FORMULATION AND EVALUATION OF DOMPERIDONE ORODISPERSIBLE TABLETS

Journal of Global Pharma Technology, 2013

Now day's formulation research is breaking barriers of conventional methods. Today, active ingredients can be delivered with a level of convenience, performance and bioavailability never seen in the market place. Fast disintegrating or Mouth dissolving tablet (ODTs) is one such novel approach to increase consumer acceptance by virtue of rapid disintegration, self administration without water or chewing. This novel type of delivery system offers convenience for treatment-resistant population who have difficulty in swallowing unit oral dosage form, namely Tablets and Capsules. These formulations are particularly beneficial to pediatric and geriatric patients. It is estimated that 50 % of the population is affected by dysphagia which results in high incidence of non-compliance and ineffective therapy. The aim of this article is to review the ideal properties, significance, characteristics, limitation, choice of drug candidates, challenges in formulation, approaches for preparation of ODTs, Patented technologies on ODTs, Suitable drug candidates for ODTs, and Evaluation tests of ODTs.

Zenodo (CERN European Organization for Nuclear Research), 2023

Oral route is presently the gold standard in the pharmaceutical industry where it is regarded as the safest, most economical and most convenient method of drug delivery resulting in highest patient compliance. Oral delivery of active ingredients includes a number of technologies, many of which may be classified as Orodispersible tablets (ODTs). Orodispersible dosage forms have lured the market for a certain section of the patient population which includes dysphagia, bed ridden, psychic, and geriatric patients. Moreover, Orodispersible tablets shows increased bioavailability as compared to conventional dosage forms. Advancements in the technology arena for manufacturing these systems includes the use of freeze drying, cotton candy, melt extrusion, sublimation, direct compression besides the classical wet granulation processes. This has encouraged both academia and industry to generate new orally disintegrating formulations and technological approaches in this field. This article attempts at discussing the ideal characteristics, advantages and disadvantages, formulation aspects, formulation technologies and future potential of ODTs.

Drug development and industrial pharmacy, 2015

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 ...

2012

Recent advances in novel drug delivery (NDDS) aims to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for ease of administration and to achieve better patient compliance. One such approach is oral disintegrating tablets (ODTs). ODTs are a solid unit dosage form, which disintegrates or dissolves rapidly in the mouth without the general requirement for swallowing, the chewing and water. Yet, dysphasia is the most common disadvantage of conventional tablets. To overcome such problems, certain innovative drug delivery systems, like ‘Mouth Dissolving Tablets’ (MDT) have been developed. These are novel dosage forms which dissolve in saliva within a few seconds, when put on tongue. Such MDTs can be administered anywhere and anytime, without the need of water and are thus quite suitable for children, elderly and mentally disabled patients.

Difficulty in swallowing (dysphagia) is common among all age groups, especially for geriatric and pediatric patients. Oral dispersible tablets (ODT) constitute an innovative dosage form that overcome the problems of swallowing and provides a quick onset of action. The aim of the present research was to prepare taste masked oral dispersible tablets by sublimation method and investigate the effects of super disintegrant (Kollidon CL) on the disintegration time as well as the percent release of a model drug from Kollidon 30, Ispaghula husk and Guar Gum based formulations. Domperidone, an anti-emetic drug was taken as the model drug for the study. A high porosity was achieved using camphor as volatilizing agent which allowed easy penetration of dissolution media followed by rapid release of drug. The granules and tablets were evaluated and found to be acceptable according to standard limits. In vitro release studies were performed using USP apparatus-II (paddle method) in 900ml of 0.1N HCl (pH 1.2) at 50rpm. The release mechanisms were explored and explained with different kinetic model. Kollidon CL was found to cause a rapid disintegration of ODTs within 24 to 39 seconds. The highest drug release was obtained from F-6 (88.19%) containing Ispaghula husk. Finally, the overall study indicate a proper balance between the rate retarding polymers and disintegrant having a drug release profile of ODT under the presence of a volatilizing agent showed an acceptable disintegration time with a percent of drug release.

