PREFORMULATION STUDIES OF NIOSOMAL GEL CONTAINING DIPIVEFRIN HYDROCHLORIDE FOR ANTIGLAUCOMATIC ACTIVITY

Abstract

Objective: The present study was focused on developing and characterizing niosomal gel formulations for ocular controlled delivery of an adrenergic agonist; dipivefrin HCl. In the present study, the pre-formulation studies are showed towards the development of Novel formulation. Methods: Preformulation studies of drug were carried out for identification (physical appearance, melting point and UV spectrophotometric analysis), solubility profile, lipophilicity (Partition Coefficient), compatibility studies by FTIR and thermal behavior by DSC. Results: The melting point of dipivefrin HCl was found to be 147.6±3 °C. The log P value was found to be 3.14±0.02, from which it can be interpreted that drug is highly lipophilic in nature. The scanned λmax were found to be 254 nm. No significant changes were found when FTIR spectra of the physical mixture compared with FTIR spectra of pure drug and excipients. This indicates absence of any possible interaction between the drug and excipients which confirms the identity and purity of drug. DSC thermogram of pure drug showed a sharp exothermic peak at 131.202 °C (area=1726.267 mJ, delta H=575.422 J/g), indicating the crystal melting point of the drug. Conclusion: These results suggest that the dipivefrin HCl serve as suitable candidate for ocular drug delivery system.