DISPERSIBLE TABLETS are uncoated or film-coated tablets intended to be dispersed in water before administration giving a homogeneous dispersion. Oral dispersible tablets (ODTs) are uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed. Dispersible tablets usually disintegrate within three minutes when put in water or a small amount of breast milk.
Many medicines are only available in adult strength; therefore the administration of accurate dosage for children is critical. The adjustment of adult formulations to paediatric dosage is often done by cutting or crushing tablets, opening the capsules and using the powder to make a liquid, diluting concentrated preparations or, using injections orally, etc.
Dispersible tablets have less physical resistance than regular tablets; they are more sensitive to moisture and may degrade at higher humidity conditions. Each tablet must be protected from ambient humidity. The dispersible tablets should not be divided or chewed. Dispersible tablets must be used immediately after removal from the blister packaging. Their stability outside of the blister cannot be guaranteed.
Advantages of dispersible tablets over conventional dosage forms
- Quicker onset action compared with conventional tablets because of improved bioavailability.
- Suitable for children and elderly persons with swallowing difficulties (Dysphagia)
- More convenient for API's with insufficient stability in water.
- Easier for transportation (less volume, less weight)
- Dispersible tablets remain solid until administration. This aids the stability of the pharmaceutically active agent, the dose accuracy, and the storage of the tablets.
ALSO READ: Friability Test for Tablets
DISPERSIBLE TABLETS can be taken without water – a benefit for ‘dry’ situations where water or other liquid drinks are not available. A pleasant taste is achievable with appropriate taste masking and flavoring, which is most often a mandatory requirement for such drug products.
Due to extensive expertise in taste-masking, numerous Pharmaceutical Services provide variable formulation concepts to achieve rapidly or fast disintegrating tablet formulations with excellent organoleptic properties.
The API(s) may be presented in the form of taste-masked API, micro pellets or microgranules.
The micropellet dosage form concept easily allows the combination of the taste masking approach with a modified drug release approach. Therefore, dispersible tablets and ODT formulations can be applied for both immediate releases and for modified-release products.
The ideal characteristics of a drug for oral dispersible tablet include:
- Ability to permeate the oral mucosa.
- At least partially non-ionized at the oral cavity pH.
- Have the ability to diffuse and partition into the epithelium of the upper GIT.
- Small to moderate molecular weight.
- Low-dose drugs preferably less than 50mg.
- Short half-life and frequent dosing drugs are unsuitable for ODT.
- Drugs should have good stability in saliva and water.
- Very bitter or unacceptable taste and odor drugs are unsuitable for ODT.
Orally disintegrating tablets have potential advantages over conventional dosage forms, which include:
- Easy to administer to the patient who cannot swallow such as pediatric, geriatric, bedridden, stroke victims, and institutionalized patients (especially for mentally retarded and psychiatric patients)
- Excellent mouths feel property produced by the use of flavors and sweeteners help to change the perception of “medication as bitter pill”, especially in the pediatric population.
- Fast disintegration of tablets leads to quick dissolution and rapid absorption which may produce rapid onset of action.
- ODTs offer all the advantages of solid dosage forms and liquid dosage forms.
- The convenience of administration and accurate dosing compared to liquids.
On the other hand, the limitations of oral dispersible tablets are
- Patients may mistake ODT for effervescent tablets.
- ODT needs to be handled carefully because some of the ODT developed may not have sufficient mechanical strength.
- Patients with dryness of the mouth or with Siogrens syndrome or who taking anticholinergic drugs may not be a suitable population for administering ODT. (Although no water is needed to allow the drug to dispense quickly and efficiently most technologies of ODT utilize the body's own salivation the decreased volume of saliva may slow down the dissolution/ disintegration/ bioavailability of the product.)
- ODT can be used easily in children who have lost their primary teeth but do not have full use of their permanent teeth and also for geriatric patients who have lost their teeth permanently.
Tags
Quality Control
