INTRODUCTION:

The screening and validation of natural products play a crucial role in the process of drug discovery and development. Natural products derived from plants, animals, or microorganisms have been a rich source of therapeutic compounds for centuries. However, the identification of promising candidates and their subsequent validation as effective and safe drugs require a systematic and rigorous approach^1-3.

This article presents key points and approaches involved in the screening and validation of natural products, encompassing screening assays, in vitro studies, cell-based assays, animal models, pharmacokinetic studies, safety evaluation, and clinical trials. By understanding these essential steps, researchers and healthcare professionals can optimize the discovery and development of natural product-based drugs, leading to improved treatment options and patient outcomes.

Screening and validation of natural products is an important step in the process of drug discovery and development. Here are key points regarding the screening and validation of natural products:

1. Screening Assays: Natural product extracts or fractions are subjected to various screening assays to evaluate their biological activities. These assays can target specific diseases, biological pathways, or cellular processes of interest. Examples of screening assays include antimicrobial assays, anticancer assays, anti-inflammatory assays, antioxidant assays, and enzyme inhibition assays. Screening assays help identify natural products with potential therapeutic effects⁴.

2. In vitro Studies: Once initial screening identifies promising natural product candidates, further in vitro studies are conducted to assess their efficacy, safety, and mechanism of action. In vitro studies involve testing the natural products on isolated cells or cellular components to evaluate their effects on specific cellular processes or targets. These studies provide insights into the biological activity and potential mode of action of the natural products⁵.

3. Cell-Based Assays: Natural products showing promising activity in in vitro studies can be evaluated in cell-based assays, where the natural products are tested on intact cells or cell lines. Cell-based assays provide a more realistic and complex cellular environment to assess the effects of natural products on cell viability, proliferation, apoptosis, or specific cellular functions. These assays help determine the potential therapeutic benefits and cytotoxicity of the natural products⁶.

4. Animal Models: Natural products that demonstrate promising activity in cell-based assays may be further evaluated in animal models. Animal models provide a more comprehensive understanding of the potential therapeutic effects, pharmacokinetics, and toxicity profiles of the natural products in a living organism. Animal studies can include efficacy studies, dose-response studies, toxicity studies, and pharmacokinetic studies. These studies help bridge the gap between in vitro and clinical evaluations⁷.

5. Pharmacokinetic Studies: Pharmacokinetic studies examine how natural products are absorbed, distributed, metabolized, and excreted within the body. These studies provide critical information about the bioavailability, metabolism, and elimination of natural products, which are crucial for optimizing dosage regimens and predicting their potential efficacy in humans. Pharmacokinetic studies often involve the administration of natural products to animals or human volunteers, followed by the analysis of blood, urine, or tissue samples⁸.

6. Safety and Toxicity Evaluation: Safety evaluation is an important aspect of natural product screening and validation. Toxicity studies assess the potential adverse effects or toxicity of the natural products on various organ systems or physiological functions. These studies help determine the safe dosage range and identify any potential risks or side effects associated with the natural products⁹.

7. Clinical Trials: Natural products that demonstrate promising activity, safety, and pharmacokinetic profiles in preclinical studies may progress to clinical trials. Clinical trials involve the administration of natural products to human subjects under controlled conditions. These trials assess the efficacy, safety, dosage, and potential interactions of the natural products in humans. Clinical trials are conducted in multiple phases, including Phase I (safety), Phase II (efficacy and dosage determination), and Phase III (large-scale efficacy and safety)¹⁰.

Screening and validation of natural products involve a combination of in vitro, cell-based, animal, and clinical studies to assess their potential as therapeutic agents. These studies help identify effective and safe natural products, optimize dosage regimens, understand their mechanisms of action, and contribute to the development of new drugs or therapeutic interventions.

Materials:

To collect information regarding current therapy in Screening and Validation of Natural Products for Drug Discovery: Key Points and Approaches, a comprehensive literature search was conducted. Peer-reviewed journal articles were examined, and electronic databases such as PubMed, Scopus, ScienceDirect, and Google Scholar were utilized. The aim was to gather data on different Screening and Validation of Natural Products for Drug Discovery: Key Points and Approachesstrategy containing safety and precautions, which have traditionally been employed in the treatment of different diseases and disorders for a pharmacological importance.

Pharmacological and mechanistic studies are essential components of ethnopharmacology research. Here are key points regarding pharmacological and mechanistic studies in ethnopharmacology:

1. Target Identification: Pharmacological studies aim to identify the specific targets or receptors in the body that are affected by bioactive compounds derived from traditional remedies. This involves investigating the interactions between natural compounds and molecular targets such as enzymes, receptors, ion channels, or signaling pathways. Identifying the target(s) helps elucidate the mechanisms of action and potential therapeutic applications of the bioactive compounds¹¹.

