Quality evaluation of simvastatin compounded capsules

Simvastatin is commercially available as tablets and compounded capsules in Brazil. Very few reports regarding these capsules' quality, and consequently their efficacy, are available. The pharmaceutical quality of 30 batches of 20 mg simvastatin capsules from the market was evaluated by weight determination, content uniformity, disintegration (Brazilian Pharmacopeia), assay and dissolution test (USP32 tablet monograph). A HPLC method was developed for assay, content uniformity and dissolution test, and specifications were also established. Out of the 30 batches evaluated, 29 showed capsule disintegration within 45 min and individual weight variation was within ±10% or ±7.5% relative to average weight, for < or > 300 mg, respectively. Only 27 batches met dissolution test criteria with values >80% of the labeled amount in 45 min; 21 batches showed simvastatin content between 90.0-110.0% of the labeled amount and 19 batches had at least 9 out of 10 capsules with content uniformity values between 85.0-115.0% of the labeled amount with RSD<6.0%. Only 14 of all (30) batches fully met pharmacopeial quality standards. The establishment of test conditions and specification parameters for simvastatin capsules showed that there are relevant pharmacopeial quality differences between batches compounded by different pharmacies. For 53.33% of the tested products hypercholesterolemic treatment efficacy may be compromised.

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

BMC Research Notes ◽

10.1186/s13104-020-05270-4 ◽

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.

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EVALUATION OF GROUNDWATER QUALITY OF SIWA OASIS

JOURNAL OF ADVANCES IN CHEMISTRY ◽

10.24297/jac.v12i4.2170 ◽

2016 ◽

Vol 12 (4) ◽

pp. 4292-4311

Author(s):

Ammar Mohammad Ashour ◽

M.A. Wassel ◽

A. Z. Sayed ◽

M.M. Abo EL-Fadl ◽

A.M. Mahmod

Keyword(s):

Water Quality ◽

Quality Evaluation ◽

Major Ions ◽

Quality Standards ◽

Water Quality Standards ◽

Water Quality Evaluation ◽

Nubian Sandstone ◽

Drinking And Irrigation ◽

Chemical Water

In discussing the water quality evaluation for use in different purposes, the author will briefly examine some of the major important water quality standards. These standards serve as a basis for appraisal of the results of chemical water analysis in terms of suitability of the water for various intended uses. According to total dissolved salts (TDS), major ions as cations ( Ca2+, Mg2+, Na+, K+), anions (CO₃2⁻, HCO₃⁻ ,SO₄2⁻, Cl⁻), with some heavy metals such as Al3+, B3+ , Cd2+, Co2+, Cr3+, Cu2+, Fe3+, Mn2+, Mo2+, Ni2+, Pb2+, Sr2+, V2+ and Zn2+ The results indicate that the samples of Nubian sandstone aquifer is suitable for drinking of human and livestock , suitable for laundry purposes and for irrigation. While the samples of Fractured dolomite limestone aquifer are unsuitable for drinking and irrigation.

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Comparative Quality of Different Brands of Metformin Tablet Marketed in Zaria, Nigeria.

Journal of Basic and Social Pharmacy Research ◽

10.52968/27456292 ◽

2021 ◽

Vol 2 (1) ◽

pp. 20-25

Author(s):

F.M. Yushau ◽

◽

S. Awwalu ◽

A. Musa

Keyword(s):

The Other ◽

Dissolution Test ◽

First Line ◽

Disintegration Time ◽

British Pharmacopoeia ◽

Percentage Content ◽

Weight Variation ◽

Different Types

Background: Metformin tablets are oral anti hyperglycaemic agents that are used as the first line agent in the management of type 2 diabetes mellitus. The proliferation of many brands of metformin tablets in the market has led to availability of different types; some of which may be substandard or counterfeit. Thus, the need to determine the quality of the various brands marketed in Zaria. Objective: To compare the quality of different brands of metformin tablets that are available in Zaria using British pharmacopoeia standards. Method: Seven brands of metformin tablet (500 mg) were randomly sampled from various community pharmacies within Zaria and analysed with respect to identification, weight variation, friability, disintegration time, dissolution and drug content assay using Pharmacopoeial standards. Results: Except for the dissolution and assay tests, the results of all the other parameters for the various brands were within the Pharmacopoeial limits. The percentage content of metformin in brand 2 was 89.90 % which is outside the official range (95 – 105 %). Furthermore, only 70.61, 75.34 and 70.58 % of metformin dissolved from brands 2, 4 and 7 respectively, after 30 minutes of the dissolution test. Conclusion: It can be concluded that of the seven brands evaluated, only four brands are interchangeable with each other and can be substitutes of each other.

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HPLC Fingerprint Combined With Multicomponent Quantification as an Efficient Method for Quality Evaluation of Pharbitidis Semen

Natural Product Communications ◽

10.1177/1934578x20931642 ◽

2020 ◽

Vol 15 (6) ◽

pp. 1934578X2093164

Author(s):

Huiwei Bao ◽

Huailei Yang ◽

Feng Wang ◽

Kaixuan Zhou ◽

Yanan Yang ◽

...

