Influence of capsule shell composition on the performance indicators of hypromellose capsule in comparison to hard gelatin capsules

• Published in: Drug development and industrial pharmacy 2015-01, Vol.41 (10), p.1726-1737
• Main Authors: Al-Tabakha, Moawia M., Arida, Adi Issam, Fahelelbom, Khairi M. S., Sadek, Bassem, Saeed, Dima Ahmed, Abu Jarad, Rami A., Jawadi, Jeevani
• Format: Article
• Language: English
• Subjects: Acetaminophen - chemistry; Capsules - chemistry; Chemistry, Pharmaceutical; Dissolution; Drug Liberation; Gelatin - chemistry; hard gelatin capsules; Humidity; hygroscopicity; hypromellose capsules; Hypromellose Derivatives - chemistry; initial disintegration time; Povidone - chemistry; powder leakage; resistance to stress; shell weight variation; Solubility; Temperature; Wettability
• ISSN: 0363-9045; 1520-5762
• DOI: 10.3109/03639045.2014.1002409

The purpose of this study was to assess the in vitro performances of "vegetable" capsules in comparison to hard gelatin capsules in terms of shell weight variation, reaction to different humidity conditions, resistance to stress in the absence of moisture, powder leakage, disintegration and dissolution. Two types of capsules made of HPMC produced with (Capsule 2) or without (Capsule 3) a gelling agent and hard gelatin capsules (Capsule 1) were assessed. Shell weight variability was relatively low for all tested capsules shells. Although Capsule 1 had the highest moisture content under different humidity conditions, all capsule types were unable to protect the encapsulated hygroscopic polyvinylpyrrolidone (PVP) powder from surrounding humidity. The initial disintegration for all Capsule 1 occurred within 3 min, but for other types of capsules within 6 min (n = 18). Dissolution of acetaminophen was better when the deionized water (DIW) temperature increased from 32 to 42 °C in case of Capsule 1, but the effect of temperature was not significant for the other types of capsules. Acetaminphen dissolution from Capsule 1 was the fastest (i.e. >90% in 10 min) and independent of the media pH or contents unlike Capsule 2 which was influenced by the pH and dissolution medium contents. It is feasible to use hypromellose capsules shells with or without gelling agent for new lines of pharmaceutical products, however, there is a window for capsule shells manufacturing companies to improve the dissolution of their hypromellose capsules to match the conventional gelatin capsule shells and eventually replace them.