Diclofenac matrix tablets with sida acuta gum: formulation and evaluation
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation and evaluation of diclofenac matrix tablets containing a hydrophilic polymer, sida acuta gum
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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Okafo Sinodukoo Eziuzo and Chukwu Amarauche
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation and evaluation of diclofenac matrix tablets containing a hydrophilic polymer, sida acuta gum
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20177-8654
Download the PDF file of the original publication
Summary of article contents:
Introduction
This study focused on the formulation and evaluation of hydrophilic matrix tablets of diclofenac using Sida acuta gum as a matrix former. The research aimed to investigate the impact of varying the drug-to-polymer ratio on the release characteristics of diclofenac from the matrix tablets. A combination of Sida acuta gum and hydroxypropylmethylcellulose (HPMC) was utilized through a non-aqueous wet granulation method. The tablets underwent thorough evaluation based on several parameters, including in vitro dissolution, swelling behavior, tablet hardness, friability, and the kinetics of drug release.
Effects of Polymer Composition on Drug Release
The results indicated that the composition of the matrix tablets significantly influenced drug release. Tablets containing Sida acuta gum exhibited varying release rates based on their formulation. Specifically, formulations DS 1, DS 3, and DS 6 released less than 50% of diclofenac after 6 hours, whereas all formulations achieved a complete drug release from 7 hours to over 12 hours. The swelling behavior also correlated with the polymer composition, as HPMC demonstrated a higher swelling index compared to Sida acuta gum, affecting the drug release profile.
Evaluation of Tablet Properties
The evaluation of tablet properties showed that the hardness and friability met the required standards for pharmaceutical tablets. The hardness varied from 1.17 to 6.22 kgf, while friability remained below the acceptable threshold of 1%. These parameters indicate that the formulations were robust enough for potential commercial applications. Furthermore, drug content analysis confirmed that the formulations maintained a drug content range from 99.10% to 103.45%, which aligns with pharmacopoeial standards for consistency and efficacy.
Kinetics and Mechanisms of Drug Release
Kinetic analysis revealed that the predominant release mechanism varied among formulations. The first-order kinetics was primarily observed in formulations DS1, DS2, DS3, DS5, DS7, and DS9, while zero-order kinetics was predominant in formulations DS6 and DS8. The Korsmeyer-Peppas model indicated that the drug release mechanism was primarily influenced by super case-II transport in many formulations, demonstrating the complexity of release mechanisms depending on the matrix composition and interaction.
Conclusion
The study concluded that Sida acuta gum can effectively function as a hydrophilic matrix polymer for the formulation of diclofenac matrix tablets. It exhibited superior efficacy in retarding the drug release compared to HPMC, demonstrating its potential as a viable alternative in pharmaceutical applications. Stability studies affirming the unchanged release profiles indicate that storage conditions have little to no impact on the effectiveness of these formulations, suggesting that Sida acuta gum is a promising candidate for sustained release dosage forms.
FAQ section (important questions/answers):
What was the focus of the study conducted by Eziuzo et al.?
The study focused on formulating and evaluating diclofenac matrix tablets using Sida acuta gum as a hydrophilic polymer. Various drug-to-polymer ratios were tested to assess their impact on drug release behavior.
What methods were used to formulate the diclofenac matrix tablets?
The diclofenac matrix tablets were formulated using the non-aqueous wet granulation method. Ingredients included Sida acuta gum, HPMC, and other excipients, followed by compression into tablets.
How was the release mechanism of diclofenac from the tablets evaluated?
The release mechanism was evaluated using various kinetic models, such as Zero Order, First Order, Higuchi's Square Root Law, and Hixson-Crowell, fitting the data to analyze the drug release patterns.
What were the results of the stability studies conducted on the tablets?
Stability studies revealed that no significant changes occurred in hardness, friability, or drug content over six months, indicating the stability of the diclofenac matrix tablets.
What are the benefits of using Sida acuta gum as a polymer?
Sida acuta gum demonstrated better drug release retardation compared to hydroxypropylmethylcellulose. It provided effective matrix properties, supporting controlled and sustained release of diclofenac from the tablets.
What evaluation methods were used for the prepared tablets?
The tablets were evaluated for weight variation, thickness, hardness, friability, drug content, in vitro dissolution, and swelling index to ensure quality and performance.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Diclofenac matrix tablets with sida acuta gum: formulation and evaluation”. 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 pharmaceutical research, 'drug' refers to the active compound being studied or formulated for therapeutic use. Here, diclofenac is the drug. Its formulation into various matrix tablets is essential for determining its release properties, stability, and overall effectiveness in treating conditions like inflammation and pain.