The purpose of this investigation was to enhancement of solubility of cinnarizine by using solid dispersion technique solvent evaporation method using polymer PEG 6000 & develop combination ODT of cinnarizine with domperidone by using direct compression technique using crospovidone, croscarmellose sodium and sodium starch glycolate as a superdisintegrants. The preformulation study includes the compatability of drugs with the polymers by using FTIR,UV,TLC. The batches were evaluated for weight variation, hardness, friability, drug content, wetting time, IN In-vitro dispersion, in-vitro dissolution. The formulation F2 which contain 8% crospovidone and 10 % sodium starch glycolate showed best results and rapid in-vitro dissolution. The results revealed that the tablets containing superdisintegrants combination had a good dissolution profile. The drug content of all the batches was within the acceptable limits of the United States Pharmacopoeia with maximum drug being released at all time intervals. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance. The results conclusively demonstrate successful enhancement of solubility, disintegration and dissolution of the formulated tablets.

Journal of Pharmaceutical Research International

The objective of the current work is to formulate and evaluate the mouth dissolving film of domperidone. It is ideally suitable for the treatment of emesis. The mouth dissolving film of domperidone is useful in the vomiting through the journey. Mouth dissolving films were formulated by the solvent casting technique and its in-vitro as well as the in-vivo evaluation was done by the usual pharmacopoeial and unofficial tests and by using human volunteers. The main benefit of the preparation technique includes fewer operation units, better content consistency. The mouth dissolving film formed was found to be disintegrated in 1 minute. The ratio of components in the aqueous phase affected the thickness, drug content, tensile strength, percentage elongation, folding endurance, and release profile of mouth dissolving film and the best results were obtained for the HPMC E15 and polyethyleneglycol. The compatibility between domperidone and excipients was confirmed by FTIR and DSC studies. Th...

Oral Delivery Systems have proven through time as best kind of approach for delivering various drugs. But certain drugs given by oral route undergo extensive First pass metabolism which leads to low bioavailability, making them less effective. To overcome this Novel Oral Drug Delivery Systems, i.e., Chewing Gums were developed as an alternate for conventional oral systems. These were used for both systemic and local delivery of drugs. These systems have advantages like increased patient compliance, increased Bioavailability and self administration. Domperidone, an anti emetic drug was given in the form of chewing gums in this study. As this drug is poorly water soluble, to enhance its solubility, solubilizers were used in various ratios. For the obtained formulations, evaluation studies were carried out. Weight variation, Drug content values were found to be within standard limits prescribed. In vitro studies were carried out using modified disintegration apparatus and all the formulations showed release between 70-90%. Ex vivo studies were carried out using porcein buccal mucosa and up to 60% of drug release was found. Drug excipient compatibility was studied by FTIR studies. ANOVA was performed to determine significance between formulations.

Int J PharmTech Res, 2009

Domperidone, an antiemetic drug, has been used as an add-on treatment in adults and children. As precision of dosing and patient's compliance become important prerequisite for quick relief from emesis, there is a need to develop a formulation for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while traveling and better compliance. Hence, the present research work was held to develop a fast dissolving tablet of domperidone, prepared with Avicel PH 102 and Sodium Starch Glycolate by direct compression method. All formulations were evaluated for characteristics such as hardness, friability, disintegration time and Dissolution rate. An effective, pleasant tasting formulation was found to have a good hardness of 3 kg/cm 2 , disintegration time of 27+1 seconds and in vitro drug release of not less than 95% within 30 minutes. The drug release was found to be comparable with the marketed dispersible tablet.

Journal of Natural Science, Biology and Medicine, 2010

The most common and preferred route of drug administration is through the oral route. Orodispersible tablets are gaining importance among novel oral drug-delivery system as they have improved patient compliance and have some additional advantages compared to other oral formulation. They are also solid unit dosage forms, which disintegrate in the mouth within a minute in the presence of saliva due to super disintegrants in the formulation. Thus this type of drug delivery helps a proper peroral administration in pediatric and geriatric population where swallowing is a matter of trouble. Various scientists have prepared orodispersible tablets by following various methods. However, the most common method of preparation is the compression method. Other special methods are molding, melt granulation, phase-transition process, sublimation, freeze-drying, spray-drying, and effervescent method. Since these tablets dissolve directly in the mouth, so, their taste is also an important factor. Various approaches have been taken in order to mask the bitter taste of the drug. A number of scientists have explored several drugs in this fi eld. Like all other solid dosage forms, they are also evaluated in the fi eld of hardness, friability, wetting time, moisture uptake, disintegration test, and dissolution test.