Fast Dissolving Oral Films of Pramipexole HCl monohydrate: Preparation and in vitro evaluation

Abstract

Pramipexole (2-amino- 4, 5, 6, 7-tetrahydro-6-propylaminobenzthiazole- dihydrochloride) is a novel, highly active, full dopamine receptor agonist used in the treatment of Parkinson’s disease (PD). Present work aimed at preparing quick onset of action which is beneficial in (PD), aiding in the enhancement of bioavailabity and is very convenient for administration without the problem of swallowing and using water. Pramipexole HCl mouth dissolving films of 27 formulations were prepared by solvent casting method using 33 response surface method where 33 indicates 3 variables and 3 levels of polymers (HPMC E15, Kollidon 30) of different grades and plasticizer (Propylene Glycol) (low, middle and high concentrations) by using Design of experiment software. Among the prepared formulations PF24 showed minimum disintegration time 10 sec, maximum drug was released i.e. 99.21±1.87% of drug within 10 min when compared to the other formulations and finalized as optimized formulation. FTIR and SEM data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 93.78±1.53 after 50 min. Therefore it can be a good alternative to conventional Pramipexole HCl for immediate action. In vitro evaluation of the Pramipexole HCl fast dissolving films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of Pramipexole HCl for the treatment of Parkinson’s disease where the quick onset of action is desired, also improved patient compliance.