orally disintegrating tablets

An ODT is a solid dosage form that disintegrates and dissolves in the mouth (either on or beneath the tongue or in the buccal cavity) without water within 60 seconds or less. The tablets are manufactured at a low compression force followed by an optional humidity conditioning treatment to increase tablet hardness (23). 38. Careful selection of formulation options and ingredients, including the selection of the matrix component and the pH, can optimize inprocess stability. All of these are well established and widely accepted ingredients in pharmaceutical formulations. The aluminum packaging provides a high moisture barrier and good environmental protection, and acceptable storage has been demonstrated at room temperature for multiple peptide and protein compounds. Figure 5 shows the difference between a standard ODT and the Bio ODT. 3 (6), 5861 (2001). Freeze-dried ODTs are manufactured and packaged in polyvinyl chloride or polyvinylidene chloride plastic packs, or they may be packed into laminates or aluminum multilaminate foil pouches to protect the product from external moisture (8). However, if it is very bitter, or produces a burning or numbing sensation, more sophisticated taste-masking techniques will be necessary. 25. 27 (11), 92100 (2003). D.J. G.L. Ghosh and W.R. Pfister, Eds. A lower dose is required as the active is not metabolized by the liver before it reaches the bloodstream. The area under the curve for the low-dose ODT is equivalent to that of 10mg formulated conventionally. J. Hontz, "Development of a Rapidly Dissolving Famotidine Tablet," paper presented at the 41st Annual International Industrial Pharmaceutical Research Conference, Madison, WI, June 1999. Dozens of ODT products have been launched worldwide over the past decade, with many new introductions in the past few years. The overall preclinical, clinical, and biopharmaceutical development programs necessary to support successful ANDA and NDA marketing applications for ODTs were recently reviewed (44) and presented in detail in a symposium on this topic (13, 45). Technol. Quick-dissolve tablets can offer several biopharmaceutical advantages such as improved efficiency over conventional dosage forms. claritin reditabs claritin tablets disintegrating orally reditabs mg hour pack A Publication of R.H. Bogner, M.F. Adults can have difficulties, too, for example bariatric patients often find swallowing a challenge, and those who have Parkinsons disease can be particularly badly affected. Therefore, the ODT will not be bioequivalent to the conventional oral dosage form. Zydis ODT technology was first developed by RP Scherer (now part of Catalent) in the 1980s, and the first products reached patients in the early 1990s. Initially, the polymer particles are deposited in a discrete polymer layer around the outside of the API particles, but the combination of the vibration and the impact of collision with the milling media cause these closepacked coating particles to deform into a continuous polymer layer. Determines particle size ranges relevant to Zydis suspension stability for insoluable API, Dynamic Vapor Sorption It is difficult to persuade infants and very young children to swallow them, and they may pose a choking hazard. The trays are stored in a freezer until a sufficient quantity has been prepared to fill the freeze dryer, and then they are transferred into the dryer. If the size of the hole is matched to the API, it can trap the unpleasant tasting active, preventing it from coming into contact with the tongues taste receptors. Orally disintegrating tablets (ODTs) have better patient acceptance and compliance and may offer improved biopharmaceutical properties, improved efficacy, and better safety compared with conventional oral dosage forms. The Bio ODT also holds out promise for oral vaccines. Ghosh and W.R. Pfister, Eds. Development work has been carried out using influenza as a model vaccine antigen. As Figure 4 shows, the ODT made using a standard fluidized bed coating technique is released very rapidly, whereas those using the new LabRAM ResonantAcoustic Mixer technique have a retarded release, which is indicative of tastemasking. S.R. Stage 3 Lyophilization Wilkosz, and C.T. It is possible that these differences may, in part, be attributed to the drug molecule, formulation, or a combination of both. V. Agarwal, "Fast Dispersing Dosage Forms: Opportunities and Challenges in Packaging," paper presented at the annual meeting of the AAPS, Salt Lake City, UT, Oct. 29, 2003. Myers et al., "Ulcer Prevention Method Using a Melt-Spun Hydrogel," US Patent 5,622,719 (1997). Table II: Orally disintegrating tablet manufacturers and technology characteristics (18). The AUC was almost identical to that for a regular cetirizine tablet. D. Brown, "Orally Disintegrating Tablets: Taste Over Speed," Drug Deliv. 