Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation | ||
| Journal of Advanced Pharmacy Research | ||
| Article 4, Volume 2, Issue 1, January 2018, Pages 36-43 PDF (699.81 K) | ||
| Document Type: Research Article | ||
| DOI: 10.21608/aprh.2018.4882 | ||
| Authors | ||
| Samia Omar* 1; Rania AbdelRashid1; Mohamed Assaly2; Tamer Sakr3, 4 | ||
| 1Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo 11795, Egypt | ||
| 2Ministry of Interior, Medical Services Sector, Al Agooza Hospital, Cairo, Egypt | ||
| 3Radioactive Isotopes and Generators Department, Hot Laboratories Centre, Atomic Energy Authority, Cairo, Egypt | ||
| 4Pharmaceutical Chemistry Department, Faculty of Pharmacy, October University of Modern Sciences and Arts (MSA), Giza, Egypt | ||
| Abstract | ||
| Objective: Directly incorporating aqueous solutions into hard gelatin capsules (HGCs) without dispersing them in an oily medium is considered a challenge for most researchers and manufacturers. The aim of the study is to evaluate the effect of gamma radiation (ɣ-radiation) on the adaptation of HGCs for aqueous solution delivery. Methods: Empty HGC shells were exposed to four of ɣ-radiation doses (1, 3, 5, 10 kGy). Then, the physicochemical properties of irradiated capsules were evaluation and compared with those of non-irradiated capsules. Fourier-transform infrared spectroscopy (FT-IR), capsule hardness, and water incorporation tests were performed. In-vitro disintegration/dissolution behavior determined as (rupture time) in different dissolution media was evaluated.Results: The results showed direct proportionality between the ɣ-radiation dose and HGC crosslinking degree up to 3 kGy, while at doses >3 kGy, degradation rather than crosslinking occurred. The results were clearly demonstrated by FTIR as peptide linkages between gelatin molecules.All the ɣ-irradiated HGCs submitted to hardness test were completely deformed without rupture with increasing capsule deformation work (J) for γ-radiation doses up to 3 kGy; the deformation work declined at doses >3 kGy. The water incorporation study revealed that capsules exposed to 3 kGy could hold up to 100 ml of methylene blue solution without deformation or leakage for 45 minutes compared with non-irradiated HGCs, which showed a significantly lower tolerance of only 2 minutes (p<0.001). The crosslinking of HGCs had a minor significant effect on in-vitro rupture time, especially at gastric pH. Conclusion:The irradiation technique may be used not only for sterilizing HGCs but also for adapting HGCs for aqueous solutions delivery, as it showed a significant positive effect, which was optimal at a dose of 3 kGy. However, these results are not sufficient for scaled-up manufacturing; thus, further investigations are strongly recommended. | ||
| Keywords | ||
| cross linking; gamma radiation; Hard gelatin capsules; Liquid-filled capsules | ||
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