Brands Of Tablets Research Articles

THE INTERCHANGEABILITY OF DOXYCYCLINE TABLETS NOT IS TOTALLY SAFE

Doxycycline is a second-generation semi-synthetic antimicrobial of tetracyclines. It is a broad spectrum antimicrobial agent used in several countries for the treatment of diseases such as chronic prostatitis, sinusitis, syphilis, chlamydia, pelvic inflammatory disease as well as additives in animal feed to improve its growth. Doxycycline is distributed free of charge through Unified Health System in Brazil, which, according to its acquisition, for subsequent distribution, does not always guarantee the same brand. Five different brands of doxycycline tablets (the reference pharmaceutical of doxycycline, two generic and two similar products) were used for evaluation of the interchangeability of the tablets by determination of average weight, hardness, friability, disintegration, the active principle content, content uniformity and in vitro dissolution. All tablets submitted to the tests of average weight, friability, hardness and disintegration were according to specification.Tests of content uniformity show drugs out of specification, with contents higher than 105 %. In test of dissolution, there no statistically differences among the profiles. Due to the results obtained, all doxycycline tablets analyzed could not be approved by the Quality Control sector. Sectors of production, analytical development and quality control should meet to resolve this issue. The involvement of all employees in these sectors is of critical importance for solving the problem. Thus, the importance of a pharmaceutical equivalence study is important to guarantee a safe interchangeability and consequently the same therapeutic effect.

In-vitro study of quality control parameters of three different brands of azithromycin tablets

Background: Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets chemical, physical and bioavailability properties.Methods: The physicochemical quality pararametrs like weight variation, size, hardness, friability, disintegration time and dissolution profile of three brands of azithromycin tablets were assessed by performing various test procedures according to established methods.Results: The different brands of tablets showed very slight variations in weight and size, not exceeding more than 5% of standard value. Similarly, hardness of all the brands was less than 5kg/f and friability ranged from 0.2 to 0.5%. All the brands tested disintegrated in <6 minutes and all the brands released >75% of the active ingredient within 45 minutes.Conclusions: All the physiochemical quality parameters of three brands of azithromycin tablets were found to be within the pharmacopeial specifications therefore all the brands were pharmaceutically and chemically equivalent and can be freely interchanged.

Assessment of quality control parameters and in vitro bioequivalence/interchangeability of multisourced marketed metformin hydrochloride tablets

Background: Metformin hydrochloride (MH) is a widely used medication for diabetes mellitus. For that, the availability of numerous multisourced MH in the drug market puts health care providers in a difficult situation for choosing the suitable brand and the possibility of interchangeable use. Objective: The aim of this study is to test 10 brands and generics of local and regional MH multisourced tablets to assess their in vitro bioequivalence and interchangeability. Methods: The in vitro bioequivalence assessment tests were carried out for ten brands of MH tablets (500 mg except one brand of 850 mg dose) based on the US Pharmacopoeia (USP 34) guideline recommendations. The content analysis test was done on 20 tablets for each brand using the UV method following USP 34 procedure and phosphate buffer (pH 6.8). Dissolution test was performed for six tablets from each brand using apparatus one (basket), with a rate of 100 rounds per minute (rpm) and 1000 ml phosphate buffer. UV scanning and calibration curve were performed to calibrate and validate the UV spectrophotometer. Dissolution profiles were compared with the reference Glucophage from Qatar by calculating the similarity factor (f2). Results: Product numbers 2, 4, 5, 8, 9, and 10 had percent dissolved within 95–105% as an acceptable range for a content test according to USP 34. All the brands had more than 70% dissolved within 45 minutes. Similarity factor results revealed that product numbers 1, 3, 4, 5, 7, and 10 were bioequivalent with the reference because they had f2 more than or equal to 50%. Conclusion: From the 10 tested products, only Glucophage® (Qatar), Diaphage®, Diamet® (Palestine), Glucophage® (Oman), Glucomet, and Glucophage® (Thailand) can be interchangeable with the chosen innovator brand (Glucophage®).

