Opt2Fill™Dispersible Tablet – A Novel Method for the Manufacture of pMDIs

Cuong Tran, Chen Zheng, Simon Warren, Glyn Taylor

Manufacture of suspension-type pressurised metered dose inhalers (pMDI) requires judicious in-process homogenization and agitation to ensure homogeneity of suspended drug(s) and accurate and reproducible canister filling. In this study, the aerosol characteristics of pMDIs manufactured by the addition of propellant dispersible tablets (Opt2Fill™ tablet) to pMDI canisters prior to the addition of HFA134a/ethanol blend was assessed. The tablets contained a combination of salbutamol sulphate (SS) and beclometasone dipropionate (BDP), a dispersant (menthol) and lactose. Each tablet weighed approximately 90 mg and contained sufficient drug for 200 metered doses each containing 120 μg of SS and 50 μg of BDP. The aerosol particle size distributions (PSD) of the Opt2Fill™ products were compared with marketed formulations containing either SS or BDP, i.e. Airomir® and QVAR® 50. The PSD characteristics clearly demonstrated effective dispersion of the Opt2Fill™ tablets with fine particle fraction (FPF) properties similar to the comparators. The PSD of Opt2Fill™ products showed acceptable pMDI performance from a solid dosage form consisting of two drugs of differing physicochemical properties, i.e. one insoluble, one soluble. It is proposed that this technology can overcome some of the challenges commonly encountered during conventional single stage and two-stage pMDI filling processes. Dispensing the solid dosage form into the canister simplifies in-process checks and eliminates the requirements for homogenisation / recirculation of suspension systems and the need for large pressure vessels. Cleaning processes between products can also be greatly simplified. Batch sizes can be readily varied and scaled ensuring process continuity from pilot batches to large commercial batches.

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