Review on photostability studies of formulation
Journal name: World Journal of Pharmaceutical Research
Original article title: Review on photostability studies of formulation
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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Mulchand A. Shende and Rajendra P. Marathe
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Review on photostability studies of formulation
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201712-9808
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The growing concern over the photostability of drugs and pharmaceuticals has spurred extensive research in this field. Photostability is crucial because photosensitive drugs can undergo significant chemical changes when exposed to light, which may lead to a loss of therapeutic efficacy, formation of harmful photoproducts, and diminished clinical effectiveness. Different classes of drugs, such as 1,4-dihydropyridine derivatives, benzodiazepines, proton pump inhibitors, and leukotriene antagonists, demonstrate varying degrees of light sensitivity, necessitating specialized storage and packaging solutions. Understanding the underlying processes of photodegradation and the related factors becomes essential for developing effective photostable formulations.
Photodegradation Process
The photodegradation of drugs can occur through two main mechanisms: direct and indirect reactions. Direct reactions proceed when a drug absorbs light energy from a radiation source, leading to the formation of intermediate products that may further degrade into stable molecules. Conversely, indirect reactions involve sensitizers that absorb light energy, transferring it to the drug and prompting degradation. Factors influencing the rate of photodegradation include the absorption spectrum of the drug relative to the light source, with certain functional groups (such as carbonyls) being particularly susceptible to photochemical transformations. Understanding these mechanisms allows for the formulation of more stable pharmaceutical products.
Factors Affecting Photostability
Multiple factors can significantly influence the photostability of pharmaceutical formulations. Experimental factors include radiation wavelength, intensity, time of exposure, and the sample holder's dimensions. In terms of dosage form, factors such as particle size, pH, ionic strength, and the presence of specific pharmaceutical excipients play vital roles. Notably, excipients can act as sensitizers during indirect reactions, making compatibility studies between drugs and excipients crucial. Concentration levels also heavily impact degradation rates; for instance, concentrated solutions typically exhibit lower rates of photodegradation than their dilute counterparts.
Strategies for Enhancing Photostability
To combat photodegradation, various strategies are employed, which can be classified into conventional and formulation approaches. Conventional methods include using light-resistant containers, incorporating antioxidants, and employing light-absorbing pigments. Formulation strategies involve implementing light-resistant coatings, using inclusion complexation (such as with cyclodextrins), and utilizing formulations like liposomes, microspheres, microcapsules, and ion-exchange resins. Recent studies highlight the effectiveness of ion-exchange resins and cyclodextrin complexation, paving the way for the commercial production of photostable formulations.
Conclusion
Ensuring the photostability of pharmaceutical formulations is critical for maintaining drug efficacy and safety. An understanding of the photodegradation process, the influential factors, and effective strategies to enhance stability can guide the development of products that withstand light exposure. As research continues to unveil new methods for improving photostability, the pharmaceutical industry can effectively address the challenges posed by photosensitive drugs, promoting better therapeutic outcomes and patient safety.
FAQ section (important questions/answers):
What is the focus of this article on photostability studies?
The article reviews various studies related to the photostability evaluation and development of photostable formulations, discussing photodegradation processes, influencing factors, and regulatory considerations to enhance stability in sensitive drugs.
What factors contribute to the photodegradation of drugs?
Factors include the wavelength and intensity of light, time of exposure, dosage form characteristics, and presence of excipients, all influencing the rate of degradation and ultimately impacting the drug's effectiveness.
How can manufacturers address photostability issues?
Manufacturers can use light-resistant containers, antioxidants, light-absorbing pigments, and specialized coatings, or employ complexation techniques with cyclodextrins and ion-exchange resins to enhance the photostability of sensitive formulations.
What are some examples of photosensitive drugs mentioned?
Examples of photosensitive drugs include nifedipine, diazepam, pantoprazole, and montelukast, all susceptible to photodegradation leading to changes in chemical, physical, or therapeutic properties upon light exposure.
What regulatory guidelines pertain to photostability testing?
The ICH guidelines, particularly ICH Q1B, Q1C, and Q3A, outline the recommended practices for assessing photostability in new drug substances and products, focusing on light exposure evaluations.
What innovative methods are being researched for photostability?
Recent studies explore methods like inclusion complexation with cyclodextrins and the use of ion-exchange resins, proving effective in enhancing the photostability of photosensitive pharmaceuticals.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Review on photostability studies of formulation”. 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 keyword 'Drug' is essential as it refers to substances used in the diagnosis, treatment, or prevention of diseases. In the context of photostability studies, certain drugs are sensitive to light and require specific formulation strategies to maintain their efficacy and avoid degradation. Understanding drug properties is crucial for developing stable pharmaceutical products.
2) Substance:
The term 'Substance' encompasses any material with a defined composition, typically used in pharmaceuticals. This article mentions various substances including active drug ingredients and excipients that may influence the photostability of formulations. Understanding the characteristics of different substances is vital for evaluating their behavior under light exposure and formulating stable products.
3) Table:
'Table' refers to the organized representation of data, often used in research articles to summarize findings. The article includes tables summarizing photostabilizers and techniques employed for photostabilization. Such tables enhance clarity and facilitate comparison, allowing researchers to quickly reference critical information relevant to their studies on photostable formulations.
4) Study (Studying):
The keyword 'Study' signifies systematic investigation or analysis aimed at understanding a phenomenon. In the context of this article, studies are conducted to evaluate the photostability of drugs and the effectiveness of various stabilizing techniques. These studies provide insights into how light affects pharmaceutical compounds and help in developing strategies to enhance their stability.