In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh

BackgroundCiprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. The study was carried out to examine the in vitro quality control tests for ten leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Bangladesh by Directorate General of Drug Administration. The quality control parameters of ten different brands of ciprofloxacin hydrochloride 500 mg tablets were determined by weight variation, friability, hardness, disintegration, dissolution and assay tests. All the tablets were evaluated for conformity with United States Pharmacopoeia-National Formulary (USP-NF) and British Pharmacopoeia (BP) standards.ResultsAmong ten brands of tablets Brand C had lower mean weight variation of 1.59% and Brand E had highest mean weight variation of 3.32%. For friability test Brand F had lowest mean friability (0.27%) and Brand G had highest mean friability (0.54%). Among ten brands mean lowest and highest hardness were founded in Brand G (4.49 kg/cm2) and Brand F (7.13 kg/cm2) respectively. The disintegration time for ten brands of ciprofloxacin tablet obtained were in the subsequent order: Brand G (8.19 min) < Brand C (9.25 min) < Brand E (9.61 min) < Brand D (10.11 min) < Brand B (11.07 min) < Brand A (12.15 min) < Brand H (13.68 min) < Brand I (14.59 min) < Brand J (16.32 min) < Brand F (17.49 min). Among ten brands for dissolution test mean percentages of drug release were not less than 80% in 45 min for four tablets (Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%), consequently they met BP standard and as per USP-NF standard six brands (Brand B, 75.62%; Brand A, 76.18%; Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%) had released not less than 75% drugs, so they also complied with the standard. The percentages of the drug content of the ten brands of ciprofloxacin tablet were obtained in the following sequence: Brand H (96.84%) < Brand J (97.34%) < Brand D (98.15%) < Brand I (98.47%) < Brand E (99.37%) < Brand F (100.28%) < Brand B (100.38%) < Brand A (100.54%) < Brand G (101.39%) < Brand C (101.46%). All of the brands met the BP and USP-NF specifications for assay. First-order, Higuchi and Korsmeyer–Peppas kinetics model fit for all of the mentioned ten brands.ConclusionThe present study revealed that all of the leading brands of this tablet met the quality control parameters as per pharmacopoeial specifications except dissolution test for four brands (Brand J, Brand H, Brand I, and Brand F).

Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had f1 values of 16.5% and 25.4% respectively and their f2 values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.

Development and validation of a reversed phase High Performance Liquid Chromatography method for content evaluation of some brands of paracetamol tablets sold in Abuja, Nigeria

A simple, rapid, accurate and economical isocratic Reversed Phase High Performance Liquid Chromatography (RPHPLC) method was developed, validated and used for the evaluation of content of different brands of paracetamol tablets. The method was validated according to ICH guidelines and may be adopted for the routine analysis of paracetamol in dosage forms both as single or combined formulation. Twelve brands of paracetamol tablets were randomly purchased from pharmacy stores around Abuja, the Federal Capital Territory (FCT) of Nigeria and coded accordingly. Samples were analyzed using a validated isocratic RP-HPLC method with UV detection at 254 nm at ambient temperature. Analysis time was 6 minutes. The inter and intraday precision coefficient of variance for 2 and 8 μg/ml were less than 5% and the percentage recovery was more than 90%. Percentage contents ranged between 93.03- 126.43% (±0.81-11.12). 41.7% of the assessed brands passed while 58.3% failed with the values being either above or below the BP specification of 95-105% for percentage content of paracetamol in tablets. Keywords: Paracetamol; Reversed Phase HPLC; Routine Analysis; Pharmacy Stores

Quality of artemisinin-based antimalarial drugs marketed in Nigeria.

Artemisinin combination therapy is first-line therapy for treatment of malaria, which is one of the most significant public health problems in Nigeria. With the increasing level of use of these drugs coupled with the emergence of resistance, there is a need for regular post-market surveillance. Twenty different brands of artesunate-containing antimalarial drugs and 10 brands of artemether-lumefantrine were multi-sourced in the south western part of Nigeria and were subjected to identification, weight uniformity test, and assay using United State pharmacopoeia and International Pharmacopoeia monographs. In vitro-dissolution test of the artemether tablets was also investigated. All 10 brands (100%) of the artemether-lumefantrine tablets met the assay requirement for artemether and 8 (80%) met the assay requirement for lumefantrine, but only 4 brands (40%) met the requirement for artemether dissolution. One of these brands failed the weight uniformity test. Of the 20 brands of artesunate-containing brands included in this study, 15 (75%) met the standard assay requirement for artesunate and two failed the weight uniformity test. There is evidence of the presence of substandard artemisinin products in the Nigerian market.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TAPENTADOL HYDROCHLORIDE IN ITS SOLID DOSAGE FORM

The present paper describes simple and sensitive, reversed phase high performance liquid chromatography (RP-HPLC) method developed for the determination of tapentadol hydrochloride in bulk and in its tablet dosage form. Chromatographic separation was achieved by using phenomenex C18 column, 250×4.6 mm, 5 μm as stationary phase. Mixture of acetonitrile: water (80:20 V/V) was used as the mobile phase and the pH was adjusted into 7.0 using orthophosphoric acid, at a flow rate of 0.7 mL/ min. Tapentadol standard shows maximum absorption in UV at 272 nm. The method was linear over the concentration range of 5-25 μg/mL. The method was validated statistically and recovery study was performed as per ICH guidelines. The analytical recovery obtained was 98-119%. As per validation data it was found that method is specific, robust and precise within the described concentration range. The described RP-HPLC method was successfully employed for the analysis of a commercial brand of tapentadol hydrochloride tablets.

