Photostability evaluation of a unani formulation sufoofe sailan
Journal name: World Journal of Pharmaceutical Research
Original article title: Photostability evaluation of a unani formulation sufoofe sailan
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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Seema Rani, Khaleequr Rahman, Mohd. Younis, Sadiya Noorul Basar
World Journal of Pharmaceutical Research:
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Full text available for: Photostability evaluation of a unani formulation sufoofe sailan
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The study focuses on the photostability evaluation of a Unani formulation known as Sufoofe Sailan (SS), a polyherbal powder used for treating gynecological disorders. Photostability is a critical factor in the stability examination of pharmaceutical products since light exposure can lead to the degradation of active compounds, resulting in loss of potency and potential safety issues. The research highlights the significance of photostability studies in ensuring drug quality throughout its shelf life, aiming to confirm that the formulation maintains its efficacy and safety when exposed to light.
Importance of Photostability Testing
Photostability testing examines how pharmaceutical products, including drug substances and their packaging, respond to light exposure. It encompasses various processes, such as degradation reactions and radical formation. As outlined by guidance from regulatory bodies like the US FDA and ICH, understanding the intrinsic photostability characteristics of drug substances is essential for their development, validation, and proper handling. The increasing demand for data on light-induced reactions in pharmaceuticals stems from the need for better safety assessments and labeling for potentially photoreactive drugs.
Methodology of Photostability Study
The study involved exposing two samples of SS to controlled light conditions in a stability chamber, maintaining temperature and humidity within specified limits. One pack was subjected to an overall illumination of 1.2 million lux hours with UV energy of 200 watt hours per square meter, while the other faced double the exposure. The formulation went through extensive physicochemical, densitometric HPTLC, and microbiological evaluation to assess its stability and the absence of harmful degradation products throughout the study duration.
Key Findings and Results
Findings showed no significant changes in the formulation from the baseline, maintaining organoleptic characteristics and physicochemical parameters within acceptable limits. The total microbial count remained below the thresholds established by WHO guidelines, and no specific pathogens were detected throughout the study. The results of the HPTLC analysis indicated minimal variation in the chemical profile of SS, confirming its light stability and compliance with ICH guidelines for photostability testing.
Conclusion
The study concludes that Sufoofe Sailan exhibits adequate photostability, with less than 5% change in organoleptic and physicochemical properties, along with microbiological counts within acceptable limits. Overall, the results emphasize the necessity of photostability studies in the pharmaceutical sector, particularly for herbal and traditional formulations. It also suggests further investigations into active components and their variations under different environmental conditions to assess the formulation's safety and efficacy comprehensively.
FAQ section (important questions/answers):
What is the focus of the photostability study in Unani formulations?
The study evaluates the photostability of the Unani formulation 'sufoofe sailan', ensuring it maintains safety and efficacy throughout its shelf-life despite exposure to light.
What herbal ingredients are found in 'sufoofe sailan'?
'Sufoofe sailan' contains gule dhawa, gule fofal, mochras, gond molsri, and sugar, which are used to address various gynecological disorders.
How was the photostability test conducted on the formulation?
The formulation was stored in airtight PET containers, exposed to specific illumination and UV energy levels, and evaluated for stability under controlled temperature and humidity.
What parameters were evaluated during the study?
Physico-chemical properties, HPTLC analysis for fingerprint characterization, and microbiological evaluation were conducted to assess stability and the presence of pathogens.
What were the findings related to microbial contamination?
Microbial counts for both bacteria and fungi were within acceptable WHO limits throughout the study, confirming the product's microbial safety.
What conclusion was drawn from the photostability study?
The study concluded that 'sufoofe sailan' is photostable, with less than 5% variation in key parameters and acceptable microbial counts, adhering to ICH guidelines.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Photostability evaluation of a unani formulation sufoofe sailan”. 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 term 'drug' refers to any substance used in the diagnosis, treatment, or prevention of disease. In the context of the study, the herbal formulation 'sufoofe sailan' is considered a drug due to its intended therapeutic effects, especially for gynecological disorders.
