Abstract:
The aim of present work was to develop a topical spray formulation of anti acne
agent, which would form a clear transparent thin film at the site of application,
effectively delivering the drug without pain or irritation. Aerosol solution contained
Eudragit E100 as a polymer, propylene glycol (PG) as a plasticizer, ethanol as a
solvent and Isopropyl alcohol (IPA) as a co-solvent. Solutions for topical sprays were
filled in aluminium containers fitted with continuous spray valve. Evaluations for the
Adapalene topical spray included determination of delivery rate, delivery amount,
pressure test, drug content, minimum fill, leakage test, flammability, spray patterns,
particles size, thickness of formed film and diffusion release profile etc. Glass
containers were used to study physical incompatibility between the aerosol
concentrate and propellant (LPG) due to the ease of visible inspection. Formulation
with eudragit E100 (0.5%), IPA (1.5%) and PG (2.0%) concentration was found to
give higher release profile. Accelerated stability studies were conducted as per ICH
guidelines at 40°C ± 2°C temperature and 75% ± 5% RH for 20 days and indicated
that optimized formulations were stable. Skin irritation studies of optimized
formulations were performed using rabbit as an animal model for 24 h and no
erythema and edema were recorded after 24 h. The result obtained shows that topical
spray of Adapalene can be used as effective topical system for treatment of Acne.