scholarly journals IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN

Author(s):  
ARWA ALSHARGABI

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.

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi

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.


Author(s):  
Mahfuza Rahman ◽  
Khurshida Akter ◽  
Md. Shahin Sarker ◽  
Jinat Fatema Sharna ◽  
Mir Imam Ibne Wahed

Aim: This study was performed to evaluate the quality of five brands of Paracetamol 500mg tablets from different manufacturers. Methods: The general quality parameters of these tablets like weight variation, hardness, thickness, diameter, friability, disintegration time and also dissolution time were evaluated according to the established protocols. For measuring weight variation, an electric analytical balance was used. The hardness, thickness and diameter were determined by an automated hardness tester. Friability was measured by a friabilator. Disintegration time and dissolution time were analyzed by disintegration apparatus and dissolution tester respectively. Results: In this study, all the five brands of the tablets passed the BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation (550.1±5.88 mg to 631.1±4.71 mg), hardness (121.60±6.6 N to 220.20±7.6), disintegration time (3 minutes 15 seconds to 5 minutes 30 seconds). However, in case of friability, although brand A showed slight deviation, the remaining had shown the satisfactory results with the standard. In addition, the drug release rate of different brands of paracetamol was satisfactory within 30 minutes and ranged from 90.88% to 103.75%. Conclusion: It can be concluded that almost all the tablets of paracetamol purchased from retail outlets in Bangladesh are manufactured and marketed according to GMP. Further work is recommended on bioequivalence of these tablets.


2021 ◽  
Vol 2 (1) ◽  
pp. 20-25
Author(s):  
F.M. Yushau ◽  
◽  
S. Awwalu ◽  
A. Musa

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.


2021 ◽  
Vol 11 (1) ◽  
pp. 60-64
Author(s):  
Rishabh Bindal ◽  
Arpna Indurkhya

Due to more versatility and comfort, mouth dissolving tablets are the most advanced type of oral solid dosage forms. Compared to conventional tablets, it increases the effectiveness of APIs by dissolving within a minute in the oral cavity after contact with less saliva, without chewing and without the need for water for administration. Mouth Dissolving Tablets of Ketorolac tromethamine were prepared by direct compression method using various superdisintegrants like crospovidone, Croscarmellose sodium, and Sodium starch glycolate in different concentrations. Prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time and in vitro drug release. Results of pre-compression and post-compression studies of all formulations were found within the standard limits. The tablets of all the batches were found to release more than 80% of drug in 5 minutes, which is the desired quality of mouth dissolving tablets that helps in faster absorption of the drug and quick onset of therapeutic effect. The the order of dissolution of various disintegrants was found to be Crospovidone˃ SSG˃ CCS. There was no significant variation in drug content of drug during stability studies for selected batch F3 in accelerated conditions over three months. It was concluded from the study that fast release of Ketorolac tromethamine from formulation F3 may reduce onset of drug action with better patient compliance. Keywords: Crospovidone, Croscarmellose sodium, Ketorolac tromethamine, Mouth dissolving tablets, Sodium starch glycolate, superdisintegrants.


Author(s):  
Md. Emran Hossain ◽  
Sukria Hossain ◽  
Md. Shahin Sarker ◽  
Mst. Mahfuza Rahman ◽  
Mir Imam Ibne Wahed

Background: The outcome of the drug therapy depends largely on the quality of the drug product. The lower quality of the drug product can be the reason for therapeutic failure. The present study was designed to evaluate the quality standard of Losartan Potassium tablet brands available in Bangladesh market to get an idea of quality standard of drug product people consuming in this country. Materials and methods: Three brands of losartan potassium were chosen randomly. Tablets of each brand were collected from individual retail outlets to gauge the qualitative evaluation and compare them by in-vitro drug release study. They were subjected to various quality control tests to measure the hardness, thickness, weight variation, friability, disintegration time, potency, stability, and dissolution profile. All these tests were performed according to the U.S. Pharmacopeia (USP) specification. Researchers further formulated a batch of tablet of Losartan Potassium and compared them with the existing brands. The formulation was prepared by optimizing the existing one available in the USP. Test results of the existing brands were taken into consideration during the optimization of the formulation. Results and discussion: Two brands passed the weight variation test, while one brand exceeded the range (±5%). The potency was determined instantly and 15 days after keeping the tablets in a stability chamber at 75% humidity and 60oC temperature. The potency of two brands degraded below the lower limit specified by the USP, while that of the remaining one was within the limits. Results of other tests were within the specified limits. Tablets prepared in the lab using an optimized formulation showed a better dissolution rate than the existing brands. Conclusion: Some of the brands failed to meet the desired quality, so the quality control system of that companies should be upgraded and a proper monitoring system should be developed by the drug administration.


