Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles

Huang, Xiaomei; Zhang, Suhua; Ma, Yan-Xia; Yang, Heng; He, Chuan Sheng; Tian, Rufang; Han, Min−Koo; Liu, Lipeng; Zhang, Bikui

doi:10.2147/dddt.s182965

Cited by 6 publications

(2 citation statements)

References 27 publications

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“…The shape of all these profiles was closer to the published original ones. Some shape similarities, including the burst between 4 and 5 h, probably, due to stress-events in GI-tract, were also observed in other bioequivalence trials with Seroquel® XR tablets - 50 mg ( 31 , 40 , 42 ), − 200 mg ( 43 ) and - 300 mg ( 41 ). However, a perfect matching of burst times barely possible because in vivo profiles are always representing the average of particular studies with a limited number of subjects and very high intra/interindividual variability.…”

Section: Discussionsupporting

confidence: 64%

IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

et al. 2020

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Purpose When establishing IVIVC, a special problem arises by interpretation of averaged in vivo profiles insight of considerable individual variations in term of time and number of mechanical stress events in GI-tract. The objective of the study was to investigate and forecast the effect of mechanical stress on in vivo behavior in human of hydrophilic matrix tablets. Methods Dissolution profiles for the marketed products were obtained at different conditions (stirring speed, single- or repeatable mechanical stress applied) and convoluted into C-t profiles. Vice versa, published in vivo C-t profiles of the products were deconvoluted into absorption profiles and compared with dissolution profiles by similarity factor. Results Investigated hydrophilic matrix tablets varied in term of their resistance against hydrodynamic stress or single stress during the dissolution. Different scenarios, including repeatable mechanical stress, were investigated on mostly prone Seroquel® XR 50 mg. None of the particular scenarios fits to the published in vivo C-t profile of Seroquel® XR 50 mg representing, however, the average of individual profiles related to scenarios differing by number, frequency and time of contraction stress. When different scenarios were combined in different proportions, the profiles became closer to the original in vivo profile including a burst between 4 and 5 h, probably, due to stress-events in GI-tract. Conclusion For establishing IVIVC of oral dosage forms susceptible mechanical stress, a comparison of the deconvoluted individual in vivo profiles with in vitro profiles of different dissolution scenarios can be recommended.

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Section: Discussionsupporting

confidence: 64%

IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

et al. 2020

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“…Eat whole meal (Composition under SmPC) within 30 minutes. (29) Meals taken are as per specification (composition) and time administration depends on type of study.…”

Section: Effect Of Asean Harmonization Of Guidelines On Pharmaceutica...mentioning

confidence: 99%

Comparative study of Regulatory requirements of Drug Product in Emerging market

Patel¹,

Badjatya²,

Hinge³

2019

Int J Drug Reg Affairs

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

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A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine

Zhang

Wang

et al. 2021

Acta Pharmaceutica Sinica B

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Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles

Cited by 6 publications

References 27 publications

IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

Comparative study of Regulatory requirements of Drug Product in Emerging market

A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine

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