A scintigraphic investigation of the disintegration behaviour of capsules in fasting subjects: A comparison of hypromellose capsules containing carrageenan as a gelling agent and standard gelatin capsules

Tuleu, Catherine; Khela, Mandeep; Evans, David F.; Jones, B.E.; Nagata, Shunji; Basit, Abdul W.

doi:10.1016/j.ejps.2006.11.008

Cited by 52 publications

(22 citation statements)

References 11 publications

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“…Additionally, the in vivo data showed slower disintegration of HPMC gell compared to gelatin capsules in both, fasted and fed states. However, very similar in vivo disintegration times in fasted state for HPMC carr and gelatin capsules was reported by Tuleu et al [20]. …”

Section: Discussionsupporting

confidence: 84%

Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract

Glube

Moos

Duchateau

2013

Results in Pharma Sciences

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PurposeIn vitro disintegration and dissolution are routine methods used to assess the performance and quality of oral dosage forms. The purpose of the current work was to determine the potential for interaction between capsule shell material and a green tea extract and the impact it can have on the release.MethodsA green tea extract was formulated into simple powder-in-capsule formulations of which the capsule shell material was either of gelatin or HPMC origin. The disintegration times were determined together with the dissolution profiles in compendial and biorelevant media.ResultsAll formulations disintegrated within 30 min, meeting the USP criteria for botanical formulations. An immediate release dissolution profile was achieved for gelatin capsules in all media but not for the specified HPMC formulations. Dissolution release was especially impaired for HPMCgell at pH 1.2 and for both HPMC formulations in FeSSIF media suggesting the potential for food interactions.ConclusionsThe delayed release from studied HPMC capsule materials is likely attributed to an interaction between the catechins, the major constituents of the green tea extract, and the capsule shell material. An assessment of in vitro dissolution is recommended prior to the release of a dietary supplement or clinical trial investigational product to ensure efficacy.

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Section: Discussionsupporting

confidence: 84%

Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract

Glube

Moos

Duchateau

2013

Results in Pharma Sciences

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“…The mean disintegration time of gelatin capsules was the shortest, and the other three are similar; however, there were no statistical differences between the four (P > 0.05). This is consistent with the previous reports (Brown et al, 1998;Cole et al, 2004;Tuleu et al, 2007), indicating that vegetable capsules have longer disintegration times than their counterparts but they have no statistical differences. It seems that this is not accordance to the bioavailability studies, which show Qualicaps® a shortest T max .…”

Section: Gamma-scintigraphic Studiessupporting

confidence: 93%

Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration

Guo

et al. 2012

Chin. J. Ocean. Limnol.

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Gelatin has been used in hard capsule shells for more than a century, and some shortcomings have appeared, such as high moisture content and risk of transmitting diseases of animal origin to people. Based on available studies regarding gelatin and vegetable shells, we developed a new type of algal polysaccharide capsule (APPC) shells. To test whether our products can replace commercial gelatin shells, we measured in-vivo plasma concentration of 12 selected volunteers with a model drug, ibuprofen, using high performance liquid chromatography (HPLC), by calculating the relative bioavailability of APPC and Qualicaps® referenced to gelatin capsules and assessing bioequivalence of the three types of shells, and calculated pharmacokinetic parameters with the software DAS 2.0 (China). The results show that APPC shells possess bioequivalence with Qualicaps® and gelatin shells. Moreover, the disintegration behavior of four types of shells (APPC, Vegcaps®, Qualicaps® and gelatin shells) with the content of lactose and radioactive element ( 99m Tc) was observed via gamma-scintigraphic images. The bioavailability and gamma-scintigraphic studies showed that APPC was not statistically different from other vegetable and gelatin capsule shells with respect to in-vivo behavior. Hence, it can be concluded that APPCs are exchangeable with other vegetable and gelatin shells.

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“…As charcoal is an insoluble material, the homogeneously distributed particles would only be able to separate from the matrix following erosion of the polymer layer around it (rather than by diffusion through the matrix, which would occur for a water soluble particle). The study of disintegration is not, however, limited to matrix tablet formulations; scintigraphic imaging has also aided in confirming performance of hard-shell capsules for ubiquitous formulation use [50]. MMI has also been reported as a suitable in vivo method for visualization and evaluation of oral dose disintegration [5,7], as has the magnetic technique ACB [49].…”

Section: In Vivo Erosion and Formulation Robustnessmentioning

confidence: 99%

IN VIVO IMAGING FOR VALIDATION OF ORAL DOSE PERFORMANCE

McInnes¹,

Stevens²

2013

Drug Delivery Applications of Noninvasive Imaging

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A scintigraphic investigation of the disintegration behaviour of capsules in fasting subjects: A comparison of hypromellose capsules containing carrageenan as a gelling agent and standard gelatin capsules

Cited by 52 publications

References 11 publications

Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract

Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract

Effects of alga polysaccharide capsule shells on in-vivo bioavailability and disintegration

IN VIVO IMAGING FOR VALIDATION OF ORAL DOSE PERFORMANCE

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