Formulation And Development Of Reconstittutable oral Suspension of Anti Asthmatic Drug

Abstract

Asthma is a chronic inflammatory disorder characterized by airway obstruction and hyperresponsiveness. Drug X has been used in this case commonly to prevent the wheezing and shortness of breath. Conventional oral tablets and granules are available. However as an alternative dosage form, reconstitutable oral suspension (4mg/5ml) will provide ease of administration and convenience to paediatric patients. It is a multi-dose formulation (6 doses) which is to be reconstituted with water and to be consumed within 7 days. Formulation of reconstitutable oral suspension was carried out by sifting, geometric mixing and direct blending approach. Mannitol, Silicon dioxide (Syloid AL1 FP), Sodium saccharin, xanthan gum, sodium bicarbonate, orange flavor and sunset yellow colour were used for formulation of reconstitutable oral suspension. The drug being highly susceptible to heat, light, pH and moisture, special care was taken while selecting the excipients and during manufacturing of batches. Drug X impurities were a major concern during stability. The drug has a tendency to form impurities during the shelf life. However the excipients were selected accordingly and impurity levels were monitered during the time period. During study, suspension was evaluated for various parameters like viscosity (80-120 cps), pH (6 -8) and % assay of reconstituted suspension (94 -105%). Stability study of dry powder (40ºC/75%RH) and reconstituted suspension (30ºC/65%RH and 2-8ºC) was carried out for reproducible batch for two months and it was within preferred criteria. This ROS formulation shall be advantageous for pediatric asthma patients. Further extensive in-vitro and in-vivo evaluation shall be carried out to confirm its effectiveness.