Abstract
SOFT GELATIN CAPSULES: APPLICATION OF QUALITY BY DESIGN (QbD) APPROACHES IN FORMULATION DEVELOPMENT AND STABILITY CHALLENGES
Dr. Ram Hari Tiwari
Deputy Manager, Quest Pharmaceuticals P. Ltd., Birgunj, Nepal
Abstract
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.
Keyword: Soft gelatin capsules; Quality by Design; Stability; Formulation; Manufacturing; Gelatin cross-linking; Drug deliver; Packaging
Article Information
| Article Type |
Review Article |
| Journal Name |
Global Journal of Pharmaceutical and Scientific Research
|
| ISSN |
3108-0103 |
| Volume |
Volume-2 |
| Issue |
Issue-10, October- 2025 |
| Corresponding Author |
Dr. Ram Hari Tiwari |
| Address |
Deputy Manager, Quest Pharmaceuticals P. Ltd., Birgunj, Nepal |
| Received |
03 Aug, 2026
|
| Revised |
11 Sep, 2026
|
| Accepted |
23 Sep, 2026
|
| Published |
02 Oct, 2026
|
| Pages |
1529-1559 |
