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Jena, Germany

Rossteuscher-Carl K.,Jenapharm GmbH and Co KG | Rossteuscher-Carl K.,University of Leipzig | Fricke S.,Jenapharm GmbH and Co KG | Hacker M.C.,University of Leipzig | Schulz-Siegmund M.,University of Leipzig
International Journal of Pharmaceutics | Year: 2014

According to the ICH Q8 guideline, analytic technologies (PAT) are important tools for characterization and optimization of pharmaceutical manufacturing processes. Particle size as a critical quality attribute for granules is therefore an important parameter that should be monitored during the fluid bed granulation process. This work focusses on optimizing position and configuration of an SFT-sensor for the in-line measurement of particle size distribution in a Glatt GPCG 3 fluid bed granulator. As model-substances, different grades of microcrystalline cellulose were used. The in-line measured particle size and particle rate in the sensor were evaluated. A sensor position in the deceleration zone of the granulator was found to be promising for in-line particle size measurement. Most reliable data were generated in this position when the probe was placed in a distance of 11 cm from the chamber wall to avoid bias by the inlet air stream. No major influence of rotation angle of the probe was found in this position. Furthermore, an entire fluid bed granulation process was successfully monitored with the sensor installed in the optimized setting. © 2014 Elsevier B.V. Source

Strowitzki T.,University of Heidelberg | Faustmann T.,Bayer AG | Gerlinger C.,Bayer AG | Gerlinger C.,Saarland University | And 4 more authors.
International Journal of Women's Health | Year: 2015

Background: In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and reduction in pain intensity in endometriosis. We describe a pooled analysis of the safety and tolerability data from these trials to confirm and further characterize the safety profile of dienogest in the treatment of endometriosis. Methods: All 332 women treated with dienogest 2 mg who participated in the four clinical trials were included in the pooled analyses for safety assessments, including adverse events, laboratory tests, vital signs, body weight, and bleeding patterns. Safety variables were analyzed using descriptive statistics. Results: Pooled analyses of this large patient population confirmed that dienogest 2 mg is well tolerated, with a favorable safety profile extending over a period up to 65 weeks in women with endometriosis. The most common adverse drug reactions were headache, breast discomfort, depressed mood, and acne, each occurring in <10% of women. All these adverse events were generally of mild-to-moderate intensity and associated with low discontinuation rates. The bleeding pattern associated with dienogest 2 mg was well tolerated, and only two women (0.6%) reported bleeding events as the primary reason for premature discon­tinuation. Laboratory and vital sign assessments indicated no safety concerns for dienogest. Estradiol levels were maintained within the low-physiological range, in support of previous evidence indicating that dienogest 2 mg demonstrates therapeutic efficacy without inducing estradiol deficiency. Conclusion: In this pooled analysis of 332 women with endometriosis, dienogest was well tolerated with a favorable safety profile extending over a period of up to 65 weeks. There is a paucity of randomized trial evidence to support the use of many treatments in endometriosis. These pooled analyses from four clinical trials of dienogest 2 mg represent a contribution to evidence-based medicine in endometriosis, providing outcomes of potential relevance to daily practice. © 2015 Hernández-Núñez and Valdés-Yong. Source

Rouskova D.,Jenapharm GmbH and Co KG | Mittmann K.,Praxis Dr. Med. Ch. Oehlwein | Schumacher U.,Jenapharm GmbH and Co KG | Dietrich H.,Jenapharm GmbH and Co KG | Zimmermann T.,Jenapharm GmbH and Co KG
Gynecological Endocrinology | Year: 2015

Background: Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.Methods: Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.Results: MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medications effectiveness/tolerability as good/very good; 84% intended to continue the treatment.Conclusion: This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency. © 2015 Jenapharm GmbH & Co. KG. Source

Wiegratz I.,University Hospital of Frankfurt | Stahlberg S.,University Hospital of Frankfurt | Manthey T.,University Hospital of Frankfurt | Sanger N.,University Hospital of Frankfurt | And 5 more authors.
Contraception | Year: 2011

Background: The present study compared the efficacy and safety of a combined oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest (EE/DNG) in conventional and extended-cycle regimen over 1 year of treatment. Study Design: In a phase III, randomized, prospective, open, two-arm, multicenter study, 1315 sexually active women (range, 18-40 years) were treated with EE/DNG either conventionally (21/7 days) or according to an extended-cycle regimen (84/7 days). Data were documented on volunteer diaries, and adverse events (AEs) were reported during five visits. Results: In the extended-regimen group, the total number of days with bleeding progressively decreased over time, and overall, the volunteers had fewer numbers of days with bleeding/spotting compared to those treated conventionally. Intracyclic bleeding, on the other hand, was more frequent in the extended-cycle group, although its frequency considerably decreased over time. Both regimens offered reliable contraception, with an unadjusted Pearl Index of 0.489 for the conventional regimen and 0.495 for the extended regimen. The number of AEs was higher in the extended-cycle group, although the group differences tended to decrease over time. Conclusions: Extended-cycle use of EE/DNG was effective and mostly well tolerated, appearing to be a favorable option for women who need or wish to omit the pill-free interval. © 2011 Elsevier Inc. All rights reserved. Source

Wiegratz I.,University Hospital of Frankfurt | Stahlberg S.,University Hospital of Frankfurt | Manthey T.,University Hospital of Frankfurt | Snger N.,University Hospital of Frankfurt | And 5 more authors.
Hormone and Metabolic Research | Year: 2010

The effects of extended regimens of combined oral contraceptives (COCs) on carbohydrate metabolism are largely unknown. The present study compared the effects of a COC containing 30g ethinylestradiol and 2mg dienogest (EE/DNG) in conventional and extended-cycle regimen over 1 year. Parameters of carbohydrate metabolism were measured in 59 women treated with EE/DNG either conventionally (13 cycles of 21+7 days) or in extended-cycle regimen (4 cycles of 84+7 days). Blood samples were taken in a control cycle, and at 3 and 12 months of treatment. The mean levels of HbA1c and fasting glucose levels remained stable in both conventional and extended-regimen of EE/DNG. The mean levels of fasting insulin and C-peptide underwent comparable increases in both regimens, suggesting a similar readjustment of glucose metabolism via slightly increased insulin secretion. For both regimens, the response to the oral glucose tolerance test (OGTT) showed a slightly impaired glucose tolerance and insulin resistance at 3 months. These changes improved or returned to baseline at 12 months. Accordingly, the mean index for insulin resistance (homeostasis model assessment of insulin resistance, HOMA-IR) increased and the mean insulin sensitivity index [ISI (composite)] decreased modestly in both groups. The present study demonstrates that there are no statistically significant differences between the effects of conventional and extended-cycle treatment on carbohydrate metabolism over 1 year of treatment. In general, the effects of both regimens were moderate and mostly transient. Source

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