Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies

Author(s):  
Eiji Kajiwara ◽  
Haruki Kamizato ◽  
Mayumi Shikano
2021 ◽  
Vol 32 ◽  
pp. S321
Author(s):  
Nobu Akiyama ◽  
Takuho Okamura ◽  
Shun-ichi Kimura ◽  
Shingo Yano ◽  
Isao Yoshida ◽  
...  

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Sahar Fahmy ◽  
Eman Abu-Gharbieh

This study was undertaken to assess thein vitrodissolution andin vivobioavailability of six brands of ciprofloxacin oral tablets available in the UAE market using rabbits. Thein vitrodissolution profiles of the six ciprofloxacin products were determined using the USP dissolution paddle method. Pharmacokinetic modeling using compartmental and noncompartmental analysis was done to determine the pharmacokinetic parameters of ciprofloxacin after single-dose oral administration.In vitrorelease study revealed that the amount of ciprofloxacin released in 20 minutes was not less than 80% of the labeled amount which is in accordance with the pharmacopoeial requirements. All tested products are considered to be very rapid dissolving except for formulae A and D. Ciprofloxacin plasma concentration in rabbits was best fitted to a two-compartment open model. The lowest bioavailability was determined to be for product A (93.24%) while the highest bioavailability was determined to be for product E (108.01%). Postmarketing surveillance is very crucial to ensure product quality and eliminating substandard products to be distributed and, consequently, ensure better patient clinical outcome. The tested ciprofloxacin generic products distributed in the UAE market were proven to be of good quality and could be used interchangeably with the branded ciprofloxacin product.


Author(s):  
Bhavana Habib ◽  
Jyoti Mittha

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_2) ◽  
Author(s):  
Masako Fujiwara ◽  
Tohru Kobayashi ◽  
Satoko Tsuru ◽  
Hiroyuki Ida

Background: In Japan, 2 guidelines are published, the clinical guidelines for medical treatment of acute stage Kawasaki disease(KD)(2012) and guidelines for diagnosis and management of cardiovascular sequelae in KD(2013). Patient Condition Adaptive Path System (PCAPS) is a technique to structure clinical knowledge. It places “patient condition” as a core, to which multiple “target conditions” are linked. On the other hand, patients of KD ware focused the severity of the disease and therapeutic strategy influences the improvement. Purpose: The purpose is confirming the PCAPS KD contents, which complied two Japanese Guidelines and to evaluate adaption of the contents. Methods: PCAPS content is composed of Clinical Process Chart (CPC) and Unit Sheet (US).CPC is an overhead view of clinical path consisting of a chain of units. CPC was made according the guidelines, and coronary evaluation, CHF, cardiac catheterization and ACS unit can activate on time. CPC stratify the patient’s severity. US are composed of specific healthcare tasks in a unit. Results: We confirm PCAPS KD contents on the base of 2 guidelines. We can evaluate diagnostic process and severity of KD by route analysis using CPC (figure). We can visualize relationship between treatments and severity by US. US are effective to support the decision on treatment and examinations. From the analysis, there are no lack of the unit and route, and confirm the advice to decision making. Conclusions: PCAPS can easily analyze the severity and clinical process from CPC route analysis because PCAPS is electrical path which can automatically store the data of each hospital. From US data, there are possibilities to find new severity score.


2018 ◽  
Vol 9 (4) ◽  
pp. 235-243 ◽  
Author(s):  
Masaaki Niino ◽  
Takashi Ohashi ◽  
Hirofumi Ochi ◽  
Ichiro Nakashima ◽  
Yuko Shimizu ◽  
...  

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