Hughes Medical Corp.

Fast Dissolving Tablets

Recent developments in technology have presented viable dosage alternatives for patients who may have difficulty swallowing tablets or liquids. Traditional tablets and capsules administered with an 8-oz. glass of water may be inconvenient or impractical for some patients. For example, a very elderly patient may not be able to swallow a daily dose of antidepressant. An eight-year-old with allergies could use a more convenient dosage form than an antihistamine syrup. A schizophrenic patient in the institutional setting can hide a conventional tablet under his or her tongue to avoid their daily dose of an atypical antipsychotic. A middle-aged woman undergoing radiation therapy for breast cancer may be too nauseous to swallow her H2-blocker. Fast-dissolving/disintegrating tablets (FDDTs) are a perfect fit for all of these patients.

FDDTs disintegrate and/or dissolve rapidly in the saliva without the need for water. Some tablets are designed to dissolve in saliva remarkably fast, within a few seconds, and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral cavity, and are more appropriately termed fast-disintegrating tablets, as they may take up to a minute to completely disintegrate.

The target populations for these new fast-dissolving/disintegrating dosage forms have generally been pediatric, geriatric, and bedridden or developmentally disabled patients. Patients with persistent nausea, who are traveling, or who have little or no access to water are also good candidates for FDDTs. In the near future, other patient populations will also be targeted. A novel application for FDDTs is in veterinary medicine, for example, to avoid pilling a cat. With fast-dissolving/disintegrating dosage forms increasingly available.

The major advantage of the FDDT formulation is that it combines the advantages of both liquid and conventional tablet formulations, while also offering advantages over both traditional dosage forms. It provides the convenience of a tablet formulation, while also allowing the ease of swallowing provided by a liquid formulation. FDDTs allow the luxury of much more accurate dosing than the primary alternative, oral liquids.

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Characteristics of Fast-Dissolving Tablets

FDDTs, as a novel dosage form, have several characteristics to distinguish them from the more traditional dosage forms. Taste-masking is of critical importance in the formulation of an acceptable FDDT. Traditional tablet formulations generally do not address the issue of taste masking, because it is assumed that the dosage form will not dissolve until passing the oral cavity. Many oral suspensions, syrups, and chewable tablets simply contain flavors, sugars and other sweeteners to overwhelm or complement the bitter taste of the drug.

Current methods of taste masking in fast dissolving/disintegrating tablets include sweeteners and flavors; however, these are not a sufficient means for taste-masking many bitter drugs. Most of the FDDT technologies incorporate unique forms of taste masking as well. The primary methods of taste-masking include adsorption onto or complexation with carriers and spray coating of drug particles. Frequently, the active drug powder is coated, and the coating does not completely dissolve until the drug has been swallowed. Drugs that are particle-coated are more appropriately termed fast-disintegrating due to the delayed release of the active molecule until they are swallowed. Additionally, effervescence is a physical method of taste-masking utilized in some of the FDDTs. More detailed information on specific taste-masking procedures in fast-dissolving/disintegrating dosage forms is proprietary.

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