scholarly journals Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

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.

2020 ◽  
Vol 17 ◽  
Author(s):  
Bhumin K. Pathak ◽  
Meenakshi Raghav ◽  
Arti R. Thakkar ◽  
Bhavin A. Vyas ◽  
Pranav J. Shah

Background: Poor dissolution of Etodolac is one of the major challenges in achieving the desired therapeutic effect in oral therapy. Objective: This study aimed to assess the potential of liquisolid compact technique in increasing the rate of dissolution of Etodolac and thus its bioavailability. Methods: Liquisolid compacts were prepared using PEG 400, Avicel PH-200 and Aerosil 200 as non-volatile liquid, carrier and coating material respectively. Optimisation was carried out by applying a 32 full factorial design using Design expert software 11.0.3.0 to examine the effects of independent variables (load factor and carrier: coating ratio) on dependent variables (angle of repose and % cumulative drug release at 30 min [Q 30 min]).Assessment of bioavailability was based on pharmacokinetic study in rabbits and pharmacodynamics evaluation in rats respectively. Results: The formulation M3 was identified as the optimised formulation based on the better flow (lower angle of repose) and a higher rate of dissolution (Q 30 min >95%). The higher dissolution rate could be due to conversion of Etodolac into an amorphous molecularly dispersed state, availability of larger surface area, enhancement of aqueous solubility and enhanced wetting of drug particles. Studies with DSC, XRD, and SEM verified the transformation of Etodolac from crystalline to amorphous state, a key factor responsible for improving the dissolution rate. Pharmacokinetic profile of M3 was prominent, demonstrating higher absorption of Etodolac in comparison of oral suspension and immediate-release conventional tablets in rabbits. Liquisolid formulation exhibited 27% increment in paw thickness as compared to 57% and 46% increments for oral suspension and immediate-release conventional tablets respectively, after 7 hrs in carrageenan-induced paw model in rats. Conclusion: The results indicated liquisolid compact technique to be a promising strategy to enhance the bioavailability of Etodolac.


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

2012 ◽  
Vol 48 (4) ◽  
pp. 801-810 ◽  
Author(s):  
Marcelo Antonio de Oliveira ◽  
Caroline Dutra Lacerda ◽  
André Fazôlo Bonella

Atorvastatin (ATV) is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm), detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v), flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q) in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.


2017 ◽  
Vol 9 (3) ◽  
pp. 334-339
Author(s):  
Rokas Semėnas

Face recognition programs have many practical usages in various fields, such as security or entertainment. Existing recognition algorithms must deal with various real life problems – mainly with illumination. In practice, illumination normalization models are often used only for Small-scale futures extraction, ignoring Large-scale features. In this article, new and more direct approach to this problem is offered, used algorithms and test results are given.


2018 ◽  
Vol 7 (3) ◽  
pp. 298-304
Author(s):  
Reefa Qudsiya ◽  
Lisdiana Lisdiana ◽  
Nugrahaningsih WH

Nervous system teaching materials available in schools do not contain scientific-related content as mandated by the 2013 curriculum. In addition, teaching materials also do not contain student character reinforcement content. The purpose of this study is to develop “Nervous Problem Based Module with a  Conservation Character” as a nervous system learning supplement. This type of research is Research and Development (R&D) using ten steps, namely identification of potential and problems, data collection, product design, product design validation, product design revisions, small scale trials, product revision I, large scale trials, product revision II, and final products. The research subjects were students of class XI of SMA N 1 Bae Kudus. Nervous Problem Based Module with a  Conservation Character  tested the feasibility, readability, and effectiveness. Feasibility tests obtained very valid results. Readability test results were very valid. Test effectiveness by applying  Nervous Problem Based Module with a  Conservation Character in learning, obtained effective results and can be used in learning. The insertion of the conservation character reinforcement in the module gives positive results on the character of students. It can be concluded that “Nervous Problem Based Module with a Conservation Character” is decent and effectively applied in the nervous system learning.


2012 ◽  
Vol 13 (3) ◽  
pp. 256
Author(s):  
Dyah Koesoemawardani ◽  
Fibra Nurainy ◽  
Sri Hidayati

This study aimed to find optimum manufacturing trash fish protein hydrolyzate using the commercial papainenzyme. It is known that fish protein hydrolysates have good functional properties, so it is more widely utilized,especially for food. The study was conducted in two stages, the first stage was to make trash fish protein hydrolyzatetreated with enzyme concentration of 3%, 5%, 7% (w/w), and pH 5; 5.5; 6; 6.5; 7, whereas second stage was to maketrash fish protein hydrolyzate with same from the first stage and so the best treatment followed by treatment ofhalf-hour long incubation and one hour. Parameters observed were soluble protein, foamability, fat binding capacityand emulsion stability. The treatment was repeated three times and the first phase of data analysis using advancedtesting LSD and the second stage using the T test. Results show that the best soluble protein to produce a trashfish protein hydrolyzate enzyme was at a concentration of 5% and pH = 6.5 that was equal to 19.71%. In half an hourincubation produce higher soluble protein values and foamability that were equal to 24.97% and 9.63%, while thebinding capacity of fat in one hour incubation produces a higher value that was equal to 5.03%. Meanwhile, emulsionstability did not differ significantly at both incubation time.