Quality control of Warfarin Sodium tablets marketed in Syria

There are several generics of Warfarin Sodium available in Syrian drug market. The aim of this study is to evaluate the physicochemical properties of three brands of Warfarin Sodium(5mg) tablets marketed in Syria. The physicochemical equivalence of three brands of warfarin sodium tablets were assessed through the evaluation of weight variation, friability, hardness, content uniformity, and dissolution rate. All the brands complied with the specifications for hardness, friability, and weight variation tests. Two brands had values within the range specified (95-105%) for content uniformity in the USP while brand C failed the test. Also brands A, B released more than 80% of drug in 30 minutes while brand C release less than 80%, so brands A, B passed USP specifications, While brand C failed this test.

In Vitro Dissolution Study and Assay of Diclofenac Sodium from Marketed Solid Dosage form in Bangladesh

The aim of this study is to determine the potency of drug available in our market in Bangladesh. Diclofenac Sodium is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) and that are widely used and it is an Over the Counter (OTC) drug in Bangladesh. Potency determination was performed to evaluate that the marketed sample comply with the declared specification or not. In vitro Dissolution study was performed to see that if potency is high but the drug is not bioavailable. Hardness is also checked to see that whether it interfere with the dissolution which ultimately effect the bioavailability. In this present study a simple, cost effective and spectrophotometric method for the potency determination of marketed Diclofenac Sodium tablets is used. Four samples were randomly collected from the market and coded as D01, D02, D03 and D04 and the potency determined are 99.30%, 103.38%, 98.22% and 102.16% respectively. Hardness and in vitro dissolution of the above four brands of Diclofenac Sodium tablets were also studied and reported in the paper. After 1 h Dissolution release of DO1, D02, D03 and D04 are 94.16%, 93.97%, 96.94% and 98.5% respectively. From all of the studies it seems that the samples were collected complies with the BP and USP requirements.

Investigation of the Dissolution Profile of Gliclazide Modified-Release Tablets Using Different Apparatuses and Dissolution Conditions.

In the absence of an official dissolution method for modified-release tablets of gliclazide, dissolution parameters, such as apparatuses (1, 2, and 3), rotation speeds, pH, and composition of the dissolution medium were investigated. The results show that although the drug presents a pH-mediated solubility (pH 7.0 > 6.8 > 6.4 > 6.0 > 5.5 > 4.5), the in vitro release of the studied tablets was not dependent on this parameter, despite of the apparatus tested. On the other hand, the rotation speed demonstrated a greater influence (100rpm >50rpm). Using similar hydrodynamic conditions, the three different apparatuses were compared in pH 6.8 and provided the following trend: apparatus 1 at 100rpm >2 at 50rpm ≈3 at 10dpm. As a complete, but slow release is expected from modified-release formulations, apparatus 2, in phosphate buffer pH 6.8 and 100rpm, were selected as the optimized dissolution method. In comparison to apparatus 1 under the same conditions, the paddle avoids the stickiness of formulation excipients at the mesh of the basket, which could prejudice the release of gliclazide. Results obtained with biorelevant medium through the developed dissolution method were similar to the buffer solution pH 6.8. The application of the optimized method as a quality control test between two different brands of gliclazide modified-release tablets showed that both dissolution profiles were considered similar by the similarity factor (f2 = 51.8). The investigation of these dissolution profiles indicated a dissolution kinetic following first-order model.

PHP32 - Temperature, Real Time, on Site, Potency Monitoring Studies of Different Brands of Cephalexin Tablets Stored in Hospital and Community Pharmacies in Different Part of Kerala

PHP32 - Temperature, Real Time, on Site, Potency Monitoring Studies of Different Brands of Cephalexin Tablets Stored in Hospital and Community Pharmacies in Different Part of Kerala

COMPARISON OF HYDROCORTISONE 10 MG TABLETS: TABLET HARDNESS OPTIMISED FOR ADULT USE HAS NEGATIVE CONSEQUENCES FOR PAEDIATRIC USE

BackgroundChildren's medicines are not always readily available as an age appropriate product and manipulation of adult products is often required. Recently the commercial manufacturing process for 10 mg hydrocortisone tablets...

