Physicochemical Evaluation of Brands of Amlodipine Besylate Tablets.

2020 ◽  
Vol 1 (5) ◽  
pp. 24-33
Author(s):  
C.A. Anyanwu-Ndulewe ◽  
◽  
L.E. Mogbolu ◽  
M.A. Oladunni ◽  
A.A. Adepoju-Bello
Keyword(s):  
Hardness Test ◽  
Drug Market ◽  
The United States ◽  
Financial Strain ◽  
Average Weight ◽  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Disintegration Time ◽  
Physicochemical Evaluation ◽  
Dissolution Efficiency

Background: Hypertension is a chronic condition, and the cost of filling prescriptions has a potential of putting a financial strain on patients, hence the need for lower priced but bioequivalent generics. The Nigerian drug market is awash with generics of Amlodipine besylate, a first line drug in the treatment of hypertension, therefore, any prescribed alternative must be bioequivalent to the originator. Objectives: This study assessed the physicochemical properties of some brands in order to predict pharmaceutical and bioequivalence and invariably, the interchangeability with the innovator brand. Methods: Compendial parameters of average weight, friability, disintegration, drug content and dissolution profile of ten generic brands were evaluated using the United States Pharmacopeia (USP) as well as the non-official hardness test. Results: Two brands failed the test for hardness, while still keeping to the stipulated friability limit. All the brands met the required disintegration time, irrespective of the discordance of some brands in the breaking force and friability values. All brands were found to contain between 92.00 and 103.57% (w/w) of Amlodipine besylate. Two brands failed to achieve ≥75% dissolution expected at 30 minutes and this was reflected in the low f2 values of 35.06% and 28.73%. The dissolution curves displayed a similarity for two brands, which was also corroborated by the high percentage dissolution efficiency (DE) of 92.00%, as well as the f1 and f2 values, compared to the innovator brand. Conclusion: Although the parameters used may predict therapeutic equivalence, interchangeability with the comparator brand is subject to relevant bioequivalence studies.

Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh

2020 ◽  
pp. 174113432094775
Author(s):  
Madhabi Lata Shuma ◽  
Shimul Halder
Keyword(s):  
Release Kinetics ◽  
The United States ◽  
Quality Parameters ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Orally Disintegrating Tablets

The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commercially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach ( f2 > 50, f1 < 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products.

scholarly journals A Comparative Study on In-vitro Quality Control Parameters of Different Brands of Loratadine Tablets Commercially Available in Bangladesh

2021 ◽  
pp. 50-58
Author(s):  
Rosy Fatema ◽  
Sumaiya Khan ◽  
A. S. M. Roknuzzaman ◽  
Ramisa Anjum ◽  
Nishat Jahan
Keyword(s):  
Research Work ◽  
Drug Market ◽  
Quality Standard ◽  
In Vitro Dissolution ◽  
Active Principle ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Local Companies

Loratadine, a second generation H1-receptor antagonist, works by blocking the action of histamine and is widely prescribed for itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergic conditions. To ensure quality the main requirements for a medicinal product are safety, potency, efficacy and stability. This research work aimed to compare and assess the quality levels of different local brands of loratadine tablets available in the drug market of Bangladesh. Six different brands of loratadine 10 mg tablet manufactured by the local companies were used for the analysis. The evaluation was performed through the determination of weight variation, hardness, friability, percent potency, disintegration time, and dissolution profile in accordance with USP-NF specifications. All brands showed acceptable weight variation and % friability. The percent potency for tested samples by UV method ranges from 97.02%-108%, showing none of the brands contains less than 90% of the active principle as per the specification. The result of the physical and chemical studies, such as in-vitro dissolution, disintegration, hardness, etc., has been found to differ but lie within the specified limit. After analyzing the data obtained from the tests, it can be claimed that loratadine 10 mg tablets manufactured and marketed by several local companies in Bangladesh meet the quality standard required to achieve the desired therapeutic outcomes.

scholarly journals COMPARATIVE STUDY OF SEVEN BRANDS OF LEVOFLOXACIN 500 MG FILM-COATED TABLET MARKETED IN YEMEN

2021 ◽  
pp. 264-268
Author(s):  
GAMIL Q. OTHMAN ◽  
YASER M. AL-WORAFI ◽  
MOHAMMED M. BATTAH ◽  
ABDULSALAM M. HALBOUP ◽  
HASSAN M. HASSAN
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Hardness Test ◽  
The United States ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Optimum Range ◽  
Weight Variation ◽  
Coated Tablet

Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market. Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High-Performance Liquid Chromatography (HPLC). Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablet passed official specified assay tests according to the United States Pharmacopeia (USP) specifications. They showed a similar profile of thickness ranged between±0.01 and 0.10%, friability ranged between 0.01% and 0.34%, disintegration time ranged between 3.00 and 15.00 min, dissolution percentage ranged between 90.650 and 103.05 and content uniformity ranged between 93.62 and 107.12%. Regarding weight variation and hardness, six brands passed the weight variation test and only three brands showed optimum range (10-20 kg) of hardness test. Only one brand failed to pass the weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness. Conclusion: There are no remarkable differences between the seven brands regarding in vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit. Regular assessment of marketed drugs is required to ensure bioequivalent to their innovators.

scholarly journals Biopharmacotechnical and physical properties of solid pharmaceutical forms containing rutin commercially acquired in Juiz de Fora city, Brazil

2020 ◽  
Vol 42 ◽  
pp. e52212
Author(s):  
Thiago Maurício de Souza Pinto ◽  
Fabrini Luiz Alves Almeida ◽  
Julianna Oliveira de Lucas Xavier ◽  
Glauciemar Del-Vechio-Vieira ◽  
Ana Lúcia Santos de Matos Araújo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Physical Properties ◽  
Therapeutic Efficacy ◽  
Average Weight ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Anti Inflammatory ◽  
Kinetics Of

Rutin is a flavonoid used in clinical practice to treat capillary fragility and prevent bleeding due to its wide variety of pharmacological actions, including antioxidant, anti-inflammatory, anti-allergic, antiproliferative, and anticarcinogenic activities. In this study, the biopharmacotechnical and physical properties of film-coated tablets containing rutin marketed in drugstores were evaluated. Using samples from three batches called A, B and C, we determined the average weight, disintegration time, hardness, content and dissolution profile, and kinetics of the tablets. The samples demonstrated average weight of 457.45 ± 12.32 to 449.15 ± 8.95 mg; disintegration time, 30.17 ± 2.14 to 15.17 ± 2.14 min; hardness, 1.92 ± 0.55 to 1.69 ± 0.36 Kgf; and rutin content, 18.34 ± 1.21 to 15.66 ± 1.29 mg. After 90 min, the dissolution profile showed 52.65, 41.80, and 79.2% for A, B, and C, respectively. The results imply that the non-conformities of the tested products can significantly compromise the drug’s therapeutic efficacy.

scholarly journals Comparative Physicochemical Evaluation of Selective Brands of Diclofenac Potassium Tablets Available in Pakistan

2020 ◽  
pp. 90-97
Author(s):  
Jabbar Abbas ◽  
Arslan Ahmer ◽  
Muhammad Yousuf ◽  
Shaib Muhammad ◽  
Durr-e-Shahwar Malik ◽  
...  
Keyword(s):  
Spectrophotometric Analysis ◽  
Local Market ◽  
Dissolution Profile ◽  
Standard Specification ◽  
Disintegration Time ◽  
Physicochemical Evaluation ◽  
Rate Profile ◽  
Unites States ◽  
Present Effort ◽  
Good Agreement

The purpose of present effort was to conduct physiochemical evaluation of miscellaneous commercially available diclofenac potassium 75 mg tablets in the local market of Sindh, Pakistan. Further comparison was made among their different parameters. In study seven brands tagged as RB1 to RB7 were evaluated for diameter, thickness, disintegration time, and assay content and dissolution profile. Obtained results of all brands conformed to the official standard specification for disintegration test, Assay Content. The attained release rate profile during dissolution study revealed that all brands achieved more than 80% in sixty minutes. The spectrophotometric analysis for assay content of all brands was within 90%-110% which in good agreement with specified in the Unites States Pharmacopoeia. In the current study all the assessed products could be regarded as being chemically similar, while no product is found as a false product, these all brands can be used alternatively. The used spectrophotometric evaluation is very simple, reasonable, and easy to adopt for analysis and could be used in routine analysis of diclofenac potassium tablets, particularly in the unavailability of advanced equipment’s just like HPLC, LCMS & GC etc. which is not easily available and accusable in many institutions.

scholarly journals The Effect of Crospovidone on the Dissolution Profile of Amlodipine Besylate from Fast Orally Dissolving Film

2019 ◽  
Vol 7 (22) ◽  
pp. 3811-3815
Author(s):  
Sumaiyah Sumaiyah ◽  
Julia Mentari ◽  
Suryanto Suryanto
Keyword(s):  
Mentally Ill ◽  
Hydroxypropyl Methylcellulose ◽  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Solid Dosage Forms ◽  
Drug Induced ◽  
Disintegration Time ◽  
Solid Dosage ◽  
Rapid Dissolution ◽  
Agent Characteristics

