Formulation and Evaluation of Oro-dispersible Bromhexine Hydrochloride Granules Using Sachelac-80

Abstract

Background: Patients with sudden episodes of allergic or epileptic attacks and those who are mentally ill are less non-compliant and there is a lack of effective therapy. The need for delivering therapy at a very fast pace is the primary objective. Though oral medications exist for such patients these have their own disadvantages. Methods: Wet granulation method was used for preparation of Orodispersible (ORD) granules using Pearlitol 200 SD and Sachelac 80. Water soluble Bromhexine HCl granules were prepared by incorporating suitable surfactants, binder, to some extent co-surfactant and oils as well, so as to increase its bioavailability. The prepared granules were characterized by standard methods. Results: FTIR studies show drug- excipient compatibility. Formulation F1 shows superior results than other batches. Drug content of 97.5 %, with excellent flow properties and drug release of 102.3 % was observed for F1. A temperature of 40 ± 2°C and relative humidity of 75 ± 5% RH, was found to be most stable for F1 formulation as it indicated there were no significant changes in any of the parameters mainly in drug content. Similarly, FTIR study suggests compatibility as there are no interaction between any of the excipients as well active ingredient. Conclusion: This study showed that the method used for preparation resulted in pharmaceutical preparation that had fast onset of action, enhanced bioavailability, compliance in patients, enhanced stability and was cost effective.