Comparative evaluation of prednisolone 5mg tablets marketed in bangladesh
Journal name: World Journal of Pharmaceutical Research
Original article title: Comparative evaluation of prednisolone 5mg tablets marketed in bangladesh
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Nabila Morshed and Shahana Sharmin
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Comparative evaluation of prednisolone 5mg tablets marketed in bangladesh
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The study conducted by Nabila Morshed and Shahana Sharmin aimed to assess the quality of Prednisolone 5mg tablets available in the Bangladeshi market, focusing on their physicochemical equivalence to ensure patient safety and efficacy. Prednisolone, a synthetic glucocorticoid derivative of cortisol, is primarily used to treat various inflammatory and autoimmune disorders. The research evaluated different brands through established quality tests including weight variation, hardness, friability, disintegration, and in-vitro dissolution, in accordance with the standards set by the British Pharmacopoeia (BP) and United States Pharmacopeia (USP).
Evaluation of Dissolution Tests
One crucial parameter assessed was the dissolution rate of the Prednisolone tablets, as it serves as a key indicator of a drug's bioavailability and effectiveness. The study found that six out of the twelve samples failed to meet the USP dissolution specification, with some showing less than 75% of the Prednisolone content released during the testing period. This suggests significant variability among the brands, highlighting the importance of adhering to standardized dissolution parameters to ensure that the therapeutic drug's intended effects are achieved in patients.
Importance of HPLC Assay
Another essential aspect of the research involved the High-Performance Liquid Chromatography (HPLC) assay used to determine the percentage content of the active ingredient in various Prednisolone brands. The results indicated that some samples contained less than the acceptable range of 90-110% of the labeled claim for Prednisolone content. This inconsistency in active ingredient concentrations raises concerns regarding the reliability of these products, which can ultimately affect patient outcomes and reinforce the necessity for stringent quality control measures within the pharmaceutical industry.
Disintegration and Physical Properties
The disintegration time of the Prednisolone tablets was also evaluated as it relates to the drug's absorption in the body. While most samples met the USP standards for disintegration, two samples demonstrated no disintegration, indicating potential issues in their formulations. The study found no major concerns regarding other physical parameters such as tablet thickness, hardness, and friability, with all tested brands falling within the acceptable limits. This indicates that while some physical characteristics are satisfactory, the efficacy and reliability of the tablets are compromised due to poor disintegration and dissolution rates in certain brands.
Conclusion
In conclusion, the investigation revealed that around 50% of the Prednisolone tablet brands available in urban Bangladesh are substandard, failing critical quality tests that affect their safety and efficacy. The findings emphasize the necessity for improved monitoring and regulation of pharmaceutical products to better protect patient health. It is crucial for local manufacturers to enhance their standards and practices to ensure that medicines meet high-quality benchmarks, particularly in a healthcare environment where patients increasingly rely on effective pharmacotherapy. Enhanced quality assurance measures will ultimately contribute to better healthcare outcomes in Bangladesh.
FAQ section (important questions/answers):
What was the aim of the study on Prednisolone tablets?
The study aimed to determine the quality and physicochemical equivalence of different brands of Prednisolone 5mg tablets marketed in Bangladesh, specifically focusing on their efficacy for patients suffering from respiratory inflammation and autoimmune disorders.
What methods were used to evaluate Prednisolone tablets?
The evaluation involved testing for weight variation, thickness, hardness, friability, disintegration, in-vitro dissolution, and HPLC assay, ensuring compliance with specifications in the British Pharmacopoeia (BP) and United States Pharmacopoeia (USP).
How many brands of Prednisolone tablets were tested in the study?
Twelve different brands of Prednisolone 5mg tablets were assessed for quality control in the study, representing both local and multinational manufacturers.
What percentage of tested tablets were found to be substandard?
The study concluded that 50% of the tested brands were substandard, failing to meet various quality control standards, particularly in dissolution and content uniformity.
What were the key findings regarding disintegration and dissolution?
Two samples did not disintegrate, and six samples showed poor in-vitro dissolution, with less than 75% active Prednisolone content, indicating quality issues with those brands.
What recommendations were made for local pharmaceutical companies?
The study recommended that lesser-known local pharmaceutical companies improve their quality standards and undergo stricter monitoring to prevent the manufacturing of substandard dosage forms.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Comparative evaluation of prednisolone 5mg tablets marketed in bangladesh”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
Drug refers to a substance intended for use in the diagnosis, cure, treatment, or prevention of disease. In this study, the focus is on Prednisolone, a synthetic glucocorticoid, used to treat inflammatory conditions. Understanding drug quality is crucial for ensuring patient safety and effective treatment outcomes.
2) Quality:
Quality denotes the standard of a product as measured against various parameters. In the study, quality assessments focus on the physicochemical properties of Prednisolone tablets. High-quality drugs ensure efficacy, safety, and consistent therapeutic outcomes, critical for patient care in managing conditions such as asthma and autoimmune disorders.
3) Water:
Water is used as a dissolution medium for the in vitro tests conducted in the study. It serves as a solvent for analyzing how well drugs like Prednisolone dissolve, which subsequently affects their bioavailability. The choice of water as a medium is essential for simulating biological conditions.
