Cephalon, Inc.

Lifecycle Pharma A/s

Anders Buur

Heidi Lopez De Diego

Michael Harold Rock

Ole Nielsen

Mark Howells

Kim Lasse Christensen

Per Holm

Birgitte Møllgaard

Jannie Egeskov Holm

Kirsten Schultz

Michiel Onne Elema

Described are crystalline forms of the pharmaceutical compound '[9S-(9&#x3b1;,10&#x3b2;,12&#x3b1;)]-5,16-Bis[(ethylthio)methyl]-2,3,9,10,11,12-hexahydro-10-hydroxy-9-methyl-1-oxo-9,12-epoxy-1H-diindolo[1,2,3-fg:3',2&#x2032;,1&#x2032;-kl]pyrrolo[3,4-i][1,6]benzodiazocine-10-carboxylic acid methyl ester', as well as methods for their use and preparation.

Crystalline forms of a pharmaceutical compound

Described are crystalline forms of the pharmaceutical compound '[9S-(9&#x3b1;,10&#x3b2;,12&#x3b1;)]-5,16-Bis[(ethylthio)methyl]-2,3,9,10,11,12-hexahydro-10-hydroxy-9-methyl-1-oxo-9, 12-epoxy-1H-diindolo[1,2,3-fg:3',2&#x2032;,1&#x2032;-kl]pyrrolo[3,4-i][1,6]benzodiazocine-10-carboxylic acid methyl ester', as well as methods for their use and preparation.

A process for the preparation of a particulate material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5&#xb0; C. or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.

Controlled agglomeration

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Allerød, Denmark

Anders Buur