how to take orally disintegrating tablets

In a study commissioned by Hermes Pharma and conducted by Spiegel Institut Mannheim based on 2,000 individuals in Germany and North America (www.epmmagazine.com accessed Sep.23, 2016). The bioavailability of ODTs is mostly comparable with that of other oral dosage forms such as conventional tablets and capsules, and bioequivalence has already been demonstrated for selected formulations. In-vitro dissolution test. Recent market studies indicate that more than half of the patient population prefers orally disintegrating dosage forms and most consumers would ask their doctors for ODTs (70%), purchase ODTs (70%). Time for the ODT to pass through the 10-mesh screen considered as disintegration time, Mouth dissolving tablet placed on a wire gauze immersed in the medium is compressed by a rotary shaft, Rotation speed and mechanical stress control the disintegration time, Constant penetration force using flat-ended probe is applied to the mouth dissolving tablet concomitantly while immersing in the aqueous medium. Smaller particles make for a better mouthfeel in an ODT; larger particles give a gritty sensation as the tablets disintegrate. The graph shown in Figure 3 shows the comparison of metabolites formed in a standard 10-mg selegeline tablet, and a 1.25-mg ODT formulation of the same active. Chewable Oral Drug Products: What's New with In Vitro Drug Release? [27,28], Extra measures such as special blister packs are required to avoid breakage or damage of dosage forms before use. By closing this message, you are consenting to our use of cookies. As an example, the monoamine oxidase B drug selegeline, used in Parkinsons disease and depression, may cause patients to suffer side-effects. Cyclodextrins are sugar-based, ring-shaped macromolecules with holes in the middle that can trap smaller molecules inside if they are the right size. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. [2] The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drafted a guidance which states ODTs as a solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. In this issue, readers will have the opportunity to explore examples of the recent studies in this area. Disintegration of the dosage form in the oral cavity followed by wetting is the primary requisite for ODTs to release the API. Search for other works by this author on: Present address: MJR PharmJet GmbH, Saarland University Medical Center, Building 7, 66424 Homburg, Germany. Such physical properties of the dosage form necessitate stringent methods to ensure the quality of the end product.

Tel: (973) 299-1200 [52] In such cases, a higher basket rotation speed of 100 rev/min is recommended, especially for quality control purposes. The compendial disintegration test alone cannot generally be recommended as a suitable method for in-vitro performance testing. The orally disintegrating tablet, or ODT, offers an easy-to-take alternative form to consumers of over-the-counter (OTC) treatments who perhaps do not have access to water, and patients of prescribed drugs who cannot, or will not, swallow standard oral dosage forms, such as tablets and capsules. In addition, ODTs provide clinical advantages such as improved safety and, in some cases, improved efficacy. Several factors affecting the disintegration time of the ODTs have been investigated. Currently, ODTs are evaluated using the disintegration test for conventional dosage forms described in the phamacopeias. Even under ambient conditions of humidity, ODTs cannot maintain physical stability[20,26,29]. For ODTs, disintegration is completed within seconds, thereby lacking the discriminatory power of the testing for quality attributes and no link to dissolution could be established. X-ray diffraction is used to determine the crystalline state of the API and relevant excipients; whether it is crystalline or amorphous will have a bearing on the structural integrity of the final dosage forms. This article reviews the current status of dissolution testing of ODTs to establish the product quality standards. In-vitro dissolution/drug release testing has become an increasingly powerful tool throughout the development of a drug product. He earned his BSc in Pharmaceutical Science from the University of Greenwich, London and his Masters in Industrial Pharmaceutical Science from the University of Manchester, UK. In many instances, individual quality test methods developed by manufacturers are not reported in publicly available sources, although a number of alternative methods have been published and these are summarized in Table 3. In contrast to a traditional coating, the coated API inside is released slowly, a phenomenon that indicates that taste-masking has been achieved, while still meeting the US Pharmacopeial convention (USP) criteria for immediate release. Here, the techniques currently available for the dissolution testing of ODTs have been reviewed. A number of technologies are available to create ODTs. This has been proven with ibuprofen, which, if formulated as an ODT, could offer significant advantage to consumers in speed of onset. defines them as uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed. [19] The market share of ODTs has grown significantly in recent times, with more than 450 commercial over-the-counter and prescription ODT products having marketing authorization in the United States, European Union and in Japan.[24].

