"Formulation and evaluation of atorvastatin, aspirin, clopidogrel capsules"
Journal name: World Journal of Pharmaceutical Research
Original article title: “formulation, development and evaluation of atorvastatin, aspirin and clopidogrel tablets in capsules form”
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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R. Margret Chandira, P. Palanisamy, B. Jaykar, A. Pasupathi, B. S. Venkateshwarlu
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: “formulation, development and evaluation of atorvastatin, aspirin and clopidogrel tablets in capsules form”
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
Summary of article contents:
1. Introduction
The research presented in this study focuses on the formulation, development, and evaluation of a combination of immediate-release tablets for Atorvastatin calcium and Clopidogrel bisulphate, along with a delayed-release tablet for Aspirin. The purpose of this combination therapy is to provide an effective strategy in chronotherapy for patients, particularly in reducing risks associated with cardiovascular conditions such as myocardial infarction. The study involved thorough evaluation of the individual tablet formulations for various pharmaceutical properties, including their physical characteristics, drug release profiles, and stability. The overall objective is to achieve optimal drug delivery and patient compliance in chronic therapy.
2. Importance of Disintegration in Tablet Formulation
An essential aspect of developing effective immediate-release tablets is the role of disintegrants. Disintegrants are substances that facilitate the breaking apart of tablets into smaller fragments upon contact with gastrointestinal fluids, which enhances the absorption of the active pharmaceutical ingredient (API). The study explores the utilization of superdisintegrants such as Croscarmellose sodium and Cross povidone, which are known for their efficient disintegration properties at relatively low concentrations. This research emphasizes the significance of selecting the right disintegrant to optimize the therapeutic effect of the tablets, leading to effective release profiles that can enhance patient outcomes.
3. Compatibility Studies
Compatibility studies between the active ingredients and excipients are critical in ensuring the stability and efficacy of pharmaceutical formulations. The research employed techniques such as Fourier Transform Infrared Spectroscopy (FT-IR) and Differential Scanning Calorimetry (DSC) to assess the interactions between Atorvastatin calcium, Aspirin, Clopidogrel bisulphate, and the chosen excipients. The results indicated that there were no significant interactions that could compromise the integrity or performance of the tablets, underscoring the importance of thorough preformulation and compatibility studies in the development of stable and effective drug formulations.
4. Stability and Release Profile Evaluation
The study included a rigorous evaluation of the stability of the optimized tablet formulations under both room temperature and accelerated storage conditions. The findings demonstrated that the selected batches of Atorvastatin, Aspirin, and Clopidogrel formulations remained stable, maintaining their physical and chemical characteristics during the three-month evaluation period. Furthermore, the in-vitro dissolution studies revealed that the optimized formulations met the required release criteria, yielding a cumulative drug release that was comparable to that of innovative products. These results validate the effectiveness of the developed formulations and their potential for clinical use.
5. Conclusion
In conclusion, this study successfully achieved the formulation, development, and evaluation of a combination therapy that incorporates Atorvastatin calcium, Aspirin, and Clopidogrel bisulphate in tablet form. The meticulous approach taken in the selection of excipients, thorough compatibility testing, and stability assessments has ensured the reliability of the formulations. By providing effective release profiles and maintaining stability over time, this combined therapy shows promise for managing cardiovascular conditions in a clinical setting, thus enhancing patient adherence and therapeutic outcomes through once-daily administration.
FAQ section (important questions/answers):
What is the purpose of formulation development in this study?
The study aims to formulate, develop, and evaluate immediate and delayed release tablets of Atorvastatin calcium, Clopidogrel bisulphate, and Aspirin for effective drug delivery in chronotherapy.
Which methods were used to prepare the tablets?
The tablets were prepared using the direct compression method, which involves mixing the drug with excipients and compressing the mixture into tablets without the need for a wet granulation process.
What were the primary drugs evaluated in this research?
The research focused on Atorvastatin calcium, an HMG Co-A reductase inhibitor, Clopidogrel bisulphate, used as an antiplatelet agent, and Aspirin, which has delayed release properties.
What analyses were performed on the tablets after formulation?
The tablets underwent various evaluations, including weight variations, hardness, friability, disintegration time, drug content assay, and in-vitro dissolution studies to ensure acceptable pharmaceutical properties.
How stable were the optimized formulations during the study?
The optimized formulations demonstrated stability under accelerated storage conditions at 40°C and 75% relative humidity for three months, maintaining their physical and chemical parameters.
What benefits do the combined drugs provide in therapy?
