Formulation and evaluation of fast disintegrating tablets for a pharmaceutical product

Sammanfattning: A new pharmaceutical product suitable to act as a negative contrast agent for Computerized Scan (CT-scan) of the abdomen is under development. At the moment the product has the form of a powder, which when dispersed in water and whipped, gives a stable foam. The foam is ingested by individuals who are about to undergo a CT-scan, as a prior preparation step. The powder form has disadvantages such as dosage accuracy and the idea is to develop a tablet that will solve this issue and permit the automatization of foam preparation. At this stage, the aim was to investigate the possibility of making functional tablets of adequate hardness, low friability that will disintegrate rapidly when immersed in water. After whipping the foam should have acceptable properties, in terms of foamability and stability. The tablets were produced by direct powder compression. Different excipients were added to the initial powder blend to improve disintegration time, hardness, friability and facilitate tableting operations. Two different composites that act as binders were used in an attempt to improve disintegration time and powder compactability. Three different combinations of two disintegrants were tested to investigate which one gives the best disintegration results. A lubricant was also used to reduce adhesion of the powder to the tablet press. Lastly four different compression levels were applied on the powder blends to specify the optimum that gives fast disintegrating tablets of adequate hardness and friability. The results show that the initial powder blend (mentioned as APL blend) has good flowing properties but poor compactability which gives as a consequence tablets of low hardness and unacceptable friability, that do not disintegrate. The powder blends with the added excipients that were tested show fairly good flowing properties, greatly improved compactability, that resulted in enhanced hardness and friability and vary in time that they need to disintegrate. Optimal levels of compression are indicated for a fast disintegrating, good quality tablet. Foamability remains in acceptable levels even though reduced by the addition of excipients. Foam stability measured three hours after whipping was not significantly influenced.