Tadalafil oral suspension

The present invention relates to an oral suspension of tadalafil comprising 0.01% to 5% w/v of tadalafil, cyclodextrin, co-processed microcrystalline cellulose and sodium carboxymethyl cellulose, xanthan gum and water as a carrier. The suspension is chemically and physically stable and shows a dissolution profile comparable to commercial tadalafil film coated tablets. The tadalafil suspension is suitable for treating male erectile dysfunction and benign prostatic hyperplasia. The invention also relates to a fixed dose combination dosage form comprising said tadalafil suspension and tamsulosin, in particular in the form of a regulated release pellet, or dutasteride. The combination form can be used for treating lower urinary tract symptoms related to benign prostatic hyperplasia. The invention also relates to a process for the preparation of said tadalafil composition. 本发明涉及他达拉非经口混悬剂，其包含0.01％至5％w/v的他达拉非、环糊精、共加工的微晶纤维素和羧甲基纤维素钠、黄原胶以及作为载剂的水。该混悬剂是化学和物理上稳定的，并且显示出与商业他达拉非膜包衣片剂相当的溶出曲线。他达拉非混悬剂适用于治疗男性勃起功能障碍和良性前列腺增生。本发明还涉