Controlled release reservoir mini tablets approach for controlling the drug release of Galantamine Hydrobromide.
The objective of this study is to explore and investigate the reservoir mini tablets approach to control the release of Galantamine Hydrobromide in comparison to desired release profile to the Innovator formulation Razadyne ER capsules as disclosed in US Patent 7,160,559 which is granted to Janseen Pharmaceutica NV. The core mini tablets were prepared using the direct compression and wet granulation methods. These core mini tablets were further coated with Galantamine Hydrobromide in two different portions; 70% as controlled release and 30% as immediate release and then filled in empty hard gelatin capsule shells. The dissolution profiles of each formulation were compared to those of Razadyne ER capsules and the mean dissolution time (MDT), dissolution efficiency (DE%) and dissolution similarity (f2 factor) were calculated. It was observed that core formulation plays an important role in controlling the drug release as well as maintaining pH independent drug release profile. The release mechanism of GAH from reservoir mini tablet formulation follows Higuchi and first order. These results imply that controlled release reservoir mini tablets which further filled into empty hard gelatin capsule shells can be a suitable method to formulate controlled release Galantamine hydrobromide.
Formulation Research Division, Aurobindo Pharma Limited Research Centre, Bachupally, Hyderabad, India. khatavkarun@indiatimes.com
Umesh Nandkumar
UN
Khatavkar
Shamkant Laxman
SL
Shimpi
K Jayaram
KJ
Kumar
Kishor Dattatraya
KD
Deo
D002800:Cholinesterase Inhibitors / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D005702:Galantamine / Q000008:administration & dosage*; D005780:Gelatin / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D012995:Solubility; D013607:Tablets
D002800:Cholinesterase Inhibitors; D003692:Delayed-Action Preparations; D013607:Tablets; D005702:Galantamine; D005780:Gelatin