scholarly journals Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

2019 ◽  
Author(s):  
Selass Kebede ◽  
Habtamu Abuye ◽  
Woldemichael Abraham ◽  
Sultan Suleman ◽  
Sileshi Belew
Keyword(s):  
Addis Ababa ◽  
Poor Quality ◽  
Content Uniformity ◽  
Dissolution Profile ◽  
Significant Difference ◽  
Physicochemical Evaluation ◽  
Model Independent ◽  
National Systems

AbstractThe safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines. Poor quality medicines do not meet official standards for strength, quality, purity, packaging and labelling. Hence, this study determines in-vitro quality attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to USP-38 drug monograph specifications. All tested brands meet the requirements for physical inspection & complied specification for friability and hardness. Besides, the tested brands met USP 38 specification for assay (99.96% to 108.85%) and for content uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met USP 38 requirements. However, significant difference with respect to dissolution profile among tested brands GL4 and GL6 were confirmed with comparator product through model independent approach. Moreover, DE values were studied and confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator product.

scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Required Quality

Abstract Objective: Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed. Results: All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

scholarly journals Chromosome aneuploidy analysis in embryos derived from in vivo and in vitro matured human oocytes

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Jianhua Li ◽  
Jing Chen ◽  
Tiecheng Sun ◽  
Shuiwen Zhang ◽  
Tingting Jiao ◽  
...  
Keyword(s):  
In Vitro Fertilization ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Poor Quality ◽  
Vitro Fertilization ◽  
Aneuploidy Rate ◽  
Significant Difference

Abstract Background In vitro oocyte maturation (IVM) is being increasingly approached in assisted reproductive technology (ART). This study aimed to evaluate the quality of embryos generated by in-vitro matured immature follicles, as a guideline for further clinical decision-making. Methods A total of 52 couples with normal karyotypes underwent in vitro fertilization, and 162 embryos were donated for genetic screening. Embryos in IVF group were generated by mature follicles retrieved during gonadotrophin-stimulated in vitro fertilization (IVF) cycles. And embryos in IVM group were fertilized from IVM immature oocytes. Results The average age of the women was 30.50 ± 4.55 years (range 21–42 years) with 87 embryos from IVF group and 75 embryos from IVM group. The rate of aneuploid with 28 of the 87 (32.2%) embryos from IVF group and 21 of the 75 (28%) embryos from IVM group, with no significant difference. The frequency of aneuploid embryos was lowest in the youngest age and increased gradually with women’s age, whether in IVF group or IVM group and risen significantly over 35 years old. The embryos with morphological grade 1 have the lowest aneuploidy frequency (16.6%), and increase by the grade, especially in IVF group. In grade 3, embryos in IVM group were more likely to be euploid than IVF group (60% vs 40%, respectively). Conclusions IVM does not affect the quality of embryos and does not increase the aneuploidy rate of embryos. It is clinically recommended that women more than 35 years have a high aneuploidy rate and recommended to test by PGS (strongly recommended to screened by PGS for women more than 40 years). Women aged less than 35 years old for PGS according to their physical and economic conditions. Embryo with poor quality is also recommended to test by PGS, especially for grade III embryos.

scholarly journals Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed in Mekelle, Ethiopia

2020 ◽  
Author(s):  
Brhane Gebrehiwot Welegebrial ◽  
Getu Kahsay ◽  
Tadele Eticha ◽  
Hailekiros Gebretsadik
Keyword(s):  
Quality Evaluation ◽  
The United States ◽  
Pharmaceutical Products ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Drug Content ◽  
Significant Difference ◽  
Objective Quality

Abstract Objective Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed.Results All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dissolution and amount of drug content among the tested samples. Thus, from this study we can conclude that all the products fulfilled the required quality evaluation parameters as stipulated in pharmacopeias except one brand which failed the disintegration test. However, the in vitro dissolution profile indicated that there may be a potential bio-in equivalence among the pharmaceutical products.

scholarly journals An Investigation into the Quality of Medicines in Yangon, Myanmar

