Abstract:
Here, we developed oral fast disintegrating film (ODF) of ranitidine hydrochloride (RHCl) by solvent casting
method and assessed the impact of various formulation ingredients i.e. polymer concentration, type of plasticizers and
superdisintegrants. Optimized film was developed with hydroxypropyl methyl cellulose (HPMC E5, 3% w/v) as film
matrix, propylene glycol (PG) (10% w/w of polymer) as plasticizer and Pearlitol flash®
(PF) (10% w/w of polymer) as
release modifier. This film was chosen based on appearance, transparency, thickness, folding endurance and in vitro
disintegration time (DT). Later on, optimized film was loaded with drug (50% w/w of polymer) (A12), which
disintegrated within 15 seconds and released 81% of RHCl within two minutes. Furthermore, FTIR studies confirmed
the absence of drug film ingredients interaction. SEM showed even distribution of RHCl and all excipients. Thus, A12
will be palatable for geriatric patients and helpful to avoid premature intestinal degradation
