Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration

Anschütz, Maria; Wonnemann, Meinolf; Schug, Barbara; Toal, Corey B.; Donath, Frank; Pontius, A.; Pauli, Kenneth D.; Brendel, E.; Blume, Henning

doi:10.5414/cpp48158

Cited by 19 publications

(14 citation statements)

References 21 publications

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“…However, pAUCs discriminate strongly and sensitively between the two formulations. The same phenomenon was observed, and the same conclusions reached, when two formulations of MR nifedipine (55) and bupropion (56) were compared.…”

Section: Partial Auc For Some Multiphasic Mr Productssupporting

confidence: 60%

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Endrényi

Tóthfalusi

2012

AAPS J

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Abstract. Metrics are discussed which are used for the evaluation of bioequivalence of modifiedrelease formulations. In order to ensure the therapeutic equivalence of the compared drug products, it would be important to contrast measures which are additional to area under the curve (AUC) and C max . For delayed-release products, the assessment of lag times is informative. For extended-release dosage forms, comparisons of the half-value duration and the midpoint duration time are useful. For some modified-release formulations with complicated, multiphasic concentration profiles, the comparison of partial AUCs is important. In determinations of the bioequivalence of extended-release dosage forms, investigations performed under steady-state conditions rather than after single dosing can yield enhanced probability of therapeutic equivalence, especially with substantial accumulation of the drug products. In steady-state investigations of bioequivalence, evaluation of the trough concentration and of the peak trough fluctuation is informative.

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Section: Partial Auc For Some Multiphasic Mr Productssupporting

confidence: 60%

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Endrényi

Tóthfalusi

2012

AAPS J

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“…примерно на 2 мм рт.ст.) [30], в связи с чем использование ко-роткодействующего нифедипина, в том числе для ку-пирования гипертонических кризов, требует опреде-ленной осторожности.…”

Section: применение нифедипина при гипертоническом кризеunclassified

Dihydropyridine Calcium Antagonists. Position of Nifedipine in Modern Cardiology Practice

Garganeeva

2011

Racionalʹnaâ farmakoterapiâ v kardiologii

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Научно-исследовательский институт кардиологии Сибирского отделения Российской академии медицинских наук. 634012, Томск, ул. Киевская, 111-А Дигидропиридиновые антагонисты кальция. Место нифедипина в современной кардиологической практике А.А. Гарганеева* Научно-исследовательский институт кардиологии Сибирского отделения Российской академии медицинских наук. 634012, Томск, ул. Киевская, 111-А Освещается место нифедипина в современной кардиологической практике. Рассматривается применение нифедипина для лечения артериальной гипертонии, в том числе в со-ставе комбинированной антигипертензивной терапии, профилактики инсультов, при гипертоническом кризе, ишемической болезни сердца. Приводятся преимущества исполь-зования современных лекарственных форм нифедипина. Отдельно рассматриваются возможности применения нифедипина при легочной гипертензии, а также во время бере-менности. Ключевые слова: антагонисты кальция, нифедипин, артериальная гипертония, ишемическая болезнь сердца. Position of nifedipine in modern cardiology practice is highlighted. Nifedipine usage for arterial hypertension therapy, including combined one, stroke prevention, treatment of hypertensive crisis and ischemic heart disease is considered. Advantages of nifedipine innovative formulations are presented. Possible usage of nifedipine in pulmonary hypertension as well as pregnancy is discussed specially.

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“…This is clearly the case in comparisons of Concerta with Metadate CD and with several other extended-release methylphenidate preparations. (14). Both drug products used OROS formulations.…”

Section: Comparisons Of Complicated Concentration Profiles Of Mr Formmentioning

confidence: 99%

“…Both drug products used OROS formulations. The reference product was the 60 mg Adalat XL tablet (Bayer Healthcare AG, Leverkusen, Germany) with a bilayer pump system, while the test formulation Figure 2 illustrates the time courses of average concentrations after the administration of a single dose to 26 fasted subjects (14). Both the peak concentrations and AUCs of the two formulations appear to be comparable.…”

Section: Comparisons Of Complicated Concentration Profiles Of Mr Formmentioning

confidence: 99%

Do Regulatory Bioequivalence Requirements Adequately Reflect the Therapeutic Equivalence of Modified-Release Drug Products?

Endrényi

Tóthfalusi

2010

J Pharm Pharm Sci

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-Purpose. To demonstrate that current regulatory requirements for bioequivalence (BE) do not always reflect therapeutic equivalence. To investigate the potential usefulness of an additional metric, the partial AUC. Methods. Pharmacokinetic information was reviewed and evaluated on the pharmacokinetics of modified-release methylphenidate and nifedipine products. Results. In studies of modified-release products of methylphenidate as well as of nifedipine, traditional regulatory criteria found two formulations to be bioequivalent even though their concentration profiles strongly diverged during the period of absorption. An additional metric, partial AUC, discriminated strongly between the concentrations of the drug products. Conclusions. The current regulatory criteria for the acceptance of BE do not always reflect the therapeutic equivalence of modified-release drug products. With some modified-release products, the application of an additional metric, the partial AUC, yields an improved discriminatory representation. __________________________________________________________________________________________

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Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration

Cited by 19 publications

References 21 publications

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations

Dihydropyridine Calcium Antagonists. Position of Nifedipine in Modern Cardiology Practice

Do Regulatory Bioequivalence Requirements Adequately Reflect the Therapeutic Equivalence of Modified-Release Drug Products?

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