In the present invention there is provided a pharmaceutical composition for
oral administration which comprises
bendamustine or a pharmaceutically acceptable, ester, salt or solvate thereof as an
active ingredient, and a pharmaceutically acceptable
excipient and which shows a
dissolution of the
bendamustine of at least 60% in 20 minutes, 70% in 40 minutes and 80% in 60 minutes, as measured with a
paddle apparatus at 50 rpm according to the European
Pharmacopoeia in 500 ml of a
dissolution medium at a pH of 1.5, and wherein the pharmaceutically acceptable
excipient is either a pharmaceutically acceptable non-ionic surfactant, selected from the group consisting of a polyethoxylated
castor oil or derivative thereof and a block
copolymer of
ethylene oxide and
propylene oxide or a pharmaceutically acceptable saccharide selected from the group consisting of one or more of a
monosaccharide, a
disaccharide, an
oligosaccharide, a
cyclic oligosaccharide, a
polysaccharide and a saccharide
alcohol, wherein the ratio by weight of the
active ingredient to the saccharide
excipient(s) is in the range of 1:1-5. The invention further relates to the above pharmaceutical composition for use for the
oral treatment of a medical condition which is selected from
chronic lymphocytic leukemia, acute
lymphocytic leukaemia, chronic myelocytic leukaemia, acute myelocytic leukaemia, Hodgkin's
disease, non-Hodgkin's
lymphoma,
multiple myeloma,
breast cancer,
ovarian cancer,
small cell lung cancer and non-
small cell lung cancer. The invention moreover relates to the above pharmaceutical composition for the above use wherein the dosage
regimen comprises at least the administration of a
dose of 100 to 600 mg / m2 / per person of
bendamustine on day 1 and day 2, optionally a
dose of 50 to 150 mg / m2 i.v. or orally of a
corticosteroid on days 1 to 5, and optionally a suitable
dose of a further
active agent selected from the group consisting of an
antibody specific for CD20, an anthracyclin derivative, a
vinca alkaloid or a platin derivative; and the repetition of said dosage
regimen 4 to 15 times after intervals of two to four weeks.