R.p.scherer Technologies, Inc.

R.p. Scherer Corporation

Catalent U.k. Swindon Zydis Limited

Leon Grother

Patrick Kearney

Richard David Green

Rosaleen McLaughlin

Juha-Matti Savola

Michael Hall

Susan Gerrard Banbury

Walter Lunsmann

Yik Teng Wong

Desmond Yik Teng Wong

Owen Murray

Päivi Juujärvi

Douglas Bryans

Krunal Bhavsar

Andrzej Jan Brzozowski

Keiko Tsutsumi

Philip Axe

Owen James Murray

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.

Compositions of different densities for fast disintegrating multi-layer tablet

Improved formulations containing substituted imidazole derivatives of the general formula 1, formula (I) wherein Y is &#x2014;CH&#x2014; or &#x2014;CO&#x2014;, Ris H, halo or hydroxy, Ris H or halo, and Ris H or lower alkyl (e.g. Cto Calkyl, preferably Cor Calkyl), or a pharmaceutically acceptable salt, such as an acid addition salt, e.g. the hydrochloride, of a compound of the general formula (I), are in solid fast-dispersing dosage form suitable for pre-gastric absorption. 

Formulations containing substituted imidazole derivatives

A solution that is stable at 5&#xb0; C. to 30&#xb0; 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.

Stable montelukast solution

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.

Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight

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.

Fast dispersing dosage forms essentially free of mammalian gelatin

This invention relates to a process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste which process comprises: (i) forming a solution or a suspension in a solvent of a water soluble or water dispersible carrier, a filler and the pharmaceutically active substance with the unacceptable taste in association with a lipid, the weight ratio of the pharmaceutically active substance to the lipid being in the range of from 1:1 to 1:10 and the weight ratio of the carrier to the lipid being in the range of from 5:1 to 1:15; (ii) forming discrete units of the suspension or solution; and (iii) removing the solvent from the discrete units under conditions whereby unit dosages are formed comprising a network of carrier/filler carrying a dosage of the pharmaceutically active substance in association with the lipid; oral solid rapidly disintegrating dosage forms prepared by such a process are also provided.

Process for preparing solid pharmaceutical dosage forms

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Swindon, United Kingdom

Leon Grother