The combination of Atorvastatin, Clopidogrel, and Aspirin offers synergistic effects that help reduce the risk of myocardial infarction and improve cardiovascular health.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “"Formulation and evaluation of atorvastatin, aspirin, clopidogrel capsules"”. 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) Table:
In scientific writing, tables are structured formats used to present data clearly and concisely. They allow researchers to organize large quantities of information systematically, making it easier to read and compare results across different experiments or formulations, such as those concerning pharmaceutical studies mentioned in the text.
2) Drug:
Drugs are substances used for medical treatment to diagnose, cure, alleviate, or prevent diseases. In the context of this research, Atorvastatin, Aspirin, and Clopidogrel are significant as they work together therapeutically to manage cardiovascular conditions by providing synergistic effects, thus highlighting their importance in pharmacotherapy.
3) Powder:
Powder indicates the physical form of many pharmaceutical ingredients, primarily referring to the finely ground state necessary for the formulation of tablets. The particle size, flow properties, and distribution of powders dictate the manufacturing process, impacting the drug's release characteristics, efficacy, and stability.
4) Study (Studying):
The term study refers to the systematic investigation aimed at discovering and analyzing facts to generate knowledge. In this context, it is specifically focused on the formulation, development, and evaluation of drug combinations, contributing to advancements in pharmaceutical sciences and patient care quality.
5) Discussion:
Discussion is integral to research papers, as it interprets the results obtained and compares them with existing knowledge. It helps elucidate the implications of findings, highlighting consistencies or discrepancies with prior studies and contemplating future directions in research or practical applications of drug combinations.
6) Calculation:
Calculations are mathematical processes that ensure precision in experimental research. They are used for determining concentration, release rates, and dosage adjustments, integral to quality control in pharmaceuticals, thereby ensuring safety and efficacy of the drug formulations being tested.
7) Performance:
Performance typically relates to the efficacy and quality of medications in terms of their therapeutic effects, stability, and release characteristics. It evaluates how well the drug formulations achieve their intended effects, which is pivotal in measuring the success of this pharmaceutical research.
8) Substance:
In pharmacology, a substance refers to any chemical compound, such as a drug or its constituent, that can have a biological effect. Understanding the properties and behaviors of these substances is crucial for developing effective pharmaceutical formulations and ensuring patient safety during treatment.
9) Medium:
Medium often denotes the solvent or environment where reactions or dissolutions occur. In drug formulation studies, it refers to the solution used for dissolution testing, critical for assessing how well a drug is absorbed in the body, ultimately influencing its therapeutic effectiveness.
10) Vinayaka (Vināyaka, Vināyakā):
Vinayaka refers to the institution involved in the study, specifically Vinayaka Mission's College of Pharmacy. This educational institution plays a vital role in pharmaceutical education and research, contributing to the academic and professional development of future pharmacists and researchers.
11) India:
India is the country where the study and pharmaceutical formulation development occurred. Its rich biodiversity and growing pharmaceutical industry make it a significant player in the global healthcare sector, providing a backdrop for the advancements in drug development and therapeutic innovations discussed.
12) Heating:
Heating involves the application of thermal energy, crucial in tablet formulation processes such as drying or coating. It affects the chemical properties of drugs and excipients, thus influencing the stability and release profiles of the pharmaceutical formulations developed in the study.
13) Purity:
Purity indicates the extent to which a drug or substance is free from impurities, contaminants, or adulterants. In pharmaceuticals, maintaining high purity is essential for ensuring safety, efficacy, and compliance with regulatory standards, contributing significantly to the quality of the final products.
14) Cage (Cāge):
In this context, cage may refer to a type of blender or equipment used during the manufacturing process. It signifies the method by which powders are mixed effectively, ensuring a uniform distribution of ingredients critical for the consistency of pharmaceutical formulations.
15) Tamilnadu (Tamil-nadu, Tamilnāḍu):
Tamil Nadu is a state in southern India, where the research was conducted. This region has a vibrant educational and industrial landscape, particularly in pharmacy, contributing to advancements in drug development and healthcare solutions, relevant to the context of this research.
16) Shalem (Śāḷēṃ, Śāleṃ):
Salem is a city in Tamil Nadu, India, where Vinayaka Mission's College of Pharmacy is located. The local culture, healthcare challenges, and resources available contribute to the research initiatives undertaken by the college, shaping its contributions to the field of pharmaceutical sciences.
