Formulation and evaluation of controlled porosity osmotic pump for oral delivery of ketorolac

Popat Mohite; Bharati Hole; V. K. Deshmukh

Authors

Popat Mohite Associate Professor, Department of Pharmaceutical Chemistry, Mula Education Society’s College of Pharmacy, Sonai- Rahuri Road, Sonai, Tal- Newasa, Dist- Ahmednagar-414105, Maharashtra, India
Bharati Hole P.G. Scholar, Mula Education Society’s College of Pharmacy, Sonai- Rahuri Road, Sonai,Tal- Newasa, Dist- Ahmednagar-414105, Maharashtra, India
V. K. Deshmukh Professor & Principal, Department of Pharmaceutical Chemistry, Mula Education Society’s College of Pharmacy, Sonai- Rahuri Road, Sonai, Tal- Newasa, Dist- Ahmednagar-414105, Maharashtra, India

Keywords:

Controlled porosity osmotic pump, core tablet, pore former, coating solution, peppas kinetics, scanning electron microscopy, Accelerated stability study

Abstract

Oral osmotic drug delivery systems that can deliver drug for extended period of time has been developed and characterized. This system contains semi-permeable membrane and water-soluble pore-former's in the coating membrane. The tablet has an orifice drilled on it by means of a laser beam or mechanical drill. The oral bio-availability of our drug (ketorolac) was 88- 92% and the biological half-life of 4-6 hours requires frequent administration to maintain the therapeutic effect. This drug delivery systems offer significant patient benefits by reducing the side effects, enhanced efficacy and also reduce the frequency or number of daily doses compared to conventional therapies. The aim of this study was to develop a controlled porosity osmotic pump based drug delivery system for controlled release of an NSAID agent, nonsteroidal anti-inflammatory, offer significant patient benefits by reducing the side effects, enhanced efficacy and also reduce the frequency or number of daily doses. This system was containing pore-forming water-soluble additives within the coating membrane, which after coming in touch with water, dissolve, leading to an in situ formation. The effect of various formulation variables, namely level of pore former (PVP), plasticizer (dibutyl phthalate) within the membrane, and membrane weight gain were studied. Drug release was inversely proportional to the membrane weight but directly associated with the initial concentration of pore former (PVP) within the membrane. Drug release was independent of pH and agitational intensity, but hooked in to the osmotic pressure of the discharge media. Based on the in vitro dissolution profile, formulation F3C1 (containing 0.5 g PVP and 1 g dibutyl phthalate in coating membrane) exhibited Peppas kinetic with Fickian diffusion-controlled release mechanism with a drug release of 93.67% in 12 hours and hence it had been selected as optimized formulation. SEM studies showed the formation of pores within the membrane. CPOP was designed for effective administration of medicine for prolonged period of your time.