2. Mode of Action: Understanding the mode of action of bioactive compounds is crucial for determining their pharmacological effects and developing effective treatments. Mechanistic studies investigate the step-by-step processes by which the bioactive compounds exert their effects on the molecular, cellular, or physiological level. This includes unraveling the molecular pathways, signal transduction cascades, or cellular responses triggered by the compounds¹².

3. Receptor Binding and Activation: Pharmacological studies involve assessing the binding affinity and selectivity of bioactive compounds to specific receptors. Techniques like radioligand binding assays or fluorescence-based assays are employed to study the interaction between the compounds and their target receptors. Functional assays can also determine the activation or modulation of signaling pathways by the compounds¹³.

4. Enzyme Inhibition or Activation: Many bioactive compounds derived from traditional remedies exhibit enzymatic activities. Pharmacological studies assess the ability of these compounds to inhibit or activate specific enzymes involved in various physiological processes. Enzyme assays help measure the potency and selectivity of the compounds in modulating enzymatic activity, providing insights into their potential therapeutic applications¹⁴.

5. Signaling Pathway Modulation: Bioactive compounds can modulate intracellular signaling pathways, influencing cellular processes and physiological functions. Pharmacological studies explore the effects of natural compounds on key signaling pathways, such as MAPK/ERK, PI3K/Akt, NF-κB, or Wnt/β-catenin pathways. By understanding the modulation of these pathways, researchers can unravel the mechanisms by which natural compounds exert their effects^15-17.

6. Molecular Interactions: Pharmacological studies employ various techniques, including molecular docking, molecular dynamics simulations, or co-crystallization, to investigate the precise molecular interactions between bioactive compounds and their target receptors or enzymes. These studies provide valuable insights into the binding modes, conformational changes, and structure-activity relationships of the compounds, aiding in the design of more potent and selective drugs¹⁸.

7. Pharmacokinetics: Pharmacokinetic studies assess the absorption, distribution, metabolism, and excretion of bioactive compounds derived from traditional remedies. These studies investigate the bioavailability, half-life, tissue distribution, and elimination routes of the compounds in the body. Pharmacokinetic data help determine optimal dosage regimens and predict the efficacy and safety profiles of the compounds in humans¹⁹.

Pharmacological and mechanistic studies in ethnopharmacology deepen our understanding of the therapeutic potential, molecular mechanisms, and target interactions of bioactive compounds derived from traditional remedies. These studies contribute to the development of evidence-based medicine, help optimize treatment strategies, and provide scientific validation for the traditional use of natural products in healthcare²⁰.

Preclinical and clinical studies are conducted to evaluate the safety, efficacy, and potential therapeutic applications of promising bioactive compounds derived from ethnopharmacology research. Here are key points regarding preclinical and clinical studies:

Preclinical Studies:

1. In vivo Efficacy Studies: Preclinical efficacy studies involve testing the bioactive compounds in animal models of the targeted disease or condition. These studies assess the compounds' ability to produce the desired therapeutic effects, such as tumor regression, reduction in disease symptoms, or improvement in physiological parameters²¹.

2. Pharmacokinetic and Pharmacodynamic Studies: Preclinical pharmacokinetic studies investigate how the bioactive compounds are absorbed, distributed, metabolized, and eliminated in animal models. These studies provide insights into the compounds' bioavailability, half-life, tissue distribution, and potential drug-drug interactions. Pharmacodynamic studies assess the compounds' effects on the intended molecular targets and relevant biological pathways²².

3. Safety and Toxicity Assessment: Preclinical safety studies are crucial for evaluating the potential adverse effects and toxicity profiles of bioactive compounds. These studies assess the compounds' toxicity to various organs, potential mutagenicity, reproductive toxicity, or carcinogenicity. They help determine the safe dosage range and any potential risks associated with the compounds²³.

4. Dose-Response and Formulation Optimization: Preclinical dose-response studies aim to establish the optimal dosage range for the bioactive compounds, balancing efficacy and safety considerations. These studies help determine the minimum effective dose and the maximum tolerated dose. Formulation optimization studies explore different delivery systems or formulations to enhance the compounds' stability, bioavailability, or targeted delivery²⁴.

Clinical Studies:

1. Phase I Clinical Trials: Phase I trials involve administering the bioactive compounds to a small number of healthy volunteers to evaluate safety, dosage, and potential side effects. These trials aim to establish the maximum tolerated dose, dosage regimens, and any dose-limiting toxicities. Pharmacokinetic studies in humans further investigate the compounds' absorption, distribution, metabolism, and excretion²⁵.

2. Phase II Clinical Trials: Phase II trials assess the efficacy and further evaluate the safety of the bioactive compounds in a larger number of patients with the targeted disease or condition. These trials provide preliminary evidence of the compounds' therapeutic effects, optimal dosage, and potential biomarkers for response prediction. Phase II trials may also include placebo-controlled or comparative studies with standard treatments²⁶.