7. QuickSolv disintegrates very rapidly but is limited to low drug content and can be used only with active ingredients that are insoluble in the extraction solvent (36). Furthermore, any minor damage to the package may cause the wafer to collapse because of moisture absorption (34). Rev.Therap. The saccharides are converted into floss by the simultaneous action of flash-melting and centrifugal force in a heat-processing machine similar to that used to make cotton candy (3743). An additional advantage is the potential to avoid the need for cold-chain storage. Common matrix-forming agents include gelatin, dextran, or alginates which form glassy amorphous mixtures for providing structural strength; saccharides such as mannitol or sorbitol for imparting crystallinity, hardness, and elegance; and water, which functions as a manufacturing process medium during the freeze-drying step to induce the porous structure upon sublimation. 10. The US Food and Drug Administration Center for Drug Evaluation and Research (CDER) defines in the Orange Book an ODT as "A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue" (1). In the long run, if such formulations gain regulatory acceptance, they could significantly improve the delivery of both biologic medicines and vaccines, particularly in environments where a lack of clean water and trained nurses present challenges to traditional drug administration. tablets orally disintegrating claritin reditabs 5mg hour pack However, if the API is suitable, then careful ODT formulation can be used to ensure the drug is absorbed in the oral cavity rather than in the gastrointestinal tract. All rights reserved. The trays are removed from the dryer, the blisters sealed and split into strips, and finally, packed in cartons ready for delivery to the patient. In contrast, some lyophilization manufacturing processes (e.g., Zydis, Cardinal Health, Dublin, OH) produce fragile freeze-dried tablets and compressed multiparticle tablets that can be packaged only in unit-dose blisters because of their high friability (8, 11, 12). Pharmacol. In addition, the matrix may contain taste-masking agents such as sweeteners, flavorants, pH-adjusting agents such as citric acid, and preservatives to ensure the aqueous stability of the suspended drug in media before sublimation. Drug Carr. To make the tablets, the excipients are first dissolved or suspended in purified water, and the API added. QuickSolv tablets are made with a similar technology that creates a porous solid matrix by freezing an aqueous dispersion or solution of the matrix formulation. Ghosh and W.R. Pfister, Eds. By paying close attention to advances in technologies, pharmaceutical companies can take advantage of ODTs for product line extensions or for first-to-market products. H. Seager, "Drug Delivery Products and the Zydis Fast-Dissolving Dosage form," J. Pharm. 30. 28. Several alternative ODT technologies are available, as can be seen in Table 1. G.L. C.C. This article compares various ODT products and technologies and highlights their manufacturing processes, development issues, and future trends for these evolving dosage forms. The technology involves the direct compression of active ingredients, effervescent excipients, and taste-masking agents (27). 29. 4. The tablet quickly disintegrates because effervescent carbon dioxide is produced upon contact with moisture. ODT products have been developed for numerous indications ranging from migraines (for which a rapid onset of action is important) to mental illness (for which patient compliance is important for treating chronic indications such as depression and schizophrenia) (3). As can be seen in Figure 3, the area under curve (AUC) over time is the same for the ODT taken both with and without water, and the standard capsule formulation. Importantly, an ODT formulation can be bioequivalent to a traditional dosage form. The European Pharmacopoeia however defines a similar term, orodisperse, as a tablet that can be placed in the mouth where it disperses rapidly before swallowing (2). Drug coatings also can be used to mask bitter drugs and to protect the drug from stomach acidinduced metabolism. The WOWTAB manufacturing technique is one successful method that features conventional tablet characteristics for ease of handling, packaging, and fast disintegration (20). Scherer (now Cardinal Health), personal communication, (2005). In general, an ODT is formulated as a bioequivalent line extension of an existing oral dosage form. Myers et al., "Apparatus for Making Rapidly Dissolving Dosage Units," US Patent 5,871,781 (1999). 43. Body weight loss, which is an indicator of the extent of the disease, was greatest for the unvaccinated and infected control group, which is demonstrated by the results shown on the lowest set of data points on the graph and shows rapid weight loss after day 2 of the study.

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