Simultaneous Quantification of Cephalexin and Sodium Benzoate in their Dosage forms by high analytical technique. Application of Lean Six Sigma and In-Vitro Dissolution studies

2020 ◽  
Author(s):  
M.A. Mohamed
Keyword(s):  
Six Sigma ◽  
Sodium Benzoate ◽  
Dosage Forms ◽  
Lean Six Sigma ◽  
In Vitro Dissolution ◽  
Analytical Technique ◽  
Dissolution Studies ◽  
Simultaneous Quantification

Formulation and Evaluation of Bilayer Sustained Release Tablets of Salbutamol and Theophylline

2009 ◽  
Vol 2 (3) ◽  
pp. 638-646
Author(s):  
R. Nagaraju ◽  
Rajesh Kaza
Keyword(s):  
Ethyl Cellulose ◽  
Xanthan Gum ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Studies ◽  
Sustained Release Tablets ◽  
Dissolution Apparatus ◽  
Single Dosage

Salbutamol and theophylline are available in conventional dosage forms, administered four times a day, leading to saw tooth kinetics and resulting in ineffective therapy. The combination of these two drugs in a single dosage form will enhance the patient compliance and prolong bronchodilation. Various polymers, such as hydroxy propyl methylcellulose K4M (HPMC- K4M), hydroxy propyl methylcellulose K100M (HPMC- K100M), xanthan gum, ethyl cellulose and hydroxy propyl methylcellulose phthalate (HPMC-P) were studied. HPMC-P and HPMC- K4M were found to be best in controlling the release. In-vitro dissolution studies were carried out for all the bi-layered tablets developed using USP dissolution apparatus type 2 (paddle). It was found that the tablet FB15-FW3 showed 50% release of salbutamol in first hour and the remaining was released for eight hours. However, theophylline was found to be released as per the USP specifications. The IR spectrum was taken for FB15-FW3 formulation and it revealed that there is no disturbance in the principal peaks of pure drugs salbutamol and theophylline. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. Also, formulation of FB15-FW3 has shown required release pattern and complies with all the evaluated parameters and comparable to the marketed formulation.

Validation and Comparative In-vitro Dissolution Studies of Cefaclor in Their Powder for Oral Suspension Dosage Forms

2018 ◽  
Vol 8 (1) ◽  
pp. 88-103 ◽  
Author(s):  
Mahmoud A. Mohamed ◽  
Amr H. Ali ◽  
Abdelfatah M. Abdelfatah ◽  
Mahmoud O. Ahmed
Keyword(s):  
Dosage Forms ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Dissolution Studies

scholarly journals HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies

2010 ◽  
Vol 46 (4) ◽  
pp. 761-768 ◽  
Author(s):  
Mustafa Çelebier ◽  
Mustafa Sinan Kaynak ◽  
Sacide Altınöz ◽  
Selma Sahin
Keyword(s):  
Method Development ◽  
Drug Product ◽  
Dosage Forms ◽  
Hplc Method ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Combination Drug ◽  
Dissolution Studies ◽  
Ultraviolet Detector

A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C18 column (ODS 2, 10 μm, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6 , 0.01 mol L-1):acetonitrile: methanol (46:44:10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min-1 and at ambient temperature. The injection volume was 20 μL and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear within the range 0.1 - 50 μg mL-1 for amlodipine, and 0.05 - 50 μg mL-1 for valsartan. The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.

scholarly journals An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 507
Author(s):  
Isabel Gonzalez-Alvarez ◽  
Marival Bermejo ◽  
Yasuhiro Tsume ◽  
Alejandro Ruiz-Picazo ◽  
Marta Gonzalez-Alvarez ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
In Vitro Dissolution ◽  
Case Examples ◽  
Dissolution Studies ◽  
Weak Bases ◽  
Transit Times ◽  
Class Iib ◽  
The Impact

The purpose of this study was to predict in vivo performance of three oral products of Etoricoxib (Arcoxia® as reference and two generic formulations in development) by conducting in vivo predictive dissolution with GIS (Gastro Intestinal Simulator) and computational analysis. Those predictions were compared with the results from previous bioequivalence (BE) human studies. Product dissolution studies were performed using a computer-controlled multicompartmental dissolution device (GIS) equipped with three dissolution chambers, representing stomach, duodenum, and jejunum, with integrated transit times and secretion rates. The measured dissolved amounts were modelled in each compartment with a set of differential equations representing transit, dissolution, and precipitation processes. The observed drug concentration by in vitro dissolution studies were directly convoluted with permeability and disposition parameters from literature to generate the predicted plasma concentrations. The GIS was able to detect the dissolution differences among reference and generic formulations in the gastric chamber where the drug solubility is high (pH 2) while the USP 2 standard dissolution test at pH 2 did not show any difference. Therefore, the current study confirms the importance of multicompartmental dissolution testing for weak bases as observed for other case examples but also the impact of excipients on duodenal and jejunal in vivo behavior.

scholarly journals The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

2012 ◽  
Vol 2 ◽  
pp. 1-8 ◽  
Author(s):  
Mubarak Nasser Al Ameri ◽  
Nanda Nayuni ◽  
K.G. Anil Kumar ◽  
David Perrett ◽  
Arthur Tucker ◽  
...  
Keyword(s):  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Testing ◽  
Generic Medicines ◽  
Solid Dosage Forms ◽  
Solid Dosage
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