Abstract

A COMPREHENSIVE REVIEW ON THE FORMULATION, MANUFACTURING, AND EVALUATION OF PHARMACEUTICAL CAPSULES

Kavya S. U.*, Annapoorna T., S. Umme Shifa, Prashant H. K., Rohan Ahmmod, Mehebub Alom

Abstract

Capsules are widely utilized in oral drug delivery due to their ease of administration, formulation adaptability, and manufacturing efficiency. This review provides a detailed overview of hard and soft gelatin capsules, including their raw materials, shell composition, production processes and structural characteristics. The physicochemical properties of gelatin, particularly the influence of moisture content on mechanical strength, shell flexibility, integrity and stability, are examined critically. Distinctions between hard and soft gelatin capsules in terms of formulation design and functional applications are outlined. Standard evaluation procedures, including disintegration testing, moisture analysis, weight uniformity assessment, and structural integrity testing, which are essential for ensuring product performance and regulatory compliance, are discussed. The influence of environmental factors such as temperature and humidity on capsule stability is also addressed. The review further highlights recent advancements in capsule technology aimed at improving formulation, performance and regulatory compliance. Collectively, these considerations underscore the importance of integrated formulation and quality control strategies in ensuring consistent therapeutic effectiveness and product reliability.

Keywords: Hard gelatin capsule, Soft gelatin capsule, Capsule manufacturing, Excipients, Quality control, Non-gelatin capsules.