Orally Disintegrating Tablets (ODTs)
Orally Disintegrating Tablets (ODTs) are a type of solid oral dosage form that are designed to rapidly disintegrate in the oral cavity without the need for water or chewing. They offer a convenient and efficient alternative to conventional tablets and capsules for patients who have difficulty swallowing or who prefer a more convenient and discreet way to take their medication.
Synonyms for Orally Disintegrating Tablets (ODTs)
Orally Disintegrating Tablets (ODTs) are also known by several other names, including:
- Fast-dissolve tablets
- Quick-dissolve tablets
- Mouth-dissolve tablets
- Soluble tablets
- Disintegrating tablets
- Melt-in-your-mouth tablets
- Orally dissolvable tablets
- Sublingual tablets
Note that the terms “fast-dissolve,” “quick-dissolve,” and “mouth-dissolve” can be used interchangeably to describe ODTs, but it’s important to check the specific properties of the product as there may be some differences in the rate of disintegration, mouth-feel, and drug release between products.
It is estimated that a significant number of people have difficulty swallowing tablets or capsules, commonly referred to as “dysphagia”. The exact number of people affected by dysphagia is difficult to determine, but it is thought to be particularly prevalent in older adults, children, and individuals with certain medical conditions such as Parkinson’s disease, stroke, and esophageal disorders.
According to a study published in the Journal of Clinical Pharmacy and Therapeutics, up to 30% of older adults have difficulty swallowing solid dosage forms, and an estimated 10% of children have difficulty swallowing tablets or capsules.
Dysphagia can lead to medication non-compliance, as individuals may avoid taking their medications due to the difficulty in swallowing. This can have a significant impact on their health and well-being, making it important for healthcare providers to identify and manage dysphagia effectively.
ODTs can offer a solution for individuals with dysphagia, providing a convenient, easy-to-take alternative to traditional tablets and capsules, and improving medication compliance and health outcomes.
Definitions according to the European Pharmacopeia and USP/NF
The European Pharmacopeia (Ph. Eur.) defines Orally Disintegrating Tablets (ODTs) as solid oral dosage forms that rapidly disintegrate in the oral cavity without the need for water or chewing. The disintegration time should be less than 3 minutes.
The United States Pharmacopeia/National Formulary (USP/NF) defines Orally Disintegrating Tablets (ODTs) as solid oral dosage forms that disintegrate rapidly in the oral cavity, without the need for water or chewing, and are intended to be taken without swallowing. The disintegration time should be less than 30 seconds.
ODTs for special patient groups
Pediatrics: Children, especially young children, can have difficulty swallowing conventional tablets and capsules, making ODTs an attractive alternative. ODTs are easy to administer, as they dissolve quickly in the mouth, eliminating the need for water. Additionally, the pleasant taste and improved bioavailability of some ODTs can make them more appealing to children, increasing their willingness to take the medication. This can be especially important in the case of children with chronic illnesses who need to take their medication regularly.
Geriatrics: Older adults are more likely to have difficulty swallowing conventional tablets and capsules, making ODTs a useful alternative. ODTs can also be helpful for elderly individuals with a decline in cognitive function, as they eliminate the need to remember to take a pill with water. Additionally, some ODTs are formulated to dissolve more quickly and provide improved bioavailability, which can be especially important for elderly individuals who may have difficulty absorbing medications.
Animals: One of the biggest advantages of ODTs for animals is the ease of administration. Many animals, particularly pets, can be uncooperative when it comes to taking pills, but ODTs dissolve quickly in the mouth, making them easier to administer. This can be especially important in the case of pets who need to take medication regularly. ODTs can also improve the bioavailability of some medications in animals, as they dissolve more quickly and allow for faster absorption. This can be especially important for animals with chronic illnesses who need to take their medication regularly.
Manufacturing Processes for Orally Disintegrating Tablets (ODTs)
There are several production technologies used for the manufacture of orally disintegrating tablets (ODTs):
- Wet Granulation: Wet granulation is a commonly used process for the production of ODTs. In this method, the active ingredient and excipients are mixed with a small amount of liquid to form a wet mass, which is then dried and compressed into tablets.
- Direct Compression: Direct compression is a simple and efficient method for the production of ODTs. In this process, the active ingredient and excipients are blended and directly compressed into tablets without the need for granulation.
- Melt Granulation: Melt granulation is a method used for the production of ODTs that are formulated with thermolabile active ingredients. In this process, the active ingredient and excipients are melted and then cooled to form a solid mass, which is then compressed into tablets.
- Lyophilization: Lyophilization, also known as freeze-drying, is a process used for the production of ODTs that require a stable, dry product. In this process, the active ingredient and excipients are freeze-dried, resulting in a stable and rapidly disintegrating tablet.
- Sublimation: Sublimation is a process used for the production of ODTs that require a rapid disintegration time. In this process, the active ingredient and excipients are compressed into tablets, and a subliming excipient is included to aid in the rapid disintegration of the tablet.
- 3D Printing: 3D printing allows for the precise control of the tablet’s geometry, composition, and release profile, making it an attractive technology for the production of ODTs. In 3D printing, a drug-excipient mixture is printed layer by layer to form the desired tablet shape. The process can also be used to produce complex and customized tablet shapes, which can be useful for patient-specific dosing.
Excipients for Orally Disintegrating Tablets (ODTs)
Excipients are inactive ingredients added to the formulation of ODTs to improve their physical, chemical, and biological properties. The selection of excipients for ODTs is critical, as they play a key role in determining the disintegration time, mouthfeel, and stability of the tablet. Some common excipients used in ODT formulations include:
- Superdisintegrants: Superdisintegrants are excipients that aid in the rapid disintegration of the tablet in the oral cavity. Examples include crospovidone, sodium starch glycolate, and cross-linked polyvinylpyrrolidone (PVP).
- Sweeteners: Sweeteners are excipients added to ODTs to improve their taste and palatability. Examples include aspartame, saccharin, and sucralose.
- Flavors: Flavors are excipients added to ODTs to improve their taste and mask any unpleasant flavors associated with the active ingredient. Examples include peppermint, cherry, and orange.
- Lubricants: Lubricants are excipients added to ODTs to improve their flow properties during the manufacturing process and prevent sticking. Examples include magnesium stearate, stearic acid, and talc.
- Binders: Binders are excipients added to ODTs to improve their strength and prevent breakage. Examples include microcrystalline cellulose, sodium carboxymethylcellulose, and polyvinyl alcohol.
Excipients for ODTs on pharmaexcipients.com:
|Advantol 300||SPI Pharma|
|Ceolus KG-1000||Asahi Kasei|
|Ceolus KG-802||Asahi Kasei|
|F-Melt® F1||Fuji Chemical Industries Co., Ltd.|
|F-Melt® Type C||Fuji Chemical Industries Co., Ltd.|
|Kollicoat® Smartseal 100 P||BASF|
|Omyanutra® 300 DC||Omya|
|Omyanutra® 300 Flash||Omya|
|Parteck® ODT||Merck KGaA|
|PEARLITOL® 200 SD||Roquette|
|PROSOLV® ODT G2||JRS Pharma|
|StarLac®||Meggle / Roquette|
|Sucralose powder EMPROVE ESSENTIAL Ph Eur,NF,JPE||Merck KGaA|
|VIVAPHARM® PVPP XL||JRS Pharma|
|VIVAPHARM® PVPP XL-10||JRS Pharma|