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39 articles for “Pharmaceutical Compliance”
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Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance
Abstract: The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 54–62 Read article
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Pharmaceutical Syrup Formulation Enhancing Bioavaibility and Patient Compliance
Abstract: Pharmaceutical syrup formulations are crucial for drug delivery, especially in pediatric and geriatric populations. However, challenges, such as bioavailability, stability, and patient compliance due to factors, like taste and viscosity, must be addressed. Strategies to enhance bioavailability include solubility enhancers, nanoparticle systems, and advanced techniques like solid dispersions and emulsions. Palatability plays a critical role in patient compliance, with flavoring agents, sweeteners, and texture modifications improving acceptability. Innovations, like controlled-release …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 1–6 Read article
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Green Analytical Chemistry in Pharmaceuticals: Pathways to Sustainability and Compliance
Abstract: This review paper explores the integration of green analytical chemistry (GAC) in the pharmaceutical industry as a pathway to EU compliance and environmental sustainability. The review highlights a range of studies that focus on the application of green solvents, green extraction methods, biocatalysts, and energy-efficient techniques. Key findings suggest that employ eco-friendly solvents, such as ethanol and water and methods, like ultrasound-assisted extraction (UAE) and supercritical fluid extraction (SFE), significantly …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 7–12 Read article
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Digital Enablers of Nanomedicine: Pharmaceutical Software Across the Lifecycle of Nanotechnology‑Based Drug Products
Abstract: Nanotechnology‑based drug products have rapidly evolved from laboratory concepts to clinically relevant therapies, yet their development is constrained by complex design variables, stringent quality requirements, and emerging regulatory expectations specific to nanomaterials. Pharmaceutical software now plays a central role in the nanomedicine lifecycle, enabling in silico design of nano‑carriers, simulation of nano–bio interactions, control of nanoscale quality attributes during manufacturing, and systematic tracking of safety signals in real‑world use. Integrated …
Published in Nano Trends – A Journal of Nano Technology & Its Applications · Vol. 28, Issue 1, 2025 · pp. 11–16 Read article
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Strategies for the Development and Optimization of Orally Disintegrating Tablets (ODTs) to Improve Bioavailability and Patient Compliance
Abstract: Background: Pharmaceutical scientists have developed Orally Disintegrating Tablets (ODTs) to advance patient drug acceptance and biological system availability through simplified medi-cation delivery especially for children and senior citizens and people who cannot swallow pills regularly. The oral disintegrating tablets dissolve in the mouth within thirty seconds or less (USP 701) while needing no additional liquid thus making them suitable for both emergency treatments. Objective: The research examines ODT development strategies …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 13, Issue 2, 2026 Read article
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Revamping of Pharmaceutical Manufacturing Processes
Abstract: The pharmaceutical sector is entering a new era marked by technological advancements and an emphasis on sustainability and efficiency. A commitment to compliance can help boost consumer confidence and regulatory approval. This abstract explores the multifaceted approach to revamping pharmaceutical manufacturing processes, encompassing technological integration, regulatory compliance, and sustainability initiatives. Technological advancements, including automation, data analytics, and artificial intelligence, are playing a pivotal role in streamlining manufacturing operations. These innovations …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 38–44 Read article
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Optimizing Chromatographic Techniques for Comprehensive Paraben Analysis to Enhance Safety in Consumer Products
Abstract: Parabens (PBs), such as methylparaben (MePB), ethylparaben (EtPB), propylparaben (PrPB), and butylparaben (BuPB), are widely used as preservatives in pharmaceuticals, food, and personal care products due to their antibacterial properties. However, there are growing worries about their potential to disrupt hormonal functions, which has led to stricter regulations. This study focuses on creating a robust high-performance liquid chromatography (HPLC) method for quickly measuring all four parabens in consumer goods. We …
Published in Journal of Polymer & Composites · Vol. 13, Issue 6, 2025 · pp. 228–243 Read article
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Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries
Abstract: The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 28–36 Read article
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Flora-Vision: A Quality Assurance System For The Pharmaceutical Industry
Abstract: In contemporary pharmaceutical production, the persistent challenges of manual labor, human error, and contamination risks pose significant obstacles to efficiency and product quality. Particularly in sectors such as Ayurvedic products, cosmetics, and medicines, the need for innovation is pressing. Revolution in production process can be addressed by introducing innovative solutions and thereby challenges could be overcome. Through the utilization of advanced technology, the proposed system streamlines sample management and quality …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 3, 2024 · pp. 53–60 Read article
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Data Integrity Best Practices in Pharmaceutical Quality Assurance: A Thorough Review
Abstract: Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 22–30 Read article
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Drug Marketing in Tropical Regions and Its Effect on Pharmacovigilance Awareness and Reporting