2) Sida (Shida):
Sida refers to the genus of plants from which Sida acuta gum is derived. This gum is utilized as a hydrophilic matrix excipient in the formulation of diclofenac tablets. The significance lies in its potential to modulate drug release, enhancing the therapeutic effect while minimizing side effects in patients.
3) Table:
In pharmaceutical studies, 'table' often denotes a systematic arrangement of data or specifications of formulations. Here, tables present the ingredients and ratios used in drug formulations and their respective evaluations. They aid in the clarity of results, allowing for better comparisons and understanding of differing formulations' characteristics.
4) Swelling:
Swelling refers to the increase in volume or size of the tablets upon exposure to a solvent, indicative of the hydrophilic properties of the matrix polymer. In drug delivery, swelling affects the release rate of the drug from the matrix. A greater swelling capacity usually enables a more controlled drug release profile.
5) India:
India is relevant in this study as the location where the research was conducted and where some of the raw materials were sourced. It represents a geographic context, influencing the choice of locally available polymers like Sida acuta gum, showcasing the utilization of indigenous resources for pharmaceutical applications.
6) Powder:
Powder is a critical form in pharmaceutical formulation, particularly for the active drug and excipients prior to tablet formation. The study investigates wet granulation methods to convert powder mixtures into granules for tablet compression. Proper powder properties ensure homogeneity, stability, and effective drug release in the final dosage form.
7) Medium:
In pharmaceutical research, the term 'medium' often refers to the solution in which drug dissolution and release studies are conducted. For this study, a phosphate buffer (pH 6.8) serves as the dissolution medium, simulating physiological conditions and allowing for the assessment of the drug's release profile from the matrix tablets.
8) Water:
Water is a universal solvent, critical in the dissolution and diffusion processes that govern drug release from matrix tablets. Its role in swelling the polymer and creating a gel-like layer around the tablet is fundamental in determining how and when the drug is released into the systemic circulation.
9) Study (Studying):
Study denotes the systematic investigation conducted to formulate and evaluate the diclofenac matrix tablets. It encompasses formulations, assessments of drug release kinetics, stability, and other physical properties. This comprehensive analysis is vital to ensuring the effectiveness, stability, and safety of the pharmaceutical product developed.
10) Dish (Dis):
Dish typically refers to the vessel used during swelling index assessments or dissolution tests. It provides a controlled environment for observing the physical changes in the matrix tablet as it interacts with the medium. The dish's role is essential in obtaining accurate and reproducible experimental data.
11) Discussion:
Discussion within a research context involves the interpretation of results obtained during experiments. It provides a critical analysis comparing findings with existing literature, implications for future research, and real-world application of study results, such as the benefits of using hydrated polymers as drug release modifiers.
12) Reflecting:
Reflecting pertains to the analytical aspect, where results and observations from the study indicate the performance characteristics of the diclofenac matrix tablets. It involves examining data trends and relationships, leading to conclusions about the effectiveness of various formulations and their suitability for therapeutic use.
13) Container:
Container signifies the physical structure used to store the formulated tablets during stability testing. The integrity of the container impacts the tablets' exposure to environmental factors, influencing their pharmacological properties. Airtight containers help preserve drug stability and efficacy throughout the shelf life.
14) Science (Scientific):
Science in this context embodies the systematic study of the physical and chemical properties of the formulations. It emphasizes the empirical methods used, such as quantitative assessments, to understand how variables like polymer type and concentration impact drug release rates and therapeutic effectiveness.
15) Family:
Family relates to the botanical classification of Sida acuta as a member of the Malvaceae family. Understanding the plant's family can provide insights into other similar plants that may possess useful therapeutic properties, as well as potential variations in the chemical composition and efficacy of extracted gums.
16) Nature:
Nature denotes the inherent characteristics of the materials studied, particularly the properties of Sida acuta gum as a hydrophilic polymer. It reflects the natural biological resources utilized in the pharmaceutical formulations, highlighting the trend towards using biodegradable and sustainable materials in drug development.
17) Cina:
China is relevant as the country of origin for some of the chemicals and materials used in the study, such as isopropyl alcohol and acetone. This emphasizes the importance of sourcing quality components in drug formulation and development, affecting the overall reliability of the pharmaceutical product created.