Keyword(s):

Cluster Analysis ◽

Caffeic Acid ◽

Evaluation System ◽

High Performance ◽

Quality Evaluation ◽

Hplc Method ◽

Hplc Fingerprint ◽

Protocatechuic Aldehyde ◽

Effective Components

Pharbitidis Semen is a traditional Chinese medicine(TCM) with a long history for treatment of edema and fullness, fecal and urinary retention, phlegm and retained fluid, and abdominal pain due to parasitic infestation. Since Pharbitidis Semen is distributed throughout the country, the quality of the medicine from different origins may be varied. Moreover, the reported method could not control the quality comprehensively. In this article, a fingerprint of Pharbitidis Semen has been established based on a high-performance liquid chromatography (HPLC) method. In addition, the contents of the 2 main effective components were determined simultaneously. The reference HPLC fingerprint was obtained according to the chromatograms of test samples. The similarity values were calculated by the Similarity Evaluation System for Chromatographic Fingerprint of TCM (2004 A edition). Cluster analysis of 10 batches of samples was performed using statistical software (SPSS 20.0). The HPLC fingerprints of 10 batches of Pharbitidis Semen showed 25 well-resolved common peaks in each chromatogram. Two of these peaks were assigned to protocatechuic aldehyde and caffeic acid. As a result, HPLC fingerprint similarities of 10 batches of samples were more than 0.99. Pharbitidis Semen from different habitats could be divided into 3 or 2 groups. The results of cluster analysis showed that samples classified into 1 group were associated with their habitats and breeds. At the same time, quantification results showed that the contents of protocatechuic aldehyde and caffeic acid were in the range of 0.026-0.088 and 0.019-0.053 mg/g−1 respectively. HPLC fingerprint combined with multicomponent quantification and data analysis techniques can be an efficient and useful method for monitoring the quality of Pharbitidis Semen. This study also provides a practical strategy for overall quality evaluation and control of traditional Chinese medicines.

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

10.21203/rs.3.rs-25674/v2 ◽

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.

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

10.21203/rs.3.rs-25674/v1 ◽

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.

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The properties and quality of goat and sheep milk and its products – a review

Czech Journal of Food Sciences ◽

10.17221/8343-cjfs ◽

2000 ◽

Vol 18 (No. 5) ◽

pp. 207-211

Author(s):

B. Hozová ◽

M. Grejtáková

Keyword(s):

Public Health ◽

Quality Evaluation ◽

Quality Standards ◽

Negative Influence ◽

Chemical Contamination ◽

Milk Products ◽

Methods Of Determination ◽

Sheep Milk

The newer knowledge from the field of the quality evaluation of goat and sheep milk and milk products are reviewed in this paper. The negative influence of microbial and chemical contamination and methods of determination are described. The significance of monitoring of the conditions (pasteurization, hygienic control) to ensure public health are accented. Quality standards adjusted for the specifics of goat/sheep milk should be considered.

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Analisis Kualitas Batu-bata Bersumber Bahan Tambahan Sampah Serbuk Gergaji dalam Berbagai Variasi Berat

JURNAL KESEHATAN LINGKUNGAN INDONESIA ◽

10.14710/jkli.16.2.46-50 ◽

2017 ◽

Vol 16 (2) ◽

pp. 46

Author(s):

Sri Slamet Mulyati ◽

Pujiono Pujiono ◽

Teguh Budi Prijanto ◽

Elanda Fikri

Keyword(s):

