Development of In Vitro-In Vivo Correlation for Potassium Chloride Extended Release Tablet Formulation Using Urinary Pharmacokinetic Data

2017 ◽  
Vol 34 (7) ◽  
pp. 1527-1533 ◽  
Author(s):  
Rajendar K. Mittapalli ◽  
Patrick Marroum ◽  
Yihong Qiu ◽  
Kathleen Apfelbaum ◽  
Hao Xiong
2017 ◽  
Vol 34 (6) ◽  
pp. 1187-1192 ◽  
Author(s):  
Rajendar K. Mittapalli ◽  
Silpa Nuthalapati ◽  
Alyssa E. Delke DeBord ◽  
Hao Xiong

2004 ◽  
Vol 58 (3) ◽  
pp. 607-614 ◽  
Author(s):  
Yaw-Bin Huang ◽  
Yi-Hung Tsai ◽  
Wan-Chiech Yang ◽  
Jui-Sheng Chang ◽  
Pao-Chu Wu ◽  
...  

2010 ◽  
Vol 383 (1-2) ◽  
pp. 99-105 ◽  
Author(s):  
Shinichiro Tajiri ◽  
Taro Kanamaru ◽  
Kamada Makoto ◽  
Tsutomu Konno ◽  
Hiroaki Nakagami

2011 ◽  
Vol 65 (1-2) ◽  
pp. 71-81
Author(s):  
Irena Homsek ◽  
Dragica Popadic ◽  
Slobodanka Simic ◽  
Slavica Ristic ◽  
Katarina Vucicevic ◽  
...  

Controlled-release (CR) pharmaceutical formulations offer several advantages over the conventional, immediate release dosage forms of the same drug, including reduced dosing frequency, decreased incidence and/or intensity of adverse effects, greater selectivity of pharmacological activity, reduced drug plasma fluctuation, and better compliance. After a drug product has been registered, and is already on market, minor changes in formulation might be needed. At the same time, the product has to remain effective and safe for patients that could be confirmed via plasma drug concentrations and pharmacokinetic characteristics. It is challenging to predict human absorption and pharmacokinetic characteristics of a drug based on the in vitro dissolution test and the animal pharmacokinetic data. Therefore, the objective of this study was to establish correlation of the pharmacokinetic parameters of carbamazepine (CBZ) CR tablet formulation between the rabbit and the human model, and to establish in vitro in vivo correlation (IVIVC) based on the predicted fractions of absorbed CBZ. Although differences in mean plasma concentration profiles were notified, the data concerning the predicted fraction of drug absorbed were almost superimposable. Accordingly, it can be concluded that rabbits may be representative as an in vivo model for predicting the pharmacokinetics of the CR formulation of CBZ in humans.


Author(s):  
Antonio Pardo ◽  
Thomas R. King ◽  
Eman Rafla ◽  
Judith C. Kando ◽  
Amy Everitt

2003 ◽  
Vol 43 (10) ◽  
pp. 1149-1157 ◽  
Author(s):  
Suryanarayana Sista ◽  
John Chi-Keung Lai ◽  
Okponanabofa Eradiri ◽  
Kenneth S. Albert

Author(s):  
Kukkadapu Pavan Kumar ◽  
Katta Sunand ◽  
Nerella Mounika ◽  
Mohammed Abdul Samad ◽  
A. Madhu Babu ◽  
...  

A drug molecule has to be water-soluble to be readily delivered to the cellular membrane. Many drugs are waterinsoluble, which creates numerous problems in the development of dosage forms. Controlled drug delivery formulation releases the drug with controlled kinetics for days and months, reducing the frequency of dosing, minimizing side effects, and improving patient compliance. Nisoldipine is a calcium channel antagonist that is indicated for the treatment of hypertension with very poor aqueous solubility. Thus, there is a need to improve the rate of drug release. Hence, the study was carried out to design, formulate and evaluate sustained-release tablet formulation of nisoldipine. Nisoldipine controlled release matrix tablets were prepared by roll compaction method. Preformulation studies have confirmed the purity and compatibility of drug with excipients used in the formulation. Pre-compression studies have confirmed the stability of formulation blends for compression. All the prepared formulations were evaluated for various physical and compression parameters such as bulk and tapped density, hardness, friability, and in vitro drug release studies. The results of drug release from prepared compressed nisoldipine extended-release tablets were found to be within the desired range.


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