Omar, S., AbdelRashid, R., Assaly, M., Sakr, T. (2018). Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation. Journal of Advanced Pharmacy Research, 2(1), 36-43. doi: 10.21608/aprh.2018.4882
Samia Omar; Rania AbdelRashid; Mohamed Assaly; Tamer Sakr. "Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation". Journal of Advanced Pharmacy Research, 2, 1, 2018, 36-43. doi: 10.21608/aprh.2018.4882
Omar, S., AbdelRashid, R., Assaly, M., Sakr, T. (2018). 'Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation', Journal of Advanced Pharmacy Research, 2(1), pp. 36-43. doi: 10.21608/aprh.2018.4882
Omar, S., AbdelRashid, R., Assaly, M., Sakr, T. Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation. Journal of Advanced Pharmacy Research, 2018; 2(1): 36-43. doi: 10.21608/aprh.2018.4882
Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation
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.
View on SCiNiTO
Top