Organic Waste ◽

Salt Content ◽

Cost Effective ◽

Quality Standards ◽

Laboratory Scale ◽

Quality Analysis ◽

Kaolin Clay ◽

Average Rating ◽

Weight Variation

Latar belakang: Serbuk gergaji kayu merupakan salah satu sumber sampah organik yang belum banyak dimanfaatkan. Keberadaannya tidak jauh di sekitar kita, relatif murah dan mudah mendapatkannya. Di beberapa negara luar seperti Uganda, Algeria, India dan lain-lain memanfaatkan serbuk gergaji ini untuk berbagai keperluan diantaranya sebagai bahan campuran batu-bata, pembentuk polimer selulosa nitrat, dan bahan adsorben polutan organik phenol. Penelitian sebelumnya memanfaatkan serbuk gergaji sebagai bahan tambahan campuran batu-bata (kaolin, tanah liat, serbuk gergaji) dengan rasio 90:70:40.Metode: Penelitian ini merupakan eksperimen semu. Selanjutnya penulis tertarik untuk mengembangkan penelitian tersebut, untuk serbuk gergaji dibuat variasi berat bahannya, sementara yang lainnya tetap. Ukuran batu-bata dirancang berukuran 10,00 x 5,00 x 2,00 cm. Untuk mengetahui kualitas batu-bata yang dihasilkan, penulis melakukan analisis kualitas terhadap batu-bata yang dihasilkan dengan berbagai variasi berat tersebut. Kualitas yang diuji baru pada tahapan daya serap air dan kandungan garam. Selain uji kualitas batu-bata juga dilakukan analisis valuasi ekonominya. Penelitian ini dilakukan pada skala laboratorium dengan harapan dapat dijadikan bahan acuan apabila akan diaplikasikan di lapangan.Hasil: Hasil penelitian menunjukkan bahwa variasi berat serbuk gergaji antara rasio 20:70:90 dan 40:70:90 menunjukkan ada perbedaan peringkat rata-rata yang bermakna dalam hal daya serap batu-bata terhadap air begitu juga antara rasio 20:70:90 dan 60:70:90. Semua campuran batu-bata berdaya serap > 20%, belum memenuhi standar kualitas berdasarkan SNI 15-2094-2000, namun semua campuran batu-bata mempunyai kadar garam (NaCl) < 50%, ini artinya sudah memenuhi standar kualitas berdasarkan SNI 15-2094-2000.Simpulan: Waktu pembakaran batu-bata dengan bahan tambahan serbuk gergaji lebih efisien 0,42 kalidibandingkan tanpa serbuk gergaji sehingga biaya lebih hemat. Abstract Title: Quality Analysis Brick Sourced Sawdust in a Variety of WeightBackground:Sawdust as organic waste has not been widely used. Its presence close to us, cheap and easy to obtain. In others countries such as Uganda, Algeria, India and others, utilize sawdust for various purposes, such as mixed materials, forming polymers cellullose nitrate, and phenol pollutant adsorbent. Previous research utilizes sawdust as mixture of brick with a ratio of 90:70:40: (kaolin, clay,sawdust).Method:This was a quasi experiment design.Furthermore, authors interested in developing such research, sawdust made weight variation while others remain. Size bricks are designed measuring 10.00 x 5.00 x 2.00 cm. To determine the quality of bricks produced, the authors analyze the quality of the bricks produced with a variety of weight of the sawdust. The quality of the tested new stage of absorption of water and salt content. In addition to testing the quality of bricks also performed a valuation analysis of its economy. This research was carried out on a laboratory scale with the hope can be used as a reference if it will be applied in the field. Result:The results showed that weight variation sawdust between 20:70:90 and 40:70:90 ratio showed no difference in the average rating is meaningful in terms of absorption bricks to water as well as the ratio of 20:70:90 and 60 : 70: 90. All blends brick absorbent> 20%, yet meet the standards of quality based on SNI 15-2094-2000, but all of a mixture of brick had higher levels of salt (NaCl) <50%, this means that it meets quality standards based on SNI 15-2094 -2000. Conclusion:Burning of bricks made from sawdust additional more efficient, ± 0.42 times from the time of burning bricks without straw, making it more cost-effective

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Research on Groundwater Quality Evaluation with Fuzzy Mathematics

Advanced Materials Research ◽

10.4028/www.scientific.net/amr.347-353.2287 ◽

2011 ◽

Vol 347-353 ◽

pp. 2287-2294

Author(s):

Jing Hao ◽

Yong Xiang Zhang ◽

Qi Jing ◽

Guo Feng Ning

Keyword(s):

Water Quality ◽

Groundwater Quality ◽

Quality Evaluation ◽

Pollution Assessment ◽

Quality Standards ◽

Fuzzy Mathematics ◽

Membership Degree ◽

Monitoring Well ◽

Set Membership

Given the ambiguity of the type and classification in groundwater quality standards, this paper based on fuzzy mathematics theory, take TDS, fluoride and other components as the nine evaluation factors, determine its weight according to the pollution of different factors on water quality; using fuzzy membership to describe the classification boundaries of the evaluation in water quality. Established a number of pollution assessment factors of fuzzy sets such as evaluation set, membership function and weight set;after the compound operation of fuzzy matrixes, using the maximum membership degree law, to evaluate the groundwater quality of a monitoring well in study area ,the conclusions are objective.

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A Comprehensive Quality Evaluation Method Based on C30-HPLC and an Analytic Hierarchy Process for the Chinese Herbal Formula, Erzhiwan

Molecules ◽

10.3390/molecules23082045 ◽

2018 ◽

Vol 23 (8) ◽

pp. 2045 ◽

Cited By ~ 6

Author(s):

Ying Nie ◽

Weifeng Yao

Keyword(s):

Analytic Hierarchy Process ◽

Quality Evaluation ◽

Evaluation Method ◽

Hplc Method ◽

Good Precision ◽

Analytic Hierarchy ◽

Important Quality ◽

Hierarchy Process

The quantitative analysis of multiple indexes remains an important quality evaluation method of traditional Chinese medicine (TCM) herbal formulas. The Chinese Pharmacopoeia 2015 only stipulates the content of a single component, specnuezhenide, in Erzhiwan composed of the Fructus Ligustri Lucidi (FLL) powder and aqueous extracts of Herba Ecliptae (HE). To generalize the intrinsic quality of Erzhiwan, a novel C30-HPLC method with good precision, accuracy, and reproducibility was developed for the simultaneous determination of six compounds, including two isomers, and then an analytic hierarchy process was further applied to integrate and discriminate the quality of four samples prepared via different methods. The results of the analysis were in agreement with the antioxidant tests in vitro. This comprehensive strategy could provide a reference and suggestions for the improvement of the quality evaluation method of TCM herbal formulas.

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