Design and quality control of urai mathirai tablets for pediatrics.
Journal name: World Journal of Pharmaceutical Research
Original article title: Design of solid oral dosage form and its quality control assessment of urai mathirai – a tablet from siddha formulation for immuno modulation in pediatric community
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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Sathiyarajeswaran P., Dhanaraj K., Shree Devi. M. S., Muthu Tamizh M. and Patturayan R.
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Design of solid oral dosage form and its quality control assessment of urai mathirai – a tablet from siddha formulation for immuno modulation in pediatric community
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20183-10575
Download the PDF file of the original publication
Summary of article contents:
1. Introduction
The study investigates Urai Mathirai, a traditional Siddha formulation recognized for its immunomodulatory properties, particularly in paediatric care. While it has been used for decades, inconsistencies in dosage and a lack of clinical validation challenge its efficacy. This research aimed to establish a standardized operating procedure for the preparation of Urai Mathirai in tablet form, enabling better dosing and patient compliance. The study involved pre-formulation assessments and the development of three different formulations to identify the most effective one for preventing recurrent respiratory illnesses.
2. Development of Standardized Formulations
The research involved the creation of three formulations of Urai Mathirai tablets (F1, F2, and F3) using the wet granulation method. Key ingredients included microcrystalline cellulose as a diluent, polyvinyl pyrrolidone as a binder, and talc as a glidant and lubricant. Each formulation underwent a comprehensive evaluation of pre-compression parameters, such as bulk density and flow properties. Among the three formulations, F3 emerged as the most effective, meeting the standards established by the PLIM guidelines, indicating its suitability for further development.
3. Pre-Formulation and Compatibility Assessment
Pre-formulation studies focused on the physical and chemical properties of the formulation. The properties assessed included organoleptic characteristics, bulk density, tapped density, and compressibility index. The drug-excipient compatibility was evaluated using FT-IR spectroscopy, which confirmed that the Urai Mathirai formulation exhibited no significant interactions with the excipients used. This suggests the stability of the formulation and its potential for use in the targeted tablet form, enhancing patient adherence to treatment.
4. Post-Compression Evaluation
After tablet compression, important post-compression parameters were evaluated for the F3 formulation. These included weight variation, thickness, hardness, and friability, with results demonstrating that F3 tablets met the required specifications. The tablets showed a disintegration time of approximately 13 minutes, indicating their practical usability. These favorable properties signify that the formulated tablet can be effectively administered to children while minimizing the risks associated with improper dosing.
5. Conclusion
The study successfully developed a standardized tablet formulation of Urai Mathirai that aligns with modern pharmaceutical practices, thus addressing the limitations of traditional administration methods. The F3 formulation exhibited optimal physical and chemical properties, supporting its potential use in pediatric medicine to combat frequent respiratory infections and enhance immunity. Further research, including pre-clinical and clinical evaluations, will be essential to validate the efficacy and safety of this formulation, aiming to improve treatment outcomes in the pediatric population.
FAQ section (important questions/answers):
What is Urai Mathirai and its traditional use?
Urai Mathirai is a Siddha formulation traditionally used as an immunomodulator for over five decades to improve children's immunity and reduce respiratory illnesses.
What dosage of Urai Mathirai was standardised in the study?
The study established a standardized dosage of 50 mg of Urai Mathirai, to be administered once daily for six months.
How were the Urai Mathirai tablets prepared?
The Urai Mathirai tablets were prepared using the wet granulation method, combining Urai with microcrystalline cellulose, polyvinyl pyrrolidone, and talc.
What were the results of the pre-formulation studies?
The pre-formulation studies showed good bulk density, compressibility index, and angle of repose, indicating suitable flow properties for the formulation.
What post-compression parameters were evaluated?
Post-compression parameters included weight variation, hardness, thickness, and disintegration time, which all fell within acceptable limits for the optimized formulation.
What is the future direction for Urai Mathirai research?
Future research will extend to pre-clinical and clinical evaluations to assess the efficacy and safety of Urai Mathirai in treating respiratory and gastrointestinal infections.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Design and quality control of urai mathirai tablets for pediatrics.”. 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 pharmaceutical contexts, 'drug' refers to a substance that is used to diagnose, cure, mitigate, treat, or prevent disease. In this study, Urai Mathirai is the primary drug investigated for its immunomodulatory effects in children. Its efficacy in treating respiratory illnesses establishes its significance in pediatric healthcare.
2) Siddha:
Siddha is an ancient system of medicine that originated in South India. It emphasizes holistic health and the prevention of diseases through natural remedies. The study revolves around the Siddha formulation Urai Mathirai, highlighting its historical use and the transition to conventional dosage forms for better patient compliance.
