4. Guidelines for the selection of pharmaceutical dosage forms

The purpose of selecting dosage forms and strengths for the drugs in the model list is to provide guidance to countries wishing to standardize or minimize the number of preparations in their own drug lists. As a general rule, pharmaceutical forms are selected on the basis of their general utility and their wide availability internationally. In many instances, a choice of preparations is provided, particularly in relation to solid dosage forms. Tablets are usually less expensive than capsules, but, while cost should be taken into account, the selection should also be based on a consideration of pharmacokinetics, bioavailability, stability under ambient climatic conditions, availability of excipients, and established local preference.

In a few instances where there is no uniformity of tablet strength, for example acetylsalicylic acid and paracetamol, a dosage range is provided from within which suitable tablet strengths should be selected on the basis of local availability and need. When precise dosage is not mandatory, the use of scored tablets is recommended as a simple method of making dosage more flexible if so required and, in some instances, to provide a convenient paediatric dose. Specific paediatric dosages and formulations are included in the list only when indicated by special circumstances. In many instances, dosage is specified in terms of a selected salt or ester, but in others - for example chloroquine - it is calculated, in accordance with common practice, in terms of the active moiety.

For certain drugs with short half-lives that are rapidly metabolized, such as carbamazepine, calcium-channel blockers and theophylline, conventional-release dosage forms must often be taken three or four times a day to maintain drug levels in the required narrow range. Sustained-release dosage forms can reduce the frequency of drug administration, thereby improving compliance and, often, the therapeutic effectiveness of the drug by maintaining a more constant drug level than can be obtained using traditional dosage forms. Because the preparation of sustained-release products is difficult and requires special expertise, a proposal to include such a product in a national list of essential drugs should be justified by adequate documentation.