Author(s):  
Abdulmajed Alsaifi ◽  
Ali Alyahawi

Paracetamol or acetaminophen is active metabolites of phenacitin. It is a widely used over-the-counter analgesic and antipyretic. Chemically, it is 4-hydroxy acetanilide (acetaminophen). Paracetamol is approved for reducing fever in people of all ages. It is commonly used for the relief of headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu remedies. Many different brands and dosage forms of paracetamol are available in Yemeni market that places health practitioners in a dilemma of drug substitution in case of non-availability of a particular brand. The aim of the present study was to evaluate the quality control of four brands of paracetamol tablets (500 mg) marketed and commonly prescribed in Yemeni market. The results and findings of the present study will be interpreted and discussed. Four brands of paracetamol tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests according to USP and BP standards and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, hardens, friability, disintegration time, dissolution test as well as assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but all  products were satisfactory for hardness. The results indicated that the overall quality of all tested paracetamol tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests.  


2019 ◽  
Vol 9 (1) ◽  
pp. 74-78
Author(s):  
Jayendra Singh Bayas ◽  
Rameshwar Sanjabrao Cheke ◽  
Prachi Lokhande ◽  
Santosh Waghmare ◽  
Shivshankar Gunjegaonkar ◽  
...  

Tablets or capsules taken orally remain one of the most effective means of treatment available. The effectiveness of such dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. The present study reveals the evaluation of four marketed sample of Telmisartan tablets. The main aim of the study is to conduct dissolution test on the tablets to determine the compliance with a given official monograph. Four different marketed samples of Telmisartan were purchased from local market. The Telmisartan tablets were evaluated for the various in-vitro tablet properties such as thickness, hardness, friability, weight variation, drug content, disintegration time and dissolution rate. In-vitro dissolution test is conducted on four different brands of telmisartan tablets to assess their equivalency. All the four marketed samples of Telmisartan have shown good tablet properties and comply with the pharmacopoeial specification. The in- vitro dissolution showed the 80% drug release within one hour from all the four brands which complies with the specification of pharmacopoeia.


2018 ◽  
Vol 13 (2) ◽  
pp. 79
Author(s):  
Bassam Abduh Ali ◽  
Mohammed Gameel Al-haddad ◽  
Abdullah Ahmed Areqi

Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.


2019 ◽  
Vol 11 (1) ◽  
pp. 49 ◽  
Author(s):  
S. Jaya ◽  
V. Amala

Objective: The present investigation was undertaken with an objective of formulating oral disintegrating tablets of amlodipine besylate to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy.Methods: The tablets were prepared by using direct compression method and evaluated for weight variation, hardness, friability, wetting time, disintegration time and in vitro drug release study. Prepared tablets were evaluated for compatibility by Fourier transform infrared spectroscopy.Results: Fourier transform infrared spectroscopy studies revealed that there was no physicochemical interaction between amlodipine besylate and other excipients. All the tablets hardness was found to be around 3.5 kg/cm2 and friability of all the formulations was less than 1%, Drug content in all the formulations was found in the range of 97.05% to 99.13%.Conclusion: The study clearly indicated that the type and concentration of superdisintegrants plays an important role in disintegration and dissolution of drug from oral disintegrating tablets. Among all the formulations, the maximum percentage of drug release and less disintegration time was found in F9 formulation containing 4% of crospovidone. 


2018 ◽  
Vol 8 (6-s) ◽  
pp. 265-268
Author(s):  
Manish Kumar ◽  
Shahnwaj Tyagi ◽  
Shailendra Bhatt ◽  
A. Pandurangan ◽  
Vipin Saini ◽  
...  

Efficacy of pharmaceuticals dosage form generally depends on their formulation properties and manufacturing methods, hence it is likely that the quality of dosage form may vary. Renin acts on angiotensinogen to form angiotensin I, which is converted to angiotensin II by angiotensin-converting enzyme (ACE). Angiotensin II, a potent vasoconstrictor increases blood pressure by increasing vasopressin production and aldosterone secretion. Enalaprilat, the active metabolite of enalapril, inhibits ACE, hence decreases levels of angiotensin II resulting in less vasoconstriction and decreased blood pressure. The study was exclusively experimental that used IP and other standard books to check in vitro quality of enalapril maleate tablet using different analytical techniques and procedure. Test for weight variation, hardness, friability, disintegration time, and dissolution were conducted. The dissolution test was performed at pH 6.8 for both the brands of the tablet. Further all the tablets passed weight variation, hardness, friability and disintegration test as per the pharmacopoeial standard. Hence we can conclude that both the brands of tablets are equal and both the brands contain equal quantity of active pharmaceutical ingredient (API). Both the brands having higher and lower costs exert similar action. Keywords: Enalapril maleate, In Vitro, Dissolution test, Enalapril


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