2) Table:
In scientific research, a 'table' organizes data to facilitate understanding and comparison of results. The study includes various tables that present the physico-chemical properties of the formulation, helping to summarize complex information effectively and make it accessible for analysis and discussion.
3) Study (Studying):
A 'study' signifies systematic investigation aimed at discovering or revising facts. This research evaluates the photostability of 'sufoofe sailan', ensuring its therapeutic efficacy and safety. The findings contribute to the broader understanding of herbal formulation stability under light exposure.
4) Medicine:
'Medicine' refers to the science and practice of diagnosing, treating, and preventing illnesses. The Unani formulation being tested represents a traditional medicinal approach used for treating various health issues, reflecting the growing interest in integrating herbal remedies into modern healthcare systems.
5) Water:
In the context of this research, 'water' is a solvent utilized for preparing the herbal formulation. Its role is crucial as it helps in extracting active compounds from plant materials, thus affecting the overall efficacy and stability of the final product.
6) Powder:
'Powder' pertains to the physical form of the Unani formulation 'sufoofe sailan'. As a powder, it allows for easier administration and dosage flexibility while ensuring the blend of the various herbal ingredients maintains its therapeutic properties.
7) Container:
'Container' refers to the packaging used for storing the formulation. In this study, airtight PET containers were employed to prevent contamination and degradation of the formulation, thereby preserving its efficacy and extending its shelf life.
8) Calculation:
'Calculation' relates to the process of determining specific values related to the photostability testing. This is critical for establishing exposure times and evaluating the formulation's reaction to light, influencing its storage conditions and overall stability.
9) Substance:
'Substance' refers to a particular kind of matter with uniform properties. In the study, the herbals used are substances whose stability under photodegradation is being evaluated, ensuring their safety and effectiveness as a therapeutic option.
10) Relative:
'Relative' denotes a relationship or comparison between two items. In the study, relative humidity is significant as it impacts the stability of the formulation. Maintaining specific conditions ensures accurate results in evaluating photostability.
11) Quality:
'Quality' is a measure of a product's efficacy, safety, and acceptability. In the study, maintaining high quality of 'sufoofe sailan’ is essential, as it directly affects the health and safety of patients who may use this herbal remedy.
12) Aureus:
'Aureus' in this context pertains to 'Staphylococcus aureus', a pathogenic bacteria tested during the microbial evaluation of the formulation. Ensuring its absence confirms the formulation's safety and adherence to WHO guidelines for quality standards.
13) India:
'India' is the geographical context where the study was conducted. As a country with rich biodiversity and traditional medicine practices, India plays a crucial role in the exploration and commercialization of herbal therapies like Unani medicine.
14) Sugar:
'Sugar' is one of the constituent ingredients in 'sufoofe sailan'. It not only serves to enhance the taste but also interacts with other herbal components, affecting the formulation's overall effectiveness and consumer acceptance.
15) Rani:
'Rani' is the last name of the lead researcher involved in the study. Her contributions are pivotal in validating the research findings and showcasing the professional engagements within the realm of pharmaceutical standards and traditional medicine.
16) Gond:
'Gond' refers to a type of gum used as an ingredient in 'sufoofe sailan'. Being a natural thickening agent, it enhances the texture and stability of the powder formulation, influencing its acceptability and efficacy.
17) Lamp:
'Lamp' relates to the photostability testing equipment used in the study. The specific lamps help simulate light exposure, ensuring the evaluation effectively mirrors potential real-world conditions the formulation may encounter.
18) Life:
'Life' in this context refers to the shelf life and potency duration of the 'sufoofe sailan' formulation. Understanding the product's longevity under varied environmental conditions is essential for ensuring its therapeutic value over time.
