Formulation and development of orodispersible sustained release tablet of domperidone

Abstract

Abstract:Commercially available domperidone orodispersible tablets (ODT) are intended for immediate release of the drug but none of them have been formulated for sustained action. The aim of the present research work was to develop and evaluate orodispersible sustained release tablet (ODT-SR) of domperidone, which has the convenience of ODT and benefits of controlled release product combined in one. The technology comprised of developing sustained release microspheres (MS) of domperidone, followed by direct compression of MS along with suitable excipients to yield ODT-SR which rapidly disperses within 30 seconds and yet the dispersed MS maintain their integrity to have a sustained drug release. The particle size of the MS was optimized to be less than 200 μm to avoid the grittiness in the mouth. The DSC thermograms of MS showed the absence of drug-polymer interaction within the microparticles, while SEM confirmed their spherical shape and porous nature. Angle of repose, compressibility and Hausner's ratio of the blend for compression showed good flowability and high percent compressibility. The optimised ODT-SR showed disintegration time of 21 seconds and matrix controlled drug release for 9 h. Invivo pharmacokinetic studies in Wistar rats showed that the ODT-SR had a prolonged MRT of 11.16 h as compared 3.86 h of conventional tablet. The developed technology is easily scalable and holds potential for commercial exploitation.

Improved therapeutic potential of tapentadol employing cationic exchange resins as carriers in neuropathic pain: evidence from pharmacokinetic and pharmacodynamics study

“…Peak plasma concentration of pure drug and DRC had no significant difference. However, T max achieved by DRC was 2.67-fold higher compared to pure drug indicating sustained absorption of drug from formulation under in vivo condition 37 , 41 . Plasma concentration – time profile of DRC showed significantly higher plasma drug concentration after 2 h of its post administration compared to free drug.…”

“…S2 ). Thus, swelling time of complex and slower diffusion of exchange ions (H + /drug ion) across hydrated resin matrix due to increased path length gradually slowed down the release rate and prolonged the duration of drug release 32 , 40 , 41 .…”

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

“…The purpose is reducing the number of daily doses of medicines maintaining the plasmatic levels of drugs without high fluctuation. The use of functional polymeric nano and microparticules and ion exchange resins are among the technological strategies exploited for this purpose (38,39).…”

“…One of the first medical devices using this technology was launched in the United States market in 2003 -Chloraseptic relief strips®, which is a fastdissolving tape containing local anesthetics for throat inflammation. The industrial production of these devices might use the assembly lines of transdermal patches (38,(40)(41)(42). Another new approach in the orodispersible technology is the production of orodispersible mini tablets (tablets with a diameter of 3 mm or less).…”

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine

“…In the recent years, ODTs have gained tremendous attention due to convenience to a large number of population owing to their ease of administration, ease of swallowing, pleasant taste, improved patient compliance, rapid onset of action and enhanced bioavailability as well as one of the aspects of life-cycle management of the product [10][11][12][13][14] . ODTs are solid, single unit dosage forms that disintegrate in mouth within matter of seconds when placed on tongue without the aid of water.…”