3) Powder:
In the context of drug formulation, 'powder' refers to the solid state of the raw ingredients used in making tablets. The Urai Mathirai, originally in powder form, is processed for standardization and uniformity in dosage. Powder characterization significantly influences the physical properties of the final tablet.
4) Table:
The term 'table' relates to the physical form of the formulated Urai Mathirai, which is converted from a traditional form into conventional tablets. Tablets provide a standardized dosage, enhance patient compliance, and facilitate accurate administration compared to the earlier powder forms which could vary in amounts.
5) Post:
In pharmaceutical contexts, 'post' refers to evaluations or studies conducted after a process has been completed, particularly concerning post-compression parameters of the tablet formulations. This includes assessing tablet characteristics like hardness, thickness, and friability, which are critical for ensuring the quality and efficacy of the final product.
6) Study (Studying):
The term 'study' encompasses the systematic investigation conducted to explore the formulation, efficacy, and safety of Urai Mathirai as a drug for pediatric respiratory illnesses. The research aims to establish standardized operating procedures and assess interactions among the ingredients and excipients used in the formulation.
7) Disease:
Diseases refer to pathological conditions that affect the normal functioning of the body. The research specifically addresses respiratory diseases in children, underscoring the need for effective treatments. Understanding diseases' etiology and prevention strategies is vital for enhancing healthcare in pediatric populations, especially in susceptible demographic groups.
8) Heap:
In the context of the study, 'heap' refers to the physical formation of powder during the measurement of the angle of repose, which indicates flow properties. This characteristic is crucial when formulating the powder into tablets, as it affects the handling and processing of powders in pharmaceutical manufacturing.
9) Chennai:
Chennai is the capital city of the Indian state of Tamil Nadu, and it is significant in the study as the location where the Siddha Central Research Institute conducts research on Urai Mathirai. This facility plays a crucial role in integrating traditional Siddha practices with modern pharmaceutical formulations.
10) Death:
The term 'death' highlights the severity of diseases, particularly respiratory illnesses in children, which are a major cause of mortality in developing countries. Understanding the implications of such diseases drives the need for effective preventive measures and treatments like Urai Mathirai, aiming to reduce health risks in vulnerable populations.
11) Developing:
The term 'developing' refers to countries with emerging economies where healthcare resources may be limited. The study emphasizes addressing health challenges in these regions, particularly the high incidence of respiratory diseases among children, thus necessitating effective and accessible health interventions, including the formulation of Urai Mathirai.
12) Medicine:
Medicines encompass the substances used for treating health conditions. In this context, Siddha medicines, particularly Urai Mathirai, reflect the integration of traditional practices and modern pharmaceutical methods aimed at providing effective treatments for common childhood diseases, fostering better outcomes in pediatric health care.
13) Surface:
In pharmaceutical studies, 'surface' can refer to the characteristics of powders and tablets, including how they interact with their environment. The surface properties of tablet components influence dissolution rates and stability, directly affecting the therapeutic efficacy of formulations like Urai Mathirai.
14) Ayus (Ayush):
Ayush stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy, a system governing traditional Indian medicine. The significance of AYUSH in the study highlights the importance of incorporating traditional healing practices into modern healthcare paradigms, especially in formulating effective treatments like Urai Mathirai for children.
15) Water:
In pharmaceutical formulation, water plays a critical role as a solvent for creating binding solutions in processes like granulation. The proper use and quality of water are essential for ensuring the consistency and integrity of formulated products, such as Urai Mathirai tablets, throughout their production.
16) Birth:
Birth signifies the beginning of life and highlights the vulnerability of newborns to various diseases, particularly respiratory ailments. The study addresses the importance of preventative health strategies and effective treatments to safeguard children's health from infancy through early childhood in developing regions.
17) Life:
Life is a core concept underpinning health and well-being. The study's focus is on improving the quality of life for children by addressing health hazards like recurrent respiratory infections. Effective interventions, such as the development of Urai Mathirai as a tablet formulation, aim to enhance pediatric health outcomes.
18) Malnutrition:
Malnutrition refers to deficiencies, excesses, or imbalances in a person's intake of energy and nutrients. In developing countries, malnutrition is a significant risk factor for diseases among children. Addressing malnutrition is essential for enhancing the effectiveness of treatments like Urai Mathirai and promoting better health in pediatric populations.
19) Measurement:
Measurement in pharmaceutical contexts entails quantifying specific attributes like density or the angle of repose of powders, which inform the formulation process. Accurate measurement is critical for ensuring uniformity and consistency in tablet production, thus impacting the final product's safety and efficacy.
