Delayed-release tablet formulation and evaluation of aspirin USP.

| Posted in: Health Sciences Science

Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation, development and evaluation of delayed release tablets of aspirin usp
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.
This page presents a generated summary with additional references; See source (below) for actual content.

Original source:

This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.

Author:

Palanisamy. P, R. Margret Chandira, 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 delayed release tablets of aspirin usp

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research

Copyright (license): WJPR: All rights reserved


Download the PDF file of the original publication


Summary of article contents:

Introduction

The study conducted by Palanisamy et al. aimed at the formulation, development, and evaluation of delayed release tablets of Aspirin. This pharmaceutical investigation utilized various analytical methods, including High-Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectroscopy (FT-IR), and Differential Scanning Calorimetry (DSC), to ensure the quality and efficacy of the formulations produced. A central focus of the research was to enhance the bioavailability of Aspirin while minimizing gastrointestinal irritation through appropriate formulation techniques, particularly the use of enteric coating.

Optimized Formulation Process

The formulation of Aspirin delayed release tablets was achieved using the direct compression method with a focus on optimizing the concentration of excipients. Sodium starch glycolate was identified as the most effective disintegrant, facilitating the desired drug release profile. Following optimization, the release profile from the best-performing batch (AF4) demonstrated a cumulative drug release of 104.21% at 90 minutes, closely matching that of an innovative product. The evaluation of the release profiles was primarily conducted through dissolution testing in both 0.1N hydrochloric acid and pH 6.8 phosphate buffer, indicating the efficacy of the formulation in controlled drug release.

Compatibility Studies

Compatibility studies were crucial in assessing potential interactions between the drug and its excipients. Using HPLC and physical observation methods, the research found no significant interactions between Aspirin and the excipients used in the formulations. FT-IR spectra and DSC thermograms confirmed the chemical stability and compatibility of the drug with various excipients, supporting the feasibility of combining components for effective tablet formulation. This analysis ensures that the formulation process does not compromise the therapeutic efficacy and stability of the Aspirin delayed release tablets.

Stability Assessment

The optimized formulations were subject to stability studies under both room temperature and accelerated conditions, as per ICH guidelines. The results indicated that the tablets maintained their integrity, with no significant deviations in physical parameters, including hardness, weight variation, and drug content, over a three-month period. Both the assay values and in-vitro release profiles remained stable, demonstrating that the formulations are robust in varying storage conditions. This stability is vital for ensuring a dependable shelf life and therapeutic effectiveness of the drug.

Conclusion

The study successfully developed a delayed release formulation of Aspirin, meeting pharmaceutical standards and showcasing favorable in-vitro release profiles consistent with established innovators' products. Through careful optimization of excipients, compatibility analyses, and stability assessments, the research provides a viable approach to enhance the bioavailability of Aspirin while mitigating gastrointestinal irritations. The findings emphasize the importance of meticulous formulation processes in achieving effective therapeutic outcomes and provide a foundation for future studies in delayed release drug formulations.

FAQ section (important questions/answers):

What was the aim of the study on delayed release tablets?

The study aimed to formulate, develop, and evaluate delayed release tablets of Aspirin, ensuring compatibility, optimized release profiles, and compliance with Pharmacopeial specifications.

What methods were used for drug and excipient compatibility?

Compatibility was assessed using FT-IR studies, Differential Scanning Calorimetry (DSC), and HPLC methods, which confirmed no interaction between Aspirin and the excipients.

Which method was chosen for formulating the delayed release tablets?

Direct granulation was selected as the method of choice for formulating the delayed release Aspirin tablets, optimizing the formulation with an effective disintegrant.

What were the results of the dissolution study for batch AF4?

Batch AF4 exhibited a cumulative drug release of 104.21% at 90 minutes, matching the release profile of the innovator product, indicating effective formulation.

How was the stability of the optimized formulation evaluated?

The stability of the optimized formulation was evaluated at room temperature and under accelerated conditions, following ICH guidelines, showing no significant changes in tablet parameters.

What key findings were established from the study on Aspirin tablets?

The study confirmed that the optimized delayed release tablets of Aspirin met specified requirements for release profiles, compatibility and stability, providing satisfactory performance.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Delayed-release tablet formulation and evaluation of aspirin USP.”. 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:
A table in this context refers to a structured format for presenting data and results clearly. Tables are crucial in scientific research as they organize large amounts of information, such as measurements, parameters, and findings from the study, making it easier for readers to comprehend and analyze the results at a glance.