3. Phase III Clinical Trials: Phase III trials involve larger populations and aim to confirm the efficacy and safety of the bioactive compounds in a statistically significant manner. These trials often include randomized, controlled studies comparing the compounds with standard treatments or placebos. Phase III trials provide more comprehensive evidence of the compounds' therapeutic benefits, allowing for regulatory approval and commercialization²⁷.

4. Post-Marketing Surveillance: After regulatory approval, post-marketing surveillance or Phase IV studies monitor the long-term safety, effectiveness, and potential rare side effects of the compounds in a larger patient population. These studies provide ongoing evaluation of the compounds' real-world usage, interactions with other medications, and rare adverse events that may not have been evident in earlier stages²⁸.

Preclinical and clinical studies are critical for establishing the safety, efficacy, and optimal use of bioactive compounds derived from ethnopharmacology research. These studies bridge the gap between laboratory investigations and the application of the compounds in real-world healthcare settings, leading to the development of evidence-based treatments and improved patient outcomes²⁹.

Pharmacovigilance and quality control are crucial aspects of ethnopharmacology to ensure the safety, efficacy, and quality of products derived from traditional remedies. Here are key points regarding pharmacovigilance and quality control in ethnopharmacology:

Pharmacovigilance:

1. Adverse Event Monitoring: Pharmacovigilance involves monitoring and evaluating the safety of products derived from traditional remedies. Adverse event monitoring collects and analyses information on any unexpected or adverse reactions associated with the use of these products. This information helps identify potential safety concerns, assess the risk-benefit profile of the products, and implement necessary regulatory actions³⁰.

2. Reporting Systems: Establishing robust reporting systems for healthcare professionals, patients, and consumers is essential for pharmacovigilance in ethnopharmacology. These systems facilitate the reporting of adverse events, allowing for the timely collection and analysis of safety data. National and international pharmacovigilance networks and databases help centralize and share this information for comprehensive monitoring³¹.

3. Risk Assessment and Management: Pharmacovigilance activities in ethnopharmacology involve risk assessment and management. This includes identifying potential risks associated with traditional remedies, determining risk factors, evaluating the severity and frequency of adverse events, and implementing risk mitigation strategies. Risk communication to healthcare professionals, regulators, and the public is essential to ensure the safe use of ethnopharmacological products³².

4. Drug-Drug Interactions and Contraindications: Ethnopharmacological products may interact with conventional medications or have contraindications for specific patient populations. Pharmacovigilance activities include assessing potential drug-drug interactions and contraindications to minimize the risks of adverse events resulting from such interactions. These evaluations help guide healthcare professionals in making informed decisions about product use and patient management³³.

Quality Control:

1. Botanical Authentication: Quality control in ethnopharmacology involves ensuring the correct identification and authentication of botanical ingredients used in traditional remedies. Botanical authentication verifies the identity and purity of plants used in the production of ethnopharmacological products, reducing the risks of adulteration or substitution. Techniques such as macroscopic and microscopic examination, chemical profiling, DNA barcoding, and chromatographic fingerprinting are employed for authentication purposes³⁴.

2. Standardization of Active Ingredients: Quality control involves standardizing the content and concentration of active ingredients in ethnopharmacological products. Standardization ensures consistency in the potency and efficacy of the products. Analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), or spectrophotometry are used to quantify and monitor the levels of active compounds³⁵.

3. Contaminant and Residue Analysis: Quality control includes testing for contaminants, such as heavy metals, pesticides, mycotoxins, microbial contaminants, or harmful adulterants, in ethnopharmacological products. Residue analysis ensures compliance with safety standards and regulations. Various analytical methods, including atomic absorption spectroscopy, liquid chromatography, and microbial testing, are employed to detect and quantify contaminants or residues³⁶.

4. Good Manufacturing Practices (GMP): Ethnopharmacological products should be manufactured following Good Manufacturing Practices to ensure quality, safety, and consistency. GMP guidelines provide a framework for the production, packaging, labelling, and storage of products. Compliance with GMP standards ensures that products meet quality specifications, are free from contamination, and are manufactured in controlled environments³⁷.

Pharmacovigilance and quality control in ethnopharmacology are critical to safeguard patient safety, ensure product efficacy, and maintain the integrity of traditional remedies. These practices contribute to evidence-based use, regulatory compliance, and the development of trustworthy and reliable ethnopharmacological products in healthcare³⁸.

The integration of traditional and modern medicine, often referred to as integrative medicine or complementary and alternative medicine (CAM), recognizes the strengths and value of both approaches and seeks to combine them for holistic patient care. Here are key points regarding the integration of traditional and modern medicine:

1. Holistic Patient Care: Integrative medicine aims to provide comprehensive and patient-centred care that addresses not only the physical symptoms but also the emotional, mental, and spiritual aspects of health. By combining traditional and modern medicine, healthcare practitioners can offer a more holistic approach to patient care, taking into account individual needs and preferences³⁹.

