Ritonavir tablet formulation development using starch 1500, Soluplus.
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation development and optimization of ritonavir tablets employing starch 1500 and soluplus
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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M. Priyadarsini, K. P. R. Chowdary and S. V. U. M. Prasad
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation development and optimization of ritonavir tablets employing starch 1500 and soluplus
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20195-14638
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The study focused on the formulation development and optimization of Ritonavir tablets, utilizing Starch 1500 and Soluplus as key excipients. Ritonavir is classified as a BCS Class II drug, characterized by low aqueous solubility and variable oral bioavailability, which presents challenges in its formulation. The objective was to enhance the dissolution rate of Ritonavir tablets, aiming for at least 85% dissolution within 10 minutes. A 2^2 factorial design was employed to systematically evaluate the effects of varying concentrations of Starch 1500 and Soluplus on the dissolution characteristics of the tablets.
Optimization of Formulation through Factorial Design
The optimization process implemented a 2^2 factorial design, which allowed for the examination of individual and combined effects of Starch 1500 (Factor A) and Soluplus (Factor B). By preparing four different tablet formulations with distinct combinations of these factors, the researchers could assess their impact on the dissolution rate of Ritonavir. The results indicated that both Starch 1500 and Soluplus significantly influenced the dissolution behavior, with highly significant variable interactions observed (P < 0.01). This structured approach provided a robust framework for optimizing the formulation criteria.
Role of Starch 1500 and Soluplus
Starch 1500 served as a modified starch diluent and a carrier for solid dispersions, while Soluplus functioned as a polymeric solubilizer. The combination of these excipients was instrumental in enhancing the solubility and dissolution rate of Ritonavir. Specifically, the study found that increasing the proportion of Starch 1500 greatly improved the dissolution rates of the tablet formulations. The polynomial equation derived from the experimental data (Y = 77.74 + 16.92(X1) + 9.42(X2) - 4.67(X1X2)) further emphasized how varying levels of both excipients could predictably influence the drug's dissolution performance.
Evaluation of Tablet Characteristics
The prepared Ritonavir tablets were subject to rigorous evaluation for physical characteristics such as hardness, friability, disintegration time, and drug content. Results indicated that all formulations met pharmacopoeial guidelines concerning these parameters. Notably, the optimized formulation achieved a dissolution rate of 85.5% in 10 minutes, confirming the effectiveness of the chosen excipient ratios in facilitating rapid disintegration and dissolution. This outcome was backed by statistical analyses, ensuring the reliability of the findings.
Conclusion
In summary, the research highlighted the successful optimization of Ritonavir tablet formulations through a systematic factorial design approach. By focusing on the roles of Starch 1500 and Soluplus, the study demonstrated significant improvements in dissolution rates. The derived polynomial equation provided a predictive tool for formulation adjustments, ensuring the ultimate goal of attaining desired dissolution profiles within the stipulated timeframe. The findings underscore the potential of employing such optimization frameworks in the development of pharmaceutical formulations for poorly soluble drugs like Ritonavir.
FAQ section (important questions/answers):
What is the main objective of the study on Ritonavir tablets?
The study aims to enhance the dissolution rate of Ritonavir by employing solid dispersion with Starch 1500 and Soluplus in tablet formulation development, targeting at least 85% dissolution in 10 minutes.
What method was used to prepare the Ritonavir tablets?
Ritonavir tablets were prepared using the direct compression method, where appropriate quantities of ingredients were blended and then compressed into tablets.
What design was employed for optimizing the Ritonavir formulations?
A 2² factorial design was utilized to optimize the formulations, analyzing the effects of Starch 1500 and Soluplus on the dissolution rate.
What were the key components in optimizing Ritonavir tablets?
The key components included Starch 1500 as a diluent and Soluplus as a solubilizer, both crucial for enhancing the dissolution rate in the formulated tablets.
How was the dissolution rate of the tablets analyzed?
The dissolution rate was studied in 0.1N Hydrochloric acid using a dissolution rate test apparatus, with samples assayed at different time intervals.
What were the results of the optimized Ritonavir tablet formulation?
The optimized formulation achieved 85.5% dissolution in 10 minutes, meeting the target requirements and demonstrating the effectiveness of the optimization technique used.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Ritonavir tablet formulation development using starch 1500, Soluplus.”. 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:
The plural 'drugs' encompasses a broader spectrum of pharmaceutical agents. In formulation studies, the focus on multiple drugs may relate to comparing their solubility profiles or therapeutic effects. Understanding the characteristics of various drugs, including their classification under BCS (Biopharmaceutical Classification System), is vital in developing effective formulations.
