Adapting Modified-Release Preparations

When a patient cannot swallow tablets or capsules, has a feeding tube, or requires a lower dose of the active substance than present in a commercial product, the pharmacist should find a way to administer the active substance. Sections 37.6.2 and 37.8.3 discuss various strategies to modify conventional (fast-release) tablets or capsules, such as the opening and emptying of a capsule, or pulverisation of a tablet and subsequently mixing it with a diluent or liquid. 

However, these modification strategies may not be possible to apply to modified-release preparations. Questions such as the following should be answered is it possible to spht the dosage form without destroying its function Is it possible to mix the content of a capsule without grinding Can the dosage form be modified into a liquid preparation And if so, should the dose or dose frequency be adjusted  

A modified-release preparation should be administered as such to have its intended effect. Sphtting is not an option, unless this is provided by the manufacturer and is specified in the product details. Sometimes, asking the manufacturer may give the desired information, but not aU manufacturers are able or willing to help with the particular situation of an individual patient. 

The product details of many licensed products do not specify what to do when a patient is not capable of taking the capsule of tablet, or requires a different dose. However, propositions have been made to improve the situation [37]. The EMA has made the 

A graph of the release profile in the product details would also benefit the application of modified-release preparations, as well as information on the dependence on physiological and anatomical factors. 

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