In vitro comparative quality evaluation of different brands of esomeprazole tablets available in selected community pharmacies in Dhaka, Bangladesh

Dulla, Oby; Sultana, Sharifa; Hosen, Shohag

doi:10.1186/s13104-018-3285-x

Cited by 18 publications

(29 citation statements)

References 5 publications

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“…Moreover, to ensure safety and efficacy, the quality of pharmaceutical products must be reliable and reproducible. [5][6][7] The quality of pharmaceutical products can be evaluated using in vivo or in vitro tests. 8 The quality of medicines is a topic of global concern, particularly in many developing countries.…”

Section: Introductionmentioning

confidence: 99%

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<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

Abebe¹,

Ketema²,

Kassahun³

2020

DDDT

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Background: The use of ineffective and poor quality drugs endangers therapeutic treatment and may lead to treatment failure. For desired therapeutic effect, drugs should contain the appropriate amount of active pharmaceutical ingredient and the required physical characteristics. Aim: The aim of this study was to evaluate quality as well as physicochemical bioequivalence of different brands of furosemide tablets marketed in Bahir Dar, Northwest Ethiopia. Methods: Five different brands of furosemide tablets were purchased from community pharmacies in Bahir Dar city, Northwest Ethiopia. The quality control parameters of furosemide tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeial standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements. Results: Identification test results revealed that all samples contained the stated active pharmaceutical ingredients. The results of weight variation tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of furosemide tablets were between the 90% and 105% limit of label claim. Similarly, all samples fulfilled disintegration time (i.e., ≤30 min) and dissolution tolerance limits (i.e., Q ≥80% at 60 min). Hence, none of the samples were found to be counterfeit and/or substandard. Difference factor (f1) values were <15 and similarity factor (f2) values were >50 for all the tested brands of furosemide tablets. Conclusion: This study revealed that all the furosemide brands met the quality specification of weight variation, hardness, friability, dissolution, disintegration and assay. The study also indicated similarity in the dissolution profile of the brands of furosemide tablets with the innovator product. Hence, all of these generic brands could be substituted with the innovator product in clinical practice.

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Section: Introductionmentioning

confidence: 99%

“…Moreover, to ensure safety and efficacy, the quality of pharmaceutical products must be reliable and reproducible. 5–7 The quality of pharmaceutical products can be evaluated using in vivo or in vitro tests. 8…”

Section: Introductionmentioning

confidence: 99%

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

Abebe¹,

Ketema²,

Kassahun³

2020

DDDT

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“…It ranged from-3.8 % to+5.13 % to-1.25 % to+3.25 % (table 3). However, small % SD values are a sign of the high homogeneity of the active ingredient and weight distribution of the Amlodipine tablets, and hence, it provides the desired therapeutic response [24].…”

Section: Weight Variation Testmentioning

confidence: 99%

In Vitro Assessment of Physicochemical Parameters of Five Generics Amlodipine Besylate Tablets Marketed in Yemen

Alshargabi

2021

Int J Pharm Pharm Sci

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Objective: The present paper aims to evaluate the quality of five different brands (local and imported) of oral film-coated tablets of generic Amlodipine besylate 5 mg marketed in Sana`a-Yemen, through physiochemical parameters. Methods: Different physicochemical parameters, including the uniformity of tablet weight, hardness, thickness, disintegration time, and an assay of active ingredients, were conducted to validate the quality of generics Amlodipine Besylate 5 mg according to USP specification. Results: From the obtained results, it was observed that all the brands of Amlodipine Besylate 5 mg have passed the tests and met the specifications of USP. Results of weight variation, hardness, thickness, and disintegration time were ranged from-3.8 % to+5.13 % to-1.25 % to+3.25 %, 5.06±0.31 to 13.21±1.5, 2.682±0.04 to 3.676±0.01 and 25 s to 2 min: 30 s, respectively. The dissolution test and the assay results of all the brands are also ranged within the acceptable label claim 93.7±2.24 to 98.4±0.85 and 93.22±0.38 to 100.15±0.33, respectively. However, there is no relation was found between the disintegration time and the dissolution test. Conclusion: According to the finding, all the selected Amlodipine Besylate 5 mg brands are met pharmacopeia standards and USP specifications. Therefore, the local and imported Amlodipine Besylate 5 mg can be used safely to get the desired therapeutic efficiency.

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“…This is a major step forward towards ensuring that Bangladesh has access to quality essential medicines at the national, regional, and global levels [18]. Approximately 300 pharmaceutical companies in Bangladesh manufacture a variety of medicines, and their products account for 97% of locally-available medicines [19].Despite recent reports outlining the issues associated with SF medicines, no systematic survey has been performed in Bangladesh regarding the rampant availability of SF medicines in the country. The current situation is uncertain, and there have been sporadic reports of falsi ed medicines and their victims, like the paracetamol tragedy reported in 1995 [13,[19][20][21].…”

mentioning

confidence: 99%

“…Approximately 300 pharmaceutical companies in Bangladesh manufacture a variety of medicines, and their products account for 97% of locally-available medicines [19].Despite recent reports outlining the issues associated with SF medicines, no systematic survey has been performed in Bangladesh regarding the rampant availability of SF medicines in the country. The current situation is uncertain, and there have been sporadic reports of falsi ed medicines and their victims, like the paracetamol tragedy reported in 1995 [13,[19][20][21]. In addition, the private retail drug shops market in Bangladesh is largely unregulated and unaccountable, resulting in poor distribution and storage conditions for medicines [22][23][24].…”

mentioning

confidence: 99%

A Comprehensive Analysis of Select Medicines Collected from Private Drug Outlets of Dhaka City, Bangladesh in a Simple Random Survey

Rahman

Yoshida

Tsuboi

et al. 2021

Preprint

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Comprehensive data are needed to prevent substandard and falsified (SF) medicines as they pose a major risk to human health. To assess the quality of select medicines, samples were collected from random private drug outlets of Dhaka North and South City Corporation, Bangladesh. Sample analysis included visual observation of the packaging, authenticity of the samples, legitimacy and registration verification of the manufacturer, physicochemical analysis, and price. Chemical analysis of the samples was performed using a portable Raman spectroscopy and high-performance liquid chromatography according to the pharmacopoeia. Several discrepancies were noted in the visual observation of samples. Among the 189 collected samples of esomeprazole (ESM), cefixime (CFIX), and amoxicillin-clavulanic acid (CVA-AMPC), 21.2% were confirmed to be authentic, 91.3% manufacturers were confirmed legitimate, and 2.1% of all samples were unregistered. Chemical analysis of the samples revealed that 9.5% (95% CI, 0.057–0.146) of samples were SFs. Falsified samples and quality variation in the same generic branded samples were both detected by Raman spectroscopic analysis. Overall, sample prices were satisfactory relative to the international reference price. Despite the relatively smaller proportions of SFs, this study documents the availability of poor-quality medicines, demonstrating the need for immediate attention by the national medicine regulatory authority.

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In vitro comparative quality evaluation of different brands of esomeprazole tablets available in selected community pharmacies in Dhaka, Bangladesh

Cited by 18 publications

References 5 publications

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

In Vitro Assessment of Physicochemical Parameters of Five Generics Amlodipine Besylate Tablets Marketed in Yemen

A Comprehensive Analysis of Select Medicines Collected from Private Drug Outlets of Dhaka City, Bangladesh in a Simple Random Survey

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