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Abstract

R. Fischer¹, H. Schütz², M. Grossmann³, H.J. Leis⁴ and R. Ammer¹

¹Medice, Iserlohn, Germany, ²BEBAC, Vienna, Austria, ³IKP, Mannheim, Germany, ⁴BPA, Graz, Austria
Objective: To assess bioequivalence between an intact capsule and the content of a capsule sprinkled on applesauce. Materials: Medikinet retard 20 mg capsules were obtained from Medice (Iserlohn, Germany). Methods: This was a single-center, completely randomized, open, 2-period, 2-sequence, balanced crossover study with a washout period of 1 week between administrations, in 12 healthy male and female subjects, aged 18 – 45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic parameters for both administrations. The main parameters were (confirmatory) AUC0-tz (extent of BA), Cmax, tmax (rate of BA) and (descriptively) AUC0-¥ and t1/2. Equivalence was concluded if the 90% confidence interval (CI) for the ratio between test and reference was 0.80 – 1.25 (AUC0-tz). Results: All 12 dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses. 90% geometric confidence intervals for AUC0-tz and Cmax data were well within accepted bioequivalence limits. The study has shown that both treatment modes lead to similar pattern of absorption and elimination following single-dose administration in the fed state. The test treatment (content of capsule sprinkled over 15 ml applesauce) is bioequivalent to the reference treatment (intact capsule) in terms of extent and rate of absorption. Conclusion: Data collected from this study demonstrate that Medikinet retard capsules can be opened and the content sprinkled on a tablespoon of applesauce without influencing the rate and extent of bioavailability. Correspondence to:
Dr. R. Fischer
MEDICE Arzneimittel
Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn, Germany
Email: [email protected]

Abstract

H. Schütz¹, R. Fischer², M. Großmann³, D. Mazur³, H.J. Leis⁴ and R. Ammer²

¹BEBAC, Vienna, Austria, ²Medice, Iserlohn, Germany, ³PAREXEL, Berlin, Germany and ⁴BPA, Graz, Austria
Objective: To assess bioequivalence between Equasym Retard and Medikinet retard containing 20 mg methylphenidate (MPH) hydrochloride in a fed state. Materials: Equasym Retard 20 mg capsules (UCB, Monheim, Germany) and Medikinet retard 20 mg capsules (Medice, Iserlohn, Germany). Methods: This was an open, single-center, randomized, 2-period, 2-sequence, balanced cross-over study with a wash-out period of 1 week between administrations in 14 healthy male and female volunteers, aged 18 – 45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic metrics for both formulations. The main metrics were AUC_0-t and C_max. Bioequivalence was concluded if the 90% confidence interval (CI) for the ratio between test and reference was 80 – 125% (AUC_0-t, C_max). Results: All dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses. The adverse events observed, mainly nervous system disorders (headache), were all mild or moderate in intensity and resolved without any action taken. The adverse event profile was consistent with the currently applicable SmPCs (Summaries of Product Characteristics) for Equasym Retard and Medikinet retard. Geometric means ± SD for AUC_0-t and C_max were 35.5 ± 10.1 ng × h/ml and 4.05 ± 0.96 ng/ml (Equasym Retard) and 39.2 ± 13.8 ng × h/ml and 5.26 ± 2.11 ng/ml (Medikinet retard). The 90% geometric confidence interval for AUC_0-t (extent of absorption) was within limits accepted for bioequivalence. Bioequivalence could not be demonstrated for the rate of bioavailability (C_max); both the lower confidence limit and the point estimate were below 80% of the reference. The study has shown that both formulations lead to a similar pattern of absorption and elimination following single dose administration in the fed state, although the test formulation shows a somewhat slimmer profile, where the first peak is less pronounced. No bioequivalence could be shown within the first 4 hours. The second peak of the test was also lower than the one of the reference (both lower confidence limit and point estimate below 80%). Conclusions: The two formulations are not bioequivalent, especially if the rate and values within the first four hours after administration are taken into account.Correspondence to:
Dr. R. Fischer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn, Germany
Email: [email protected]

Abstract

Biomarker response on exposure to sunitinib and its primary metabolite (SU12662) in metastatic colorectal cancer patients

F. Kanefendt, A. Lindauer, M. Kinzig, D. Strumberg, M.E. Scheulen, K. Mross, R. Fischer, B. Moritz, F. Sörgel and U. Jaehde

Abstract

A preliminary report of a Phase II study of folinic acid, 5-fluorouracil, irinotecan (FOLFIRI) plus sunitinib with toxicity, efficacy, pharmacokinetics, biomarker, imaging data in patients with colorectal cancer with liver metastases as 1st line treatment

K. Mross, M. Büchert, U. Fasol, U. Jaehde, F. Kanefendt, D. Strumberg, J. Arends, J. Hense, B. Moritz, R. Fischer and M.E. Scheulen

Abstract

Intensiv- und Notfallbehandlung, Jahrgang 41, Nr. 1/2016, S. 26-33

Der seltene Fall: Suizidversuch mit ungewöhnlichen Komplikationen

L. Mende¹, A. Schulz¹, T. Wedel¹, B. Pero², R. Fischer³, C. Schwarz⁴ und K. Pracht¹

¹Klinik für Anästhesie, Intensivmedizin, Schmerztherapie und Palliativmedizin, ²Institut für Radiologie, ³Klinik für Innere Medizin, ⁴Zentrale Notaufnahme, Sana Kliniken Leipziger Land
Wir berichten über das seltene Zusammentreffen einer akzidentiellen Kohlenmonoxid( CO)-Intoxikation, dem Vorliegen eines Hirnödems und eines spontanen Mediastinalemphysems unklarer Genese bei einem 18-jährigen Patienten nach einem Suizidversuch. Bei rasch fallender CO-Hb- Konzentration wurde auf die Durchführung einer Hyperbaren Oxygenierung (HBO) verzichtet und anstelle dieser eine konservative Therapie der CO-Intoxikation mittels hochdosierter Sauerstoffzuführung im Rahmen einer invasive Beatmung durchgeführt. Der weitere Verlauf war von einer massiven Zunahme des Mediastinalemphysems mit operativer Revision und der Entwicklung eines Adult Respiratory Distress Syndromes (ARDS) aufgrund einer Aspiration gekennzeichnet. Nach 8 Tagen konnte der Patient erfolgreich vom Respirator entwöhnt und in eine neurologische Rehabilitationseinrichtung verlegt werden.Correspondence to:
Dr. med. Ludger Mende
Sana Klinikum Leipziger Land
Bereich Interdisziplinäre Intensivmedizin
Klinik für Anästhesie, Intensivmedizin, Schmerz- und Palliativmedizin
Rudolph-Virchow Straße 2
04552 Borna
Email: [email protected]

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