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Orally disintegrating tablets: the path to improved patient compliance and enhanced life cycle management? Orally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.

Article Excerpt
In the quest to maintain market share and brand equity following patent expiries, many major pharmaceutical companies are focusing on effective product life cycle management as an important growth strategy. Of the various drug delivery technologies available to develop a line extension with improved therapeutic benefit, orally disintegrating tablets (ODTs) provide an attractive alternate to conventional solid oral dosage forms.

ODTs disintegrate rapidly in the mouth (<30 s) without water, and are an attractive dosage form for a wide range of patients, including children, elderly subjects, and patients with behavioural disorders, persistent nausea, Parkinson's disease or cancer who have difficulty swallowing. (1), (2) The FDA's Center for Drug Evaluation and Research defines ODT as: "A solid dosage form containing medicinal substances which disintegrates rapidly usually within seconds, when placed upon the tongue". (3)

The global ODT market is flourishing and growing steadily, with more than 100 products sold worldwide and sales exceeding [euro]3 billion. (1) Recently conducted surveys indicate that many patients prefer ODTs to other dosage forms; approximately 70% of patients would purchase ODTs, or prefer ODTs, rather than regular tablets or liquids. (4)

The key benefits of and indications for ODTs are shown in Tables 1 and 2, respectively.

Table 1: Advantages of ODTs--patient benefits and business
opportunities.

Benefits for patients Business opportunity

Provides faster absorption and onset of Provide market
action as a result of rapid differentiation
disintegration/dissolution in mouth

Minimizes first pass effect Provide line
extension
opportunities
and patent
protection

Administration on demand without water. Provide a
cost-effective
product suitable
for OTC market

Offers good organoleptic (taste, mouth
feel, etc.) properties.

Promotes wide acceptance among paediatric
and geriatric patients (ease of
administration resulting in improved
patient compliance)

Applicable to a wide variety of drugs


Table 2: ODT usage and indications.

Usage condition Indication

For faster onset Pain, fever, diarrhoea, migraine, anxiety, insomnia,
of action sinus, emesis

For critical Parkinson's disease, Alzheimer's disease, psychosis,
conditions schizophrenia, hypertension, lipid management

Paediatric Allergy, pain, fever
conditions


An ODT is intended to be placed on the tongue and ingested without water. Upon contact...

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