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ACTA Pharmaceutica Sciencia
2011 , Vol 53 , Num 1
DEVELOPMENT OF CONTROLLED RELEASE FORMULATION BASED ON OSMOTIC TECHNOLOGY FOR A PHENYL PROPANALAMINE HYDROCHLORIDE: IN VITRO, PHARMACOKINETIC AND PHARMACODYNAMIC CHARACTERIZATION
Centre for Biopharmaceutics and Pharmacokinetics, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Andhra Pradesh, India
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Elementary osmotic pump (EOP) for controlled release of phenyl propanolamine hydrochloride (PPA) was developed based on osmotic technology using an osmogen, sodium chloride. The formulations comprise of a core tablet coated with a semi permeable coating polymer and cellulose acetate. The coated tablets are drilled with microneedle and evaluated for physicochemical characteristics and in vitro release studies. The optimized formulation was evaluated for in vivo performance by pharmacokinetic and pharmacodynamic studies. Zero order release of PPA was achieved with increasing concentrations of osmogen. Bioavailability study in healthy volunteers reveal that the release of PPA from EOP was extended to 24 h compared to immediate release formulation which could release the drug up to 12 h and showed a statistically significant difference (p<0.05). The changes in blood pressure and pulse rate after administration of EOP compared to immediate release capsule are insignificant (p>0.05). The optimized formulation was found to be stable for 6 months. A good in vitro-in vivo correlation was observed and was found to be type A. The EOP containing PPA could be developed. The system can also be used for loading of other water soluble drugs.
Keywords :
PHENYL PROPANOLAMINE, ELEMENTARY OSMOTIC PUMP, OSMOTIC, EXTENDED RELEASE, BIOAVAILABILITY