Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?

Zaid, Abdel Naser; Rinno, Tamara; Jaradat, Nidal; Jodeh, Shehdeh; Khammash, S

doi:10.26719/2013.19.6.542

Cited by 6 publications

(9 citation statements)

References 10 publications

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“…Various studies conducted in Malaysia, Palestine, Pakistan, Bangladesh, and India have investigated brands of paracetamol and fulfilled the requirements on USP for disintegration time. 3,7,[19][20][21] Dissolution was another parameter directly related to the absorption and bioavailability of the drug. Drugs with poor dissolution profiles will not be sufficiently available in the body to produce the desired therapeutic outcome.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…It is bioavailability is estimated between 63-89% in adults and approximately 90% metabolized by glucuronidation and sulphation to non-toxic metabolites in the liver and excreted through the urine. 3 According to the definition of the International Organization for Standardization (ISO), "quality is a totality of features and characteristics of a product or service that bears its ability to satisfy stated or desired needs". 4 The quality of the tablet is the collection of features and characteristics that contribute to its ability to meet given pharmacopeial requirements.…”

Section: Introductionmentioning

confidence: 99%

“…It is bioavailability is estimated between 63–89% in adults and approximately 90% metabolized by glucuronidation and sulphation to non-toxic metabolites in the liver and excreted through the urine. 3 …”

Section: Introductionmentioning

confidence: 99%

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In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

Abebe¹,

Beressa²,

Yimer³

2020

DHPS

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Background The aim of this research was to evaluate quality control parameters of available brands of paracetamol tablets in Gondar city since standard quality parameters are essential for a better quality of the product. The different brands of paracetamol tablets were obtained from local pharmacies in Gondar town and the University of Gondar (UOG) hospital pharmacies. Methods Five brands of paracetamol, from each, 102 tablets were collected from private pharmacies, government health centers, and UOG pharmacies. The popular brands in the city, Panadol, Para-denk, Paramol, Paracetamol (EPHARM), and Cadimol, conventional tablets of 500 mg strength were chosen and the tablets were assessed for different quality parameters: weight variation, hardness, friability, disintegration, dissolution, and drug content (assay) using compendial methods. The tablets were evaluated to check if they comply with the specifications of USP (United States Pharmacopeia). Results From the results, it was observed that all the brands of paracetamol have passed the tests and met the specifications of USP. Results of weight variation, hardness, friability, and disintegration time ranged from 0.46 to 1.11%, 117.0 to 174.70 N, 0.07 to 0.63%, and 01 to 08 minutes for all the tablets, respectively. The dissolution profiles of all the brands are within the acceptable label claim. The assay results showed that the drug content of the paracetamol brands ranged from 95.04% to 106.81%. The dissolution rate was significantly different (p < 0.05) as compared to code 1 with all brands tested at 30 minutes. The disintegration time of different brands was also significantly different from the comparator (code 1) except code 2. Conclusion Based on the finding from this study, there were no significant deviations from pharmacopeia standards and specifications. The brands studied were safe enough and could be used to achieve the desired therapeutic effect.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

Abebe¹,

Beressa²,

Yimer³

2020

DHPS

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“…Therefore, in vitro postmarketing surveillance, which involves pharmacopeial and technological quality control (QC) assessment of drug products, may be used as a quick and cheap alternative to the in vivo surveillance studies. 16 , 17 …”

Section: Introductionmentioning

confidence: 99%

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Zaid

Ghanem²,

Shweiki

et al. 2016

TCRM

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ObjectivesThe objectives of this study were to evaluate the general quality of the most prescribed products of valsartan (VL; alone or in combination) and to evaluate their efficacy and safety among Palestinian population through in vivo postmarketing surveillance.Patients and methodsThe first part was pharmacopeial quality control assay, including dissolution, disintegration, friability, and weight uniformity for VL. The second part was a 3-month cardiology clinics, observational, postmarketing surveillance pilot study that included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as monotherapy or combination therapy. The end points were reduction in blood pressure (BP) and the rate of incidence of adverse effects (AEs) at weeks 4 and 8.ResultsAccording to our quality control tests, all VL products showed high-quality standards according to the international guidelines. A reduction in BP was observed at weeks 4 and 8, and no significant difference was observed between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of the AEs were of mild-to-moderate intensity. In general, the most frequently reported AEs included headache (17.5%), dizziness (11.75%), and weakness (11.7%). No serious AEs or death cases were reported during the study period.ConclusionHigh quality of VL tablet products was used; hence, the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension.

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Comparing the environmental impacts of paracetamol dosage forms using life cycle assessment

Sharma

Raju

Sarkar

et al. 2021

Environ Dev Sustain

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A medicine can be administered in varied dosage forms which are having different environmental impacts. Two dosage forms of paracetamol (tablet and syrup) have the same function but are prepared and packaged differently, meaning that the environmental impacts arising out of their production will be of different magnitude. This study utilizes the life cycle assessment technique to find and compare the environmental impacts of two dosage forms of the paracetamol. Life cycle assessment software 'GaBi' v 8.0 has been utilized to carry out this study. Midpoint and endpoint impact assessment methods from 'ReCiPe' impact assessment method are used to carry out the life cycle impact assessment. The midpoint impact assessment results show that syrup production has 90% contribution in climate change impact category and more than 50% environment impact in fine particulate matter formation, fossil depletion, freshwater consumption, freshwater eutrophication, freshwater ecotoxicity, ionizing radiation, photochemical ozone formation, stratospheric ozone depletion, and terrestrial ecotoxicity midpoint impact categories. Tablet production has major impacts in 3 midpoint impact categories that are human toxicity, ionizing radiation, and metal depletion. Syrup production has major impacts (more than 70%) in 8 out of the 11 endpoint impact categories considered, while tablet production has a major impact in 3 impact categories that are human toxicity and ionizing radiation endpoint impact categories. Syrup production has a visibly higher impact in more number of midpoint as well as endpoint impact categories considered. The environmental hotspot is, however, dependent on the individual impact categories. The results of the study add to the existing knowledge of environmental sustainability assessment in the pharmaceutical sector and will benefit the environmental managers to better manage the environmental sustainability of pharmaceutical products.

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Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?

Cited by 6 publications

References 10 publications

In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

In-vitro Evaluations of Quality Control Parameters of Paracetamol Tablets Marketed in Gondar City, Northwest Ethiopia

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Comparing the environmental impacts of paracetamol dosage forms using life cycle assessment

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