A NEW SUBLINGUAL FORMULATION OF APOMORPHINE IN THE TREATMENT OF PATIENTS WITH PARKINSONS-DISEASE

Citation
T. Vanlaar et al., A NEW SUBLINGUAL FORMULATION OF APOMORPHINE IN THE TREATMENT OF PATIENTS WITH PARKINSONS-DISEASE, Movement disorders, 11(6), 1996, pp. 633-638
Citations number
20
Categorie Soggetti
Clinical Neurology
Journal title
ISSN journal
08853185
Volume
11
Issue
6
Year of publication
1996
Pages
633 - 638
Database
ISI
SICI code
0885-3185(1996)11:6<633:ANSFOA>2.0.ZU;2-N
Abstract
A new formulation of a sublingual tablet with 10 mg apomorphine was ex amined in 13 patients with Parkinson's disease. Vitamin C (250 mg) was added sublingually to lower the salivary pH. Four patients received s ublingual apomorphine and nine received sublingual apomorphine as well as vitamin C. Subcutaneous apomorphine was given to all patients. The study was de signed as a randomized three-way cross-over study. T-max , C and bioavailability (F) were determined. Clinical efficacy was ass essed by hand-tapping during 30 s, walking time over 25 m, and a 4-poi nt tremor score. The mean T-max, after subcutaneous apomorphine was 14 .5 +/- 1.9 min with a mean C-max, of 19.2 +/- 3.8 ng/ml. The mean clea rance of all patients was 3.8 +/- 0.6 L/min. The mean T-max, after sub lingual apomorphine was 61.1 +/- 6.9 min vs. 61.7 +/- 8.2 min with vit amin C. The mean C was 7.4 +/- 1.0 ng/ml (- vitamin C) vs. 4.3 +/- 1.3 ng/ml (+ vitamin C). These data resulted consequently in a not signif icantly different mean bioavailability, varying from 17.6% (- vitamin C) to 6.1% (+ vitamin C), The latency of onset of clinical efficacy va ried between 25.0 +/- 8.5 min (- vitamin C) and 26.0 +/- 5.3 min (+ vi tamin C). The duration of effect was lower (not significantly) when vi tamin C was added: 88.0 +/- 12.5 min (- vitamin C) vs. 61.0 +/- 11.9 m in (+ vitamin C). These data show that 10 mg apomorphine sublingually was effective in 56% of the patients, The combination with vitamin C d id not significantly change the latency of onset or duration of clinic al efficacy. Sublingual apomorphine should be considered as an alterna tive in the treatment of ''off''-periods in Parkinson's disease, in pa rticular when patients have the capacity to anticipate their off-perio ds.