PHARMACEUTICAL DOSAGE FORM COMPRISING POLYMERIC CARRIER COMPOSITION

• Main Authors: THOMAS KESSLER, MARKUS MAGERLEIN, BERND LIEPOLD, CLAUDIA PACKHAEUSER, JOERG BREITENBACH
• Format: Patent
• Language: English; Japanese
• Published: 09.04.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

PROBLEM TO BE SOLVED: To provide a polymeric carrier composition for the formation of solid dispersions that exhibit higher drug dissolution power and/or allow a reduction of the viscosity of the melt without deteriorating the mechanical properties and storage stability of the dosage form.SOLUTION: The invention relates to a pharmaceutical dosage form which comprises a solid dispersion product of at least one active ingredient dispersed in a polymeric carrier composition, the polymeric carrier composition comprising: a) a vinylpyrrolidone homopolymer having a molecular weight distribution such that at least 95 wt.% of the homopolymer has a molecular weight within the range from 1,000 to 13,000; and b) a vinylpyrrolidone copolymer having a weight-average molecular weight from 5,000 to 1,500,000. The dosage form is provided by forms of a powder, a granule, a tablet, a capsule, etc. consisting of a composition of an active ingredient and a polymeric carrier by a solvent evaporation method, a spray coating method, and an extrusion method. 【課題】より高い薬物溶解力を示し、および／または剤形の機械的性質と保存安定性を劣化させることなく融成物の粘度の低下を可能とする固体分散を形成するための高分子担体組成物の提供。【解決手段】高分子担体組成物に分散した少なくとも１種の有効成分の固体分散生成物を含有してなる薬学的剤形であって、該高分子担体組成物が、ａ）ビニルピロリドンホモポリマー（該ホモポリマーの少なくとも９５重量％が、１，０００〜１３，０００の範囲内の分子量を持つような分子量分布をもつ）およびｂ）５，０００〜１，５００，０００の重量平均分子量をもつビニルピロリドンコポリマーを含有してなる薬学的剤形。該剤形は溶媒蒸発法、噴霧コーティング法、押出し法により有効成分及び高分子担体の組成物からなる粉末、顆粒、錠剤、カプセル等の形態により提供される。【選択図】なし