2) Drug:
A drug is a substance used for medical purposes, particularly to diagnose, cure, treat, or prevent disease. In the researched formulation, Aspirin serves as the drug being studied. Understanding the properties and effectiveness of the drug is essential for developing effective medicinal products and ensuring patient safety.

3) Powder:
Powder refers to the physical form of a substance that is finely ground, which can affect its solubility, stability, and bioavailability in tablet formulations. The powdered form of drugs and excipients enables better mixing and consistent dosages. Particle size and flow properties of the powder can influence the manufacturing process.

4) Study (Studying):
A study refers to a systematic investigation or analysis of a subject or phenomenon. In this context, it entails the formulation, development, and evaluation of delayed-release Aspirin tablets. Scientific studies are conducted to establish the efficacy and safety of drugs, ensuring they meet regulatory standards before reaching consumers.

5) Discussion:
Discussion in a scientific paper involves interpreting the results, explaining their implications, and comparing findings with previous research. It helps contextualize the study within the broader scientific community. This section critically assesses the methodology, findings, and potential applications of the research, contributing to scientific knowledge and future studies.

6) Vinayaka:
Vinayaka Mission’s College of Pharmacy is an educational institution located in Tamil Nadu, India, where this research was conducted. The institution plays a pivotal role in training pharmacy professionals and conducting innovative research. The college provides resources and support for students and faculty to explore pharmaceutical sciences and drug development.

7) India:
India is the country where the research was conducted. It has a large pharmaceutical industry known for its production of generic drugs and research initiatives. The country’s regulatory framework and growing focus on research and development are significant for advancements in pharmaceutical formulations, enhancing global health outcomes.

8) Substance:
A substance refers to a specific material or compound with distinct properties. In pharmaceutical research, the term often pertains to active pharmaceutical ingredients (APIs) and excipients used in drug formulations. Understanding the chemical and physical properties of a substance is critical for developing effective medications that are safe for consumption.

9) Calculation:
Calculation in this context refers to the quantitative analysis performed during the study, such as determining assay values, release percentages, and other crucial metrics. Accurate calculations are essential for validating the results, ensuring that the formulations meet therapeutic targets, and maintaining compliance with pharmacopeial standards.

10) Observation:
Observation entails the systematic noting of specific events or behaviors throughout the study. In research, observations lead to valuable insights regarding the stability, efficacy, and other characteristics of the drug formulations. This data is crucial for assessing how well the dosage forms perform under various conditions over time.

11) Performance:
Performance refers to how well the drug formulations achieve their desired outcomes in terms of release profiles, dissolution rates, and stability over time. The performance metrics help establish whether a formulation meets therapeutic objectives and regulatory requirements, thereby influencing its potential for clinical use.

12) Tamilnadu (Tamil-nadu):
Tamil Nadu is a state in India where the research was conducted. It is known for its educational institutions, including Vinayaka Mission’s College of Pharmacy. The region’s emphasis on higher education and research in the pharmaceutical sector contributes to advancements in drug development and healthcare improvements.

13) Shalem (Salem, Salem):
Salem is a city in Tamil Nadu, India, that hosts Vinayaka Mission’s College of Pharmacy. The location is relevant to the research as it provides the necessary educational resources, infrastructure, and a supportive environment for conducting pharmaceutical research and training future professionals in the field.

14) Tamil:
Tamil refers to the language predominantly spoken in Tamil Nadu, India. The cultural and linguistic identity of the region enriches the educational and scientific environments. Understanding local languages can enhance communication among researchers, educators, and the community, facilitating better collaboration and dissemination of scientific knowledge.

15) Nadu:
Nadu is part of the name 'Tamil Nadu' and refers to the state in Southern India. The state's dedication to developing education and healthcare systems influences research opportunities. The regulatory environment in Tamil Nadu supports pharmaceutical innovations, ensuring access to quality medications and advancing public health.

16) Heating:
Heating refers to the application of temperature changes during the manufacturing process of pharmaceutical formulations. Controlled heating can influence the properties of drug-excipient mixtures, affecting their behavior during processing and stability. Proper heating methods are essential for ensuring uniformity and quality in drug formulations.

