Effects of Vessel Geometric Irregularity on Dissolution Test Results

2011 ◽  
Vol 100 (3) ◽  
pp. 1093-1101 ◽  
Author(s):  
Zongming Gao ◽  
Shafiq Ahadi ◽  
Terry W. Moore ◽  
William H. Doub ◽  
B.J. Westenberger ◽  
...  
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.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mohammad Sofiqur Rahman ◽  
Naoko Yoshida ◽  
Hirohito Tsuboi ◽  
Yuichiro Ishii ◽  
Yoshio Akimoto ◽  
...  

AbstractThe purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more.


2012 ◽  
Vol 1 (2) ◽  
Author(s):  
Nanang Yunarto

The government through the Ministry of Health is very serious about revitalizing the use of generic drugs by issuing a policy that stipulated in the Regulation of the Minister of Health No. HK. 02.02/Menkes/068/1/2010 about duty to use generic drugs in government health care facilities. To maximize the use of generic drugs, it is very important to improve understanding and trust of society that generic drugs have the quality, safety and effectiveness are similar to branded drugs. Besides that, there is a lot of research and the study of generic drugs will increase the knowledge, so that health professionals, especially doctors do not hesitate to prescribe generic drugs. Quality used as a basis of reference to establish the truth of the eficacy and safety. For availability of certain products can be demonstrated in vitro. Studies of drug dissolution gave the same indication with drug bioavailability. Ideally, in vitro drug dissolution correlates bioavailability in vivo. From the research results of dissolution test generic drugs Amoxiciline 500 mg tablets, Isosorbit Dinitrat 5 mg tablets and Omeprazole capsules compared to branded drugs show no less generic drugs than branded drugs, dissolution test results even better generic drugs


2013 ◽  
Vol 37 ◽  
pp. 5379-5386 ◽  
Author(s):  
R.R. Haese ◽  
T. LaForce ◽  
C. Boreham ◽  
J. Ennis-King ◽  
B.M. Freifeld ◽  
...  

2018 ◽  
Vol 11 (13) ◽  
pp. 210 ◽  
Author(s):  
Minda Sari Lubis

  Objective: The objective of this study was to know maltodextrin can be used as a superdisintegrant and to know the dissolution time and to know disintegration and dissolution test of metoclopramide orally disintegrating tablet (ODT) better than conventional metoclopramide tablets.Methods: The methods used in this study include the formulation of banana starch, formulation of maltodextrin, and then maltodextrin formulated into ODT with metoclopramide drug model, and evaluated the disintegration and dissolution test of ODT metoclopramide.Results: The results of the evaluation of 5 ODT formulas studied, showed ODT with maltodextrin 15% (ODT 4) gave the fastest in vitro disintegration of 22.2 s, the in vivo disintegration averaged between 55.38 s and 75.72 s, and dissolution test results against ODT 4 and metoclopramide tablets (positive comparator) showed statistically significant differences (p<0.05).Conclusion: Maltodextrin can be formulated superdisintegrant on metoclopramide ODT by giving disintegration, and dissolution was better than the conventional tablets.


1992 ◽  
Vol 23 (1) ◽  
pp. 52-60 ◽  
Author(s):  
Pamela G. Garn-Nunn ◽  
Vicki Martin

This study explored whether or not standard administration and scoring of conventional articulation tests accurately identified children as phonologically disordered and whether or not information from these tests established severity level and programming needs. Results of standard scoring procedures from the Assessment of Phonological Processes-Revised, the Goldman-Fristoe Test of Articulation, the Photo Articulation Test, and the Weiss Comprehensive Articulation Test were compared for 20 phonologically impaired children. All tests identified the children as phonologically delayed/disordered, but the conventional tests failed to clearly and consistently differentiate varying severity levels. Conventional test results also showed limitations in error sensitivity, ease of computation for scoring procedures, and implications for remediation programming. The use of some type of rule-based analysis for phonologically impaired children is highly recommended.


2020 ◽  
Vol 29 (2) ◽  
pp. 188-198
Author(s):  
Cynthia G. Fowler ◽  
Margaret Dallapiazza ◽  
Kathleen Talbot Hadsell

Purpose Motion sickness (MS) is a common condition that affects millions of individuals. Although the condition is common and can be debilitating, little research has focused on the vestibular function associated with susceptibility to MS. One causal theory of MS is an asymmetry of vestibular function within or between ears. The purposes of this study, therefore, were (a) to determine if the vestibular system (oculomotor and caloric tests) in videonystagmography (VNG) is associated with susceptibility to MS and (b) to determine if these tests support the theory of an asymmetry between ears associated with MS susceptibility. Method VNG was used to measure oculomotor and caloric responses. Fifty young adults were recruited; 50 completed the oculomotor tests, and 31 completed the four caloric irrigations. MS susceptibility was evaluated with the Motion Sickness Susceptibility Questionnaire–Short Form; in this study, percent susceptibility ranged from 0% to 100% in the participants. Participants were divided into three susceptibility groups (Low, Mid, and High). Repeated-measures analyses of variance and pairwise comparisons determined significance among the groups on the VNG test results. Results Oculomotor test results revealed no significant differences among the MS susceptibility groups. Caloric stimuli elicited responses that were correlated positively with susceptibility to MS. Slow-phase velocity was slowest in the Low MS group compared to the Mid and High groups. There was no significant asymmetry between ears in any of the groups. Conclusions MS susceptibility was significantly and positively correlated with caloric slow-phase velocity. Although asymmetries between ears are purported to be associated with MS, asymmetries were not evident. Susceptibility to MS may contribute to interindividual variability of caloric responses within the normal range.


1972 ◽  
Vol 15 (4) ◽  
pp. 852-860 ◽  
Author(s):  
Zoe Zehel ◽  
Ralph L. Shelton ◽  
William B. Arndt ◽  
Virginia Wright ◽  
Mary Elbert

Fourteen children who misarticulated some phones of the /s/ phoneme were tape recorded articulating several lists of items involving /s/. The lists included the Mc-Donald Deep Test for /s/, three lists similar to McDonald’s but altered in broad context, and an /s/ sound production task. Scores from lists were correlated, compared for differences in means, or both. Item sets determined by immediate context were also compared for differences between means. All lists were found to be significantly correlated. The comparison of means indicated that both broad and immediate context were related to test result. The estimated “omega square” statistic was used to evaluate the percentage of test score variance attributable to context.


1986 ◽  
Vol 51 (2) ◽  
pp. 176-180 ◽  
Author(s):  
Audrey L. Holland ◽  
Davida Fromm ◽  
Carol S. Swindell

Twenty-five "experts" on neurogenic motor speech disorders participated in a tutorial exercise. Each was given information on M, a patient who had communication difficulties as the result of stroke, and asked to complete a questionnaire about his problem. The information included a detailed case description, an audiotape of M's speech obtained at 4, 9, 13, and 17 days post-stroke, and test results from the Western Aphasia Battery, the Token Test, and a battery for apraxia of speech. The experts were in excellent agreement on M's primary problem, although it was called by seven different names. The experts were in poor agreement on his secondary problem(s), e.g., the presence and type of aphasia and dysarthria. The results suggest that labeling is difficult, even for "experts." Furthermore, the practicing clinician needs to be sensitive to the likelihood of more than one coexisting problem.


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