5) Lamp:
'Lamp' refers to a device that produces light, often used in experiments to simulate solar or artificial light conditions. In the context of photostability testing, different types of lamps can be used to evaluate how drugs behave under light exposure. Understanding lamp specifications helps in conducting standardized experiments to assess drug photostability.
6) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in India where several pharmaceutical research institutions are located, as mentioned in the article's affiliations. Its relevance lies in the contribution of local research efforts to the field of pharmaceutical sciences. Understanding the specific regional focus enhances the relevance of the study findings for local drug development.
7) Container:
The term 'Container' refers to the packaging or vessels used to store pharmaceutical products. It plays a crucial role in protecting light-sensitive drugs from photodegradation. The article discusses light-resistant containers as a key factor in ensuring the stability of photosensitive formulations, emphasizing the importance of appropriate packaging in drug efficacy.
8) Activity:
'Activity' denotes the biological effect or therapeutic effectiveness of a drug. In the context of photostability, light exposure can lead to a decrease in drug activity through photodegradation. Understanding how light affects drug activity is vital for assessing the safety and efficacy of pharmaceutical formulations over their shelf life.
9) India:
'India' refers to the country where the research and institutions mentioned in the article are located. Its relevance is tied to the growing pharmaceutical industry and research landscape, where studies on photostability of drugs are essential for ensuring quality and efficacy in medication formulations produced within the country.
10) Life:
'Life' in this context relates to the stability of pharmaceutical products and their longevity when exposed to light. The term underscores the importance of ensuring that drugs maintain their active properties and do not undergo detrimental changes that could impact patients' treatment outcomes, thus affecting the quality of life.
11) Amravati:
Amravati is a city in Maharashtra, India, serving as the location for one of the pharmaceutical institutions mentioned. Its mention highlights the regional focus of the research. Understanding regional contributions in pharmaceutical studies can lead to localized solutions for drug formulation challenges, particularly in addressing photostability issues for local products.
12) Species:
'Species' refers to specific organisms or groups of organisms. In the context of the article, it refers to chemical species that may undergo photodegradation. Recognizing the various species involved in drug formulations is essential for understanding the photochemical processes and developing effective stabilization techniques for sensitive compounds.
13) Surface:
'Surface' pertains to the outer layer of a dosage form, which is often where photodegradation occurs, especially in solid formulations. Understanding surface interactions in the context of light exposure can help researchers design better formulations that minimize degradation and protect the stability of sensitive drugs.
14) Aman (A-man):
'Aman' may refer to a researcher or contributor mentioned in the article, indicating collaboration in the studies presented. This highlights the importance of teamwork in scientific research, as collaborative studies can yield comprehensive insights and advancements in understanding the complexities of photostability and formulation science.
15) Turmeric:
Turmeric is a spice known for its active compound, curcumin, which is mentioned as a natural photo stabilizer for certain drugs. Its relevance lies in its potential application in pharmaceutical formulations to enhance stability against photodegradation, showcasing how natural ingredients can be integrated into modern medication development processes.
16) Methane:
'Methane' is a simple hydrocarbon and, while not extensively discussed in the article, its mention in chemical terms highlights the broader context of organic chemistry involved in photostability studies. Understanding the chemical properties of hydrocarbons can aid in comprehending photochemical interactions in drug formulations.
17) Nature:
'Nature' signifies the inherent characteristics of drugs and their behavior under environmental conditions, including light exposure. The nature of a drug affects its photostability. Understanding these intrinsic properties is vital for researchers focused on drug formulation, ensuring that effective and safe medications are developed.
18) Reason:
'Reason' denotes the rationale behind why photostability studies are conducted. The article explores the reasons for decreased efficacy and drug degradation due to light exposure. Understanding these reasons aids researchers in developing better strategies and formulations to combat photodegradation and maintain drug integrity.
19) Field:
'Field' refers to a specific area of study or profession. In this context, it relates to pharmaceutical sciences, particularly photostability research. Recognizing the field enhances comprehension of the context in which the study is situated, demonstrating the ongoing need for research in pharmaceutical development to ensure drug efficacy.
20) Food:
'Food' indirectly connects to pharmaceutical studies through the concept of nutritional supplements or certain food sources that may have photostabilizing properties. The interaction between nutrition and pharmacology can play a role in drug effectiveness, showcasing the importance of multidisciplinary approaches in pharmaceutical research.
21) Road:
'Road' symbolizes pathways and the progress in pharmaceutical research. Metaphorically, it represents the journey of ongoing investigations into photostability and the various routes researchers take to discover innovative solutions for stabilizing light-sensitive drugs, highlighting the development of effective formulations.
22) Pir:
'Peer' refers to colleagues or fellow researchers in the scientific community. Collaboration among peers is crucial in advancing knowledge in photostability studies. Peer-reviewed research ensures credibility and robustness of findings, which is important in the pharmaceutical field for developing reliable and effective drug formulations.
23) Pur:
'Poor' highlights the consequences of inadequate photostability in drug formulations, which can lead to ineffective medications and negative health outcomes. Understanding the implications of poorly stabilized drugs underlines the significance of rigorous research to enhance drug formulations and improve patient safety.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Review on photostability studies of formulation’. Further sources in the context of Science might help you critically compare this page with similair documents:
Active principle, Experimental method, Adverse effect, Clinical efficacy, Therapeutic Activity, Pharmaceutical formulation, Nifedipine, Sweetening agent, Experimental factors, Complexation with cyclodextrin.