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4882

Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation

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Last updated: 03 Jan 2025

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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.

DOI

10.21608/aprh.2018.4882

Keywords

cross linking, gamma radiation, Hard gelatin capsules, Liquid-filled capsules

Authors

First Name

Samia

Last Name

Omar

MiddleName

-

Affiliation

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo 11795, Egypt

Email

omarsamia3@hotmail.com

City

-

Orcid

-

First Name

Rania

Last Name

AbdelRashid

MiddleName

-

Affiliation

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo 11795, Egypt

Email

-

City

-

Orcid

-

First Name

Mohamed

Last Name

Assaly

MiddleName

-

Affiliation

Ministry of Interior, Medical Services Sector, Al Agooza Hospital, Cairo, Egypt

Email

mohamed_3asaly@hotmail.com

City

-

Orcid

-

First Name

Tamer

Last Name

Sakr

MiddleName

-

Affiliation

Radioactive Isotopes and Generators Department, Hot Laboratories Centre, Atomic Energy Authority, Cairo, Egypt , Pharmaceutical Chemistry Department, Faculty of Pharmacy, October University of Modern Sciences and Arts (MSA), Giza, Egypt

Email

tamer_sakr78@yahoo.com

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-

Orcid

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Volume

2

Article Issue

1

Related Issue

824

Issue Date

2018-01-01

Receive Date

2017-10-05

Publish Date

2018-01-01

Page Start

36

Page End

43

Print ISSN

2357-0547

Online ISSN

2357-0539

Article File

APRH_Volume 2_Issue 1_Pages 36-43.pdf

PDF . 716.6kB

Link

https://aprh.journals.ekb.eg/article_4882.html

Detail API

https://aprh.journals.ekb.eg/service?article_code=4882

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4

Type

Research Article

Type Code

318

Publication Type

Journal

Publication Title

Journal of Advanced Pharmacy Research

Publication Link

https://aprh.journals.ekb.eg/

MainTitle

Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation

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Article

Created At

22 Jan 2023