Chronotherapeutic drug delivery for early morning surge in blood pressure: A programmable delivery system

Nayak, Usha Yogendra; Shavi, Gopal Venkatesh; Nayak, Yogendra; Averinen, Ranjith Kumar; Mutalik, Srinivas; Reddy, Sreenivasa M; Gupta, Purshottam Das; Udupa, N.

doi:10.1016/j.jconrel.2009.02.008

Cited by 40 publications

(25 citation statements)

References 19 publications

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“…The lag time is controlled by a plug which is pushed away by swelling/erosion and the drug is released as a ''pulse'' from the insoluble capsule body. The Pulsincap is one of such system which is capable of releasing its drug at a predetermined time (Krogel & Bodmeier, 1998;Nayak et al, 2009). Nayak et al (2009) has modified this technology, the hydrogel plug has been replaced by an erodible tablet, which has a tight fit in the capsule to prevent entry of fluid.…”

Section: Introductionmentioning

confidence: 99%

“…The Pulsincap is one of such system which is capable of releasing its drug at a predetermined time (Krogel & Bodmeier, 1998;Nayak et al, 2009). Nayak et al (2009) has modified this technology, the hydrogel plug has been replaced by an erodible tablet, which has a tight fit in the capsule to prevent entry of fluid. The OROS Push-Pull system was developed by ALZA to overcome the challenges of delivering poorly soluble drugs using osmotic drug delivery.…”

Section: Introductionmentioning

confidence: 99%

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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%

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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“…There was a potential problem of variable gastric residence time, which was overcome by enteric coating the system to allow its dissolution only in the higher pH region of small intestine [15][16][17][18][19] ( Figure 4). …”

Section: A Single Unit Systemmentioning

confidence: 99%

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2012

IJPSR

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Many therapeutic agents are most effective when made available at constant rates, near the absorption sites or at the correct time of administration. Pulsatile drug delivery system is the most interesting time-specific and sitespecific system. This system is designed for chronopharmacotherapy which is based on circadian rhythm. Recently a greater effort has been taken in designing delivery systems which synchronize drug delivery with circadian rhythms in order to optimize efficacy and /or minimize side effects. Pulsatile systems deliver the drug at right site of action at the right time and in the right amount. Chronotherapeutics is the discipline concerned with the delivery of drugs according to inherent activities of a disease over a certain period of time. Chronotherapy can particularly benefit patients suffering from allergic rhinitis, rheumatoid arthritis and related disorders, asthma, cancer, cardiovascular diseases, and peptic ulcer disease. This review gives an outline as to how pulsatile drug delivery systems based on circadian rhythms are developed.

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“…Although regulatory concerns were raised by the use of the hydrogel polymer, the tolerability and patient compliance of a four-week placebo treatment that involved multiple daily dosing were established (Binns et al, 1996). However, erodible hydrophilic polymers, such as HPMC of various viscosity grades, PVA, PEO, guar gum and sodium alginate, were later employed as alternative matrix-forming agents to prepare the release-controlling plug Ross et al, 2000;Gohel and Sumitra, 2002;Mastiholimath et al, 2007;Nayak et al, 2009;McConville et al, 2009). In some instances, effervescent or highly swellable (e.g.…”

Section: Delivery Systems Based On Release-controlling Plugsmentioning

confidence: 99%