Chronopharmaceutical Drug Delivery from a Pulsatile Capsule Device based on Programmable Erosion

Ross, Alistair C.; MacRae, Ross J.; Walther, Mathias; Stevens, H. N. E.

doi:10.1211/0022357001774787

Cited by 62 publications

(24 citation statements)

References 22 publications

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“…[5][6][7] In order to achieve the chronopharmaceutical design for these time-controlled release preparations, currently formulation design to control the lag time is prior to the substantial release of drug. [8][9] Recently, a TIMERx technology with an erosion mechanism was developed to achieve the chronotherapeutic delivery system. 10 Ethylcellulose (EC) is a well-known water-insoluble polymer that has long been used as a rate-controlling membrane in medication dosage forms to regulate drug release.…”

Section: Introductionmentioning

confidence: 99%

Hydrophilic excipients modulate the time lag of time-controlled disintegrating press-coated tablets

Lin

2004

AAPS PharmSciTech

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An oral press-coated tablet was developed by means of direct compression to achieve the time-controlled disintegrating or rupturing function with a distinct predetermined lag time. This press-coated tablet containing sodium diclofenac in the inner core was formulated with an outer shell by different weight ratios of hydrophobic polymer of micronized ethylcellulose (EC) powder and hydrophilic excipients such as spray-dried lactose (SDL) or hydroxypropyl methylcellulose (HPMC). The effect of the formulation of an outer shell comprising both hydrophobic polymer and hydrophilic excipients on the time lag of drug release was investigated. The release profile of the press-coated tablet exhibited a time period without drug release (time lag) followed by a rapid and complete release phase, in which the outer shell ruptured or broke into 2 halves. The lag phase was markedly dependent on the weight ratios of EC/SDL or EC/HPMC in the outer shell. Different time lags of the press-coated tablets from 1.0 to 16.3 hours could be modulated by changing the type and amount of the excipients. A semilogarithmic plot of the time lag of the tablet against the weight ratios of EC/SDL or EC/HPMC in the outer shell demonstrated a good linear relationship, with r = 0.976 and r = 0.982, respectively. The predetermined time lag prior to the drug release from a presscoated tablet prepared by using a micronized EC as a retarding coating shell can be adequately scheduled with the addition of hydrophilic excipients according to the time or site requirements.

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Section: Introductionmentioning

confidence: 99%

Hydrophilic excipients modulate the time lag of time-controlled disintegrating press-coated tablets

Lin

2004

AAPS PharmSciTech

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“…These systems normally consist of a core and a coating. The core is coated with different barriers by film or compression, and the coating can prevent drug quick-release from the core until the shell is completely swollen or eroded by liquid substance in vivo (Ross et al, 2000;Li and Zhu, 2004). These new pharmaceutical preparations can exhibit drug release constantly at a steady rate, the slow and sustained…”

Section: Introductionmentioning

confidence: 99%

Preparation and release characteristics study on the novel minocycline hydrochloride sustained-release capsule

Zhao

Zhang

et al. 2016

Bangladesh J Pharmacol

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In present study, a novel minocycline hydrochloride sustained-release capsule was prepared with the new extrusion-spheronization method. The in vitro release studies were performed using marketed sample as a reference and data were analyzed in terms of cumulative release amounts as a function of time. Results demonstrated that the developed analysis method was reliable and convenient for the quantification and dissolution study of minocycline hydrochloride. The release characteristics of different batches of preparations were quite similar with each other, similarity factors f2 of 12 batches were all within 50-100, and our developed sample was similar to reference preparation in release characteristics in vitro. The developed sustained-release preparation may be a promising alternative dosage form for treatment of related diseases.

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“…4,5 Capsule-based pulsatile release systems have also been developed which are coated with a water-impermeable or semipermeable membrane containing a hydrogel polymer plug which swells with time after coming into contact with gastrointestinal fluid, and exerts an internal pressure leading to release of drug after rupture of the membrane. [6][7][8] Pulsatile tablet formulations are manufactured with a rapid-release core (reservoir) encased in a barrier layer formed by rupturable press coating or liquid coating of erodible and swelling polymer. [9][10][11] Polymers like various grades of Eudragit ® or ethyl cellulose have been tested as film coating to achieve the desired lag time.…”

Section: Introductionmentioning

confidence: 99%

Chronomodulated press-coated pulsatile therapeutic system for aceclofenac: optimization of factors influencing drug release and lag time

Patil¹,

Pund²,

Joshi³

et al. 2011

CPT

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Background:The objective of this study was to develop and evaluate a press-coated pulsatile drug delivery system intended for treatment of early morning stiffness and symptomatic relief from pain in patients with rheumatoid arthritis. Methods: The formulation involved press coating of a rupturable coat around a rapidly d isintegrating core tablet of aceclofenac. A three-factor, two-level, full factorial design was used to i nvestigate the influence of amount of glyceryl behenate, amount of sodium chloride in the coating c omposition, and the coating level on the responses, ie, lag time to release and amount of aceclofenac released in 450 minutes. Results: Glyceryl behenate and the coating level had a significant influence on lag time, while sodium chloride helped in the rupture of the coat by acting as a channeling agent. After the coat was ruptured, the core tablet showed a rapid release of aceclofenac due to the presence of Ac-Di-Sol ® . Graphical analysis of effects by Lenth's method and Bayesian analysis of coefficients enabled identification of variables active on the selected responses. The optimized formulation comprised 20% w/w glyceryl behenate and 2.2% w/w sodium chloride with a 650 mg coating level, and showed a desired lag time of 358.23 minutes, which mimics the fluctuating symptoms of rheumatoid arthritis, followed by rapid release of aceclofenac.

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Chronopharmaceutical Drug Delivery from a Pulsatile Capsule Device based on Programmable Erosion

Cited by 62 publications

References 22 publications

Hydrophilic excipients modulate the time lag of time-controlled disintegrating press-coated tablets

Hydrophilic excipients modulate the time lag of time-controlled disintegrating press-coated tablets

Preparation and release characteristics study on the novel minocycline hydrochloride sustained-release capsule

Chronomodulated press-coated pulsatile therapeutic system for aceclofenac: optimization of factors influencing drug release and lag time

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