4) Study (Studying):
Study signifies the systematic investigation undertaken to compare the quality of different brands of Prednisolone tablets. The aim is to assess physicochemical equivalence and identify substandard products. Detailed analysis through rigorous testing provides insights essential for healthcare, ensuring that patients receive safe and effective medications.
5) Table:
Table refers to the tabulated data showcasing various physicochemical test results of Prednisolone tablets. These tables summarize findings like weight, thickness, hardness, and dissolution rates for each brand. They serve as visual aids to highlight differences in quality and help in making informed assessments on drug reliability.
6) Medium:
Medium in this context refers to the dissolution medium employed during the in vitro tests. The choice of medium is vital for accurately simulating conditions in which the drug would be absorbed in the human body. It influences the dissolution rate and subsequent bioavailability of the drug.
7) Relative:
Relative pertains to comparing qualities or quantities of various drug samples in the study. The relative differences in physicochemical parameters such as dissolution and content uniformity provide insights into which products meet the specifications and which do not, guiding healthcare professionals in prescribing effective treatments.
8) Performance:
Performance relates to how the drug behaves in terms of its dissolution and bioavailability, essential for therapeutic effectiveness. Assessing the performance of Prednisolone tablets through various tests helps ensure that patients receive medications that will work effectively to manage their conditions responsibly and safely.
9) Crushing:
Crushing refers to the process of grinding the Prednisolone tablets to conduct HPLC assays for active ingredient measurement. This action ensures uniformity when preparing samples for testing. The crushing of tablets is crucial in pharmacological studies as it affects the subsequent evaluation of drug release and stability.
10) Pranali:
Pranali appears to be an author's name in the study. It signifies the contributions of individuals involved in the research, highlighting collaboration in scientific inquiry. The authors' work provides credibility and ownership of the findings, which are vital for subsequent referencing and peer review in academic contexts.
11) Pur:
Poor is a descriptor used to signify substandard products in the study. When referring to the quality of some Prednisolone tablets, it highlights that certain samples did not meet the established specifications for active ingredient content and dissolution rates, raising concerns about their effectiveness and safety for patients.
12) Life:
Life, in the context of this study, refers to the shelf life of pharmaceutical products. The shelf life indicates the period during which the drug is expected to remain effective and stable. Understanding shelf life is crucial in evaluating medication quality and ensuring that patients receive potent treatments.
13) Inflammation:
Inflammation is a physiological response to harmful stimuli, often treated with drugs like Prednisolone. It involves swelling, redness, and pain, typically associated with conditions such as asthma and autoimmune disorders. Effective management of inflammation is crucial for improving patient comfort and quality of life.
14) Measurement:
Measurement in this context pertains to quantifying the physicochemical properties of the Prednisolone tablets. Accurate measurements of parameters such as drug content, dissolution rate, and physical dimensions are critical for assessing quality standards. Consistent measurement practices are essential for ensuring reliability in pharmaceutical evaluation.
15) Discussion:
Discussion refers to the section where the study’s findings are interpreted and analyzed. It highlights the significance of results, linking them to existing literature and drawing conclusions. This section is vital for providing context to the results, allowing for better understanding and potential implications in the pharmaceutical field.
16) Developing:
Developing indicates the context where substandard drug issues are prevalent, especially in low-income countries. Studies like this are crucial for identifying quality control problems in local pharmaceutical industries. Addressing issues in developing contexts is imperative for improving patient healthcare and ensuring accessibility to effective medications.
17) Suffering:
Suffering refers to the impact of diseases such as asthma and autoimmune disorders on individuals. The study highlights the importance of providing high-quality medications to alleviate patient suffering, ensuring that treatments are effective and correspond to the healthcare needs of the population.
18) Medicine:
Medicine denotes the substances used to prevent, treat, or cure ailments. In this study, Prednisolone represents a critical medicine for managing inflammation. Ensuring the quality of medicines is essential to maintain therapeutic efficacy and safeguard public health, particularly in the context of increasing incidences of substandard drugs.
19) Purity:
Purity refers to the absence of contaminants or deviation in active ingredient concentration within pharmaceutical products. The study evaluates the purity of Prednisolone tablets, which is crucial for confirming their therapeutic effectiveness. Maintaining purity ensures that patients receive medicines that meet safety and efficacy standards.
20) Powder:
Powder signifies the form of the crushed Prednisolone tablets used for HPLC assay preparation. This processing step is essential for determining the concentration of active ingredients accurately. The powdered form allows for uniform sampling and reliable analysis, crucial for validating drug quality and consistency in formulations.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Comparative evaluation of prednisolone 5mg tablets marketed in bangladesh’. Further sources in the context of Science might help you critically compare this page with similair documents:
Comparative evaluation, Quality assurance, Quality Control, Therapeutic efficacy, Shelf life, High performance liquid chromatography, Safety and efficacy, Standard drug, Weight variation, Raw material, Market sample, Friability test, Sample preparation, Statistical method, Disintegration test, Hardness test, Absorbance measurement, Pharmaceutical dosage form, Quality Control Test, Pharmaceutical product, Standard preparation, Chronic Active Hepatitis, Auto immune disorder, Quality specification.