1. EVALUATION OF PARENTRAL PRESENTED BY:-. Mr.SHUBHAM V. WANKHEDE (B-PHARM 7th SEM) GUIDED BY:- Dr. AIJAZ A. SHEIKH (M.PHARM, PHD) ANURADHA COLLEGE OF PHARMACY, CHIKHALI

2. CONTENT INTRODUCTION ADVANTAGES DISADVANTAGES ROUTE OF ADMISTRATION TYPE OF PARENTRAL PREFORMULATION FACTOR FORMULATION OF PARENTRAL GENERAL REQUIREMENTS GENERAL PROCEDURE CONTAINER AND CLOSURE EVALUATION TEST REFERENCE

3. INTRODUCTION Parentral preparation are sterile preparation containing one or more active ingredient intended for admisterered by injection infusion or implantation of body. Parentral derived from greek word para means outside and enteron means intestine. It denote that route of administration other than oral route.

4. ADVANTAGES Onset action is quick. Drug can not admisterered oral route can be administered this route. The patient who are vomitting or unconcianess can not take oral route. In such case drug are administered this case. The drug action can be prolonged by modifying formulation. Suitable for nutritive like glucose and electrolyte.

5. DISADVANTAGES Injection cause pain at site of action. Trainin person required for admistration. Self admistration not possible. Pyrogen preparation lead to very harmful effects. Once injection can not controlled. (retreat)

6. ROUTE OF ADMISTRATION 1.Intradermal 2.Hypodermis 3.Intramuscular 4.Intravenous 5.Intraarterial 6.Intracardiac 7.Intrathecal 8.Intracisternal 9.Peridural 10.Intraarticular 11.Intracerebral

7. TYPE OF PARENTRAL 1.Powder for injection Ex.Cefuroxine for injection 2.Colloidal solutions Ex.Iron dextran 3.Ingetable emulsion Ex.Propofal USP 4.Injectable suspension Ex.Methylpredisolon acetate 5.Oil injection Ex.Dimercaprol injection 6.Infusion fluid

8. PREFORMULATION FACTORS It is study of physical and chemical property of drug substance prior formulation is called as preformulation They are PH Solubility Pka Dissociation constants Compatibility studies Oxidation and reduction Partical size

9. FORMULATION OF PARENTRAL 1.Vehicle 2.Adjuvants a.Solubilizing agent b.Stabilizer c.Buffering agent d.Antimicrobial agents e.Chelating agents f.Suspending agent g.Wetting agent h.Emulsifying agent i.Tonicity factors

10. GENERAL REQUIREMENTS 1.Stability 2.Sterility 3.Free from pyrogen 4.Free from forgen partical 5.Chemical purity 6.Isotonicity 7.pH 8.Osmotic pressure

11. GENERAL PROCEDURE 1.Cleaning and washing of container 2.Collection of material 3.Preparation of material 4.Filtration 5.Sterilisation 6.Evaluation of parentral 7.Labeling and packaging

12. CONTAINER AND CLOSURE 1.Glass 2.Plastic Ampoules Vial Cartridges Automatic injectors 3.Rubber closure with aluminium cap Small volume parentral : less than 100 ml Large volume parentral : more than 100 ml

13. EVALUATION TEST A.Sterility test B.Clarity test C.Leakage test D.Pyrogen test E.Assay

14. STERILITY TEST The test for sterility is done by detecting the presence of viable forms of bacteria, fungi and yeast in parentral preparation. The sterility test is carried out in aseptic condition. Culture media must be required. The test of sterility may be carried out by 1.Membrane filtration method 2.Direact innoculation method

15. CLARITY TEST Clarity test is performed by product are free from forgen particle Each parentral preparation in it's final container subjected individually. The unlabelled container are illuminated black and white screen. White screen is used for dark colour partical. Black screen is used for light coloured particle. The content of container are slowly inverted and rotated Lastly, solutions examine presence of forgen particle.

16. LEAKAGE TEST These test is performed only ampoules. Leakage test is performed in a vacuum chamber. The ampoules are dipped in 1% solutions of methylene blue and vaccum is applied. When vaccum is realesed the colour solutions will be enter the ampoules with defective sealing. The presence of dye in the ampoules, confirm leakage and hence rejected.

17. PYROGEN TEST These test are use to check presence or absence of pyrogen in parentral preparation. These test is done as per IP. The test involve measurements of the rise in body temperature of rabbit by intravenous injection of sterile solutions of parentral preparation being examined. Rabbit are used to perform this test, because there body temperature increases when pyrogen are introduced into their bodies.

18. ASSAY Assay is performed according to method given in the monograph of that parentral preparation in pharmacopoeia. Assay is done to check the quantity of medicament present in the parentral preparation.

19. REFERENCES Remington. The science and practice of pharmacy 21 st edition. The theory and practice of industrial pharmacy A.liberman, joseph L-kanig. Textbook of pharmaceutics-2nd, 4th edition, R.M. MEHTA page no. 244-269.

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