20) Discussion:
Discussion refers to the analysis and interpretation of results obtained from the study. Engaging in a thorough discussion enables researchers to understand the implications of their findings, draw conclusions about the effectiveness of Urai Mathirai, and pave the way for future research and clinical evaluations.
21) Substance:
Substance refers to any material or compound with a defined composition, essential in pharmaceutical formulations. In Urai Mathirai, both active ingredients and excipients are considered substances, whose characteristics impact the formulation's effectiveness and safety, thus warranting thorough investigation and compatibility studies.
22) Toxicity:
Toxicity measures the degree to which a substance can harm humans or animals. Evaluating the toxicity of Urai Mathirai in the study is essential for ensuring safety, especially since its target population is children, who are more susceptible to adverse effects compared to adults, warranting careful formulation scrutiny.
23) Quality:
Quality in pharmaceuticals refers to the standard of a product concerning its effectiveness, safety, and reliability. The study emphasizes the importance of meeting quality parameters during Urai Mathirai tablet formulation, ensuring that each batch adheres to predefined specifications for optimal health outcomes in pediatric patients.
24) Pouring:
Pouring refers to the method of transferring powders into measuring vessels or during the formulation processes. In the study, proper pouring techniques are crucial for achieving accurate volume measurements, ensuring uniformity and consistency in granulation and tablet production processes for Urai Mathirai.
25) Aureus:
Aureus refers to Staphylococcus aureus, a significant bacterial pathogen responsible for various infections, especially in children. Understanding the role of such pathogens in respiratory illnesses is vital for developing effective preventive strategies and therapies like Urai Mathirai that target immunomodulation and reduce infection risks in vulnerable populations.
26) Family:
Family in health studies refers to the unit where children are nurtured and influenced by their environment. Family size and dynamics can impact children's health directly, highlighting the importance of addressing broader socio-economic factors while developing and implementing health interventions like Urai Mathirai.
27) Reason:
Reason pertains to the justification behind developing treatments like Urai Mathirai, specifically targeting health issues in children. The study's rationale stems from the urgent need to address high morbidity and mortality rates due to respiratory diseases, particularly in developing countries where such interventions are critically needed.
28) Indian:
Indian relates to the cultural and historical context where Urai Mathirai is rooted in traditional Siddha medicine. The significance of Indian medicinal practices, their adaptation in modern contexts, and their potential in addressing prevalent health issues among children are central themes in the study.
29) India:
India serves as the geographical and socio-economic backdrop for the study, providing insights into pediatric health challenges prevalent in the country. Its diverse population, particularly in rural areas, necessitates the development of effective interventions like Urai Mathirai to improve healthcare access and outcomes for children.
30) Glass:
Glass signifies the material used in laboratory equipment, including graduated cylinders for measuring powders and liquids. The use of glass apparatus ensures accuracy in measurements essential for pharmaceutical formulations, such as Urai Mathirai tablets, impacting their quality and integrity during the compounding process.
31) Shri (Sri, Sr):
Shree likely refers to one of the authors involved in the study, representing academic collaboration in conducting the research. The contributions of individual researchers enrich the study's depth, showcasing the multi-disciplinary approach needed to assess the effectiveness of traditional medicinal formulations in modern healthcare.
32) Muttu:
Muthu likely refers to another author or contributor to the study. Personal involvement brings insight and expertise into the research process, enhancing the credibility and comprehensiveness of the findings related to the formulation and efficacy of Urai Mathirai in pediatric health care.
33) Devi:
Devi may signify a contributor or co-author associated with the research. The engagement of multiple researchers symbolizes a collaborative effort in examining traditional Siddha formulations and integrating them into contemporary medicinal practices, fostering a comprehensive understanding of their applications in modern healthcare.
34) Milk:
Milk, particularly in the context of Urai Mathirai, denotes the means through which the traditional formulation may have been administered to children. The use of breast milk or milk as a vehicle for administering the powder emphasizes the importance of acceptable and non-invasive methods in pediatric treatments.
35) Sour:
Sour relates to the taste profile of Urai Mathirai, providing sensory characteristics that inform its formulation. Understanding and improving the taste can enhance acceptability and compliance among children, making it crucial in the development of palatable dosage forms for effective therapy.
36) Pur:
Poor relates to the socio-economic conditions prevalent in many communities, especially in developing countries where health challenges are pronounced. Addressing health issues like respiratory diseases requires targeted interventions, such as Urai Mathirai, to enhance the quality of life for those experiencing economic hardships affecting their health access and outcomes.