Smithkline Beecham Corporation

Capsugel Belgium Nv

Pfizer Corporation

Capsugel Belgium Bvba

Stephen Mark McAllister

Adrian Brown

Brian Hewitt

Ronald K Raby, Jr

Allan J Clarke

Wayne Matthews

Daniel N Margetson

Klimentina Dimitrova Pencheva

Melissa Jane Birch

Ian Leonard Smales

Daniel M Margetson

Martin Gregory Rowland

Melissa J Birch

This invention relates to acrystalline form of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-5-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h] [2,5,11]benzoxadiazacyclo-tetradecine-3-carbonitrile (lorlatinib) free base (Form 7). This invention also relates to pharmaceutical compositions comprising Form 7, and to methods of using Form 7 and such compositions in the treatment of abnormal cell growth, such as cancer, in a mammal.

Crystalline form of lorlatinib free base

The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Pharmaceutical formulations

Capsule shells for use in multi-part dosage forms have generally cylindrical shell members with a snap fit component on an interior surface adjacent an open end, for connection to a linker part of the dosage form. The shell member also has a plurality of spaced apart integrally formed thin (relative to circumferentially adjacent shell member portions) panels located adjacent a closed shell member end, for preferential dissolution and release of pharmaceutical compositions from the shell member interior. The ratio of the thickness of the panels to the thickness of the shell member ranges from about 0.2 to about 0.6. The panels can be integrally formed together with the shell member as reliefs or depressions on the inner surface of the shell member by injection molding, and panel thicknesses as thin as about 0.1 mm can be achieved.

Paneled capsule shells for release of pharmaceutical compositions

The present invention is directed to pharmaceutically acceptable polymeric compositions suitable for injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Pharmaceutical formulation

A method of manufacturing a linker of the type having an injection molded jacket radially confining a preformed tablet. The method includes grasping the tablet about the outer surface with a plurality of pincers and positioning the grasped tablet and the pincers with respect to a molding apparatus. The method also includes supporting the tablet via the pincers and injecting jacket material to cover the outer tablet surface and the pincers. The method further includes extracting the jacketed tablet from the molding apparatus and removing the pincers from the jacketed tablet. The method may also include supporting and longitudinally positioning the tablet within the mold via a plurality of additional pincers.

Method and apparatus for manufacturing filled linkers

The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for melt extrusion and injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form.

Capsule link

Capsule linker

Capsule

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Harlow, United Kingdom

Stephen Mark McAllister