19) Mimusops elengi:
'Mimusops elengi' is a key botanical ingredient in 'sufoofe sailan'. This species is recognized for its medicinal properties, contributing to the formulation's therapeutic efficacy and traditional significance in treating gynecological disorders.
20) Discussion:
'Discussion' is a critical analysis section in research that interprets the results obtained. It helps contextualize the findings within existing knowledge, evaluating implications and potential applications of the study outcomes for future herbal formulations.
21) Developing:
'Developing' pertains to regions or contexts that are growing or evolving, particularly in terms of healthcare. The study highlights the increasing adoption of traditional remedies in developing countries, acknowledging the need for enhanced quality control and standardization.
22) Karnataka:
'Karnataka' is the state in India where the research was conducted. It represents a specific regional focus with a rich heritage of traditional herbal medicine, thus playing a vital role in the research and validation of indigenous medical practices.
23) Inference:
'Inference' involves deriving conclusions from the study results. In this research, the inference made about the photostability of 'sufoofe sailan' assures its safety and viability for therapeutic use, contributing to confidence in traditional medicine.
24) Toxicity:
'Toxicity' is the degree to which a substance may harm living organisms. The study emphasizes evaluating the formulation's degradation products for toxicity, ensuring that the product remains safe for consumer use throughout its shelf life.
25) Disease:
In this context, 'disease' refers to the gynecological disorders targeted by 'sufoofe sailan'. Understanding the formulation's effectiveness in treating specific diseases underscores the significance of evaluating its stability and safety under various conditions.
26) Dealer:
'Dealer' refers to individuals or businesses involved in the procurement of raw herbal materials. Their role is significant in ensuring the availability and authenticity of high-quality herbal products for incorporation into traditional formulations.
27) Indian:
'Indian' signifies the cultural and traditional heritage associated with the Unani medicine being studied. It highlights the significance of indigenous knowledge and practices in developing effective herbal remedies for various health concerns.
28) Filling (Filled):
'Filled' pertains to the process of packaging the herbal formulation into containers for storage. This step is crucial in maintaining the integrity of the product, preventing contamination and ensuring longevity and stability.
29) Botany:
'Botany' is the scientific study of plants essential for understanding the medicinal properties of the ingredients used in traditional formulations. Knowledge of botany supports effective ingredient selection and validates the therapeutic use of herbal substances.
30) House:
'House' can refer to the domestic or institutional setting where the formulation of 'sufoofe sailan' was prepared. This pertains to the environment ensuring controlled conditions during preparation, contributing to the product's quality and safety.
31) Line:
'Line' may refer to the continuity or sequence in research methodology, outlining distinct phases in the study. Maintaining a clear and cohesive line of inquiry is critical for achieving reliable and interpretable results in scientific research.
32) Male:
'Male' relates to the specific demographic targeted by part of the Unani formulation’s therapeutic benefits. Understanding the effects of 'sufoofe sailan' on male health conditions emphasizes the broader applicability of the product.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Photostability evaluation of a unani formulation sufoofe sailan’. Further sources in the context of Science might help you critically compare this page with similair documents:
Environmental factor, Quality Control, Ayurvedic formulation, Shelf life, Physico-chemical parameters, Drugs and Cosmetics Rules, World Health Organization, High performance thin layer chromatography, Physicochemical standards, Polyherbal formulation, Water soluble ash, Traditional System of Medicine, Stability testing, Total bacterial count, Total fungal count, Physico-chemical characteristics, Gynecological disease, Ayurvedic Pharmacopoeia of India, Acid insoluble ash, HPTLC analysis, Organoleptic character, Pharmacognosist, Environmental influence, Total microbial count, Sufoofe Sailan, Microbiological analysis, Adverse drug effect, Loss of weight on drying, Quality-control method, Total alkaloid, Microbial evaluation, ICH Guideline, Stability chamber, Unani formulation, Herbal drug standardization, Standardisation, Phytochemical constituent, Total glycoside.