Soft gelatin capsules are widely used for delivering drugs, nutraceuticals, and poorly water-soluble active ingredients. However, their quality and stability are influenced by complex interactions among the gelatin shell, fill formulation, manufacturing process, packaging, and storage environment. This review highlights the application of Quality by Design (QbD) principles in softgel development, focusing on the Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters, risk assessment, Design of Experiments, and control strategies. Major stability challenges, including gelatin cross-linking, moisture migration, shell brittleness, leakage, fill-shell interactions, oxidation, and dissolution changes, are discussed. The effects of temperature, relative humidity, light, oxygen, formulation, packaging, and transportation are also examined. Emerging approaches such as Process Analytical Technology, predictive stability modelling, advanced packaging, and digital technologies are highlighted for improving softgel robustness and lifecycle management. Overall, QbD provides a systematic approach for developing stable, reproducible, and high-quality formulation of soft gelatin capsule products.

Dr. Ram Hari Tiwari

October 2, 2026

Mefenamic acid is a non-steroidal anti-inflammatory drug with poor aqueous solubility and lipophilic properties, which may limit its suitability for conventional topical delivery. The present study was undertaken to develop and evaluate a Mefenamic acid emulgel for improved topical drug delivery. Ten formulations (F1F10) were prepared using Carbopol 934 as the gelling agent, isopropyl myristate as the oil phase, and Tween 80 and Span 80 as emulsifying agents. The prepared formulations were evaluated for physical appearance, homogeneity, pH, viscosity, spreadability, extrudability, drug content, in-vitro drug release, and stability. All formulations showed satisfactory physical characteristics with acceptable pH and good homogeneity. The drug content of the formulations ranged from 96.5% to 99.7%. Formulation F5 showed satisfactory overall characteristics, with a pH of 6.5, viscosity of 24,890 cP, spreadability of 22.4 g•cm/sec, extrudability of 91.2%, and drug content of 99.6%. F5 exhibited 98.2% cumulative drug release after 12 h and was selected as the optimized formulation based on its overall physicochemical and release profile. Stability studies showed that F5 maintained satisfactory physical appearance, pH, viscosity, and drug content without phase separation during storage. The results indicate that the developed Mefenamic acid emulgel provides satisfactory formulation characteristics and sustained in-vitro drug release, suggesting its potential as a suitable topical delivery system for Mefenamic acid. Further ex-vivo permeation and in-vivo studies are required to confirm its topical performance and anti-inflammatory efficacy. Previous research has also demonstrated the potential of Mefenamic acid emulgels for topical delivery and anti-inflammatory activity.

Rajesh Kumar Gautam, Dr. Saurabh Parmar

October 2, 2026

Polyherbal formulations have emerged as promising therapeutic options for the management of diabetes, offering a multifaceted approach to addressing the complex pathophysiology of the disease. Through a comprehensive review of preclinical and clinical studies, this review highlights the efficacy, safety, and potential applications of polyherbal formulations in diabetes management. Key findings indicate that these formulations, composed of synergistic combinations of herbs, demonstrate significant improvements in glycemic control, insulin sensitivity, and reduction of diabetes-related complications. Importantly, polyherbal formulations exhibit favorable safety profiles, making them suitable for long-term use as adjunctive therapies alongside conventional treatments. Embracing holistic principles, these formulations address not only glycemic control but also overall health and well-being, aligning well with the principles of integrative medicine. Moving forward, opportunities for further research include optimization of formulations, elucidation of mechanistic insights, and large-scale clinical validation to facilitate their integration into mainstream clinical practice. By capitalizing on the synergistic benefits of polyherbal formulations, clinicians and healthcare providers can enhance therapeutic outcomes and improve the quality of life for individuals living with diabetes.

Raju Singh Thakur, Dr. Vijay Kumar Yadav

October 2, 2026

UV-Spectrophotometric method was carried out for profiling of phytochemicals .The method of analysis of Beta Caryophyllene oxide (BCO) in the lab has been developed. BCO exhibited absorption maximum of 285 nm. Analytical parameter including linearity and range, precision, accuracy, robustness and ruggedness were established following the International Conference on Harmonization (ICH) guidelines. The calibration curve showed a linear response according to Beer-Lambert's law for BCO concentration ranging from 0.1 to 0.9 mg/ml, with a correlation coefficient of 0.9963. Accuracy ranged from 99.78 to 102.24, while precision, expressed as relative standard deviation (% RSD) was 1.1164 % (Intraday) and 0.6948% (Interday) across nine sample preparations. The method's sensitivity was demonstrated by a limit of detection (LOD) of 0.0378 mg/ml and limit of quantification (LOQ) of 0.1147 mg/ml. Ruggedness, assessed by two analysts, showed %RSD values 0.801% and 0.751%. Robustness was evaluated at three wavelengths (284 nm, 285 nm, and 286 nm) yielding values of 1.705, 1.581, and 1.695, respectively. The study concluded that developed method was linear, accurate, precise, and cost-effective. It is suitable for routine analysis of BCO formulations.

Jyotsana Sonkar1,, Sarita Kumari Yadav2, Alok Mukerjee3, Mohammed Ibrahim Khan1, Danish Ahmed*1

October 2, 2026