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Evaluation of an Alternative Solid Dosage Form to Enteric Coated Pellets Containing Ibuprofen: A Case Study

Recent works have evaluated the potential of minitablets contained in hard gelatine capsules. To get the benefits and advantages of multi particulate dosage forms, it is necessary for tablets of between 2 mm and 4 mm diameter to be used. Tablets larger than 4 mm could not be contained in a hard gelatine capsule in any great number, similarly, tablets smaller than 2 mm would be extremely difficult to manufacture. Studies have shown that tablets of this size have a similar emptying pattern to standard pellet formulation. Caterina Funaro at IMA Active summarises that the results of this work have shown that minitablets are a good alternative solid dosage form to pellets. Both enteric coating processes were performed on the same equipment, GS coating pan HP025 standard configuration.

Extract:

Evaluation of an Alternative Solid Dosage Form to Enteric Coated Pellets Containing Ibuprofen: A Case Study

The demonstration of the feasibility to obtain Ibuprofen minitablets alternative to pellets was the performance of a comparative study of the two enteric coated solid forms.

Generally, the reasons for using an enteric coating are to protect the stomach wall from the effect of the drug contents in a dosage form or to protect the drug contents in a dosage form from the degradation effect of gastric contents. It can also be used to deliver the active ingredient to the particular region of the intestine (e.g., the upper part of the small intestine), so as to enhance the bioavailability of the drug. In any case, the multiparticulate dosage forms, consisting of a single dose of drug subdivided into many small dosage units, are the more suitable system to protect and delay the drug release. In fact, multiparticulate disperse freely in the gastro-intestinal tract to maximise the absorption, minimise the side effects, and reduces inter and intra-patient variability. Enteric coated pellets contained within a hard gelatine capsule are widely used as a protection or delay release device; an alternative to the coated pellets may be the coated minitablets contained within capsules too.

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