Abstract: The present disclosure is directed to use of surfactant with fish gelatin based, freeze dried orally disintegrating tablets. Specifically, Applicants discovered that a small amount of surfactant in combination with high molecular weight fish gelatin in a pharmaceutical formulation can ensure good solution/suspension flow into preformed molds during dosing in order that the finished dosage form has an acceptable shape.

Abstract: The present disclosure is directed to oral dosage forms and processes for producing the oral dosage forms. The dosage forms include an Epinephrine hormone or pharmaceutically acceptable salt or solvate thereof, an antioxidant, and a chelating agent. The antioxidant can be sodium metabisulfate and the chelating agent can be edetate disodium (“EDTA”).

Abstract: Described herein is a method for forming multi-layer drug dosage forms having at least two layers. In the method, a first formulation comprising a non-gelling matrix forming agent and having a first density is dosed into a preformed mold. A second formulation comprising a non-gelling matrix former and having a second density not equal to the first density is subsequently dosed into the preformed mold. Then, the combination of the formulations dosed into the mold is freeze dried to form the multi-layer dosage form having at least two layers. The use of a density difference between the first and second formulations ensures formation of a product with two distinct layers.

Abstract: Described herein is a method for forming multi-layer drug dosage forms having at least two layers. In the method, a first formulation comprising a non-gelling matrix forming agent and having a first density is dosed into a preformed mold. A second formulation comprising a non-gelling matrix former and having a second density not equal to the first density is subsequently dosed into the preformed mold. Then, the combination of the formulations dosed into the mold is freeze dried to form the multi-layer dosage form having at least two layers. The use of a density difference between the first and second formulations ensures formation of a product with two distinct layers.

Abstract: A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described.

Abstract: A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described.

Abstract: The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is at least one fish gelatin predetermined on the basis of the molecular weight profile of the gelatin. In some embodiments, particularly when the concentration of carrier comprises a relatively lower percentage of the total composition, the carrier may be exclusively a high molecular weight fish gelatin, or may be comprised of a mixture with standard molecular weight gelatin in which high molecular weight gelatin comprises a predominant portion. In those embodiments where the concentration of carrier comprises a relatively larger percentage of the total composition, the carrier may be an exclusively standard molecular weight fish gelatin, or may be comprised of a mixture in which standard molecular weight gelatin comprises a predominant portion. Thus, compositions may be designed to optimize performance for various required gelatin concentration formulations.

Abstract: In order to reduce the disintegration time of solid, oral, fast-dispersing, lyophilized, pharmaceutical dosage forms, an edible acid such as citric acid is included in a composition used to produce said dosage forms where there is a pharmaceutically active ingredient having a low water solubility.

Abstract: The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90% by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.