Non-target impurity profiling of marketplace Cetirizine using high-resolution mass spectrometry and multivariate data analysis.

As always, drug impurity is the first concern of medication safety. The quality of pre- and post-marketed drugs is estimated through systematic analysis of potential hazardous substances by impurity profiling. Impurity profile is the general name of all unwanted materials which may affect the purity of an active pharmaceutical ingredient (API). The safety of original drugs is guaranteed by an enormous amount of animal experiments and clinical research while the safety of generic drugs should also be ensured by comparative analysis for consistency evaluation. The significantly differential impurities between them should be focused on and the toxicity should be further estimated if necessary. Herein, we take a marketplace drug named Cetirizine as an example to investigate if there was a method which could effectively discover the potential markers among Cetirizine tablets with different brands and describe specific impurity profiling which makes the unknown brand of Cetirizine tablets predictable. Liquid chromatography coupled with high-resolution mass spectrometry (LC/HRMS) was applied to capture the characteristic features of the impurity profile for three brands of marketplace Cetirizine tablets using full scan data-dependent MS/MS scan mode (FS-ddMS(2) ). Unsupervised learning: principal component analysis (PCA) and supervised learning: consensus orthogonal partial least squares discriminant analysis (OPLS-DA) were utilized to reveal the essential character of Cetirizine impurity profile; 16 differential impurities were finally found, their structures were speculated by HRMS(2) data. The cause of formation was further elucidated which gave a suggestion for production process optimization. Copyright © 2016 John Wiley & Sons, Ltd.

Comparative in-vitro analysis of different brands of paracetamol tablets available in Nepal

Objective: To examine the physico-chemical parameters of commercially available local and multinational brands of paracetamol tablets in Nepal. Methods: Different five paracetamol brands were explored by testing various parameters according to standard methods. The studied parameters included weight variation, friability, disintegration, dissolution and assay. The limits of the official test were referenced from official guidelines of Indian Pharmacopoeia (IP) and British Pharmacopoeia (BP). All brands were tested according to their pharmacopoeial claim and methods for these tests were successfully conducted to find out their qualities. Those methods were economic and authentic. Results: Requirements of weight variation and friability value were complied by all brands. Fifteen minutes of disintegration time were also complied by all the brands according to the BP/IP recommendation for uncoated tablets. All brands showed not less than 80% drug release in 45 min as per BP and not less than 85% in 30 min as per IP. Content of each brand was found to be within the range of 95%–105%. The present findings suggested that about every paracetamol brand which was accessible in Nepali market encountering the IP/BP requirements. Conclusions: Although the physico-chemical examinations such as weight variation, friability, disintegration, dissolution and assay were detected varying brand wise, but were found interior to defined limits. Being an over-the-counter drug, the consumption of paracetamol is too high. Therefore, it is important for each brand to be genuine, good manufactured and well marketed. So, additional exploration over the quality of paracetamol is compulsory for safe human consumption.

In-Vitro Evaluation of Different Brands of Desloratadine Tablets Available in Bangladeshi market

Desloratadine, a long acting antihistamine with high selectivity for peripheral histamine H1- receptors has a rapid onset of action and a duration of action of 24-hours. Due to difference in the formulation process for different brands different physicochemical properties may vary which ultimately leads to change in the efficacy and duration of action of the drug when given orally. The aim of this study was to analyze the quality and stability of desloratadine 5mg tablet by evaluating various in-vitro parameters. For this purpose, five different brands from different pharmaceutical companies of Bangladesh were collected. The quality control parameters including weight variation, hardness, friability, disintegration test and dissolution test were performed to get a comparison between these marketed products. As desloratadine is an INN (International Nonproprietary Names) drug, it has no specific dissolution method in USP (United State Pharmacopoeia) or BP (British Pharmacopoeia). So, a dissolution method listed by USFDA (United States Food &amp; Drug Administration) was followed. Various results were obtained from the test and compared with the specifications. Minimum disintegration time was found 31 sec. Best Dissolution was shown 97.67% after 45 minutes. From the study, it can be concluded that the most brands of desloratadine tablets of the local brands have the desired and optimum therapeutic efficacy.