17) Water:
Water serves as a solvent and medium for many chemical reactions and formulations in pharmaceutical processes. Its quality and purity are paramount in drug studies, affecting solubility, stability, and overall effectiveness of the products being developed and tested.
18) Tamil (Tamiḻ):
Tamil refers to the language predominantly spoken in Tamil Nadu, highlighting the cultural and regional context of the research. It reflects the demographic of the study's primary population and may influence communication within the local scientific community and educational institutions.
19) Nadu (Nāḍu):
Nadu indicates 'land' or 'country' in Tamil, forming part of the name Tamil Nadu. It emphasizes the regional identity and significance of the state's contributions to the healthcare sector, especially in pharmaceuticals and education, within the broader context of India.
20) Observation:
Observation involves meticulous examination and data collection during experiments. It plays a crucial role in formulating conclusions about the drug formulations being studied, establishing relationships between variables, and ensuring that accurate data informs further research decisions in pharmaceutical development.
21) Filling (Filled):
Filled in this context usually refers to the process of encapsulating the pharmaceutical formulations into capsules. This method aids in ensuring precise dosing, improving patient compliance, and maintaining the stability of the active drug components during storage and transportation.
22) Life:
Life signifies the fundamental aspect of drug development aimed at enhancing the quality of life for patients. It underscores the ultimate goal of pharmaceutical research, which is to create effective therapeutic interventions that contribute positively to health outcomes in society.
23) Similarity:
Similarity emphasizes the comparison of drug release profiles and characteristics between the optimized formulations and innovator products. This is crucial for establishing bioequivalence, ensuring that new formulations provide the same therapeutic effects as established treatments for effective healthcare solutions.
24) Knowledge:
Knowledge is integral to the research process, representing the understanding and insights gained through study and observation. The development of new drug formulations relies fundamentally on expanding existing knowledge, ensuring that researchers can innovate while adhering to established scientific principles.
25) Swallowed:
Swallowed refers to the method of drug administration, commonly highlighting the oral route. It emphasizes the importance of designing pharmaceutical formulations that are patient-friendly, ensuring effective delivery of medication to achieve desired therapeutic effects.
26) Relative:
Relative indicates the importance of comparatives in research, particularly regarding the effectiveness and performance of new formulations compared to existing standards. This perspective is vital in evaluating drug formulations to ensure they meet or exceed established benchmarks in the pharmaceutical domain.
27) Surface:
Surface refers to the area exposed or in contact with other materials, essential in formulations as it impacts dissolution rates and bioavailability. In pharmaceuticals, the surface area of particles can influence absorption rates and overall drug efficacy.
28) Nature:
Nature emphasizes the inherent qualities and characteristics of drug substances and excipients. Understanding the nature of these components is fundamental for effective formulation strategies, ensuring compatibility, stability, and desired therapeutic action in products being developed.
29) House:
House often symbolizes a laboratory or research facility. It indicates the institutional environment in which scientific inquiries occur, highlighting the importance of infrastructure, resources, and expertise in conducting pharmaceutical research and development.
30) Post:
Post refers to the phase following certain processes, typically indicating post-compression or post-manufacturing evaluations. This phase is crucial for assessing the final quality attributes of pharmaceutical products, ensuring they meet predefined specifications of safety and efficacy.
Other Science Concepts:
Discover the significance of concepts within the article: ‘"Formulation and evaluation of atorvastatin, aspirin, clopidogrel capsules"’. Further sources in the context of Science might help you critically compare this page with similair documents:
Therapeutic effect, Calcium carbonate, Synergistic action, Specification, Chronotherapy, Temperature and humidity, Weight variation, Disintegration time, Aspirin, Accelerated stability studies, Tablet formulation, Compatibility studies, Manufacturing procedure, Room temperature, Myocardial infarction, HPLC Method, Physicochemical Parameter, Stability Studies, Weight variation test, Physical parameter, Combination of Drugs, Disintegration test, Formulation Development, In Vitro Dissolution Study, Direct compression method, High performance liquid chromatography system, Flow properties, Dissolution profile, Dissolution study, Preformulation studies, FT-IR spectroscopy, Phosphate buffer, Dissolution media, Standard calibration curve, Atorvastatin Calcium, Release profile, Injection Volume, Superdisintegrant, Excipient, Drug delivery, DSC studies, Immediate release tablet, Quality Control Test, FT-IR, Pharmaceutical properties, DSC thermogram, DSC, Optimization, Enteric coating, Film coated tablet, Enteric coated tablet, Capsule form, Chronic therapy, Capsule filling, Peak Value, Dosage unit.