Author(s):  
Mr. V. Karthick

Ferro concrete is one of the developments arising material an alternative for the traditional RCC in numerous viewpoints. Ferro concrete is the fate of the minimal expense houses and precast houses. Folded plates are answer for the more extended range rooftops in prudent and aesthetical manner. This project consolidates the upsides of both Ferro concrete and collapsed plate. The box type Ferro concrete collapsed plates of size 0.6 m x 1.80 m x 0.15 m are casted by thinking about various diaries and RCC collapsed plates in thought while fixing dimensions. In first period of trial various properties of materials utilized for projecting are tried and compressive strength of the mortar utilized is tried, the test is done at 1:2 of concrete: sand proportion and 0.35 water concrete ratio. In second stage the example is casted with Stainless Steel cross section of 2 mm opening is utilized and 2 layers on front and posteriors of 6mm width 150m divided skeleton steel is laid. The projected examples is tried for 28 days strength in stacking outline and the outcomes are contrasted and logical investigation Using ANSYS for load versus redirection and reasonableness of Ferro concrete application in collapsed plates are studies. The test results are shown acceptable outcomes, at last with low consumption and low self-weight Ferro concrete constructions are acceptable substitute for RCC.


2019 ◽  
Vol 11 (2) ◽  
pp. 183-201
Author(s):  
Yona Namira ◽  
Iskandar Andi Nuhung ◽  
Mudatsir Najamuddin

This study aims to 1) identify factors that affect the import of rice in Indonesia 2) analyze the influence of these factors on imports of rice in Indonesia. The data used in this research are time series data from 1994 to 2013 from the Central Statistics Agency (BPS), the Ministry of Agriculture, Ministry of Commerce, National Logistics Agency (Bulog), and Bank Indonesia. Multiple linear regression through SPSS software version 21 was employed to analyze the data. The test results together indicated the variables of productions, consumptions, stocks of rice, domestic rice prices, international rice prices and the rupiah against the US dollar affect the imports of rice in Indonesia.


Author(s):  
Yunita Rochmawati Jonan

ABSTRAK Tujuan penelitian pengembangan ini adalah menghasilkan sebuah rubrik penskoran pada asesmen otentikuntuk materi volume dan luas balok yang dapat digunakan oleh guru dan siswa. Rubrik ini dibuat sesuai dengan standar penilaian dalam kurikulum 2013. Penelitian pengembangan (R&D) ini menggunakan model Borg and Gall yang terdiri dari lima tahap yaitu penelitian dan pengumpulan data awal, perencanaan, pengembangan format produk, uji coba skala kecil, revisi akhir dan penyempurnaan produk. Hasil penelitian pengembangan ini berupa rubrik penyekoran holistik dan analitik dengan nilai sangat valid sebesar 94%. Analisis dari penelitian ini adalah angket kebutuhan bagi guru dan siswa sedangkan uji coba dilakukan melalui perorangan, kelompok kecil dan kelompok besar. Sedangkan kelayakan rubrik penskoran dari penilaian oleh ahli dengan menggunakan angket uji validitas materi, hasil belajar siswa, respon siswa serta tanggapan guru pengajar. Hasil penelitian ini menunjukkan bahwa rubrik penskoran ini efektif dalam membantu memperbaiki hasil ulangan dan cukup praktis serta dapat dipergunakan untuk memberikan penilaian hasil belajar yang sesuai dengan kurikulum 2013. Kata kunci: rubrik, penskoran, asesmen otentik.   ABSTRACT The purpose of this development research is to produce a scoring rubric on an authenticity assessment for the volume and area materials that can be used by teachers and students. The rubric is made in based on the assessment standards in the 2013 curriculum. This development research (R&D) uses the Borg and Gall model consisting of five stages of preliminary data research and collection, planning, product format development, small-scale trials, final revisions and product enhancements. The results of this development research include holistic and analytic scoring rubric with a very valid score of 94%. The rubric is analyzed fromquestionnaire for teachers and students, while trials are conducted through individuals, small groups and large groups. The feasibility of the scoring rubric from assessment by members by using the material validity test questionnaire, student learning results, student response and teacher responses. The results of this study show that the scoring rubric is effective in helping to improve the test results and is practical and can be used to provide assessment of learning outcomes in accordance with the 2013 curriculum. Keywords: rubric, scoring, authentic assessment.


Sign in / Sign up

Export Citation Format

Share Document