; and wherein the high molecular weight fish gelatin is a fish gelatin in which more than 50% of the molecular weight distribution is greater than 30,000 daltons and the standard molecular weight fish gelatin is a fish gelatin in which more than 50% of the molecular weight distribution is below 30,000 daltons.