Journal of Pharma and Drug Regulatory Affairs (e-ISSN:2582-3043)

Formulation, Development, and Evaluation of a Novel Polyherbal Anti-Acne Roll-on Containing Nyctanthes arbor-tristis (Parijat) and Moringa oleifera Extracts

Pradeep P. Sonwane — 2026-06-17

Acne is a common long-term skin problem caused by bacteria called Cutibacterium acnes, excess oil production, and stress that can damage skin cells. Nowadays, many people prefer herbal treatments because they are gentle on the skin, have fewer side effects, and may also help against bacteria that do not respond well to regular medicines. In this study, a herbal anti-acne roll-on was prepared using Nyctanthes arbor-tristis (parijat) and Moringa oleifera. Parijat has antibacterial, anti-inflammatory, and antioxidant properties. The formulation was evaluated using properties like Phytochemical, antibacterial, and stability. Acne vulgaris affects a large portion of the population, particularly adolescents and young adults, and can have a significant impact on self-esteem and quality of life. Conventional treatments such as antibiotics and synthetic topical agents are often associated with side effects, including skin irritation, dryness, and the development of antimicrobial resistance. Therefore, the demand for safe and effective herbal alternatives has increased considerably. Moringa oleifera is a medicinal plant known for its rich content of bioactive compounds, including flavonoids, phenolics, and vitamins, which contribute to its antimicrobial and antioxidant activities. The combination of Nyctanthes arbor-tristis and Moringa oleifera may provide a synergistic effect in reducing acne-causing bacteria and inflammation while promoting healthy skin. The herbal roll-on formulation was developed for convenient application and better patient compliance. Various evaluation parameters were carried out to determine its quality, efficacy, and stability. The results indicated the presence of beneficial phytochemicals and demonstrated antibacterial activity against acne-causing microorganisms. Stability studies also confirmed that the formulation remained physically and chemically stable under different storage conditions, suggesting its potential as a natural and effective anti-acne treatment.

Quality by Design in Pharmaceutical Manufacturing: A Strategic Framework for Process Understanding and Regulatory Compliance — A Critical Analysis

Bhuvaneesh S. L — 2026-03-31

Quality by Design (QbD) is a forward-thinking approach in pharmaceutical development that focuses on ensuring product quality from the very beginning rather than relying only on final testing. It encourages a deep understanding of how a product is formulated and how different factors influence its performance. The process begins with defining the Quality Target Product Profile (QTPP), which describes the intended characteristics of the final product. Based on this, critical quality attributes (CQAs) are identified, and potential risks are carefully evaluated to understand how raw materials and processing conditions may affect the outcome. A key concept within QbD is the “design space,” which refers to the range of conditions under which the product can be manufactured consistently without compromising quality. To establish this range, Design of Experiments (DoE) is commonly used. DoE is a structured statistical technique that allows researchers to study several variables at once and determine how they interact and influence the final product. Specialized software tools such as JMP, Minitab, and Design-Expert simplify this process by supporting experimental design, data analysis, and interpretation of results. When selecting a DoE tool, factors like ease of use, regulatory compatibility, and analytical capabilities should be considered. Successful implementation of QbD also relies on proper training and collaboration among teams. Overall, combining QbD with DoE leads to more consistent, efficient, and high-quality pharmaceutical products.

Beauty with a Price: A Study on Mercury-Containing Skin Lightening Creams

Arvinder Kaur — 2026-06-17

Mercury-containing creams are cosmetic products that are often used for skin lightening and the treatment of pigmentation. These creams often contain inorganic mercury compounds that decrease melanin production and make the skin appear lighter. However, the presence of mercury in cosmetic products creates serious health and safety concerns.

Long-term use of such creams may cause several harmful effects, including skin irritation, redness, rashes, discoloration, and permanent skin damage. Mercury can also enter the body through the skin and gradually accumulate in organs, affecting the kidneys, nervous system, and immune system. Pregnant women and infants are especially at higher risk from mercury exposure.