BACKGROUND: Fast Orally Dissolving Film preparation can be used for patients with problems in ingesting solid dosage forms, such as mentally ill, elderly, geriatric and patients who are reducing fluid intake or nausea. AIM: This study aimed to formulate and evaluate the rapid dissolution of amlodipine besylate. METHODS: Amlodipine besylate film was prepared by solvent casting method by using hydroxypropyl methylcellulose (HPMC) as film formers, crospovidone as superdisintegrant with Varian concentration F1 (2%), F2 (4%), F3 (6%) and F4 (8%), PEG 400 as plasticizer, sucralose and sorbitol as sweetener, citric acid as saliva stimulation, and grape essence as flavoring and coloring agent. Characteristics of films include organoleptic, weight uniformity, film thickness, surface pH, swelling, uniformity of content, time of disintegration, and dissolution. RESULTS: All formulated films produced a good film, smooth, transparent and uniform physical properties. F2 with polymer HPMC and the 4% concentration of crospovidone was the best formula with 31.50 seconds of disintegration time, the index expanding at the 15 second by 242.29% and the cumulative percent of the drug at 80 seconds by 98.08%. CONCLUSION: Amlodipine besylate can be formulated into fast orally dissolving film preparations using HPMC and crospovidone polymers so that they may be considered for use in the treatment of hypertension for patients with drug-induced problems in tablet or capsule form.

scholarly journals Assessment of the pharmaceutical equivalence and in vitro dissolution studies of amlodipine tablets marketed in Northern Nigeria

2021 ◽  
Vol 17 (2) ◽  
pp. 200-207
Author(s):  
Ponjul Dandam ◽  
Jennifer D. Audu-Peter
Keyword(s):  
Hardness Test ◽  
Cost Effective ◽  
Poor Quality ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Pharmaceutical Equivalence ◽  
Drug Content ◽  
Effective Manner

The extensive supply of poor quality and/or counterfeit drug products in many developing countries has made it vital to frequently carry out suitable tests to assess bioequivalence (BE) in a cost-effective manner. This study was intended to assess the pharmaceutical equivalence and dissolution profile of amlodipine 5mg tablets marketed in Jos and Kaduna metropolis. Ten brands of Amlodipine 5mg tablets were obtained from different community pharmacies and evaluated for different quality control parameters such as percent drug content, friability, hardness, thickness, weight uniformity, disintegration time, and dissolution. The results showed that brands F and I failed the test for percent drug content while the rest of the brands passed it. In addition, all the brands passed the disintegrationand friability test while Brands C, F and I did not pass the hardness test. The dissolution profiles of all the brands were similar to the innovator brand at pH 6.8, whereas at pH 1.2, only four brands (B, E, H and I) had similar dissolution profile to the innovator. This study serves to justify for the assessment of in vitro parameters of commercially available amlodipine generics which may aid the prescribers’ decision making. Keywords: Amlodipine; Jos; Tablet properties, Dissolution profile

scholarly journals 3DP Printing of Oral Solid Formulations: A Systematic Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 358 ◽  
Author(s):  
Chiara R. M. Brambilla ◽  
Ogochukwu Lilian Okafor-Muo ◽  
Hany Hassanin ◽  
Amr ElShaer
Keyword(s):  
Systematic Review ◽  
Data Extraction ◽  
New Technology ◽  
Three Dimensional ◽  
Extraction Process ◽  
Carcinogenic Risk ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Advantages And Disadvantages

Three-dimensional (3D) printing is a recent technology, which gives the possibility to manufacture personalised dosage forms and it has a broad range of applications. One of the most developed, it is the manufacture of oral solid dosage and the four 3DP techniques which have been more used for their manufacture are FDM, inkjet 3DP, SLA and SLS. This systematic review is carried out to statistically analyze the current 3DP techniques employed in manufacturing oral solid formulations and assess the recent trends of this new technology. The work has been organised into four steps, (1) screening of the articles, definition of the inclusion and exclusion criteria and classification of the articles in the two main groups (included/excluded); (2) quantification and characterisation of the included articles; (3) evaluation of the validity of data and data extraction process; (4) data analysis, discussion, and conclusion to define which technique offers the best properties to be applied in the manufacture of oral solid formulations. It has been observed that with SLS 3DP technique, all the characterisation tests required by the BP (drug content, drug dissolution profile, hardness, friability, disintegration time and uniformity of weight) have been performed in the majority of articles, except for the friability test. However, it is not possible to define which of the four 3DP techniques is the most suitable for the manufacture of oral solid formulations, because the selection is affected by different parameters, such as the type of formulation, the physical-mechanical properties to achieve. Moreover, each technique has its specific advantages and disadvantages, such as for FDM the biggest challenge is the degradation of the drug, due to high printing temperature process or for SLA is the toxicity of the carcinogenic risk of the photopolymerising material.

