DESIGN AND DEVELOPMENT OF PULSATILE DRUG DELIVERY SYSTEMS FOR SALBUTAMOL SULPHATE

Pulsatile drug delivery systems for salbutamol sulphate were prepared with a view to release the salbutamol around 4am with a lag time of 6 hours after it's administration (10pm). In this investigation pulsatile drug delivery systems were formulated with two different approaches namely press coated systems and modified pulsin cap technique as they are simple and easy to prepare when compared with other techniques. Press coated systems were prepared with different ratios of swelling and rupturable polymers [HPMC: Eudragit]. The lag time was dependent on composition of these polymers and the desired lag time was observed form the formulation containing only Eudragit. Modified Pulsin cap is based on cross linked hard gelatin capsules with formaldehyde and filled with hydrogel plug. The hydrogel plug was prepared with different ratios of swellable polymer HPMC and diluent Dicalciumphosphate. The lag time was dependent on the polymer and diluent ratio. The desired lag time was observed form the formulation containing HPMC: DCP (3:1) ratio. The blends were examined for micromeritic properties and the finished dosage forms were subjected to various quality control tests. The lag time of the drug release decreased by increasing the inner swelling layer and increased by the rupturing layer levels. Pulsin cap technique was found to be more suitable to achieve prolonged lag time when compared with the compression coated tablets.