Parameters Affecting on Intrinsic Uniformity Test For MEDISO

10.5580/487 ◽  
2010 ◽  
Vol 5 (2) ◽  
Keyword(s):  
2020 ◽  
Vol 17 (1) ◽  
pp. 29-33
Author(s):  
Kudirat B. Mustapha ◽  
Marlene D. Ekpo ◽  
Isa H. Galadima ◽  
Rukaiyatu A. Kirim ◽  
Olubukola A. Odeniran ◽  
...  

Erythromycin is one of the most frequently prescribed antibiotics. With the increasing number of pharmaceutical industries, the possibility of  purchasing a substandard product is on the high side. This makes it necessary to subject various commercially produced brands of erythromycin to quality evaluation in order to ascertain the quality. In this quality assessment study, six (6) brands of erythromycin tablets were subjected to physicochemical assay using standard physical methods and UV/VIS spectrophotometric analysis at 480 nm. The calibration curve for reference erythromycin was linear over a concentration range of 10-100 μg/ml with a correlation coefficient (R2) of 0.999. All the brands had standard deviation of weight greater than ±5 for the weight uniformity test. 66.67% of the brands passed the test for content of active ingredient. 83.33% of the brands examined passed the hardness test. All the brands failed the friability test because the percentage weight loss are greater than 1% as specified in the official book. Keywords: Erythromycin stearate; Tablets; Brands; Pharmaceutical Industries


2018 ◽  
Author(s):  
Abdelmoneim Zakaria Mohamed ◽  
Troy Robert Peters ◽  
Abid Sarwar ◽  
Don McMoran

2014 ◽  
Vol 996 ◽  
pp. 325-330 ◽  
Author(s):  
František Menda ◽  
Patrik Šarga ◽  
František Trebuňa

The evaluation of residual stresses using Ring-Core method requires complex analysis of the acquired strain values. The development is based on ASTM Standard E837-08 for hole-drilling method, but the specific approach for Ring-Core is needed. The input data sets obtained from strain gage rosette are categorized by proposed uniformity test. The influence of geometric parameters of the specimen on this test and subsequently on the both uniform and nonuniform calculations is considered.


2016 ◽  
Vol 32 (9) ◽  
pp. 1162-1166 ◽  
Author(s):  
Nicholas J. Dudley ◽  
Darren J. Woolley

Author(s):  
RESMI MUSTARICHIE ◽  
DOLIH GOZALI ◽  
YEDI HERDIANA

Objective: Ciprofloxacin hydrochloride tablets which are not extended-release will produce non-constant drug levels in the blood. This study aimed to overcome this problem by making ciprofloxacin hydrochloride extended-release tablets with a combination of hydroxypropyl methylcellulose (HPMC) K100M and hydroxypropyl methylcellulose (HPMC) K4M by a direct compression method. Methods: The method in this study consisted of preformulation, formula design, manufacture of ciprofloxacin hydrochloride tablets, tablet print mass testing, IPC (In-Process Control) slow-release tablet mass print, IPC (In-Process Control) quality of slow-release tablet preparation, dissolution test, and statistical analysis. Preformulation was carried out aiming to determine the physical and chemical properties of active-excipient substances based on a certificate of analysis. This was done using a Fourier Transform Infrared (FT-IR) and UV-Vis spectrophotometer. Five kinds of ciprofloxacin hydrochloride tablet formulations were made using the direct pressing method with variations in the concentration of HPMC K100M and HPMC K4M. The ratio of percentage of HPMC K100M and HPMC K4M were F1 0,5%: 1%, F2 1%: 0,5%, F3 0,75%: 0,75%, F4 1%: 0%, F5 0%: 3%. Evaluation of tablet preparations (IPC control) included weight uniformity test, size uniformity test, hardness test, and friability test. The dissolution test was carried out for 2 h by hydrochloride acid 0,1 N pH 1.2 as (pH of gastric acid). Statistical analysis using Perfect Block Random Design (PBRD) method and further testing using the Newman-Keuls test was applied for the data obtained. Results: The test results with FTIR showed that ciprofloxacin hydrochloride used compared to ciprofloxacin hydrochloride BPFI is equivalent and has a purity index of 0.992739. Determination of the level of the active ingredient ciprofloxacin hydrochloride was carried out by measuring the absorbance of a 5 ppm sample solution at a wavelength of 276 nm. The percentage of absorbance of the solution is then calculated and the result obtained is 98.87%. The range of levels that have been set is 98%-102%. These test results were under those listed on the certificate of analysis. The results of the IPC test in the form of weight uniformity test, size uniformity test, hardness test, friability test, and uniformity of ciprofloxacin hydrochloride levels in the preparation, showed all data obtained fulfilling the requirements set by USP 36 convention (2013). The result from dissolution tablet test on 30, 60, and 120 min showed the release of active substance on F1 56.00 %, 67.76 %, and 87.57 %. F2 were 53.42 %, 65.16 %, and 91.44 %. F3 were 59.18 %, 72.15 %, and 91.20 %. F4 were 50.51 %, 70.70 %, and 95.29 %. F5 were 53.75 %, 69.55 %, and 92.05 %. Statistical analysis was applied for the data obtained. Dissolution results illustrated the level of active substances dissolved in the dissolution medium for 2 h or in other words the dissolution test results indicated the number of active substances from tablets that were released and enter the digestive tract and came in contact with body fluids. Conclusion: The dissolution test results as a basis of extended-release tablets showed all of the formulae met dissolution requirements of the United States Pharmacopeia (USP) 36 convention.


2005 ◽  
Vol 75 (3) ◽  
pp. 217-235
Author(s):  
Y. Marhuenda ◽  
D. Morales ◽  
J. A. Pardo ◽  
M. C. Pardo

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