Formulation and evaluation of aceclofenac effervescent granules

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Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation and evaluation of aceclofenac effervescent granules
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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Original source:

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Author:

Subhashitha S. Nikhil H. Y., Pallavi Nayak, Shwetha Nayak and Sri Lakshmi Prasida, Swasthi and Ravi Kumar Naik


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: Formulation and evaluation of aceclofenac effervescent granules

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

Doi: 10.20959/wjpr20241-30600

Copyright (license): WJPR: All rights reserved


Download the PDF file of the original publication


Summary of article contents:

Introduction

Effervescent granules are an innovative dosage form composed of dried aggregates of solid particles containing one or more Active Pharmaceutical Ingredients (APIs) along with excipients. The production of carbon dioxide when the granules are mixed with water is a crucial property that makes them unique, enhancing solubility and patient compliance. Aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), has been identified for this study due to its therapeutic potential and poor solubility in water. The aim of this research was to formulate and evaluate aceclofenac effervescent granules, with a focus on enhancing drug release and patient adherence.

Formulation Methodologies

The formulation of aceclofenac effervescent granules involved a wet granulation method with various excipients. A calibration curve was established to determine the concentration of aceclofenac in solution using UV spectrophotometry. The granules were prepared by mixing the API with other ingredients, including citric acid, tartaric acid, and sodium bicarbonate, among others, and subsequently passing the mixture through sieves to achieve the desired granule size. This meticulous approach aimed to create granules with optimal properties conducive to rapid dissolution and efficient drug release.

Evaluation of Effervescent Granules

The prepared effervescent granules underwent rigorous evaluation regarding their physical properties, including flowability and dissolution rates. Key parameters such as the angle of repose, bulk density, tapped density, and Carr's index were calculated to assess the granules' flow characteristics. The study revealed that F3 formulation exhibited the best flow properties and compressibility, alongside good drug content estimation, making it a favorable candidate for subsequent analyses. Additionally, effervescence time, an essential parameter indicating the granules' dissolution speed, was measured to ascertain their performance in an aqueous environment.

Dissolution Study Findings

The dissolution profiles of the five formulations of aceclofenac effervescent granules indicated a remarkable release of the active compound within a short time frame. Notably, formulation F4 displayed the highest percentage of drug release, achieving 99.1% dissolution within five minutes. This rapid release rate can be attributed to the effective interaction between the granules and water, leading to the granules breaking down into fine particles. The interaction between the alkaline and acidic components during dissolution plays a pivotal role in enhancing drug bioavailability, showcasing the efficacy of the effervescence in drug formulation.

Conclusion

In summary, the study successfully developed aceclofenac effervescent granules through the wet granulation method, demonstrating desirable properties for effective drug delivery. The various formulations underwent thorough evaluation, revealing that formulation F3 presented the best characteristics among the batches. The incorporation of effervescence not only improved the solubility and release rate of aceclofenac but also addressed patient compliance due to its ease of use. This research paves the way for the further development of effervescent dosage forms that can significantly enhance the therapeutic outcomes for patients requiring nonsteroidal anti-inflammatory treatments.

FAQ section (important questions/answers):

What is the aim of the study on aceclofenac granules?

The study aims to develop and evaluate aceclofenac effervescent granules using a salt formation technique to enhance drug efficacy, improve patient compliance, and minimize first-pass metabolism.

What methods were used to prepare the effervescent granules?

Effervescent granules were prepared using the wet granulation method, mixing active ingredients and excipients, followed by drying and sieving to achieve the desired granule size.

What parameters were evaluated for the granules' formulation?

The evaluated parameters included bulk density, tapped density, angle of repose, effervescence time, and drug content to ascertain the granules' quality and performance.

What was the result of the dissolution study for formulation F4?

Formulation F4 demonstrated a high drug release profile, achieving 99.1% dissolution within 5 minutes, attributed to effective granule disintegration and effervescence.

Which formulation exhibited the best flow properties and dissolution rates?

Formulation F3 displayed optimal flow properties and drug release, indicating it was the most effective among the five formulations evaluated.

What composition was included in the granules' formulation?

The granules were formulated with ingredients such as aceclofenac, citric acid, tartaric acid, sodium bicarbonate, and disintegrants like sodium citrate and mannitol to enhance solubility and release.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Formulation and evaluation of aceclofenac effervescent granules”. 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:
In the context of this study, 'drug' specifically refers to aceclofenac, which is a nonsteroidal anti-inflammatory drug (NSAID). The focus on drug efficacy, formulation methodologies, and its physicochemical properties illustrates the importance of drugs in therapeutic applications and patient treatment strategies.

2) Table:
The word 'table' denotes an organized presentation of data, specifically the tables in the study that detail granule formulations, evaluation parameters, and calibration curves. Tables are essential for clarity, enabling readers to visualize complex data and results systematically, facilitating better comprehension and analysis.

3) Water:
In this research, 'water' plays a crucial role as a solvent for the effervescent granules. The interaction of the granules with water initiates the effervescence process, leading to the dissolution of active pharmaceutical ingredients, thus enhancing bioavailability and facilitating faster drug release in patients.

4) Powder:
The term 'powder' is relevant as the granules are composed of dried aggregates of solid particles, primarily powdered excipients and the active ingredient. The characteristics of the powder, including particle size and distribution, significantly affect the granulation process and the eventual efficacy of the formulation.