This assists in calculating the necessary times for freeze-drying, while ensuring that the frozen product does not melt during the drying process. technologies and commercialization of these products bring numerous marketing advantages such as expanded product lines, improved life-cycle management and extended patent life. Montville, NJ 07045 Johannes Kraemer, Jayachandar Gajendran, Alexis Guillot, Julian Schichtel, Akif Tuereli, Dissolution testing of orally disintegrating tablets, Journal of Pharmacy and Pharmacology, Volume 64, Issue 7, July 2012, Pages 911918, https://doi.org/10.1111/j.2042-7158.2012.01473.x. Based on experimental results, it appears that it may be feasible to rely on the dissolution test without a need for disintegration studies for selected ODTs on the market. Cited by lists all citing articles based on Crossref citations.Articles with the Crossref icon will open in a new tab. [6] The physiological conditions of the oral cavity should be considered for in-vivo testing, including the biopharmaceutical properties of the API at a salivary pH of 5.57,[7,8] salivary flow rate and chronobiological state of the target population. Orodispersible formulations have also been named as orally disintegrating, orodisperse, mouth-dissolving, quick-dissolve, fast-melt and rapid-disintegrating and freeze-dried formulations. The list of compendial and non-compendial product quality tests are summarized in Table 2. Recent developments have made it possible to formulate a number of different types of medicine as ODTs that at first sight, one might think would not be compatible with this type of oral dosage form. 1. It may be waived on a product-by-product basis. The release characteristics are then further optimized using various formulation techniques used for the manufacturer.

In both cases; the hepatic first-pass effect as well as gastric degradation is avoided; therefore, the efficacy is enhanced. October 24-25 He is responsible for driving the global marketing strategy for the oral drug delivery solutions business unit, including patient-centric Solutions, Zydis ODT technology, FlexDose solutions for stick pack, and Opti-Dose CR for optimal and modified controlled release. Dosage forms that are applied via a similar route include medicated gums, sublingual tablets, buccal tablets and lozenges. Web design and development by WalkerTek. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. Therefore, formulators continue to explore alternative approaches to enhance absorption of the drugs across oral mucosa. Leon Grother is Principal Scientist at Catalent Pharma Solutions in Swindon, UK. Intrabuccaly rapidly disintegrating tablet. One of the biggest challenges is to ensure rapid disintegration without negatively affecting the mechanical strength of the formulation. The experiments were performed in triplicate. Samples were withdrawn at standardized intervals and the amount released was quantified using HPLC-UV determination. Therefore, the desired product characteristic for an ODT includes a disintegration time of less than 30 s without any aid. More than three-quarters of a test group claimed its taste profile was acceptable and that the reformulated product incorporating Zydis technology was more pleasant tasting than the standard formulation. These include Catalents Zydis, To view this issue and all back issues online, please visit, is Principal Scientist at Catalent Pharma Solutions in Swindon, UK. No solvent is needed for this coating process. We use cookies to improve your website experience. October 16-19 Over the past three decades, orally disintegrating tablets (ODTs) as well as films, which require less than a minute to dissolve in the mouth, have gained more attention as an alternative to conventional sublingual, buccal formulations and lozenges. Mathias Bayru is Catalent Pharma Solutions Group Product Manager for Drug Delivery Solutions. Register a free Taylor & Francis Online account today to boost your research and gain these benefits: Orally disintegrating tablets, fast-dissolving, buccal and sublingual formulations, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey, Faculty of Pharmacy, Ankara University, Ankara, Turkey, Pharmaceutical Development and Technology. The drug released from orodispersible formulations is absorbed through pregastric (oral cavity, pharynx, and esophagus), and gastric segments. This material may not be published, broadcast, rewritten, or redistributed withoutpermission. One way this can be achieved is via the Zydis Ultra formulation. The buffer solutions were maintained at 37C. The dissolution conditions were 500 ml of buffer solution adjusted to pH 6.8 for products A and B, and additionally pH 1.2 for product B. It can be easier to give a medication to a child using an ODT and of course, in the animal health arena, it can be a significant challenge to get pets or livestock to swallow tablets. [5] Agitation speeds as low as 25 rev/min using paddle and 50 rev/min for basket (USP I) apparatus have been recommended for certain ODT formulations. The compendial disintegration method was thus deemed unsuitable for ODTs, since the large volume, mechanical agitation and lack of homogeneous mixing in the medium (as assessed by sampling at different points in the disintegration vessel) precluded discrimination between the products. The peptide drug calcitonin has been successfully formulated in this way, and vaccine ODTs could be particularly important in the future. The temperature of the test medium was maintained at 37C. ODTs are designed to disperse quickly within the oral cavity, removing the need to swallow a solid tablet or capsule. For example, ODTs can be made from very lipophilic APIs, by way of using an oily emulsion in place of the aqueous solution or suspension that is normally the starting point for an ODT formulation. This is particularly important for biologic products, such as vaccines, that are destined for developing countries, where access to refrigeration cannot be relied upon, and in pandemic situations, where speed of distribution is key to success. [37,38] Tablet hardness and porosity are directly linked to the disintegration time. As an ODT is designed to reside in the mouth for only a number of seconds; it cannot avoid the taste buds. Up to date, numerous drugs have been investigated for sublingual and buccal delivery; however, there are few products available in the market, which are mostly fast dissolving formulations.