Chemical equivalence assessment of three brands of carbamazepine tablets and their anticonvulsant outcome on electrically-induced seizures in chicks

Assay for content of active ingredients is a critical test of drug quality; failure to meet up the standard for content of active ingredients will result to sub therapeutic quantities. Three brands (A, B and C) of carbamazepine were assayed to determine their chemical equivalence as well as their anticonvulsant activities. This was aimed at determining the possible relation between the chemical equivalence of the brands and their anticonvulsant outcomes. The brands were randomly selected from Community Pharmacies in Zaria, Kaduna State, and assayed for chemical equivalence to establish weight uniformity and identity; percentage content of active ingredients, using UV spectrophotometric analysis. Similarly all the brands were evaluated for anticonvulsant activity using maximal electroshock seizure model in chicks at doses of 20, 10 and 5 mg/kg. All the brands passed weight uniformity test as none of the tablets deviated from the mean by more than 7.5%. Similarly, their melting points were found to conform to standard average melting point (191oC) according to B.P. official monograph. However, the content of the active ingredients for Brands B and C did not conform to official standard of 95-105% while brand A conformed. Thus, the percentage contents for brands A, B and C were 99.49%, 76.02% and 87.59% respectively. Also, all the brands at the tested doses offered protection against seizures, ranging from 70-100%; but Brand C at 5 mg/kg offered only 40% quantal protection. The three brands of carbamazepine tablets were not chemically equivalent and their chemical equivalence indices could not be said to be the determinant of anticonvulsant effect.Key words: carbamazepine, anticonvulsant and chemical equivalence

Medication Safety

Medication Safety

Evaluation of microbial quality of selected blister-packed paracetamol tablets and paracetamol syrups marketed in Nigeria

Ten brands of blister-packed paracetamol tablet and twenty brands of paracetamol syrup marketed in Nigeria were evaluated for their microbial quality. While no microbial contaminant was isolated from all blistered-packed paracetamol tablets, ten of syrups were contaminated with organisms such as Escherichia coli , Klebsiellaspp , Pseudomonas aeruginosa and Staphylococcus aureus at 14.3, 21.4, 21.4 and 42.9% occurrence respectively. Penicilliumspp was isolated from two brands. Antibiotic susceptibility profile revealed all bacterial isolates to be multidrug resistant with Escherichia coli resistant to all antibiotics tested, while Staphylococcus aureus isolates were sensitive to Oxacillin, Cefuroxime and vancomycin. Pseudomonas aeruginosa isolates were sensitive to ofloxacin and gentamycin while Klebsiella isolates were sensitive to ofloxacin and nitrofurantoin. The study concluded that compliance with the provisions of good manufacturing practice as well as good quality control play role in determining the microbial bioburden of pharmaceutical products while isolation of multi-drug resistant organisms calls for establishment and adherence to antibiotics use policy in Nigeria. Keywords: Blister-pack, multidrug resistance, good manufacturing practice, quality control, bioburden

Evaluation of the Physicochemical and in vitro Dissolution Properties of Metformin Hydrochloride Tablet Brands Marketed in Five Cities in Ghana

Aim: A comparative evaluation of the physicochemical and in vitro dissolution properties of metformin hydrochloride tablet brands sampled in five cities in Ghana was undertaken to assess their pharmaceutical equivalence. Place and Duration of Study: Department of Pharmaceutics, KNUST, Kumasi, Ghana, between August 2012 and December 2012 Methodology: Fourteen brands of metformin tablets plus the innovator brand, Glucophage, purchased from retail pharmacies were studied. The genuineness of the samples was determined using Fourier transform infra-red (FTIR) spectroscopy and thin layer chromatography (TLC). Pharmacopoeia tests such as uniformity of weight, hardness, friability, disintegration and assay were used to assess the physicochemical equivalence of the tablet brands. In vitro dissolution testing was conducted and the dissolution data subjected to analysis involving dissolution efficiency (DE), similarity factor (f2) and Biopharmaceutics classification system (BCS)-based biowaiver conditions, as a surrogate for bioequivalence studies. Results: All the tablet brands complied with the official specifications for identification, uniformity of weight hardness and disintegration. Brand M9 failed the friability test while brands M5, M9 and M12 failed the assay test. Dissolution efficiency (DE) and similarity factor (f2) of the brands varied with pH of dissolution media with M4 (in 0.1 M HCl) having the highest DE and M9 (in phosphate buffer pH 6.8) the lowest. Conclusion: Eleven of the fifteen tablet brands passed all the official tests and could be regarded as pharmaceutically equivalent but f2 analysis showed only six brands were similar to the reference brand (with f2 values ≥50 in the three dissolution media used). None of the metformin brands satisfied the criteria for BCS-based biowaiver for rapidly dissolving tablets. The study has shown that not all the metformin tablet brands sampled in five cities in Ghana are pharmaceutically equivalent.