Performance qualification of a new hypromellose capsule: Part II. Disintegration and dissolution comparison between two types of hypromellose capsules

Ku, M. Sherry; Lu, Qinghong; Li, Weiyi; Chen, Yansong

doi:10.1016/j.ijpharm.2011.02.048

Cited by 33 publications

(15 citation statements)

References 21 publications

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“…Thus far, there are a few studies published looking at the in vitro rupture time of HPMC capsules, however most of the methods used were different from the USP guidelines applied in our experiments or focus on other active ingredients; e.g. Chiwele et al [14] employed a ball bearing method, El-Malal and Nazzal [15] and Ku et al [16] used the USP apparatus II with real time dissolution spectroscopy and Vardakou et al [17] estimated capsule rupture time with a USP apparatus I as well as with a novel in vitro dynamic gastric model. From those experiments, a trend for increased rupture time in the following order was observed: Gelatin capsules < HPMC carr < HPMC < HPMC gell .…”

Section: Discussionmentioning

confidence: 99%

“…Similar trends were found in various in vivo scintigraphic measurements to estimate capsule rupture time as well as in in vitro dissolution studies. Ku et al showed that HPMC is favourable over HPMC carr (HPMC capsules containing carrageenan as a gelling agent) with respect to rupture time at low pH but in vitro dissolution profiles with a range of compounds at higher pH were similar [17]. The differences in rupture time between the capsules with and without gelling agent are however small (∼3 min) in relation to the time of a dissolution test (60 min).…”

Section: Discussionmentioning

confidence: 99%

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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: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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 first 5 min of acetaminophen release from Capsule 4 was slow and this can be attributed to the time required for the hydration of HPMC shells 18 and the ingress of medium through the shell. Capsule 5 and 6 showed signs of leaking but without any noticeable rupture initially which may indicate the need for an enteric band to seal the cap onto the body of the capsules if these capsules are to function properly.…”

mentioning

confidence: 99%

Performances of New Generation of Delayed Release Capsules

Al-Tabakha¹,

Arida²,

Fahelelbom³

et al. 2014

JYP

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Objective: The purpose of this study was to verify the claimed acid-resistant properties and other performance indicators for AR Caps (Capsule 5 from CapsCanada) and DRcaps (Capsule 6 from Capsugel) and compare them with the immediate release hydroxypropyl methylcellulose "HPMC" capsules (K-CAPS from CapsCanada). Methods: Shell weight variability, reaction to different relative humidity conditions, empty shells response to stress under the absence of moisture, powder leaking, disintegration and dissolution properties were assessed. Results: Shell weight variability was highest among Capsule 4. At 45% RH and 23 o C different types of capsules had similar loss on drying (LOD range: 5.23% -6.68%). In the absence of moisture and following the application of a stress, empty Capsule 4 shells performed the best with the highest percentage of intactness of capsules (80%) followed by Capsule 6 (50%) and then Capsule 5 (20%). Both disintegration and dissolution test results for Capsule 4 deemed satisfactory for conventional release purposes, but Capsule 5 and 6 do not comply with the USP requirement for delayed-release dosage form. None of the tested capsules have the ability to protect hygroscopic encapsulated material from humid conditions as generally claimed. Conclusion: While HPMC capsule made for conventional release properties may be fit for that purpose, the new generation of capsules designed to protect the ingredient from the acid environment of stomach have not performed in such a manner as to comply with the USP requirements for disintegration and dissolution of delayed-release dosage form.

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“…Obviously, the transport phenomenon concerns electric charge carriers, including organic and non-organic ions. It must be recalled that the tablet dissolution testing is one of the most important test during the developments of solid dosage forms (Ku et al 2011).…”

Section: Resultsmentioning

confidence: 99%

Modeling of the Dissolution Kinetics of Arbutus Wild Berries-Based Tablets as Evaluated by Electric Conductivity

Abbas-Aksil¹,

Salem²

2015

JSM

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Performance qualification of a new hypromellose capsule: Part II. Disintegration and dissolution comparison between two types of hypromellose capsules

Cited by 33 publications

References 21 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

Performances of New Generation of Delayed Release Capsules

Modeling of the Dissolution Kinetics of Arbutus Wild Berries-Based Tablets as Evaluated by Electric Conductivity

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