17) Medium:
Medium refers to the solvent or environment used for dissolution testing, such as 0.1N Hydrochloric acid or buffer solutions. The choice of medium is critical in assessing the solubility and release characteristics of drug formulations, reflecting how they may behave in the gastrointestinal tract.

18) Water:
Water is a universal solvent integral to many pharmaceutical processes, including dissolution and stability testing. In this research, purified water is used for disintegration tests and as a medium to simulate the body’s environment. Its purity and quality are vital for obtaining accurate and reproducible results.

19) Life:
Life, in the context of pharmaceuticals, often refers to the bioavailability and therapeutic effectiveness of drugs in living organisms. Ensuring that drug formulations enhance the quality of life for patients is a primary goal of pharmaceutical research, which focuses on safety, efficacy, and patient adherence to treatments.

20) Irritation:
Irritation refers to the adverse effects that medications can have on the gastrointestinal tract or other tissues. Avoiding irritation is essential when formulating delayed-release tablets, as it enhances patient compliance and wellbeing. The research focused on mitigating such issues by using enteric coatings in the tablet formulation.

21) Knowledge:
Knowledge implies the understanding and insights gained from research activities. In pharmaceutical sciences, knowledge encompasses drug formulation, development processes, and the pharmacological properties of substances. It is paramount for advancing drug therapy and creating effective patient-centered medication regimens.

22) Disease:
Disease pertains to any abnormal condition affecting the body, which pharmaceutical research aims to address through effective drug formulations. The development of medications like Aspirin targets various conditions, such as pain, inflammation, and cardiovascular diseases, directly influencing public health and treatment strategies on a global scale.

23) Purity:
Purity indicates the extent to which a substance is free from contaminants and impurities. In pharmaceutical formulations, ensuring high purity levels of active ingredients and excipients is crucial for guaranteeing safety and efficacy. Purity assessments are a part of the quality control measures during drug development.

24) Nature:
Nature, in a scientific context, often refers to the intrinsic properties and characteristics of substances. Understanding the nature of drugs and excipients, including their physical and chemical behaviors, is fundamental for successful formulation development and enhancing the overall performance of pharmaceutical products.

25) House:
House can refer metaphorically to the institution or laboratory where research occurs. It encompasses the environment and facilities conducive to scientific discovery and drug development, fostering collaboration among researchers and creating an atmosphere for innovative thinking and breakthroughs in pharmaceuticals.

26) Cage:
Cage may refer to a containment or design element in laboratory settings, potentially referencing how substances are handled or analyzed under controlled conditions. In various experimental procedures, ensuring that samples remain undisturbed or contained is crucial for accurate data collection and validity of results.

27) Post:
Post indicates a phase following a certain action, such as post-compression or post-manufacturing studies. In pharmaceutical research, post-process evaluations are essential for assessing the stability, efficacy, and overall quality of formulations, ensuring they meet Established Pharmacopeial specifications before reaching consumers.

Other Science Concepts:

[back to top]

Discover the significance of concepts within the article: ‘Delayed-release tablet formulation and evaluation of aspirin USP.’. Further sources in the context of Science might help you critically compare this page with similair documents:

Hardness, High performance liquid chromatography, Bioavailability, Disintegration time, Accelerated stability studies, Differential scanning calorimetry, Friability test, Compatibility studies, Chemical stability, Manufacturing procedure, Melting point, HPLC Method, Stability Studies, Weight variation test, Disintegration test, In vitro dissolution studies, Carr's Index, Sodium starch glycolate, Pharmaceutical dosage form, Optimized formulation, Angle of repose, Flow properties, Dissolution profile, FTIR Spectrum, Preformulation studies, Bulk density, Tapped density, Oral drug delivery, Magnesium stearate, Drug content uniformity, Content uniformity, Release profile, Accelerated condition, Hausner ratio, Assay, Titanium dioxide, Optimization, Enteric coating, ICH Guideline, Solubility, Enteric coated tablet, Tablet dimension, Physical observation, Tablet shape.

Let's grow together!

I humbly request your help to keep doing what I do best: provide the world with unbiased sources, definitions and images. Your donation direclty influences the quality and quantity of knowledge, wisdom and spiritual insight the world is exposed to.

Let's make the world a better place together!

Like what you read? Help to become even better: