New Methods for the Production of Oral Dosage Forms

Oral drug delivery remains the preferred method of API administration, but Biopharmaceutical Classification System Class II drugs are not ideally suited to this due to their inherent poor solubility. The current study aims to utilise the innovative formulation technique of aerosol jet printing to increase the dissolution capability of poorly soluble drugs. Aerosol jet printing Class II drugs with an appropriate stabilising polymer reduces crystallinity, increasing drug solubility. Furthermore, in the presence of sufficient polymer content, fully amorphous products can be produced resulting in enhanced dissolution capabilities. The intrinsic dissolution rate of fenofibrate was found to increase by 10-fold on printing with PVP K30. A lesser increase was typically seen on printing the materials as separate layers, but a slight loss of crystallinity does suggest that there are some interactions happening at the interface. Printing with PVP K30 was also found to increase the intrinsic dissolution rate of ibuprofen, with 3-fold increase on formation of amorphous material. Aerosol jet printing also allows a high degree of precision, enabling control of drug location to the micrometre, production of scalable dosage forms and control of drug distribution within solid dispersions. This high degree of precision has also enabled design of more complex dosage forms with a view to generating a pulsatile release profile in an entirely novel manner. Scale up of printing was attempted to allow demonstration of high precision printing of a full-size tablet. Unfortunately, dissolution testing of the full-size tablet failed but it is hoped this technology could be developed further in the future. Overall this thesis demonstrates the ability of the aerosol jet technology to be applied to pharmaceutical manufacturing in a precise manner to increase dissolution of poorly soluble compounds. Future work could include development of the technique for use in production of more complex customisable dosage forms