Treatment of autoimmune disease in a patient receiving additionally a beta-blocker
a technology of autoimmune disease and beta-blocker, which is applied in the direction of immunodeficiency syndrome, drug composition, muscular disorder, etc., can solve the problems of permanent neurological problems and significant number of patients not receiving effective medication for the management of their disease states, and achieves a better safety profil
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example 1
on of Immediate Release Tablets
[0409]For the titration / maintenance regimen, 0.25 mg, 0.5 mg, 1 mg and 2 mg siponimod immediate release film-coated tablets can be prepared as described below.
Process Blending:
[0410]In order to obtain a final mixture ready to be processed to a dosage form, e.g. a tablet, siponimod hemifumarate, e.g. having a X90 value of 18 μm, is blended with different excipients according to the flow diagram of FIG. 1. Therefore, siponimod hemifumarate is pre-blended in step 1 with a mixture of glyceryl behenate as moisture protective agent and spray-dried lactose as filler. The pre-blending is carried out in a diffusion mixer Bohle PM400S (L. B. Bohle Maschinen+Verfahren GmbH, Ennigerloh, Germany) for 10 min at 10 rpm. The mixture of step 1 is then sieved in step 2 using a screening mill having a mesh size of 800 μm. The sieved mixture is then blended in step 3 with further spray-dried lactose as filler, Aerosil as glidant, polyvinylpolypyrrolidon XL (crospovidone) ...
example 2
Trial
[0414]Participants
[0415]Healthy volunteers (men and women) aged between 1.8 and 55 years with a body mass index of 18-30 kg / m2 were included in the study. Subjects were required to have an FEV1 of ≥90% of predicted normal, a systolic blood pressure (BP) of 90-140 mm Hg, a diastolic BP of 50-913 mm Hg and a pulse rate of 50-90 bpm. Women of childbearing potential, pregnant or lactating women, homozygous carriers for CYP2C9*3 genotype, smokers, those with current or medical history of cardiovascular disorders or bronchospastic disease were excluded from this study. At screening, a 24 h Halter recording was performed on all subjects to exclude those with any significant arrhythmia.
[0416]Study Design
[0417]This was a double-blind, randomised, placebo-controlled study consisting of the following periods: screening (28 days), baseline evaluation (2 days), treatment (20 days) and study completion evaluation (approximately 10 days after the last drug administration; FIG. 1). Eligible su...
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Abstract
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