R.p. Scherer Corporation

Other

John Wyeth Brother, Limited

R.p.scherer Technologies, Inc.

Richard J Yarwood

Andrew R Thompson

Patrick Kearney

Albert Opalko

Gerald Bradley

Geoffrey P Carr

A process for the preparation of a rapidly disintegrating dosage form a pharmaceutically active substance which has an unacceptable taste wherein there is formed a solution or a suspension in a solvent of a form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a water-soluble or water-dispersible carrier material. Discrete units of the suspension or solution are formed and the solvent is removed from the discrete units under conditions whereby a network of the carrier material carrying a dosage for the less soluble and more palatable form of the pharmaceutically active substance is formed.

Process for preparing solid dosage forms for unpalatable pharmaceuticals

The invention permits the application of an identifying mark onto a fast-dissolving dosage form without the need for application of pressure or printing directly onto the dosage unit. The invention comprises preparing of a fast-dissolving dosage unit that is embossed with an identifying mark such as a manufacturer's logo, medicinal component strength, or other information relating to the unit. The desired identifying mark is first embossed onto the base of the container such as a blister pocket. Liquid suspension is then filled into the container and solidified, e.g., freeze-dried, therein. The resulting dosage unit in the container is thereby embossed with a substantial copy of the identifying mark that was embossed on the base of the container. The embossed identifying mark on the base of the container remains thereon as well thereby affording the ability to learn the identifying mark on the enclosed unit without opening the packet.

Method of applying indicia to a fast-dissolving dosage form

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 forming a solution or a suspension in a solvent of a form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension or solution and removing the solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable form of the pharmaceutically active substance is formed.

Process for preparing solid pharmaceutical dosage forms

Process for preparing solid pharmaceutical dosage forms of hydrophobic

Method for manufacturing freeze dried dosages in a multilaminate blister

The invention permits the application of an identifying mark onto a freeze-dried tablet without the need for application of pressure or for printing directly on the tablet. The invention comprises the preparation of a freeze-dried unit that is embossed with an identifying mark such as a manufacturer's logo, medicinal component strength, or other information relating to the unit. The desired identifying mark is first embossed onto the base of a container such as a blister pocket. Liquid suspension is then filled into the container and freeze-dried therein. The resulting freeze-dried unit in the container is thereby embossed with substantial copy of the identifying mark that was embossed on the base of the container. The embossed identifying mark on the base of the container remains thereon as well, providing at reduced manufacturing cost the added ability to learn the identifying mark on the enclosed freeze-dried unit without opening the blister pack.

Method of identifying freeze-dried dosage forms

An improved method for manufacturing freeze dried pharmaceutical tablets in blister packs is disclosed. Liquid dosages are introduced into a multilayer laminated blister sheet having an impermeable intermediate layer that is positioned between first and second outer layers, each of which has substantially the same coefficient of thermal expansion. The properties of the outer layers of the blister sheet are such that there are no inter-layer stresses that will cause curvature of the blister sheet when it is subjected to temperature changes during the freezing and freeze drying steps. Following the introduction of the dosages into the depressions of the blister sheet, the dosages are frozen and freeze dried. A lidding sheet is then attached to the blister sheet to seal the solid dosages into the blister pack.

The invention concerns a new stable crystal form of anhydrous, crystalline 1,4-dihydro-2-(imidazol-1-ylmethyl)-6-methyl-4-(3-nitrophenyl)pyridine)-3, 5-dicarboxylic acid 3-ethyl 5-methyl diester hydrochloride, 'having a melting point greater than about 215.degree. C., an infra red spectrum (nujolmull) having sharp peaks at 3195 cm.sup.-1, 3100 cm.sup.-1, 2735 cm.sup.-1 and 2625 cm.sup.-1 and an x-ray powder diffraction pattern with specific peaks occurring at 2.theta.=12.3.degree. and 44.5.degree..'

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Collingbourne Kingston, United Kingdom

Richard J Yarwood