2) Table:
In this context, 'table' typically refers to the format used to present collected data, such as the physical and chemical properties of the Ritonavir tablets and their dissolution profiles. Tables facilitate easier comparison and understanding of complex data by organizing information into row and column formats, enhancing clarity and aiding analysis.
3) Study (Studying):
'Study' refers to rigorous scientific investigation aimed at understanding particular phenomena—in this case, the optimization of Ritonavir tablet formulations. The study comprises experimental designs, methods of formulation, and statistical analyses to draw valid conclusions that advance pharmaceutical sciences and enhance drug formulation techniques for better patient outcomes.
4) Water:
Water is a ubiquitous solvent in pharmaceutical formulations, often used in testing dissolution rates and stability. Its role is critical since many drugs, including Ritonavir, exhibit poor solubility in physiological conditions. Therefore, understanding water's properties helps formulate drug products that enhance solubility and bioavailability in the body.
5) Pur:
The term 'poor' characterizes the inadequate solubility or bioavailability of drugs like Ritonavir. Poorly soluble drugs pose significant challenges in pharmaceutical development; hence, understanding and addressing the associated issues through formulation optimization techniques is crucial to enhancing therapeutic effectiveness and ensuring successful treatment outcomes.
6) Quality:
'Quality' refers to the degree to which a pharmaceutical product meets established standards, including safety, efficacy, and consistency. In the formulation of Ritonavir tablets, maintaining high-quality attributes is fundamental. Various parameters, like hardness, friability, and dissolution rates, are rigorously evaluated to ensure the tablets function as intended.
7) Nature:
'Nature' in this context relates to the intrinsic properties of excipients or active pharmaceutical ingredients and how these characteristics impact drug behavior. For example, the nature of Starch 1500 and Soluplus significantly affects the dissolution rate of Ritonavir, delineating the importance of choosing suitable excipients in formulation development.
8) Pose:
'Pose' is used to indicate the challenges or issues that arise in pharmaceutical development, especially with drugs that have poor solubility. For Ritonavir, the poor aqueous solubility of the drug poses manufacturing challenges that necessitate innovative strategies like solid dispersions to improve its dissolution and bioavailability in the body.
9) Measurement:
Measurement pertains to the techniques and tools used to quantify various attributes in drug formulation and evaluation, such as the drug content, dissolution rates, and hardness of the tablets. Accurate measurements are essential for validating that the formulations meet the desired quality standards and therapeutic effectiveness established in pharmaceutical research.
10) Discussion:
'Discussion' involves interpreting the results obtained from the study and relates to the implications of the findings. In pharmaceutical research, the discussion might analyze the relationship between experimental variables and their impact on drug formulation outcomes, thus providing insights into optimizing formulations for better drug delivery systems.
11) Relative:
'Relative' indicates the comparison of different values in the study, such as the disintegration time or dissolution rates of varying formulations. The relative performance of each formulation helps in ranking their effectiveness for delivering the drug and supports the scientific evaluation of the optimization conducted through the factorial design approach.
12) Science (Scientific):
'Science' refers to the systematic study and application of knowledge to better understand phenomena in the natural world. In pharmaceutical research, science drives the inquiry into drug formulation processes, mechanisms of action, and optimization techniques, ensuring that new therapies can effectively meet clinical needs and improve patient outcomes.
13) Powder:
'Powder' indicates the form in which many pharmaceutical drugs and excipients are processed. In the context of Ritonavir tablets, the powdered forms of the active ingredient and excipients are blended to facilitate tablet formation through methods such as direct compression. Proper powder characteristics are crucial for achieving uniformity in tablet formulations.
14) Glass:
'Glass' in this context typically refers to laboratory glassware used for various measurements and preparations, such as during the analysis of drug content or dissolution tests. Additionally, glass is often associated with UV spectrophotometric devices used in the study for quantification of Ritonavir at specific wavelengths, ensuring precision in drug assessment.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Ritonavir tablet formulation development using starch 1500, Soluplus.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Disintegration time, Friability test, Dissolution rate, Formulation Development, Direct compression method, UV spectrophotometric method, Polynomial equation, Dissolution efficiency, Factorial design, Kinetic model, Soluplus, BCS class II drug, Optimization, Ethanol Solution.