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 96 ◽  
Author(s):  
Md. Islam ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Chisana Uwatoko ◽  
Mohammad Rahman ◽  
...  
Keyword(s):  
Poor Quality ◽  
Cefuroxime Axetil ◽  
Quality Analysis ◽  
Content Uniformity ◽  
Counterfeit Medicines ◽  
Ceftriaxone Sodium ◽  
Substandard Medicines ◽  
Dissolution Tests ◽  
Microbial Assay

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.

scholarly journals Comparative Quality Evaluation of Selected Brands of Cefuroxime Axetil Tablets Marketed in the Greater Accra Region of Ghana

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Christina Osei-Asare ◽  
Esther Eshun Oppong ◽  
Frederick William Akuffo Owusu ◽  
John Antwi Apenteng ◽  
Yvonne Ochesinda Alatu ◽  
...  
Keyword(s):  
Quality Evaluation ◽  
Poor Quality ◽  
Cefuroxime Axetil ◽  
Disintegration Time ◽  
Substandard Medicines ◽  
Antibiotic Drug ◽  
Model Independent ◽  
Greater Accra Region ◽  
Global Health Challenge

The ever-growing commercialization of poor-quality and substandard medicines, especially anti-infectives characterized by inadequate postmarket surveillance by stakeholders remains a major global health challenge, particularly in developing countries, where antibiotic drug resistance and its repercussions on human health remain dominant. This research sought to evaluate the pharmaceutical quality of six randomly selected brands of cefuroxime axetil tablets (250 mg) marketed in the Greater Accra region of Ghana. The selected brands were coded and subjected to both compendial and noncompendial tests. Statistical analysis and model-independent parameter (similarity factor, f2) were employed in analyzing the dissolution profiles of all the brands. All brands including the reference brand conformed to the pharmacopeial specifications for both compendial and noncompendial tests, indicating that they were of good quality. However, there were significant variations ( p < 0.05 ) in the disintegration time amongst the various brands. All the brands had ƒ2 values > 50 indicating similarity of their drug release profiles with the innovator. Hence, all the sampled cefuroxime axetil brands can be considered as pharmaceutical equivalents to the innovator drug. These brands can, therefore, be used as a substitute for the innovator drug by physicians to patients in cases of unaffordability or unavailability of the innovator brand.

scholarly journals Design Optimization and In Vitro-In Vivo Evaluation of Orally Dissolving Strips of Clobazam

2014 ◽  
Vol 2014 ◽  
pp. 1-15 ◽  
Author(s):  
Rajni Bala ◽  
Sushil Khanna ◽  
Pravin Pawar
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Content Uniformity ◽  
In Vivo Evaluation ◽  
Disintegration Time ◽  
Significant Difference ◽  
Film Formulation ◽  
Test Film

Clobazam orally dissolving strips were prepared by solvent casting method. A full 32 factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm2), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of Cmax (95.87%), tmax (71.42%), AUC0−t (98.125%), and AUC0−∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

scholarly journals Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi
Keyword(s):  
Quality Evaluation ◽  
Diclofenac Sodium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
United States Pharmacopoeia ◽  
Weight Variation ◽  
Tablet Formulations ◽  
Enteric Coated

Abstract Objective To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. Results A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25–75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97–103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99–103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69–90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.

scholarly journals The biological seal of the implant–soft tissue interface evaluated in a tissue-engineered oral mucosal model

2012 ◽  
Vol 9 (77) ◽  
pp. 3528-3538 ◽  
Author(s):  
Wen L. Chai ◽  
Ian M. Brook ◽  
Anders Palmquist ◽  
Richard van Noort ◽  
Keyvan Moharamzadeh
Keyword(s):  
Soft Tissue ◽  
Cell Attachment ◽  
Tritiated Water ◽  
Three Dimensional ◽  
Permeability Test ◽  
Significant Difference ◽  
Surface Topographies ◽  
Tissue Interface