Abstract: Drug marketing practices in tropical regions present a complex interplay between pharmaceutical promotion, healthcare infrastructure limitations, and public health outcomes. These regions – characterized by high disease burden, socio-economic disparities, and diverse healthcare delivery systems – often experience unique challenges in ensuring safe and rational drug use. Aggressive and sometimes unregulated marketing strategies by pharmaceutical companies may significantly influence prescribing behavior, patient compliance, and, ultimately, pharmacovigilance systems. Pharmacovigilance, defined as …
Published in International Journal of Tropical Medicines · Vol. 3, Issue 2, 2026 · pp. 1–17 Read article
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Self-Healing Polymer Composites for Pharmaceutical Packaging Applications
Abstract: Pharmaceutical packaging plays a crucial role in ensuring the safety, stability, and effectiveness of pharmaceutical products. Conventional polymer-based packaging materials are prone to mechanical damage, microcracks, and environmental degradation, which can compromise drug integrity. Self-healing polymer composites (SHPCs) offer a promising solution by enabling autonomous or stimuli-responsive repair mechanisms that restore packaging integrity, enhance durability, and extend product shelf life. These materials function through intrinsic mechanisms, such as dynamic covalent …
Published in Journal of Polymer & Composites · Vol. 13, Issue 4, 2025 · pp. 648–658 Read article
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A Brief Review on Herbal Excipients
Abstract: Natural or herbal excipients are significantly more advantageous than their synthetic equivalents because they are readily available, non-toxic, and less expensive. The pharmaceutical industries are becoming more interested in using these herbal excipients – mainly polymers of natural origin – in formulation development because of growing knowledge of them. The purpose of this study is to provide light on the possibility of using natural excipients, which are biocompatible and able …
Published in Research and Reviews : A Journal of Ayurvedic Science, Yoga and Naturopathy · Vol. 12, Issue 2, 2025 · pp. 5–14 Read article
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4D Printing in Drug Delivery: Application of Shape- Morphing Materials in Controlled Drug Release
Abstract: Four-dimensional printing technology has transformed the pharmaceutical landscape, offering unprecedented opportunities for innovation in drug development and delivery. This emerging technology enables the creation of complex geometries and customized structures, facilitating the design of personalized medications tailored to individual patient needs. Personalized dosing and drug release profiles, customized pill shapes and sizes for improved swallowability. Enhanced drug solubility and bioavailability, rapid prototyping and testing of pharmaceutical products. Development of complex …
Published in Trends in Drug Delivery · Vol. 12, Issue 3, 2025 · pp. 08–16 Read article
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The Contribution of A. I. in Pharmaceutical Software
Abstract: The integration of Artificial Intelligence (AI) in pharmaceutical software has significantly transformed drug development, regulatory processes, and clinical management. AI-powered tools are revolutionizing data analysis, predictive modeling, and decision-making, enhancing the efficiency and accuracy of drug discovery and development. This article explores the multifaceted contributions of AI to pharmaceutical software, including its applications in drug screening, personalized medicine, clinical trial optimization, and regulatory compliance. Additionally, we examine how AI is …
Published in International Journal of Biomedical Innovations and Engineering · Vol. 3, Issue 1, 2025 · pp. 1–10 Read article
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Chewable Healthcare: The Rising Impact of Gummy Supplements in Modern Medicine
Abstract: Gummy supplements, a chewable dosage form historically associated with pediatric vitamin products, are increasingly recognized as a versatile platform for delivering a wide range of nutraceutical and pharmaceutical agents. Their consumer appeal lies in their palatability, convenience, and the ability to overcome swallowing difficulties—a significant barrier to adherence in multiple patient populations. Recent advances in formulation science have expanded the potential of gummy supplements beyond basic vitamin delivery to include …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 3, 2025 · pp. 52–68 Read article
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Role of Pharmaceutical Software in Vaccine Development and Manufacturing Process Optimization
Abstract: Vaccine development and manufacturing have become increasingly complex due to the emergence of diverse vaccine platforms, stringent regulatory expectations, and global demand for safe and effective immunization. Across the vaccine lifecycle – from antigen design and preclinical evaluation to large‑scale manufacturing and post‑marketing surveillance – pharmaceutical software now plays a central role in handling data, optimizing processes, and ensuring regulatory compliance. Software tools support in silico antigen and epitope design, …
Published in International Journal of Vaccines · Vol. 3, Issue 1, 2026 · pp. 1–8 Read article
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Microsphere-Based Drug Delivery: A Critical Review of Innovations and Applications
Abstract: Microspheres have emerged as a revolutionary approach in pharmaceutical sciences, offering controlled and targeted drug delivery with improved bioavailability, stability, and patient compliance. These spherical carriers, ranging from nanometers to micrometers in size, can encapsulate both hydrophilic and hydrophobic drugs, enabling sustained and site-specific release. The development of microspheres has been significantly driven by the need to enhance drug efficacy while minimizing systemic side effects. This review provides a comprehensive …
Published in Trends in Drug Delivery · Vol. 12, Issue 2, 2025 · pp. 52–59 Read article
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Pharmaceutical Bead Formulations: A Comprehensive Overview into Advanced Drug Delivery
Abstract: Pharmaceutical beads are a unique and flexible drug delivery vehicle that provides numerous possibilities to control the release of drugs, protect them, and increase their therapeutic performance. These beads make it possible to design several types of therapeutic regimens by incorporating active pharmaceutical ingredients in a polymeric or lipid matrix. This review discusses the bead technology in drug delivery from its inception to its present application, focusing on the most …
Published in Trends in Drug Delivery · Vol. 12, Issue 2, 2025 · pp. 78–100 Read article