2. Combining Therapies: Integrative medicine encourages the use of both traditional and modern therapeutic approaches to optimize patient outcomes. Traditional therapies, such as herbal medicine, acupuncture, Ayurveda, or traditional Chinese medicine, can be combined with modern medical interventions, including pharmaceuticals, surgery, or advanced diagnostic techniques. The integration allows for a personalized treatment plan tailored to the patient's specific condition and needs^40-41.

3. Evidence-Based Practice: Integrative medicine promotes the use of evidence-based practices by integrating scientific research and traditional knowledge. It recognizes the importance of rigorous scientific studies to validate the safety and efficacy of traditional therapies and guides their integration into modern healthcare. Evidence-based practice ensures that the integration of traditional and modern medicine is based on sound scientific principles and clinical research⁴².

4. Prevention and Health Promotion: Integrative medicine places emphasis on disease prevention and health promotion by combining various approaches. Traditional medicine often focuses on maintaining balance, preventing illness, and promoting overall well-being. Integrating traditional practices with modern preventive strategies, such as lifestyle modifications, nutrition, exercise, and stress management, can contribute to a comprehensive approach to disease prevention and health maintenance⁴³.

5. Collaborative Care: Integrative medicine encourages collaboration among healthcare practitioners from different disciplines, including traditional healers, physicians, naturopaths, and other complementary therapists. Collaboration facilitates the exchange of knowledge, expertise, and best practices, allowing for a more integrated and cohesive approach to patient care. It also promotes mutual respect and understanding between different healthcare traditions⁴⁴.

6. Patient Education and Empowerment: Integrative medicine emphasizes patient education and empowerment. It encourages patients to actively participate in their healthcare decisions and make informed choices regarding traditional and modern treatment options. Patient education includes providing information about the benefits, risks, and potential interactions of different therapies, empowering individuals to make informed decisions about their health⁴⁵.

7. Research and Training: Integrative medicine recognizes the importance of research and training to further the understanding and integration of traditional and modern medicine. Research efforts focus on studying the safety, efficacy, and mechanisms of traditional therapies, as well as exploring their potential synergies with modern interventions. Training programs educate healthcare practitioners about both traditional and modern approaches, fostering a multidisciplinary and integrative mindset^46-50.

The integration of traditional and modern medicine offers a comprehensive and patient-centred approach to healthcare. By combining the strengths of both systems, patients can benefit from a wider range of treatment options, improved outcomes, and a more personalized approach to their health and well-being. It also promotes cultural diversity, respect for traditional healing practices, and the preservation of indigenous knowledge and cultural heritage.

CONCLUSION:

The screening and validation of natural products for drug discovery and development involve a rigorous and systematic approach. Through a series of steps including screening assays, in vitro studies, cell-based assays, animal models, pharmacokinetic studies, safety evaluation, and clinical trials, researchers can identify and validate potential therapeutic compounds. This process enables the development of effective and safe natural product-based drugs, contributing to improved treatment options and patient outcomes. The integration of traditional and modern medicine, along with the practice of evidence-based medicine, further enhances the understanding and utilization of natural products in healthcare. By combining the strengths of both traditional and modern approaches, researchers and healthcare professionals can optimize the discovery, development, and integration of natural product-based drugs, leading to holistic and personalized patient care^47-48.The screening and validation of natural products involve a series of steps aimed at identifying and validating potential therapeutic compounds. Screening assays are used to evaluate the biological activities of natural product extracts or fractions, targeting specific diseases, pathways, or cellular processes. Promising candidates undergo in vitro studies, which provide insights into efficacy, safety, and mechanism of action. Cell-based assays offer a more realistic cellular environment to assess natural product effects, while animal models provide a comprehensive understanding of therapeutic effects, pharmacokinetics, and toxicity profiles. Pharmacokinetic studies examine how natural products are absorbed, distributed, metabolized, and excreted within the body, optimizing dosage regimens. Safety evaluation encompasses toxicity studies to determine safe dosage ranges and identify potential risks. Finally, clinical trials assess the efficacy, safety, dosage, and interactions of natural products in humans. This comprehensive screening and validation process contributes to the development of effective and safe natural product-based drugs, ultimately improving patient care.

CONFLICT OF INTEREST:

The authors have no conflicts of interest.

ACKNOWLEDGMENTS:

The authors would like to thank NCBI, PubMed and Web of Science for the free database services for their kind support during this study.

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Received on 25.07.2023 Modified on 16.01.2024

Asian J. Pharm. Res. 2024; 14(2):162-168.

DOI: 10.52711/2231-5691.2024.00027