For dental implants, it is vital that an initial soft tissue seal is achieved as this helps to stabilize and preserve the peri-implant tissues during the restorative stages following placement. The study of the implant–soft tissue interface is usually undertaken in animal models. We have developed an in vitro three-dimensional tissue-engineered oral mucosal model (3D OMM), which lends itself to the study of the implant–soft tissue interface as it has been shown that cells from the three-dimensional OMM attach onto titanium (Ti) surfaces forming a biological seal (BS). This study compares the quality of the BS achieved using the three-dimensional OMM for four types of Ti surfaces: polished, machined, sandblasted and anodized (TiUnite). The BS was evaluated quantitatively by permeability and cell attachment tests. Tritiated water (HTO) was used as the tracing agent for the permeability test. At the end of the permeability test, the Ti discs were removed from the three-dimensional OMM and an Alamar Blue assay was used for the measurement of residual cells attached to the Ti discs. The penetration of the HTO through the BS for the four types of Ti surfaces was not significantly different, and there was no significant difference in the viability of residual cells that attached to the Ti surfaces. The BS of the tissue-engineered oral mucosa around the four types of Ti surface topographies was not significantly different.

scholarly journals Effect of Hyaluronan on Developmental Competence and Quality of Oocytes and Obtained Blastocysts fromIn VitroMaturation of Bovine Oocytes

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Jolanta Opiela ◽  
Joanna Romanek ◽  
Daniel Lipiński ◽  
Zdzisław Smorąg
Keyword(s):  
Dna Fragmentation ◽  
Oocyte Maturation ◽  
Developmental Competence ◽  
Meiotic Maturation ◽  
Nuclear Maturation ◽  
Significant Difference ◽  
The Mean ◽  
Bovine Oocytes

The objective of the present study was to evaluate the effect of hyaluronan (HA) during IVM on meiotic maturation, embryonic development, and the quality of oocytes, granulosa cells (GC), and obtained blastocysts. COCs were maturedin vitroin control medium and medium with additional 0.035% or 0.07% of exogenous HA. The meiotic maturity did not differ between the analysed groups. The best rate and the highest quality of obtained blastocysts were observed when 0.07% HA was used. A highly significant difference (P<0.001) was noted in the mean number of apoptotic nuclei per blastocyst and in the DCI between the 0.07% HA and the control blastocysts (P<0.01). Our results suggest that addition of 0.035% HA and 0.07% HA to oocyte maturation media does not affect oocyte nuclear maturation and DNA fragmentation. However, the addition of 0.07% HA during IVM decreases the level of blastocysts DNA fragmentation. Finally, our results suggest that it may be risky to increase the HA concentration during IVM above 0.07% as we found significantly higherBaxmRNA expression levels in GC cultured with 0.07% HA. The final concentration of HA being supplemented to oocyte maturation media is critical for the success of the IVP procedure.

effect of treating wheat straw with sodium hydroxide and calcium oxide alone or in combination with hydrogen peroxide on the in Vitro dry matter digestibility

1990 ◽  
Vol 1990 ◽  
pp. 119-119
Author(s):  
A. S. Chaudhry ◽  
E. L. Miller
Keyword(s):  
Hydrogen Peroxide ◽  
Wheat Straw ◽  
Nutritional Quality ◽  
Dry Matter ◽  
Poor Quality ◽  
Alkaline Hydrogen Peroxide ◽  
Dry Matter Digestibility ◽  
Farm Scale

That alkali treatments can improve the nutritional quality of poor quality roughages has long been established (Sundstol and Owen, 1984). However, their effectiveness is limited by their potential hazards to the animals and mankind. Alkaline hydrogen peroxide (AHP) has recently emerged as a possible substitute (Gould, 1985) but its farm scale application is limited by the need for high amounts of chemicals and water. Lack of any information regarding its effectiveness over NaOH alone is another factor which requires further investigation. The present study was, therefore, planned to assess the effectiveness of pH-regulated (11.5±0.2) H2O2 (AHP) in improving the in vitro dry matter digestibility (IVDMD) of wheat straw (WS, Avalon) under different laboratory conditions. The possibility of using CaO on its own or to regulate pH for AHP was also tested.

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