scholarly journals Pain and Hardship Among Older Men: Examining the Buffering Effect of Medicare Insurance Coverage

2018 ◽  
Vol 12 (5) ◽  
pp. 1439-1449 ◽  
Author(s):  
Gillian L. Marshall ◽  
Tamara A. Baker ◽  
Chiho Song ◽  
David B. Miller
Keyword(s):  
Insurance Coverage ◽  
Interactive Effect ◽  
Later Life ◽  
Older Men ◽  
The United States ◽  
Pain Severity ◽  
Financial Strain ◽  
Cross Sectional ◽  
Retirement Study

To better understand the health status of men in the United States, this study aimed to assess the association of hardship on the presence of and pain severity among men 50 years of age and older. Cross-sectional multivariate logistic regression analyses were conducted using the 2010 wave of the Health and Retirement Study ( N = 3,174) to assess the association between four hardship indicators and the presence of pain and pain severity among this sample of older men. Results suggest that the association between the presence of pain and hardship was statistically significant across all four indicators: ongoing financial hardship (CI [1.05, 1.63], p < .05), difficulty paying bills (CI [1.42, 3.02], p < .001), food insecurity (CI [1.46, 3.15], p < .001), and not taking medication due to cost (CI [1.06, 1.66], p < .05), even after adjusting for all demographic factors. The associations between pain severity and ongoing financial strain (CI [1.23, 2.83], p < .01) and difficulty paying bills (CI [1.02, 3.18], p < .05) were statistically significant. Results also indicate that education was a buffer at all levels. In addition, the interactive effect of hardship and Medicare insurance coverage on pain severity was significant only for ongoing financial strain (CI [1.74, 14.33], p > .001) and difficulty paying bills (CI [1.26, 7.05], p < .05). The evidence is clear that each hardship indicators is associated with the presence of pain and across some of the indicators in pain severity among men aged 50 and older. In addition, these findings stress the importance that Medicare insurance plays in acting as a buffer to alleviate some of the hardships experienced by older men. These findings also highlight the association between the presence of pain and pain severity for the overall quality of life, health outcomes, and financial position of men in later life.

scholarly journals EVALUATION OF MUSA ACUMINATA FRUIT AS A NATURAL SUPERDISINTEGRANT FOR TABLET FORMULATION

2018 ◽  
Vol 11 (10) ◽  
pp. 167
Author(s):  
Gopinath E
Keyword(s):  
Nutritive Value ◽  
Low Cost ◽  
Cost Effective ◽  
Musa Acuminata ◽  
Tablet Formulation ◽  
Angle Of Repose ◽  
Average Weight ◽  
Disintegration Time ◽  
Solubility Study ◽  
Orodispersible Tablet

Objective: The objective of the present work was to develop and evaluate a new, low-cost effective superdisintegrant from Musa acuminata fruit for tablet formulation.Methods: The study involved collection of M. acuminata fruit powdered and evaluated for physicochemical properties. Propranolol Hcl was used as a model drug for tablet formulation. Different concentrations of M. acuminatea powder were used as superdisintegrant, and orodispersible tablet is prepared and evaluated. In the present study, sodium starch glycolate was used as synthetic superdisintegrant for comparative study.Result: The powder was dark brownish and did not change throughout the study. The percentage porosity of powder was found to be 42.88% and angle of repose of was found to be 33.69°. The solubility study shows that the powders are sparingly soluble in water and disperse into individual particles. Total ash and acid insoluble ash values of powder were found to be 2.61 and 2.11% w/w, respectively. The average weight of tablets was ranged from 101.42 to 103.52 mg and averaged hardness was found to be 3.4 kg/cm2. Moreover, the tablets exhibited acceptable friability. Disintegration time of all formulations was found to be in the range of 22–80 s and wetting time was found to be 07–18 s.Conclusion: From the study, it was concluded that M. acuminatea powder in the range of 2–12% can be used as superdisintegrant in orodispersible tablet formulation and shall be preferred as having nutritive value as well as cost profit in the development of orodispersible tablet than synthetic polymer.

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