Although many countries have restricted or banned mercury in cosmetic preparations, these products are still sold in certain markets because of poor regulation and a lack of public awareness. This project focuses on the use of mercury in cosmetic creams, its toxic effects on human health, and the importance of spreading awareness and enforcing strict regulations.

In conclusion, mercury-based cosmetic creams should be avoided, and safer skincare alternatives should be encouraged to protect both human health and the environment.

Pirfenidone in Idiopathic Pulmonary Fibrosis: Mechanistic Insights, Clinical Evidence, and Future Therapeutic Horizons

Devi Thamizhanban — 2026-05-04

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressively worsening interstitial lung disorder characterized by excessive deposition of extracellular matrix and irreversible decline in pulmonary function. Pirfenidone, a synthetic pyridone derivative, exhibits antifibrotic, anti-inflammatory, and antioxidant activities by modulating key mediators, including TGF-β, TNF-α, IL-1β, and NOX4. Evidence from both preclinical and clinical investigations indicates that pirfenidone effectively slows disease progression. Pharmacokinetic studies show that pirfenidone is rapidly absorbed and undergoes extensive hepatic metabolism, primarily via the CYP1A2 enzyme, leading to the formation of active metabolites. Phase III clinical trials, including the CAPACITY and ASCEND studies, have demonstrated that pirfenidone significantly reduces the rate of decline in forced vital capacity (FVC), improves progression-free survival, and provides overall survival benefits in pooled analyses. Although adverse effects such as gastrointestinal disturbances and photosensitivity are commonly reported, they are generally manageable with appropriate dose adjustments. Drug interaction studies highlight significant interactions with strong CYP1A2 inhibitors, including fluvoxamine, whereas no clinically relevant interactions have been observed with nintedanib. Emerging research focusing on inhaled delivery systems, combination therapies, and biomarker-driven strategies suggests expanded therapeutic potential. Overall, pirfenidone represents a well-established, evidence-based option for slowing disease progression in IPF and other fibrosing interstitial lung diseases.

Analytical Quality by Design in Pharmaceuticals: Concepts, Applications, and Future Directions

Dr. Pratik M Tailor — 2026-02-25

The pharmaceutical sector has undergone a significant shift in mindset, transitioning from traditional, reactive quality testing to the more forward-looking and structured approach known as Analytical Quality by Design (AQbD). Rather than testing quality into a method after development, AQbD embeds quality from the very beginning by applying Quality by Design (QbD) principles to analytical science. It promotes a scientific, risk-based strategy that ensures analytical methods are fit for their intended purpose throughout their lifecycle. The AQbD process starts with clearly defining the goal of the method through the Analytical Target Profile (ATP), which outlines both the objective of the analysis and the expected quality of the reported results. To support this, systematic Quality Risk Management (QRM) tools—such as Ishikawa (fishbone) diagrams and Failure Mode and Effects Analysis (FMEA)—are employed to identify, assess, and prioritize variables that may influence method performance. This structured evaluation allows researchers to concentrate on the most critical parameters that truly affect analytical outcomes. Instead of relying on the traditional one-factor-at-a-time (OFAT) approach, AQbD utilizes Design of Experiments (DoE) to study multiple variables simultaneously. This multivariate approach provides deeper insight into how method parameters interact with one another and how these interactions influence critical method attributes, ultimately leading to more robust and reliable analytical procedures. The culmination of this process is the establishment of a Method Operable Design Region (MODR), a multidimensional space of validated input variables that assures method quality. Operating within the MODR provides enhanced method robustness and significant regulatory flexibility, as adjustments within this pre-approved space are not considered changes requiring further filing. While implementation requires a cultural shift and an initial investment in training and resources, AQbD ultimately delivers more robust, flexible, and well-understood analytical methods essential for modern pharmaceutical development and lifecycle management.