Presented by: Navjot Kanwar M.

PHARM- 1

Implants are sterile system contains a huge amount of drug which can provide the required blood concentration ranging from a day, a week, few months or even for few years.

All materials used for implants being physically and chemically stable, but vitally important that the materials are biocompatible. Desirable criteria for implantable drug delivery biomaterials include: The biomaterial must be chemically inert in that it does not cause any biological effect or interact with other adjuvant in formulation. Biomaterial must not cause any inflammatory or foreign body reaction in the body.

 Biomaterial

must not be carcinogenic. Biomaterial should not cause any allergic or hypersensitivity reactions. It should be mechanically stable. Does not cause any thrombogenecity. The biomaterial must have ability to be easily removed after its therapeutic duration. Must be compatible with a wide range of drugs.

These responses are due to its: Physical properties resulting in epithelial encapsulation,thickening of connective tissue, presence of giant cells. Chemical reaction between biomaterial and tissue resulting in inhibition of of epithelial growth, induction of epithelial hypertrophy, connective tissue inflammation, vacuolization of tissue. Presence of additives during polymer production.

 Implant

size Implant shape Implant material Surface wettability Surface charge Surface roughness

Little is known about problems that arise when blood or other tissue fluids make contact with foreign surfaces. Electric phenomenon occurring at interface could lead to thrombosis formation. Materials with high negative zeta potential resist this tendency.

Possible effects of biomaterials on living environment due to lack of blood compatibility are thrombogenecity and induction of haemolysis.

Prevention of thrmbosis: To prevent this thrombosis , surface of vascular implants should be smooth and in contact only with an area of high velocity.

 Variuos

methods: Kinetic clotting test Ex-vivo measurement of amount of thrombus and estimation of its platelet and fibrin content by radiotracer techniques Critical surface tension test Haemolysis and shear stress test Caval ring implant test

Venous blood from dog is taken

Blood enters a specifically designed chamber that contains test biomaterial, through a short segment of silicone rubber tubing
Amount of free haemoglobin are measured spectrophotometricalyy at 254 nm at periodic intervals

It only measures the end product (blood clot) and not the factors determining blood compatibility. Therefore there is no guarantee that the biomaterial is fully compatible if there is no clot formation. There could also be problems with the venous blood coming into contact with silicone tubing before test biomaterial as silicone itself also activate coagulation factors.

 This

is done by radio tracer technique. Carotid arterial blood to jugular vein of dog is connected ex-vivo to two test chambers containing stainless steel shafts. The connection shunt is a 20 cm long silicone rubber tube.

Silicone rubber shunt could create interpretation problems on the suitability of the biomaterial. Centrifugal force of the rotating stainless steel shafts and the difficulty of coating the shaft with test biomaterial causes test and result interpretation problems.