Universität zu Köln

Elshoff, Jan-Peer, Timmermann, Lars, Schmid, Miriam, Arth, Christoph, Komenda, Michael, Brunnert, Marcus and Bauer, Lars (2013). Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr. Med. Res. Opin., 29 (12). S. 1657 - 1663. LONDON: INFORMA HEALTHCARE. ISSN 1473-4877

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Abstract

Objective: Rotigotine transdermal patch is approved for the treatment of early and advanced idiopathic Parkinson's disease (PD) and moderate-to-severe idiopathic restless legs syndrome (RLS). A cold chain manufacturing and distribution process was temporarily implemented in 2008, as this reduced the crystal formation reported within patches stored at room temperature. In order to overcome the crystallization issue and meet EMA and FDA requirements, a new room temperature stable formulation was developed. The three studies reported here were conducted to determine whether the new room temperature stable patch demonstrated similar bioavailability and adhesiveness to the original and intermediate patches. Methods: Data are reported from three cross-over studies that compared the original, cold chain and room temperature stable patch. Two open-label bioequivalence studies investigated the 2 mg/24 h dosage in healthy individuals (SP951, n=52 [Clinicaltrials. gov: NCT00881894]; SP0987, n= 50 [NCT01059903]) and a double-blind patch adhesiveness study investigated the 8 mg/24 h dosage in patients with PD (SP1066, n=56 [NCT01338896]). Results: Plasma concentration-time curves and geometric means for pharmacokinetic parameters were similar for the cold chain vs. original patch in SP951 (AUC((o-tz)): 2.68 vs. 2.71 ng/mL* h; point estimate: 0.99 [90% confidence interval (Cl): 0.91, 1.07]) (C-max: 0.131 vs. 0.136 ng/mL; 0.96 [0.89, 1.04]) and for the room temperature stable vs. cold chain patch in SP0987 (AUC((o-tz)): 4.51 vs. 4.87 ng/mL*h; 0.90 [0.84, 0.97]) (C-max: 0.23 vs. 0.23 ng/mL; 0.95 [0.88, 1.02]). In both studies, 90% Cls for ratios of AUC((o-tz)) and Cmax were within the bioequivalence acceptance range (0.8-1.25). In SP1066, overall median adhesiveness scores were similar for cold chain (0.5 [range: 0-4]) and room temperature stable (0 [0-4]) formulations. Conclusion: These results demonstrated bioequivalence and indicated similar adhesiveness of the approved room temperature stable rotigotine patch with the original and cold chain patches. Potential limitations include the enrolment of healthy volunteers in the bioequivalence studies, as these individuals were likely to be younger than the general PD or RLS population.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Elshoff, Jan-Peer UNSPECIFIED UNSPECIFIED UNSPECIFIED Timmermann, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmid, Miriam UNSPECIFIED UNSPECIFIED UNSPECIFIED Arth, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Komenda, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Brunnert, Marcus UNSPECIFIED UNSPECIFIED UNSPECIFIED Bauer, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-470977
DOI:	10.1185/03007995.2013.841666
Journal or Publication Title:	Curr. Med. Res. Opin.
Volume:	29
Number:	12
Page Range:	S. 1657 - 1663
Date:	2013
Publisher:	INFORMA HEALTHCARE
Place of Publication:	LONDON
ISSN:	1473-4877
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ADVANCED PARKINSONS-DISEASE; PLASMA-LEVELS; ADHERENCE; PROFILE; SAFETY Multiple languages Medicine, General & Internal; Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/47097