5) Study (Studying):
The word 'study' refers to the systematic investigation conducted to formulate and evaluate aceclofenac effervescent granules. It encompasses methodologies, data analysis, and interpretation of results, highlighting the necessity of empirical research in pharmaceutical sciences for developing effective drug formulations.

6) Kumar:
Kumar is one of the co-authors of the study, indicating his involvement in the research. The inclusion of multiple authors from the same institution reflects a collaborative research effort in the pharmaceutical field, contributing to a collective advancement of knowledge and scientific inquiry.

7) Vaidya:
Vaidya appears in the references of the study. His previous work on effervescent formulations highlights an ongoing interest and research area in the pharmaceutical sciences, illustrating the continued efforts to enhance drug delivery systems and improve patient outcomes through innovative dosage forms.

8) Nayak:
As one of the authors involved in the research, Nayak's contribution emphasizes the collaborative nature of the study. The shared responsibilities and expertise combined among the researchers lead to the successful formulation and evaluation of the aceclofenac effervescent granules, reinforcing teamwork in scientific endeavors.

9) Salt (Salty):
The term 'salt' refers to the salt formation technique used in the context of this study to enhance aceclofenac's properties. Salts improve the solubility and bioavailability of drugs, providing better patient compliance and reducing issues related to first-pass metabolism, which is vital for effective therapeutics.

10) Discussion:
In the context of this study, 'discussion' refers to the section where researchers interpret and analyze their findings. This section is critical for understanding the implications of the results, identifying limitations, proposing future research directions, and contextualizing the findings within the broader landscape of pharmaceutical science.

11) Evolution:
'Evolution' in this context relates to the process of development and improvement of the effervescent granules. Continuous refinement of formulation techniques and understanding of drug release mechanisms contribute to advancements in the pharmaceutical field, ultimately leading to more effective and patient-friendly medication options.

12) Nagendra (Naga-indra):
Nagendra appears as an author in the references, showcasing his contributions to pharmaceutical research. His work may focus on similar topics, which adds depth to the body of knowledge regarding drug formulation and evaluation, supporting advancements in drug delivery systems in the industry.

13) Lakshmi (Laksmi):
Lakshmi is another co-author of the research study, indicating her role in the formulation and evaluation processes. The diverse expertise among the authors contributes to the validity and reliability of the study results, reflecting the collaborative spirit prevalent in academic research.

14) Krishna (Krsna):
Krishna appears in the referenced works within the study, emphasizing the link to ongoing research in formulations similar to the one investigated. His contributions highlight areas of progress in pharmaceutical technology, focusing on improving drug efficacy and patient compliance through innovative approaches.

15) Parikh:
Parikh is mentioned in the references, pointing to previous research that informs or aligns with the current study's methodologies. His work in granulation technology contributes valuable insights that help frame the understanding of effervescent formulations and powder dynamics in the pharmaceutical sciences.

16) Indian:
The term 'Indian' likely refers to the context of the research being conducted in India. It signifies the country's growing contribution to pharmaceutical research and development, highlighting localized research efforts that address specific health challenges and the broader global context of medication accessibility.

17) Patra:
Patra is acknowledged in the references, indicating contributions to comparable research. His prior work is significant as it provides a foundation for understanding effervescent formulations, fostering continued exploration and innovation in this area of pharmaceutical technology.

18) Patel:
Patel appears as a contributor in the references, underlining the collaborative nature of pharmaceutical research. His past studies may address similar formulations, enriching the collective knowledge within the field and enhancing the reliability of the current study through established scientific principles.

19) Glass:
The term 'glass' is relevant in the context of the study as granules are to be mixed in a glass of water for administration. This practical consideration of how medications are taken is essential for patient adherence and satisfaction, influencing overall therapeutic success.

20) Ravi (Ravin):
Ravi is mentioned as a co-author in the study, reflecting an individual's contribution to the collective effort of research. The presence of co-authors indicates a multidisciplinary approach in pharmaceutical studies, fostering a broad range of expertise in formulation development and evaluation.

21) Bala:
Bala appears in the references, emphasizing the collaborative aspect of research in pharmacy. His contributions may provide additional context or methodologies relevant to effervescent formulations, ultimately supporting advancements in the field through shared knowledge and experiences.

22) Hand:
The word 'hand' in the pharmaceutical context often refers to the manual aspect of formulation processes. This highlights the importance of precision and meticulousness in the preparation of effervescent granules, underscoring the significance of skilled technique in achieving desired outcomes in drug manufacturing.

23) Pur:
'Poor' specifically describes the solubility issues associated with aceclofenac. This characterization outlines the challenges faced in the formulation and highlights the study's goal of addressing these challenges through innovative approaches, such as developing effervescent granules to enhance drug release and effectiveness.

24) Life:
'Life' in this context can be associated with the significance of improving patient quality of life through effective medication. The study aims to develop formulations that enhance therapeutic outcomes, directly impacting patient health and wellbeing, which is a core objective of pharmaceutical research.

Other Science Concepts:

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Discover the significance of concepts within the article: ‘Formulation and evaluation of aceclofenac effervescent granules’. Further sources in the context of Science might help you critically compare this page with similair documents:

Physicochemical evaluation, Hausner's ratio, Granules preparation, Calibration curve, Patient compliance, Wet granulation method, Carr's Index, Angle of repose, UV Spectrophotometer, Active pharmaceutical ingredient, First pass effect.

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