The Shell Dissolution of Various Empty Hard Capsules.

Chiwele, Irene; Jones, B.E.; Podczeck, Fridrun

doi:10.1248/cpb.48.951

Cited by 76 publications

(39 citation statements)

References 1 publication

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“…However, longer HGC rupture times were observed n phosphate buffer (pH 7.4) than in deionized water (p<0.001). These results are in agreement with those previously presented by Chiwele et al (2000), which showed that presence of potassium and/or calcium ions in the dissolution medium significantly delayed the rupture of HGCs containing acetaminophen, while the effect of pH on HGC dissolution was minimal 22 .…”

Section: Effects Of Dissolution Medium and γ-Radiation Dose On Hgc Insupporting

confidence: 93%

“…The covalent bonding produced by this type of crosslinking is irreversible, and dissolution of the shell must involve breaking the peptide bonds enzymatically or by changing the pH or temperature. Water did not dissolve the HGC shells well at temperatures below 30°C 11,22 , thus, HGC dissolution was estimated at 37°C.…”

Section: Figure 1 Ftir Spectra Of (A) Non-irradiated Hgcs (F1) and Hmentioning

confidence: 99%

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

Omar

Abdel-Rashid

Assaly³

et al. 2018

Journal of Advanced Pharmacy Research

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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.

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Section: Effects Of Dissolution Medium and γ-Radiation Dose On Hgc Insupporting

confidence: 93%

Section: Figure 1 Ftir Spectra Of (A) Non-irradiated Hgcs (F1) and Hmentioning

confidence: 99%

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

Omar

Abdel-Rashid

Assaly³

et al. 2018

Journal of Advanced Pharmacy Research

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“…The dissolution time of the HPMC capsules was slightly higher than that determined for gelatin hard capsules (Table 3), confirming the data reported in the literature. 13 Both the capsule hardness and the dissolution time did not seem to be significantly affected (1-way ANOVA, P 9 .05) by the nature of radiation used and the applied irradiation dose ( Table 3). …”

Section: Technological Performancesmentioning

confidence: 90%

Comparison between gamma and beta irradiation effects on hydroxypropylmethylcellulose and gelatin hard capsules

et al. 2005

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The effects of electron beam or γ-irradiation on technological performances (capsule hardness, expressed as deforming work and dissolution time) of empty 2-shell capsules made of gelatin or hydroxypropylmethylcellulose (HPMC) were studied. Capsule structural changes induced by radiation treatment were investigated by capillary viscometry and atomic force microscopy (AFM). The capsules were irradiated in the air at 5, 15, and 25 kGy. The deforming work of nonirradiated HPMC capsules (0.06 ± 0.01 J) was lower than that of gelatin capsules (0.10 ± 0.01 J). The dissolution time of the HPMC capsules (414 ± 33 seconds) was slightly higher than that determined for gelatin hard capsules (288 ± 19 seconds). The hardness and dissolution time of gelatin and HPMC capsules were not significantly influenced by the irradiation type and the applied irradiation dose. As the viscometry analyses are concerned, irradiation caused a reduction of the intrinsic viscosity and water and dimethyl sulfoxide solvent power in both the cases. AFM analysis showed that the radiation treatment did not appreciably affect the surface roughness of the samples nor induce structural changes on capsule surface. However, measurements of force-distance curves pointed out a qualitative parameter for the identification of the irradiated capsules. On the bases of these preliminary results, empty gelatin or HPMC hard capsules can be sanitized/ sterilized by ionizing radiation.

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“…However, gelatin capsule shells failed to dissolve below 30 °C. Thus, in order to ensure therapeutic efficacy, gelatin capsules should preferably be ingested with warm drinks and HPMC capsules can be administered with cold or warm drinks [38].…”

Section: Effect Of Temperature Of Dissolution Mediummentioning

confidence: 99%

“…Statistically significant differences in dissolution times were observed for HPMC capsules of size 0 and 3 [38]. In another study, no difference in drug release profile could be seen in HPMC capsules of different sizes, prepared without gelling agent [16].…”

Section: Effect Of Size Of Capsulementioning

confidence: 99%

HPMC as Capsule Shell Material: Physicochemical, Pharmaceutical and Biopharmaceutical Properties

Majee¹,

Avlani²,

Biswas³

2017

Int J Pharm Pharm Sci

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The most common instability problem of gelatin capsules arises from negative impact of extremes of temperature and especially atmospheric relative humidity on the mechanical integrity of the capsule shells with adverse effect extended even to the fill material. Moreover, choice of fill materials is highly restricted either due to their specific chemical structure, physical state or hygroscopicity. Additional reports of unpredictable disintegration and dissolution of filled hard gelatin capsules in experimental studies have prompted the search for a better alternative capsule shell material. The present review aims to provide an overview on the physicochemical, pharmaceutical and biopharmaceutical properties of hydroxypropyl methylcellulose (HPMC) as capsule shell material and perform comparative evaluation of HPMC and gelatin in terms of in vitro/in vivo performance and storage stability. HPMC capsule provides a highly flexible and widely acceptable platform capable of solving numerous challenges currently facing the pharmaceutical and nutraceutical industries and expands the possibilities for selection of different types of fill materials. The current topic introduces a new section on influence of various factors on in vitro dissolution of HPMC capsules. Delayed in vitro disintegration/dissolution of HPMC capsules in aqueous medium does not produce any negative effect in vivo. However, advancements in the processes of production and filling of HPMC capsule shells and detailed studies on effects of various parameters on their in vitro/in vivo dissolution would establish their supremacy over hard gelatin capsules in future.

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The Shell Dissolution of Various Empty Hard Capsules.

Cited by 76 publications

References 1 publication

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

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

Comparison between gamma and beta irradiation effects on hydroxypropylmethylcellulose and gelatin hard capsules

HPMC as Capsule Shell Material: Physicochemical, Pharmaceutical and Biopharmaceutical Properties

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