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PARENTERALS : A REVIEW K.Senthil Kumar & R.Saravanan Asst.Prof QIS college of pharmacy , Ongole .A.P


INTRODUCTION The administration of drugs through the patient by injection under through one or more layer of the skin or mucous membrane. The term parenteral derives from the greek word 1. Para (outside ) 2. Enteron (Intestine) It denotes that route of administration other than oral route.


ADVANTAGES It provides rapid onset of action It provides immediate therapeutic action It can be administered accurate dose. It can be given to patients who cannot take oral medication. It minimize the first pass effect. It provides more bioavailability

disadvantage : 

disadvantage It should be administred aseptically It produces pain at the site of injection The administred of drug through wrong route may prove fatal effect Self administration is not possible If pyrogenic preparations lead to very harmful effect.

Routes of administration : 

Routes of administration Intra Muscular (IM) Intra dermal (ID) Intravenous (IV) Subcutaneous / Hypodermic (SC) Intra articular Intra synovial Intra spinal Intrathecal Intrarterial Intra cardiac Intra cisternal Intra peritonial Intraplueral


TYPES OF PARENTERALS Powder for injection -Eg. Cefuroxime for injection Colloidal solution - Eg. Iron dextran Injectable emulsion-Eg. Propofol USP Injectable suspension –Eg. Methylprednisolone acetate Oily injection (solution)-Eg. Dimercaprol injection. Infusion fluid


PREFORMULATION FACTORS: It is study about physical & chemical properties of drug substance prior formulation is called as preformulation. They are pH Solubilty pka Dissociation constant Compatabilty studies- FTIR / DSC Oxidation & reduction particle size


FORMULATION OF PARENTERALS 1. Solutes 2.Added substance Antimicrobial agent Buffers Antioxidants Tonicity agent Cryoprotectant Suspending agent Emulsifying agent 3.Vehicle Aqueous -WFI Non- aqueous Eg. arachis oil


GENERAL PROCEDURE Cleaning & washing of container ,closures Preparation of solutions Sterilizaation (Filteration) Filling Packaging

Lyophilization techniques : 

Lyophilization techniques It is a process of removal of solvent from the product or substances is called as lyophilization. It consist of three steps Freezing Primary drying Secondary drying

Creteria for parenterals : 

Creteria for parenterals Sterility Pyrogen Isotonicity Stability Ph Osmotic pressure

Containers & closures : 

Containers & closures 1.Glass 2.Plastic Ampoules( single dose ) Vials( multiple dose) Cartridges Automatic injector 3.Rubber closure with aluminium caps Small volume parenterals: less than 100ml Large volume parenterals : more than 100ml

Evaluation test for parenterals : 

Evaluation test for parenterals Test for pyrogen Sterilty testing Rabbit test Clarity test LAL test Leaker test

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