A pulsatile drug delivery system based on rupturable coated hard gelatin capsules

Bussemer, Till; Dashevsky, Andrei; Bodmeier, Roland

doi:10.1016/j.jconrel.2003.08.012

Cited by 87 publications

(41 citation statements)

References 19 publications

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“…A pulsatile release profile, where the drug is released completely at once after a predetermined lag period of time, is advantageous in case of several drugs or therapies for the adaptation of therapeutic needs to circadian rhythms of body functions or diseases (Bussemer et al, 2003;Barzegar-Jalali et al, 2006). The understanding of circadian rhythm and their correlation in the risk of disease constitutes the rationale for chronotherapy.…”

Section: Introductionmentioning

confidence: 99%

Osmotically controlled pulsatile release capsule of montelukast sodium for chronotherapy: Statistical optimization,in vitroandin vivoevaluation

Ranjan¹,

Nayak²,

Reddy³

et al. 2013

Drug Delivery

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The purpose of present study was to design, optimize and evaluate osmotically controlled pulsatile release capsule (PRC) of montelukast sodium (MKS) for the prevention of episodic attack of asthma in early morning and associated allergic rhinitis. Assembly of the capsular systems consisted of push, active and plug tablet arranged from bottom to top in hard gelatin capsule. The capsule system was coated with a semi-permeable membrane of cellulose acetate and drilled towards plug side in cap. A three-factor, three-level central composite design (CCD) with ¼ 1 was introduced to execute the experiments and quadratic polynomial model was generated to predict and assess the independent variables with respect to the dependent variables. The composition of optimal formulation was determined as weight of push tablet 138 mg (coded value: þ0.59), plug tablet 60 mg (coded value: þ0.49) and coating weight gain of 8.4 mg (coded value: À0.82). The results showed that the optimal formulation of PRCs had lag time of 4.5 h, release at 6 and 12 h are 61.95% and 96.29%, respectively. The X-ray radiographic imaging study was carried out to monitor the in vivo behavior of developed barium sulfate-loaded PRCs in rabbits under fasting conditions. In vivo pharmacokinetic study revealed T max of 2 h for marketed tablets; however 7 h for PRCs with initial lag time of 4 h. Thus designed capsular system may be helpful for patients with episodic attack of asthma in early morning and associated allergic rhinitis.

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Section: Introductionmentioning

confidence: 99%

Osmotically controlled pulsatile release capsule of montelukast sodium for chronotherapy: Statistical optimization,in vitroandin vivoevaluation

Ranjan¹,

Nayak²,

Reddy³

et al. 2013

Drug Delivery

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“…The rate of medium uptake decreased with increasing coating level while the extent of medium uptake was almost the same for the different coating levels. Bussemer et al (2003a) found that the test conditions, such as surfactant addition to the release medium or floating vs complete immersion of capsules in the medium, affected the lag time. Li et al (2008) developed a novel system for threepulse drug release based on 'tablets in capsule' device.…”

Section: Time Controlled Systemmentioning

confidence: 98%

“…Polymers used for designing this hydrogel plug are various viscosity grades of HPMC, polyvinyl alcohol, PVA, and PEO. Bussemer et al (2003a) developed a PDDS based on hard gelatin capsules coated with the rupturable polymer. The objective of their study was to develop and evaluate a PDDS based on drug contained hard gelatin capsules coated first with a swelling layer and then with an outer insoluble, water-permeable polymeric coating.…”

Section: Time Controlled Systemmentioning

confidence: 99%

Chronopharmaceutics: As a clinically relevant drug delivery system

Gandhi¹,

Mundada²,

Gandhi³

2010

Drug Delivery

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“…There is no current successful pulsatile system of PTH release, although a variety of delivery strategies have been explored for the pulsatile release of other agents from polymeric implants [14][15][16][17][18][19]. Based on the triggering mechanisms, they can be classified as stimulus-induced pulsatile release systems and self-regulated pulsatile release systems.…”

Section: Introductionmentioning

confidence: 99%

Pulsatile release of parathyroid hormone from an implantable delivery system

et al. 2007

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Intermittent (pulsatile) administration of parathyroid hormone (PTH) is known to improve bone micro-architecture, mineral density and strength. Therefore, daily injection of PTH has been clinically used for the treatment of osteoporosis. However, this regimen of administration is not convenient and is not a favorable choice of patients. In this study, an implantable delivery system has been developed to achieve pulsatile release of PTH. A well-defined cylindrical device was first fabricated with a biodegradable polymer, poly(lactic acid) (PLLA), using a reverse solid free form fabrication technique. Three-component polyanhydrides composed of sebacic acid, 1,3-bis(pcarboxyphenoxy) propane and poly(ethylene glycol) were synthesized and used as isolation layers. The polyanhydride isolation layers and PTH-loaded alginate layers were then stacked alternately within the delivery device. The gap between the stacked PTH-releasing core and the device frame was filled with PLLA to seal. Multi-pulse PTH release was achieved using the implantable device. The lag time between two adjacent pulses were modulated by the composition and the film thickness of the polyanhydride. The released PTH was demonstrated to be biologically active using an in vitro assay. Timed sequential release of multiple drugs has also been demonstrated. The implantable device holds promise for both systemic and local therapies.

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A pulsatile drug delivery system based on rupturable coated hard gelatin capsules

Cited by 87 publications

References 19 publications

Osmotically controlled pulsatile release capsule of montelukast sodium for chronotherapy: Statistical optimization,in vitroandin vivoevaluation

Osmotically controlled pulsatile release capsule of montelukast sodium for chronotherapy: Statistical optimization,in vitroandin vivoevaluation

Chronopharmaceutics: As a clinically relevant drug delivery system

Pulsatile release of parathyroid hormone from an implantable delivery system

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